Document:

License Agreement dated as of January 2, 2001

 Exhibit 10.10 

Portions of this exhibit marked [*] are omitted and are requested to be treated confidentially. 

LICENSE AGREEMENT 

THIS AGREEMENT is effective as of the      day of
            , 2001 (the “Effective Date”) by and among Pharmaceutical Product Development, Inc., a North Carolina corporation having a place of business at 3151
South Seventeenth Street, Wilmington, NC 28412 (hereinafter “PPD”) and its wholly owned subsidiary GenuPro, Inc., d/b/a PPD GenuPro, a North Carolina corporation having a place of business at 3900 Paramount Parkway, Morrisville, North
Carolina 27560 (hereinafter “GenuPro”), and Alza Corporation, a Delaware corporation having a place of business at 1900 Charleston Road, Mountain View, CA 94043 (hereinafter “Licensee”). PPD, GenuPro and Licensee are sometimes
referred to herein individually as a “Party” and collectively as the “Parties.” 
 WITNESSETH THAT: 

 WHEREAS, GenuPro and PPD have performed research and development with respect to dapoxetine pursuant to a Development and Commercialization
Agreement between Eli Lilly and Company (“Lilly”), PPD and GenuPro dated May 22, 1998 (the “Lilly Agreement”); 

WHEREAS, pursuant to the Lilly Agreement, both PPD and Lilly have forfeited the right to develop and commercialize dapoxetine in the Field and GenuPro
has obtained a license from Lilly to develop and commercialize dapoxetine in the Field under the Lilly Patents, Lilly Know-How and Lilly Manufacturing Know-How (as later defined herein); 

WHEREAS, GenuPro and/or PPD are the owner(s) of the entire right, title and interest in the GenuPro Patents and GenuPro Know-How (as later defined
herein); and 
 WHEREAS, GenuPro wishes to have rights under the Lilly Patents, Lilly Know-How, Lilly Manufacturing Know-How, GenuPro Patents
and GenuPro Know-How further developed and marketed at the earliest possible time; 
 WHEREAS, Licensee wishes to enter into an agreement to
obtain exclusive licenses to the Lilly Patents, Lilly Know-How, Lilly Manufacturing Know-How, GenuPro Patents and GenuPro Know-How in the Field from GenuPro in order to practice the invention claimed therein and to make, use and sell in the
commercial market the therapeutic product made in accordance therewith; and 
 WHEREAS, GenuPro and PPD are willing to grant such licenses to
Licensee under the terms and conditions set forth in this Agreement. 
 NOW, THEREFORE, PPD, GenuPro and Licensee hereby agree as follows:

  

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 ARTICLE I - DEFINITIONS 

1.01. “Adverse Event” means any adverse event associated with the use of a Compound, CTM Product or Licensed Product in humans, whether
or not considered drug-related, including the following: an adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose whether accidental or intentional; an adverse
event occurring from drug abuse; and an adverse event occurring from drug withdrawal; and any failure of expected pharmacological action. 

1.02. “Affiliate” of a Party hereto shall mean any entity that controls, is controlled by or is under common control with such Party.
For purposes of this definition, a Party shall be deemed to control another entity if it owns or controls, directly or indirectly, at least fifty percent (50%) of the voting equity of another entity (or other comparable ownership interest for
an entity other than a corporation) or if it has management control of the other entity. 
 1.03. “Combination Product” means
any product in any dosage form that contains, in addition to a Licensed Product, one or more other active ingredients having significant prophylactic or therapeutic activity. 

1.04. “Compound” means the GenuPro Compound, a Peripheral Compound or a SAR Compound. 

1.05. “Confidential Information” means any and all information relating to Licensed Products or their development, manufacture, use or
sale (including Product-Related Improvements and Know-How) disclosed, directly or indirectly, by one Party to another Party, whether in writing or orally, (a) prior to the Effective Date pursuant to the terms of the Confidential Disclosure
Agreement in effect between the Parties dated June 5, 2000 (“CDA”), or (b) during the term of this Agreement. 
 1.06.
“Controlled” means, with respect to any compound, material, information or intellectual property right, that the Party owns or has a license to such compound, material, information or intellectual property right and has the ability to
grant to the other Party access, a license or a sublicense (as applicable under this Agreement) to such compound, material, information or intellectual property right as provided for herein without violating the terms of any agreement or other
arrangements with any Third Party existing at the time such Party would be first required hereunder to grant the other Party such access, license or sublicense. 

1.07. “CTM Product” means Compound together with any formulation ingredients in a finished pharmaceutical dosage form suitable for
administration and dosing to humans in clinical trials, but not in suitable form for commercial sale (for example, without limitation, not in packaged form such as blister packs or other containers and not including external packaging and package
inserts). 
 1.08. “Development Plan” means a development plan prepared by Licensee, its Affiliate or sublicensee, by
which Licensee intends to achieve regulatory agency registration of Licensed Product, including, but not be limited to, a description of the CMC, preclinical, clinical, and regulatory activities, with estimated timelines necessary to achieve such
approval in the Field in the Territory. 
  

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 1.09. “Diligent Efforts” means the carrying out by Licensee or its sublicensee of
obligations or tasks in a manner consistent with the efforts Licensee devotes to a product of similar market potential, profit potential or strategic value, based on the conditions then prevailing with respect to the product and the relevant market
and consistent with reasonable business practices in the industry.  
 1.10. “Enforceable Claim” means a claim included
in an issued and unexpired patent that has not been: (i) abandoned or disclaimed; or (ii) declared invalid or unenforceable by a decision of a court or other governmental agency of competent jurisdiction, which decision is unappealable or
unappealed within the time allowed for appeal. 
 1.11. “Field” means the treatment only in humans of the therapeutic
indications within the urogenital area including premature ejaculation, primary urinary incontinence, urge, stress and mixed incontinence, urinary urgency, interstitial cystitis, neurogenic bladder, bladder sphincter dyssynergia and irritative
symptoms of benign prostate hypertrophy (“BPH”), hypoactive sexual desire, hyperactive sexual desire, impotence, retarded ejaculation, delayed orgasm and anorgasmia; provided, however, that “Field” shall not include diseases of
the kidney. 
 1.12. “First Commercial Sale” means the first transaction following regulatory approval in which Licensee, its
Affiliate or sublicensee transfers physical possession and title to a Licensed Product to a Third Party in exchange for value and after which transfer the seller has no right or power to determine the Third Party’s resale price. Transfer for
research, development or testing purposes shall not constitute the First Commercial Sale. 
 1.13. “Generic Product” means,
with respect to a particular Licensed Product, a dapoxetine-containing product approved for the same indication as such Licensed Product (a) wherein such approval is based on an Abbreviated New Drug Application (“ANDA”) or an
equivalent of an ANDA or (b) wherein the dapoxetine in such product (in bulk or finished form) is made by Lilly or under license (directly or indirectly) from Lilly. 

1.14. “GenuPro Compound” means: [*]. 

1.15. “GenuPro Intellectual Property” shall have the meaning set forth in Section 8.01(a). 

1.16. “GenuPro Know-How” means any Know-How, other than Lilly Know-How or Lilly Manufacturing Know-How, Controlled by GenuPro or PPD
during the term of this Agreement. GenuPro Know-How includes, without limitation, all Know-How related to the composition of matter of Compounds, or their manufacture or use. 

1.17. “GenuPro Patents” means all Patents, other than Lilly Patents, that are Controlled by GenuPro or PPD during the term of this
Agreement and that claim Compounds or Licensed Products or the development, manufacture, intermediates made during the manufacture thereof, purification, use or formulation thereof. GenuPro Patents include without limitation patents that claim
GenuPro Intellectual Property. 
 1.18. “HSR Act” means Hart-Scott-Rodino Antitrust Improvement Act. 

 

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

 

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 1.19. “Joint Development Committee” or “JDC” means a committee composed as
set forth in Section 4.04 and having the duties set forth in Section 4.05. 
 1.20. “Key Country” means [*].

 1.21. “Know-How” means any unpatented or unpatentable inventions, information, data, drawings, plans, specifications and
designs relating to Compounds, CTM Products or Licensed Products including, in particular, any marketing information, pre-clinical, clinical, toxicology, analytical, regulatory, ADME information and/or data. 

1.22. “Licensed Product” means a Patented Product or a Non-Patented Product. 

1.23. “Lilly Know-How” means any Know-How, other than Lilly Manufacturing Know-How, which Lilly licensed to GenuPro under the Lilly
Agreement. 
 1.24. “Lilly Manufacturing Know-How” means any Know-How that relates to the manufacture of Compound or Licensed
Product, including processes and analytical methods therefor, and that Lilly licensed to GenuPro under the Lilly Agreement. 
 1.25.
“Lilly Patents” means all Patents licensed by Lilly to GenuPro under the Lilly Agreement that claim a Compound or Licensed Product or method of making or using a Compound or Licensed Product, including without limitation the Patents
listed on Schedule 1.25. 
 1.26. “Marketing Plan” means an annual marketing plan prepared by Licensee, its Affiliate or
sublicensee, that includes, but is not limited to, a description of Licensee’s commercial objectives for the year with respect to Licensed Product in the Field in the Territory and strategy by which Licensee intends to achieve such objectives.

 1.27. “NDA” shall mean a New Drug Application filed with the United States Food and Drug Administration in conformance with
applicable laws and regulations. 
 1.28. “Net Sales” means the total amount billed or invoiced in United States dollars (or
converted thereto in accordance with the Agreement) on sales of the Licensed Product by Licensee, its Affiliates, sublicensees and/or Affiliates of sublicensees in the Territory to Third Parties, less the following deductions (i) trade, cash
and quantity discounts actually taken on such Licensed Product; (ii) taxes on sales (such as sales or use taxes) to the extent added to the sale price and set forth separately as such in the total amount invoiced; (iii) freight, insurance
and other transportation charges to the extent added to the sale price and set forth separately as such in the total amount invoiced; and (iv) reserves for amounts to be repaid or credited by reason of rejections, defects, recalls or returns or
because of retroactive price reductions, chargebacks, rebates or commissions, made in accordance with generally accepted accounting principles and Licensee’s accounting policies. Sales between Licensee and its Affiliates and sublicensees shall
not be treated as Net Sales hereunder. 
  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

 

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 1.29. “New Formulation or Use” shall have the meaning set forth in Section 5.08(c).

 1.30. “Non-Patented Product” means any product that: (a) is in suitable form for commercial sale, (b) contains or
comprises a Compound, and (c) the manufacture, use or sale of which would not, in the absence of the licenses granted herein, infringe an Enforceable Claim of any GenuPro Patent or Lilly Patent issued in the country in which such product
is sold. For clarity, a particular product may be a Patented Product when sold in one country and a Non-Patented Product when sold in another country. 

1.31. “Patent” means (i) unexpired letters patent (including inventor’s certificates) which have not been held invalid or
unenforceable by a court of competent jurisdiction from which no appeal can be taken or has been taken within the required time period, including without limitation any substitution, extension, registration, confirmation, reissue, re-examination,
renewal or any like filing thereof and (ii) pending applications for letters patent, including without limitation any continuation, division or continuation-in-part thereof and any provisional applications. 

1.32. “Patented Product” means any product that: (a) is in suitable form for commercial sale, (b) contains or comprises a
Compound, and (c) the manufacture, use or sale of which would, in the absence of the licenses granted herein, infringe an Enforceable Claim of any GenuPro Patent or Lilly Patent issued in the country in which such product is sold. For clarity,
a particular product may be a Patented Product when sold in one country and a Non-Patented Product when sold in another country. 
 1.33.
“Peripheral Compound” means any compound that is an isomer, homolog, analog or prodrug of the GenuPro Compound and that is made, identified or characterized at any time by Licensee, PPD, GenuPro or Lilly (to the extent to which GenuPro
or PPD has rights to such compounds made, identified or characterized by Lilly). The term “isomers” includes compounds of identical elemental composition (empirical formulae) and specifically encompassing chain, geometrical, sterochemical,
keto-enol, optical and position isomerism. The term “homologs” includes carbon compounds, conforming to the same general formula and in which each member differs from another by a constant linear increment of the atomic groups –CH2-
or –CH2-CH2-. The term “analogs” includes compounds which are structurally closely related to the GenuPro Compound or a compound that is a bioisostere or a halogen, alcohol, ester, ether or acid substituted variant of the GenuPro
Compound. 
 1.34. “Phase III Clinical Study” means a trial involving administration of a Compound to sufficient numbers of
human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be
considered as a pivotal study for submission of an NDA. 
 1.35. “Product-Related Improvement” means any invention, patentable
or not, information or data which (a) is not the composition of matter of a Compound, (b) relates to a Compound, and (c) is either (i) made, identified, conceived, reduced to practice or generated at any time solely or jointly by
Licensee’s employees or agents in the course of performance of the Project or further development of Licensed Product during the term of this Agreement or (ii) made, identified, conceived, reduced to practice or generated solely or jointly
by Licensee’s, PPD’s or 
  

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GenuPro’s employees or agents in the course of performance of the Project or further development of Licensed Product during the term of this Agreement. Product-Related Improvements include
but are not limited to New Formulations or Uses, dosage forms of Compounds or methods of synthesis or manufacturing. 
 1.36.
“Product-Related Improvement Patents” shall have the meaning set forth in Section 8.01(b). 
 1.37. “Project”
means a development and clinical trial program to be directed primarily by Licensee or its Affiliates or sublicensees, the aim of which is to achieve commercialization of a Licensed Product for indications in the Field in the Territory.

 1.38. “SAR Compound” means the Compound which results from any structure activity relationship studies which may be
conducted by Licensee or GenuPro as part of any other studies conducted pursuant to this Agreement. Performance of such studies shall be at Licensee’s sole discretion. SAR Compounds will relate to the GenuPro Compound or a Peripheral Compound.
 
 1.39. “Serious Adverse Event” means any Adverse Event occurring at any dose that results in any of the following
outcomes: death, a lifethreatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that
may not result in death, be life-threatening, or require hospitalization may be considered a Serious Adverse Event when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical
intervention to prevent one of the outcomes listed in this definition. 
 1.40. “Territory” shall mean all countries of the
world. 
 1.41. “Third Party” means any person or entity other than PPD, GenuPro or Licensee or an Affiliate of PPD, GenuPro or
Licensee. 
 ARTICLE II - LICENSES AND EXCLUSIVITY 

2.01. Other Licensing Arrangement. The Parties to this Agreement acknowledge that the scope of rights granted to Licensee under the Lilly
Patents, Lilly Know-How and Lilly Manufacturing Know-How are limited by and can be no greater than the rights granted to GenuPro under the Lilly Agreement. 

2.02. Sublicense to Lilly Patents, Lilly Know-How and Lilly Manufacturing Know-How.  

(a) Effective as of the Effective Date, GenuPro hereby grants Licensee an exclusive, royalty bearing sublicense (with the right to
further sublicense as provided in Section 2.04) under the Lilly Patents and Lilly Know-How to develop, use, offer for sale and sell Licensed Products in the Territory solely in the Field. 

(b) Effective as of the Effective Date, GenuPro hereby grants Licensee an exclusive, royalty bearing sublicense (with the right to
further sublicense as provided in Section 2.04) of GenuPro’s non-exclusive license under the Lilly Patents, Lilly Know-How and Lilly 

 

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Manufacturing Know-How, to make, have made and import Licensed Products in the Territory solely in the Field. For the avoidance of doubt, GenuPro is sublicensing to Licensee under this
Section 2.02(b) all of GenuPro’s rights under Section 6.07 of the Lilly Agreement with respect to Licensed Products, which such rights are non-exclusive. 

(c) The Parties acknowledge and agree that, provided Licensee does not promote or pursue regulatory approval for the use of
Licensed Products outside the Field, the sale of Licensed Product to a Third Party who uses it outside the Field shall not be a breach by Licensee of the Field restrictions in the sublicenses set forth in this Section 2.02. 

2.03. License to GenuPro Intellectual Property. 

(a) Effective as of the Effective Date, GenuPro and PPD hereby grant Licensee an exclusive, royalty bearing license (with the
right to sublicense as provided in Section 2.04) under the GenuPro Patents and GenuPro Know-How, to develop, make, have made, use, sell, offer for sale, have sold and import Licensed Products in the Territory solely in the Field. 

(b) Effective at such time as GenuPro or PPD acquires rights to practice any GenuPro Patents or GenuPro Know-How outside the Field,
GenuPro and PPD hereby grant Licensee an exclusive, royalty-bearing (pursuant to Section 5.03) license (with the right to sublicense as provided in Section 2.04) under the GenuPro Patents and GenuPro Know-How, to develop, make, have made,
use, sell, offer for sale, have sold and import Licensed Products in the Territory outside the Field. 
 2.04. Right to Sublicense.
With respect to the sublicenses and licenses granted to Licensee in Sections 2.02 and 2.03 above, such sublicenses and licenses shall include the right of Licensee to sublicense to any party, including without limitation an Affiliate, so long as
such sublicense is consistent with the terms of this Agreement. Licensee shall be responsible for the performance by its sublicensee(s) of all obligations imposed under the terms of this Agreement. 

2.05. No Other Rights. Except as otherwise expressly provided herein, this Agreement does not grant Licensee any license or other right
under Lilly Patents, Lilly Know-How, Lilly Manufacturing Know-How, GenuPro Patents or GenuPro Know-How. 
 2.06. Exclusivity.
During the term of this Agreement, PPD and GenuPro and their Affiliates will not conduct (itself or directly or indirectly with a Third Party) any material development or commercialization activities (or grant any rights to Third Parties to do
so) with respect to the Compounds or any product containing or comprising a Compound, other than under this Agreement. 

ARTICLE III - SUPPLIES OF LICENSED PRODUCT 

3.01. Licensee Supply Requirements. Licensee shall at its own expense provide all quantities of Compound, CTM Product and Licensed Product
that Licensee needs in order to develop, commercialize and market Licensed Product in the Field in the Territory. 
 3.02. Transfer of
Material. GenuPro shall in good faith and at no charge to Licensee promptly following the Effective Date, but in any event within ten (10) days of the Effective 

 

 7 

 
Date if this Agreement, transfer to Licensee all GenuPro Compound and CTM Product in its possession as of the Effective Date of this Agreement. The amounts of each are listed on Schedule 3.02.
Such transfer of material shall be accompanied by applicable quality and regulatory information necessary to permit use of such materials in clinical testing. 

3.03. Assistance in Third Party Contractor Identification. Upon request by Licensee, GenuPro shall take reasonable steps to assist Licensee
to identify and qualify a Third Party contractor for the supply of quantities of Compound or CTM Product to Licensee and direct services by such Third Party contractor. 

ARTICLE IV - INITIATION AND CONDUCT OF PROJECT 

4.01. General Principle. During the term of this Agreement, as among Licensee, PPD and GenuPro, Licensee shall be responsible for
development and marketing of Compounds in such countries of the Territory as it deems appropriate, consistent with its obligations under this Agreement. Licensee will use Diligent Efforts to submit applications for regulatory approval to market a
Licensed Product in the [*] and [*]. Licensee will select in its sole discretion, prior to NDA submission, at least [*] Key Countries in which Licensee shall use Diligent Efforts to submit applications for regulatory approval to
market a Licensed Product, wherein [*] of such countries are [*]. Licensee shall have responsibility for obtaining all necessary regulatory approvals to do so, and Licensee, or its subcontractors, shall hold legal title of any
Investigational New Drug Application (“IND”) and NDA filed by Licensee with the United States Food and Drug Administration, or any equivalents of such items in countries within the Territory, and shall assume full responsibility for all
development and marketing activities pursuant to and in support of such application. 
 4.02. Transfer of Know-How. To facilitate
Licensee’s accomplishment of the responsibilities set forth in Section 4.01 above, within thirty (30) days of the Effective Date of this Agreement GenuPro shall in good faith supply Licensee with copies of the GenuPro Know-How, Lilly
Know-How and Lilly Manufacturing Know-How pertinent to the development of the GenuPro Compound in the Field that GenuPro is able to provide using commercially reasonable efforts and which is in the possession of GenuPro on the Effective Date, and
shall transfer to Licensee the legal title to any IND on the GenuPro Compound presently on file in GenuPro’s name with the FDA and any comparable filings in other countries of the Territory. GenuPro shall also facilitate transfer of GenuPro
Compound manufacturing-related information (including any associated quality and analytical information) to Licensee from those Third Parties from which GenuPro or PPD has received quotations for manufacturing GenuPro Compound that GenuPro is not
under any obligation to keep confidential from a third party. GenuPro will provide Licensee with all relevant information available and known to GenuPro or PPD concerning the safety, handling, use, disposal and environmental effects of the GenuPro
Compound or as may be useful to Licensee to conduct the Project, including but not limited to any communications with regulatory agencies. 

 

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

 

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 4.03. Development and Commercialization. Licensee shall use Diligent Efforts (and shall cause
any sublicensees or subcontractors participating in the subject matter of this Agreement to use Diligent Efforts) to develop and introduce Licensed Product to commercial market and to market Licensed Product thereafter. 

4.04. Joint Development Committee. Within thirty (30) days of the Effective Date of this Agreement, GenuPro and Licensee shall
assemble a JDC. Initially, the JDC will be composed of at least two, but no more than four, representatives each from GenuPro or its Affiliates and Licensee. The initial members of the JDC will be those representatives the names of whom will be
provided to the other Party within ten days after the Effective Date. Each Party will promptly notify the other Party in writing of any change in its appointed representatives. The chairperson of the JDC will be one of Licensee’s
representatives. 
 4.05. Duties of JDC. Licensee shall have full control over implementation of the development and marketing of
Licensed Product throughout the term of this Agreement. The duties of the JDC shall include, but not be limited to, (a) monitoring the progress of the Development Plan and Marketing Plan; and (b) providing GenuPro with detailed annual
updates describing the progress made in implementing the Development Plan and Marketing Plan. Licensee shall consult GenuPro members of the JDC to obtain assistance with completion of the Development Plan and Marketing Plan. The JDC may consult
additional GenuPro representatives (who GenuPro shall deem appropriate at its sole discretion) on an as-needed basis should issues arise where the JDC reasonably believes GenuPro personnel have expertise particularly relevant to the issue being
addressed. Notwithstanding the above, a GenuPro JDC member shall have the right to consult with the JDC where the GenuPro JDC member reasonably believes input from GenuPro is appropriate in order to protect GenuPro’s interests in the subject
matter of this Agreement. To accomplish its objectives, the JDC will meet quarterly, or more often if mutually agreed upon by the Parties, during the term of the Development Plan and will meet at least annually thereafter. The JDC may meet in person
or by telephone conference. In-person JDC meetings will be at a site designated by Licensee and will alternate between a site on the west coast and a site on the east coast of the continental United States. Each Party will bear all expenses of its
personnel arising from attending such meetings. Among other duties, one of Licensee’s JDC members shall prepare written minutes of each such meeting, which minutes will, without limitation, record the updates given at the meetings describing
the progress made in implementing the Development Plan and Marketing Plan. 
 4.06. Adverse Event Reporting. PPD and GenuPro will
report all Serious Adverse Events of which it becomes aware to Licensee as soon as possible, but within 48 hours in any event. Licensee will report Adverse Events and Serious Adverse Events to GenuPro in accordance with reporting requirements
provided for in Section 2.06 and Schedule 2.06 of the Lilly Agreement, and changes recorded in the letter to Dr. Winston Satterlee of PPD dated January 7, 1999 and the letter from Lilly to Dr. Paul Covington of PPD dated
March 19, 1999. 
  

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 ARTICLE V - FEES AND ROYALTIES 

5.01. License Fees. As consideration for the exclusive licenses set forth in Sections 2.02 and 2.03, GenuPro shall be entitled to a
one-time, upfront payment from Licensee, upon the later of (a) ten (10) days after the expiration of all applicable waiting periods under the HSR Act and (b) the Effective Date, of a license fee of [*]. 

5.02. Milestones.  

(a) Clinical Milestone Payments. 

(i) Initiation of Phase III Clinical Trials. Licensee will notify GenuPro in writing upon its first
initiation of a Phase III Clinical Study in the Field involving a CTM Product within fourteen (14) days of such initiation. Within thirty (30) days of such initiation, Licensee will pay GenuPro a one-time milestone payment of [*].

 (ii) Filing of NDA. Licensee will notify GenuPro, in writing, within fourteen (14) days of
the first acceptance by the FDA of a filing of an NDA for the use of a Licensed Product in the Field in the U.S. Within thirty (30) days of such acceptance, Licensee will pay GenuPro a one-time milestone payment of [*] if such acceptance
occurs on or before [*], or [*] if such acceptance occurs after [*]. 
 (iii) Approval
of NDA. Licensee will notify GenuPro, in writing, of its first written approval of an NDA by the FDA for the use of a Licensed Product in the Field, within fourteen (14) days of Licensee’s receipt thereof. Within thirty
(30) days of Licensee’s receipt of such written approval, Licensee will pay GenuPro a one-time milestone payment of [*] if such approval occurs on or before [*], or [*] if such approval occurs after [*].

 (iv) First [*] Approvals In [*]. Licensee will notify GenuPro, in writing within fourteen
(14) days of Licensee’s receipt thereof, of the first [*] written approvals of all regulatory filings (including any pricing approval that is required for commercial launch of a product) required to market a Licensed Product in the
Field in countries in [*]. Within thirty (30) days of Licensee’s receipt of each such written approval, Licensee will pay GenuPro a milestone payment of [*] per country, if such approval occurs on or before [*] or
[*] per country if such approval occurs after [*]. Licensee shall make a maximum of [*] payments pursuant to this Section 5.02(a)(iv) . The total of such payments shall equal: [*]. 

(b) Net Sales-based Milestone Payments. Licensee shall pay to GenuPro one-time milestone payments in accordance with the
following schedule, based on total Net Sales for four consecutive calendar quarters, such payment to be made within forty-five (45) days after the first time such milestone has been achieved (the Parties recognize that one or more milestones
hereunder may be achieved before expiration of four consecutive quarters). In no event shall Licensee be obligated to pay to GenuPro more than $50,000,000 under this Section 5.02(b). 

 

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

 

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 Milestone Payment Schedule. 

 

			
	Consolidated annual Net Sales level(s) of Licensed Products in
the Territory to which milestone payments shall be applied	  	Amount of one-time milestone payment per consolidated annual Net Sales level(s)
		
	Net Sales greater than [*]	  	[*]
		
	Net Sales greater than [*]	  	[*]
		
	Net Sales greater than [*]	  	[*]
		
	Net Sales greater than [*]	  	[*]

 5.03. Royalties. Subject to the
terms and conditions of this Agreement, Licensee shall pay to GenuPro a royalty in accordance with the schedule set forth in this Section 5.03, subject to the following conditions:  

(a) Patented Products without Competition From Generic Products. If a Patented Product is sold in a country where a
Generic Product is not then being sold in such country, then a royalty, in accordance with the royalty schedule set forth below, based on the consolidated annual Net Sales of such Patented Product by Licensee, its Affiliates, and sublicensees in
such countries (the “Patented Country Net Sales”) shall be paid by Licensee to GenuPro: 
  

			
	Consolidated annual Patented Country Net Sales level(s) of Patented Products in the Territory to which royalty rates(s) shall
be applied	  	Royalty rate(s) per annual Patented Country Net Sales level(s)
		
	On the portion of annual Patented Country Net Sales less than or equal to [*]	  	[*] of Net Sales
		
	On the portion of annual Patented Country Net Sales equal to or greater than [*] but not greater than [*]	  	[*] of Net Sales
		
	On the portion of annual Patented Country Net Sales equal to or greater than [*]	  	[*] of Net Sales

  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

 

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 (b) Patented Products with Competition by Generic Products. If a Patented
Product is sold in a country where a Generic Product is also sold at such time, then a royalty of [*] of the Net Sales of the Patented Product in such country shall be paid by Licensee to GenuPro. 

(c) Non-Patented Products with Competition by Generic Products. If a Non-Patented Product is sold in a country where a
Generic Product is also sold at such time, then a royalty of [*] of the Net Sales of the Non-Patented Product in such country shall be paid by Licensee to GenuPro. 

(d) Non-Patented Products without Competition by Generic Products. If a Non-Patented Product is sold in a country where a
Generic Product is not then being sold in such country, then a royalty, in accordance with the royalty schedule set forth below, based on the consolidated annual Net Sales of such Non-Patented Product by Licensee, its Affiliates, and sublicensees in
such countries (the “Non-Patented Country Net Sales”) shall be paid by Licensee to GenuPro: 
  

			
	Consolidated annual Non-Patented Country Net Sales level(s) of Non-Patented Products in the Territory to which royalty rates(s) shall be applied	  	Royalty rate(s) per annual Non-Patented Country Net Sales level(s)
		
	On the portion of annual Non-Patented Country Net Sales less than or equal to [*]	  	[*] of Net Sales
		
	On the portion of annual Non-Patented Country Net Sales equal to or greater than [*] but not greater than [*]	  	[*] of Net Sales
		
	On the portion of annual Non-Patented Country Net Sales equal to or greater than [*]	  	[*] of Net Sales

 5.04. Royalty Reduction.
In the event that a Third Party markets, for the same indication as a Licensed Product, a product containing or comprising a Peripheral Compound or an SAR Compound (as “Peripheral Compound” and “SAR Compound” are defined in
the Lilly Agreement rather than in this Agreement) of the GenuPro Compound and such Third Party is Lilly or acquired rights to such compound from Lilly, then the rate at which Licensee is obligated to pay royalties to GenuPro with respect to such
Licensed Product under Section 5.03 shall be reduced [*] during the time that such Third Party is marketing such product. 

 

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

 

 12 

 5.05. Royalty Period. Licensee’s obligation to pay royalties to GenuPro under
Section 5.03 shall begin, on a country by country basis, upon the date of the First Commercial Sale in such country of such Licensee’s Licensed Product and shall end upon termination of sale of the Licensed Product in such country.

 5.06. Payments to Third Parties. Licensee shall have a royalty credit equal to [*] of all amounts paid by Licensee to
Third Parties with respect to licenses to intellectual property rights covering a Licensed Product or its manufacture or use in the Field. Such royalty credit may be applied against royalties due under Section 5.03 with respect to such Licensed
Product, provided that the royalty paid by Licensee after the application of any credit shall not, as a result of such adjustment, be less than [*] of the royalty rate which would otherwise apply under Section 5.03 to such Licensed
Product, unless the royalty reduction set forth in Section 5.04 applies to such Licensed Product. 
 5.07. Payments to Lilly.
If Licensee licenses from Lilly intellectual property rights that cover a Licensed Product or its development, manufacture, use, sale or offer for sale in the Field, then PPD shall pay directly to Lilly on behalf of Licensee, and in accordance with
the payment provisions of such license, all amounts owed by Licensee to Lilly as a result of such license. 
 5.08. Method of
Calculation. The calculation of the amount of annual royalties due under the provisions of Section 5.03 shall be subject to and in accordance with the following provisions: 

(a) Frequency. Royalties shall be calculated and paid on a quarterly basis. Licensee shall provide GenuPro with a
statement of royalties owed to GenuPro within forty-five (45) days after the end of each calendar quarter other than the last quarter in any calendar year, and the quarterly royalty payment shall be made at the time of such statement. At the
end of each calendar year, aggregate royalties shall be calculated on aggregate annual sales to determine additional royalty payments owed to GenuPro by Licensee. Within sixty (60) days after the end of each calendar year, Licensee shall
provide GenuPro with a statement of such additional aggregate royalty payments owed to GenuPro and a written report showing the method by which the royalty payments for such year were calculated, including a breakdown of gross sales and Net Sales
for each Licensed Product sold, including any exchange rates used. If there are no sales of Licensed Product in a country in a given year, then no statement shall be included in such yearly report. Licensee shall submit any additional aggregate
royalty payments to GenuPro together with such statement and written report. 
 (b) Combination Products. Licensee
shall pay GenuPro royalties with respect to any Combination Product at a royalty rate that is equal to a percentage (which shall not exceed 100%) of the otherwise applicable royalty rate under Section 5.03. Such percentage shall be equal to
[*]. If the numerator and denominator cannot be determined in the manner set forth above, then the Parties shall enter into good-faith negotiations regarding the amount of such percentage. 

 

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

 

 13 

 (c) New Formulations. In the event that Licensee develops a new formulation or
dosage form of a License Product that requires clinical studies for regulatory approval or [*] (a “New Formulation or Use”), Licensee shall pay royalties to GenuPro on such New Formulation or Use at the same rate as set forth in
Section 5.03 hereof, provided that the amount of royalties otherwise due under this Section 5.08(c) will not be paid until Licensee [*]. New Formulation or Use shall include [*].  

(d) Sales upon Invoicing. A sale of Licensed Product shall be deemed to have occurred upon the invoicing of such Licensed
Product to a Third Party; or if not invoiced, then when delivered, shipped, or paid for, whichever first occurs. Regardless of the number of patents or other components of Know-How that cover a Licensed Product, only one royalty shall be payable
upon sale of a Licensed Product. 
 (e) Other Consideration. In the case of a sale or other disposal of
Licensee’s Licensed Product for value other than in an arm’s-length transaction exclusively for money, such as barter or counter-trade, the amount of such sale shall be calculated using the fair market value of such Licensed Product (if
higher than the stated sales price) in the country of disposition. 
 ARTICLE VI - Royalty Records, Verification and
Payment 
 6.01. Books and Records. Licensee shall keep and shall require any Affiliates and sublicensees selling Licensed
Products to keep proper records and books of account, in accordance with generally accepted accounting practices, showing the Net Sales of Licensed Products upon which the royalty payments of Licensee are based, and all other information necessary
for the accurate determination of payment to be made hereunder. 
 6.02. Audit. On reasonable written notice, GenuPro, at its own
expense, shall have the right, no more than once a year, to have an independent certified public accountant inspect and audit the books and records of Licensee, including any Net Sales reports received from its Affiliates and its sublicensees,
during usual business hours for the sole purpose of, and only to the extent necessary for, determining the correctness of royalty payments due under this Agreement. Such examination with respect to any fiscal year shall not take place later than
three years following the expiration of such period. The expense of any such audit shall be borne by GenuPro; provided, however, that, if the audit with respect to a particular calendar year discloses an error in excess of [*] or [*],
whichever is greater, in favor of the Licensee, then Licensee shall pay, in addition to the amount of any underpayment, the cost of the audit. Licensee shall include substantially the same audit rights in any sublicense it grants in order to ensure
correctness of payments due hereunder. 
 6.03. Foreign Payments. Royalties based on Net Sales outside of the U.S. shall be
payable in the United States in dollars. Dollar amounts shall be calculated in the foreign currency for the country in which sales are recorded and will be translated into dollars as published by the Wall Street Journal on the last business day of
the quarter for which such payments are due. Payments in dollars shall be paid by wire transfer to GenuPro. 
  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

 

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 ARTICLE VII - CLINICAL DEVELOPMENT COLLABORATION 

Upon Licensee’s request, the Parties shall negotiate in good faith a separate written agreement whereby PPD shall perform specified clinical
research activities (including Phase II, Phase III or Phase IV clinical studies). 
  

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 ARTICLE VIII - INTELLECTUAL PROPERTY 

8.01. Ownership of Peripheral Compounds and Product-Related Improvements.  

(a) GenuPro shall own all right, title and interest in and to all intellectual property rights covering [*] (“GenuPro
Intellectual Property”). 
 (b) Licensee shall own all right, title and interest in and to [*]. 

8.02. Patent Prosecution. 

(a) GenuPro shall have the right to control the preparation, filing, prosecution, maintenance and defense of GenuPro Patents and
be responsible for all costs associated with the GenuPro Patents. Licensee shall provide GenuPro and any person designated by GenuPro, any reasonable assistance required to perfect the rights defined in Section 8.01(a) . GenuPro shall provide
Licensee with drafts of all proposed patent filings (including, without limitation, patent applications, amendments and responses to official actions) at least 30 days before filing and shall take into account any comments provided by Licensee to
GenuPro within 30 days after Licensee’s receipt of the applicable draft. If GenuPro decides not to file or maintain any applications or patents on a country-by-country basis or patent family basis any GenuPro Patent, GenuPro shall give Licensee
reasonable notice of same and after receipt of such notice, Licensee may, at its expense, file or maintain such applications or patents at its own expense, and GenuPro shall assign such patents and patent applications to Licensee that Licensee
elects to file or maintain. 
 (b) Licensee shall have the right to control the preparation, filing, prosecution,
maintenance and defense thereof and be responsible for all costs associated with [*]. GenuPro shall provide Licensee and any person designated by Licensee, any reasonable assistance required to perfect the rights defined in
Section 8.01(b). Subject to the last sentence in this Section 8.02(b), if Licensee decides not to file or maintain any applications or patents on a country-by-country basis or patent family basis any [*], Licensee shall give GenuPro
reasonable notice of same and after receipt of such notice, GenuPro may, at its expense, file or maintain such applications or patents at its own expense, and Licensee shall assign such patents and patent applications to GenuPro that GenuPro elects
to file or maintain. The previous sentence shall not apply to any decision of Licensee that is based on its determination, in its sole discretion, that the value of a particular [*] will most likely be maximized by a form of intellectual
property protection other than patent protection, or that a particular filing would detract from the overall value of the patent estate. 

(c) PPD and GenuPro covenant to exercise all rights they have under the Lilly Agreement to ensure that the Lilly Patents are
competently prosecuted and maintained in force. If PPD and GenuPro become aware of a potential abandonment of a Lilly Patent that cannot be avoided by PPD’s and GenuPro’s actions, PPD or GenuPro shall provide prompt notice to Licensee of
such potential abandonment and the circumstances surrounding it. 
  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

 

 16 

 8.03. Notification. At each JDC meeting, Licensee shall notify GenuPro of any Peripheral
Compound, SAR Compound or Product-Related Improvement made by Licensee’s employees since the previous meeting (or, in the case of the first meeting of the JDC, since the Effective Date), and PPD and GenuPro shall disclose to Licensee all
GenuPro Know-How made during such period. 
 8.04. Assignment. 

(a) Licensee hereby irrevocably assigns to GenuPro any intellectual property rights Licensee may obtain which GenuPro shall own
pursuant to Section 8.01(a) . GenuPro shall have the right to obtain and to hold in it own name, patents or such other protection as may be appropriate to the subject matter, and any extensions and renewals thereof. Licensee shall provide
GenuPro and any person designated by GenuPro any reasonable assistance required to perfect the rights defined in this Section 8.04(a). 

(b) GenuPro hereby irrevocably assigns to Licensee any rights GenuPro may obtain which Licensee shall own pursuant to
Section 8.01(b). Licensee shall have the right to obtain and to hold in it own name, patents or such other protection as may be appropriate to the subject matter, and any extensions and renewals thereof. GenuPro shall provide Licensee and any
person designated by Licensee any reasonable assistance required to perfect the rights defined in this Section 8.04(b). 
 8.05.
Trademarks. Licensee shall own all trademarks developed by Licensee used to identify a Licensed Product. 

ARTICLE IX - PATENT AND INFRINGEMENT 

9.01. Scope of Rights under Other Arrangements. Notwithstanding anything to the contrary in this Article 9, the Parties acknowledge that
the scope of rights to initiate or defend claims of patent infringement or invalidity regarding Lilly Patents are limited by and must be consistent with the terms of Article 9 of the Lilly Agreement. 

9.02. Infringement of Patent Rights. 

(a) Each Party to this Agreement shall notify the other in writing promptly of any actual, potential or suspected infringement
(collectively “alleged infringement”) of the Product-Related Improvement Patents as they relate to Licensed Products of which such Party becomes aware and shall promptly provide the other Party with available evidence of such alleged
infringement. In such event, the Parties shall discuss the most appropriate action to take. If and when the Parties to this Agreement have the right to initiate an infringement claim, then the Parties shall reasonably cooperate with each other in an
attempt to terminate such third-party infringement through means other than litigation. If, within sixty (60) days after the date of notification of infringement, attempts to abate such infringement are unsuccessful, then Licensee may, at its
own initiative and expense, bring and conduct an infringement action against such Third Party, and Licensee shall be entitled to any recoveries, damages or awards obtained in such action (through settlement, court order, or otherwise). If Licensee
refuses to bring an infringement action against the Third Party, then GenuPro may, at its own initiative and expense, 

 

 17 

 
bring and conduct such action, and GenuPro shall be entitled to any recoveries, damages or awards obtained in such action (through settlement, court order, or otherwise). 

(b) Each Party to this Agreement shall notify the other in writing promptly of any actual, potential or suspected infringement
(collectively “alleged infringement”) of the GenuPro Patents or Lilly Patents as they relate to Licensed Products of which such Party becomes aware and shall promptly provide the other Party with available evidence of such alleged
infringement. If a Lilly Patent is the subject of such alleged infringement, GenuPro shall inform Lilly so that Lilly may pursue its prosecution rights pursuant to Sections 9.02 and 9.04 of the Lilly Agreement. At such time as the JDC decides it is
appropriate, GenuPro shall request, in accordance with Section 9.02(b) or 9.04(b) of the Lilly Agreement that Lilly take legal action against such infringement. If Lilly commences an infringement action regarding a Lilly Patent or a GenuPro
Patent, Licensee shall be entitled to that portion of any recovery described in Section 9.02(a)(ii)(3) or 9.04(a)(ii)(3) of the Lilly Agreement, as applicable. If GenuPro obtains the right to prosecute an action of infringement pursuant to
Section 9.02(b) or 9.04(b) of the Lilly Agreement or if a GenuPro Patent is the subject of such alleged infringement, the Parties shall discuss the most appropriate action to take. If and when the Parties to this Agreement have the right to
initiate an infringement claim, then the Parties shall reasonably cooperate with each other in an attempt to terminate such third-party infringement through means other than litigation. If, within sixty (60) days after the date of notification
of infringement, attempts to abate such infringement are unsuccessful, then GenuPro may, at its own initiative and expense, bring and conduct an infringement action against such Third Party, any recoveries, damages or awards obtained in such action
(through settlement, court order, or otherwise) shall be allocated in accordance with Section 9.02(b)(ii) or 9.04(a)(ii) of the Lilly Agreement, as applicable. GenuPro shall not settle any action in a manner that is prejudicial to any of
Licensee’s rights under GenuPro Patents or Lilly Patents licensed hereunder without Licensee’s prior written approval, which approval shall not be unreasonably withheld. If GenuPro refuses to bring an infringement action against the Third
Party or refuses to continue such a suit, then Licensee may, at its own initiative and expense, bring, conduct and/or continue such action (and GenuPro grants Licensee the right to do so in its name), and Licensee shall be entitled to any
recoveries, damages or awards obtained in such action (through settlement, court order, or otherwise). 
 9.03. Infringement of Third
Party Patent Rights. If a Party’s conduct under this Agreement becomes the basis of a claim of infringement of any patent or other proprietary right of any Third Party, such Party shall promptly give notice to the other Party and the
Parties shall confer to consider the claim and an appropriate course of action. If and when a Party to the instant Agreement have the right to defend an infringement claim, each Party shall have the right to conduct the defense against any such
claim or infringement action brought against it, and shall have the right and authority to settle any such claim or action after consultation with the other Party, provided that such defending Party shall not make any admission or take any action
that would prejudice any of the other Party’s patent rights without the prior written approval of the other Party, which approval shall not be unreasonably withheld. The other Party shall cooperate with the defending Party, as reasonably
requested by it, in connection with the defense against such claim or action, at the defending Party’s expense. [*]  

 

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

 

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 9.04. Patent Marking. To the extent permitted by applicable laws and regulations, Licensee
agrees to mark, and to cause any Affiliate or sublicensee to mark, Licensee’s Licensed Products (through a marking on containers, packaging or labels, or an Orange Book or like listing) made, sold, or otherwise disposed of by it or them with
any notice of patent rights necessary or desirable under applicable law to enable patent rights to be enforced to their full extent in any country where such Party’s Licensed Products are to be sold. 

ARTICLE X - CONFIDENTIAL INFORMATION 

10.01. Obligations. Each Party (the “Receiving Party”) will maintain the Confidential Information disclosed by the other Party
(the “Disclosing Party”), confidential throughout the Project and for a period continuing through [*] years after the termination of this Agreement. However, such obligation of confidentiality shall not apply to any Confidential
Information that: 
 (a) is, as of the Effective Date, in the public domain or subsequently enters the public domain
through no fault of the Receiving Party; 
 (b) was known to the Receiving Party prior to disclosure by the Disclosing
Party hereunder and was acquired without breach of any obligation to the Disclosing Party and can be documented by written records; 

(c) is disclosed to the Receiving Party by a Third Party lawfully in possession of same and having the right to disclose same;

 (d) is independently developed by Receiving Party, as demonstrated by written evidence, without reference to
information disclosed by Disclosing Party; 
 (e) is disclosed pursuant to the Disclosing Party’s prior written
approval; 
 (f) is required to be disclosed by a governmental authority provided reasonable notice of the impending
disclosure is provided to the Disclosing Party, and the Disclosing Party has agreed to such disclosure in writing or has exhausted its right to contest such disclosure; 

(g) is disclosed to a Third Party in order to allow Disclosing Party to defend against litigation with a Third Party, to file and
prosecute patent applications or to comply with governmental regulations; 
 (h) is required to be disclosed in order to
allow Receiving Party to obtain regulatory agency approval to market a Licensed Product in the Field within the Territory; 

(i) is required by a governmental entity to be disclosed (for example, without limitation, on product labeling or a product
insert) in order to market a Licensed Product in the Field within the Territory; 
 (j) is disclosed to a Third Party in
connection with developing, testing, evaluating or applying for or securing regulatory agency approval of Licensed Product in the Field within the 

 

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

 

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 Territory, provided such Third Party has agreed in writing to be bound by confidentiality terms at least as
stringent as those in this Agreement; or 
 (k) is disclosed to a Third Party who has entered into, or is contemplating
entering into a written agreement with Receiving Party regarding commercialization of Licensed Product for an indication or indications in the Field within the Territory, provided such Third Party has agreed in writing to be bound by confidentiality
terms at least as stringent as those in this Agreement. 
 10.02. Limitations on Publications. The Parties agree that no one Party
shall publish the results of any studies, whether conducted by its own employees or in conjunction with a Third Party, carried out pursuant to this Agreement or Confidential Information received from the other Party that is relating to the Project,
without the prior written approval of the other Party. Each Party agrees to provide the other Party with a copy of any proposed abstracts, presentations, manuscripts, or any other disclosure which discloses clinical study results pursuant to this
Agreement or Confidential Information received from the other Party relating to the Project at least [*] days prior to their intended submission for publication and agrees not to submit or present such disclosure until the Party not seeking
to disclose such information provides its prior written approval. Such written approval will not be unreasonably withheld unless such proposed disclosure could reasonably harm or impair a Party’s intellectual property assets or may reasonably
cause commercial harm to a Party. 
 ARTICLE XI - WARRANTIES 

11.01. Warranties By GenuPro and PPD. GenuPro and PPD represent and warrant to Licensee the following: 

(a) GenuPro has the full right and power to grant the licenses set forth in Sections 2.02 and 2.03 in the manner and to the extent
set forth in this Agreement (including Licensee’s right to further sublicense), free and clear of any adverse assignment, grant or other encumbrances inconsistent with such grant. 

(b) The GenuPro Compound has been developed to the “Proof of Concept” stage as defined under the Lilly Agreement and
GenuPro provided notice thereof to Lilly on September 29, 1999 in compliance with the procedures set forth in Section 4.01 of the Lilly Agreement. 

(c) Neither GenuPro nor PPD nor an Affiliate of either has received any notice or other communication from Lilly regarding the
exercise by Lilly of its rights under Section 4.01 of the Lilly Agreement with respect to the GenuPro Compound and Lilly no longer has the right to provide such notice. 

(d) PPD has not exercised its rights under Section 4.02 of the Lilly Agreement with respect to the GenuPro Compound.  

 (e) PPD has no rights under Section 4.02 of the Lilly Agreement with respect to the GenuPro Compound.

  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

 

 20 

 (f) GenuPro has provided to Lilly and PPD, in compliance with the procedures set
forth in Section 4.04 of the Lilly Agreement, notice of GenuPro’s intent to sign this Agreement. PPD has not submitted a counteroffer to GenuPro in accordance with its right under Section 4.04 of the Lilly Agreement and has waived its
right to submit such a counteroffer. PPD has been notified in writing by Lilly that Lilly will not exercise its right to submit a counteroffer under Section 4.04 of the Lilly Agreement. The terms of this Agreement are not materially different
from the terms submitted to Lilly on November 1, 2000 and the additional information submitted to Lilly on November 15, 2000. Lilly has no further rights under Section 4.04 of the Lilly Agreement with respect to the transaction
contemplated by this Agreement. 
 (g) Lilly has in fact granted to GenuPro the licenses set forth in Sections 6.03 -6.07
of the Lilly Agreement and such licenses are currently in full force and effect. To the best of their knowledge, Schedule 1.25 includes all intellectual property of Lilly that is applicable to Compounds. 

(h) Neither GenuPro nor PPD nor an Affiliate of either has received any notice or other communication from Lilly regarding any
breach by GenuPro or PPD of their obligations under the Lilly Agreement, including without limitation the diligence obligations set forth in Section 2.03 of the Lilly Agreement. 

(i) GenuPro and PPD have licensed to Licensee in this Agreement all rights that GenuPro and PPD have with respect to Compounds and
Licensed Products, including without limitation those rights received pursuant to the Lilly Agreement. 
 (j) Neither
GenuPro nor PPD shall assert in any way any patent or other intellectual property right Controlled by GenuPro or PPD against Licensee or its sublicensees or Affiliates, or their customers (direct or indirect), agents or contractors with respect to
the development, manufacture, use, import, offer for sale or sale of a Licensed Product. 
 (k) GenuPro and PPD have
disclosed to Licensee in writing all Peripheral Compounds and SAR Compounds (as defined in the Lilly Agreement) that relate to the GenuPro Compound and that have been made prior to the Effective Date and are in their possession as of the Effective
Date. Such Peripheral Compounds and SAR Compounds include all such compounds disclosed to GenuPro or PPD by Lilly pursuant to Section 8.04 of the Lilly Agreement. 

(l) GenuPro and PPD have shown to Licensee the complete, unredacted text of all provisions of the Lilly Agreement that apply
to the GenuPro Compound, except certain financial information. The information that GenuPro and PPD redacted from the “Field” definition in the version of the Lilly Agreement provided to Licensee describes uses for proprietary Lilly
compounds unrelated to dapoxetine. 
  

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 (m) All GenuPro Patents and GenuPro Know-How comprise “Joint Improvements”
as defined in the Lilly Agreement. Neither GenuPro nor PPD Control any Know-How or Patents relating to Compounds, CTM Products or Licensed Products that are not classified as “Joint Improvements” under the Lilly Agreement and are not
subject to the exclusive license to Lilly set forth in the last sentence of the second paragraph of Section 6.03 of the Lilly Agreement. [*] 

(n) To the best of their knowledge, the Compounds, CTM Products and Licensed Products and methods of making or using them do
not infringe or misappropriate the intellectual property rights of any Third Party, and no royalties are owed to any Third Party with respect to such compounds and products. Neither GenuPro nor PPD nor an Affiliate of either has received any notice
or other communication alleging that a Compound, CTM Product or Licensed Product infringes or misappropriates the intellectual property rights of a Third Party. 

(o) PPD and GenuPro are not aware of any Third Party patent rights relating to the Manufacturing Know-How, and Lilly has not
brought any such Third Party patent rights to the attention of PPD or GenuPro pursuant to Lilly’s obligation under Section 5.04 of the Lilly Agreement. In the event that Lilly brings such Third Party patent rights to the attention of PPD
or GenuPro during the term of this Agreement, PPD and GenuPro shall promptly and fully disclose such information in writing to Licensee. 

(p) PPD and GenuPro are not aware of any intellectual property rights Controlled by Lilly that (i) are not licensed to
GenuPro pursuant to the Lilly Agreement and sublicensed to Licensee pursuant to this Agreement, and (ii) are necessary to develop, make, have made, use, import, offer for sale or sell a Licensed Product. 

(q) PPD and GenuPro have disclosed to Licensee all material adverse data relating to the Compounds and their safety in animals and
humans, development status and regulatory status known to GenuPro as of the Effective Date of this Agreement. 
 (r) PPD
and GenuPro are not aware of any lawsuits (either former or current) which arose from clinical trials performed by PPD, GenuPro or Lilly using the CTM Product. Neither GenuPro nor PPD nor an Affiliate of either has received any notice or other
communication regarding a claim arising from a clinical trial performed by PPD, GenuPro or Lilly upon CTM Product. 
 (s)
GenuPro is validly existing and in good standing under the laws of the state of its incorporation and has the corporate power and authority to enter into this Agreement. This Agreement has been duly executed and delivered by GenuPro and
constitutes the valid and binding obligation of GenuPro, enforceable against it in accordance with its terms except as enforceability may be limited by bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium and other laws relating
to or affecting creditors’ rights generally and by general equitable principles. The execution, delivery and performance of this Agreement have been duly authorized by all necessary action on the part of GenuPro, its officers and directors.

  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

 

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 11.02. Warranties by Licensee. Licensee represents and warrants to GenuPro the following:
Licensee is validly existing and in good standing under the laws of the state of its incorporation and has the corporate power and authority to enter into this Agreement. This Agreement has been duly executed and delivered by Licensee and
constitutes the valid and binding obligation of Licensee, enforceable against it in accordance with its terms except as enforceability may be limited by bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium and other laws
relating to or affecting creditors’ rights generally and by general equitable principles. The execution, delivery and performance of this Agreement have been duly authorized by all necessary action on the part of Licensee, its officers and
directors. 
 11.03. Employee Agreements. Each Party warrants that it has entered into a proprietary information and inventions
agreement with each of its employees prior to the time that any such employee shall receive Confidential Information from a Disclosing Party or begin work related to this Agreement. Such agreement shall minimally set forth employee obligations to
assign inventions to the inventing Party and to maintain confidentiality of Confidential Information consistent with the terms of this Agreement. Each Party shall enter into a similar agreement with any Third Party retained by the Party to perform
services hereunder prior to the time that such Third Party receives any Confidential Information from a Disclosing Party or begins work related to this Agreement. 

ARTICLE XII - TERM AND TERMINATION 

12.01. Term. Unless otherwise terminated by operation of law or in accordance with the provisions of this Article XII, the licenses granted
herein and the obligations assumed hereunder with respect to the Licensed Product shall commence as of the Effective Date of this Agreement and shall continue in full force and effect until all payment obligations of Licensee to GenuPro under this
Agreement relating to the Licensed Product are terminated. 
 12.02. Hart-Scott-Rodino Act. Licensee may terminate this Agreement,
effective immediately, if the Parties do not receive approval of their filing under the HSR Act with respect to this Agreement by 60 days after the Effective Date. 

12.03. Material Breach. This Agreement will be terminable upon the material default of either Party. In the event of such material default
by a Party (“Defaulting Party”), the other Party (“Non-Defaulting Party”) shall give the Defaulting Party written notice of the default and its election to terminate this Agreement at the expiration of a cure period one hundred
eighty (180) days from the date of the notice. If the Defaulting Party fails to resolve the default during the cure period by: (a) curing the default, (b) providing a written explanation satisfactory to the Non-Defaulting Party that a
default has not occurred, or (c) entering into a written agreement with the Non-Defaulting Party for the cure or other resolution of the default, then the Non-Defaulting Party may terminate this Agreement by giving written notice to the
Defaulting Party. The termination will be effective upon Defaulting Party’s receipt of such terminating notice. All termination rights shall be in addition to and not in substitution for any other remedies that may be available to the
Non-Defaulting Party. Termination pursuant to this section will not relieve the Defaulting Party from liability and damages to the Non-Defaulting Party for default. Waiver by either Party of a single default or a succession of defaults will not
deprive such Party of any 
  

 23 

 
right to terminate this Agreement arising by reason of any subsequent default. If GenuPro should terminate this Agreement under this Section 12.03, Licensee shall irrevocably lose any and
all licenses granted to Licensee by GenuPro pursuant to Sections 2.02 and 2.03. Licensee also shall (and shall cause any subcontractors or sublicensees under contract with Licensee to) transfer to GenuPro (and into GenuPro’s name where
appropriate) at no cost to GenuPro all quantities of Compound, CTM Product, or Licensed Product, as well as all Know-How, Product-Related Improvements and Lilly Manufacturing Know-How in Licensee’s possession related to Licensed Product
including, but not limited to, all regulatory files and filings related thereto, any patents or patent applications encompassing Product-Related Improvements. Licensee shall irrevocably assign its intellectual property rights in Product-Related
Improvements to GenuPro. GenuPro shall have the right to obtain and to hold in it own name, patents or such other protection as may be appropriate to the subject matter, and any extensions and renewals thereof. Licensee shall provide GenuPro and any
person designated by GenuPro any reasonable assistance required to perfect such rights. Notwithstanding the foregoing, if Licensee challenges GenuPro’s right to terminate this Agreement, no transfer of rights under this Section 12.03 shall
occur unless and until GenuPro’s right to terminate has been affirmed in an arbitration pursuant to Section 12.09. 
 12.04.
Termination for Insolvency. If either GenuPro or Licensee: (a) makes a general assignment for the benefit of creditors or becomes insolvent (for the purposes of this Agreement, “insolvent” shall mean the inability of a
Party to pay its debts as they become due in the ordinary course of business), (b) files an insolvency petition in bankruptcy, (c) petitions for or acquiesces in the appointment of any receiver, trustee or similar officer to liquidate or
conserve its business or any substantial part of its assets, (d) commences under the laws of any jurisdiction any proceeding involving its insolvency, bankruptcy, reorganization, adjustment of debt, dissolution, liquidation or any other similar
proceeding for the release of financially distressed debtors, or (e) becomes a Party to any proceeding or action of the type described above in (c) or (d) and such proceeding or action remains undismissed or unstayed for a period of
more than sixty (60) days, then the other Party may by written notice terminate this Agreement in its entirety with immediate effect. 

12.05. Residual Obligation upon Termination. Termination of this Agreement for any reason whatsoever will not release or discharge either
Party from the performance of any obligation, the payment of any debt or responsibility for any liability which may have previously accrued and remains to be performed, paid or discharged, at the date of such termination. However, upon termination
no further obligations under this Agreement shall be incurred by the Parties. Moreover, termination of this Agreement shall not release either Party of the obligations of confidentiality set forth in Section 10.01. Sections 12.05, 12.06, 12.07,
12.08, 12.09, 13.01, 13.06, 13.09, 13.14, 13.15, and 13.17 and Articles I, VIII and XI shall survive any expiration or termination of this Agreement.  

12.06. Additional Remedies. Termination of this Agreement under Sections 12.03 or 12.04 shall not be exclusive or prejudicial to any other
rights or remedies each Party may have on account of such breach or default under this Agreement or otherwise. 
  

 24 

 12.07. Remaining Licensed Product. Upon any termination of this Agreement, Licensee shall have
the right for [*] to sell all Licensed Product then on hand, and to complete all orders for such Licensed Product then on hand, and royalties shall be paid to GenuPro with respect to such Licensed Product as though this Agreement had not
terminated. 
 12.08. Pre-Arbitration Efforts. In the event of any controversy or claim arising from or relating to any provision
of this Agreement, or any term or condition hereof, or the performance by a Party of its obligations hereunder, or its constructive or its actual or alleged breach, the Parties shall try to settle their differences amicably between themselves. If
the representatives of the Parties are unable to reach agreement on any such issue, the issue shall be submitted for consideration, in the case of Licensee, to its General Counsel, or its designee, and in the case of GenuPro, to its General Counsel,
or its designee. If such representatives are unable to agree within fourteen (14) days, then the issue shall be submitted for consideration to, in the case of Licensee, to the Chief Operating Officer, and, in the case of GenuPro, to its Chief
Executive Officer. If such representatives are unable to agree within fourteen (14) days, then any disputes remaining unresolved between the Parties, except as otherwise provided in this Agreement, shall be finally resolved by binding
arbitration, as set forth below. 
 12.09. Arbitration 

(a) Arbitration Jurisdiction. Any dispute or controversy arising out of or relating to this Agreement not able to be
resolved between the Parties as provided in Section 12.08 will be finally decided by arbitration in accordance with the then-current Licensing Agreement Arbitration Rules of the American Arbitration Association; provided, however, that the code
of civil procedure of the state in which arbitration is being held shall apply to any such proceeding. If GenuPro commences an arbitration proceeding, it will be conducted in Santa Clara County, California, if Licensee commences an arbitration
proceeding, it will be conducted in Wilmington, North Carolina. The Parties agree that any arbitration panel will include members knowledgeable as to evaluation of pharmaceutical technology. 

(b) Arbitration Procedures. Whenever a Party decides to institute arbitration proceedings, it shall give written notice to
the other Party. A single arbitrator mutually chosen by the Parties shall conduct the arbitration. If the Parties cannot agree upon a single arbitrator within fifteen (15) days after the institution of the arbitration proceeding, then the
arbitration will be conducted by a panel of three arbitrators appointed in accordance with applicable AAA rules; provided, however, that each Party shall within thirty (30) days after the institution of the arbitration proceedings appoint one
arbitrator, with the third arbitrator being chosen by the other two arbitrators. If only one Party appoints an arbitrator, then such arbitrator shall be entitled to act as the sole arbitrator to resolve the controversy. All arbitrator(s) eligible to
conduct the arbitration must agree to render their opinion(s) within thirty (30) days after completion of the final arbitration hearing. The arbitrator(s) shall have the authority to grant injunctive relief and specific performance, and to
allocate between the Parties the costs of arbitration in an equitable manner; provided, however, that each Party shall bear its own costs, attorneys fees and witness fees. 

 

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

 

 25 

 Notwithstanding the terms of this Section, a Party shall also have the right to obtain, prior to the
arbitrator(s) rendering the arbitration decision, provisional remedies, including injunctive relief or specific performance, from a court having jurisdiction thereof. The arbitrator(s) will, upon the request of either Party, issue a written opinion
of the findings of fact and conclusions of law and shall deliver a copy to each of the Parties. Decisions of the arbitrator(s) shall be final and binding on all of the Parties. Judgment upon the award rendered may be entered in the highest court or
forum, state or federal, having jurisdiction; provided, however, that the provisions of this Section will not apply to decisions on the validity of patent claims or to any dispute or controversy as to which any treaty or law prohibits such
arbitration. 
 ARTICLE XIII - MISCELLANEOUS 

13.01. Indemnification and Insurance. 

(a) Indemnification.  

(i) Except to the extent an action is described in this subsection (i) involves gross negligence or
intentional misconduct by Licensee, its officers, directors, employees and/or agents, GenuPro and PPD shall indemnify, hold harmless and defend Licensee, its officers, employees and/or agents against any and all claims, suits, losses, damage, costs,
fees (including reasonable attorney’s fees) and expenses resulting from or arising out of GenuPro’s or PPD’s activities contemplated under this Agreement, including, but not limited to, breach of their warranties and obligations
hereunder. GenuPro’s and PPD’s obligation to indemnify, hold harmless and defend shall include, but not be limited to, claims, demands, judgments or costs whether for money damages or equitable relief by reason of alleged personal injury
(including death) to any person or alleged property damage. 
 (ii) GenuPro and PPD shall indemnify, hold
harmless and defend Licensee, its officers, employees, agents, sublicensees, Affiliates, customers (direct or indirect) and/or contractors against any and all claims, suits, losses, damage, costs, fees (including reasonable attorney’s fees) and
expenses resulting from or arising out of any allegation by Lilly or its Affiliate or licensee that the development, manufacture, use, import, offer for sale or sale of a Licensed Product in the Territory in the Field infringes or misappropriates
any intellectual property rights Controlled by Lilly or licensed by Lilly to such Affiliate or licensee. 

(iii) GenuPro and PPD shall indemnify, hold harmless and defend Licensee, its officers, employees, agents,
sublicensees, Affiliates, customers (direct or indirect) and/or contractors against any and all claims, suits, losses, damage, costs, fees (including reasonable attorney’s fees) and expenses resulting from or arising out of any allegation by a
Third Party that the practice of the license set forth in Section 2.02(b) results in infringement of a patent right owned or Controlled by such Third Party, provided that Lilly was obligated under Section 5.04 of the Lilly Agreement to
inform GenuPro of such Third Party patent right and Lilly breached such obligation. 
 (iv) Except to the
extent an action is described in this subsection (iv) involves gross negligence or intentional misconduct by GenuPro or PPD, their officers, directors, employees and/or agents, Licensee shall indemnify, hold harmless and defend GenuPro and PPD

  

 26 

 
or their officers, employees and/or agents against any and all claims, suits, losses, damage, costs, fees (including reasonable attorney’s fees) and expenses resulting from or arising out of
Licensee’s activities contemplated under this Agreement, including, but not limited to, breach of its warranties and obligations hereunder. Licensee’s obligation to indemnify, hold harmless and defend shall include, but not be limited to,
claims, demands, judgments or costs whether for money damages or equitable relief by reason of alleged personal injury (including death) to any person or alleged property damage. 

(b) Insurance. Prior to Licensee initiating any clinical trial (other than clinical trials for which PPD is acting as a
clinical research organization, in which case PPD will obtain such insurance and provide documentation to Licensee and GenuPro), Licensee shall have and maintain such type and amounts of liability insurance covering the development activities
contemplated hereunder and that are normal and customary in the pharmaceutical industry generally for Parties similarly situated. Within five (5) days of GenuPro’s written request, Licensee shall provide GenuPro with a copy of its
policy(ies), along with any amendments and revisions thereto. In addition, Licensee shall furnish to GenuPro certificates evidencing the insurance coverage within five (5) days of GenuPro’s written request. Each of the certificates shall
provide that the coverage will not be canceled until at least thirty (30) days after written notice has been given by Licensee to GenuPro. 

13.02. HSR Filing. Each Party agrees to make an appropriate filing with the FTC under the HSR Act as soon as possible after the Effective
Date and to respond to any questions of the FTC with respect thereto as soon as practicable, in order to obtain prompt FTC clearance of the transactions proposed by this Agreement. Each Party shall use their best efforts to expedite the filing. The
Parties will share equally the HSR Act filing fee and will request early termination of the waiting period. 
 13.03. Amendment.
This Agreement may not be amended, supplemented or otherwise modified except by an instrument in writing signed by an authorized representative of both Parties. 

13.04. Lilly Agreement. Licensee hereby adopts the Lilly Agreement, to the extent applicable to Licensee and related to the GenuPro
Compound. 
 13.05. Entire Agreement. The Parties acknowledge and agree that this Agreement includes the Schedules and constitutes
the entire agreement and understanding relating to the subject matter of this Agreement. As such, the instant Agreement supersedes all previous communications, proposals, representations and agreements, whether oral or written, including the
Confidentiality Agreement, relating to the subject matter of this Agreement. 
 13.06. Severability. Each Party agrees that,
should any provision of this Agreement be determined by a court of competent jurisdiction to violate or contravene any applicable law or policy, such provision will be modified by the court to the extent necessary to comply with the applicable law
or policy, and such modified provision and the remainder of the provisions hereof will continue in full force and effect; and if such provision cannot be so modified, it shall be severed from this Agreement and the remaining provisions shall be
equitably adjusted if necessary, and shall remain in full force and effect. 
  

 27 

 13.07. Waiver. The waiver of a breach hereunder may be effected only by a writing signed by
the waiving Party and shall not constitute a waiver of any other breach. 
 13.08. Notices. Any notice required or permitted to be
given or delivered hereunder or by reason of the provisions of this Agreement shall be in writing and shall be deemed to have been properly served if: (a) delivered personally, (b) delivered by a recognized overnight courier service
instructed to provide next-day delivery, (c) sent by certified or registered mail, return receipt requested and first class postage prepaid, or (d) sent by facsimile transmission followed by confirmation copy delivered by a recognized
overnight courier service the next day. Such notices, demands and other communications shall be sent to the addresses set forth below, or to such other addresses or to the attention of such other person as the recipient Party has specified by prior
written notice to the sending Party. Date of service of such notice shall be: (i) the date such notice is personally delivered or sent by facsimile transmission (with issuance by the transmitting machine of confirmation of successful
transmission), (ii) three days after the date of mailing if sent by certified or registered mail, or (iii) one day after date of delivery to the overnight courier if sent by overnight courier. Unless otherwise specified in writing, the
mailing addresses of the Parties shall be as described below. 
  

			
	For:	  	 GenuPro
 PPD GenuPro

c/o PPD, Inc.
 3151 South 17th Street

Wilmington, NC 28412
 Facsimile:
(910) 343-5920
 Attn: Chief Executive Officer

Facsimile: (910) 772-6951
 Attn: General
Counsel

		
	For:	  	 For: ALZA Corporation
 1900
Charleston Road
 Mountain View, CA 94043

Facsimile: (650) 564-7848
 Attn: General
Counsel

 13.09. Governing Law. This Agreement shall be governed by, and construed in accordance with, the laws
of the State of California, United States, excluding any choice of law rules which may direct the application of the law of any patents encompassed within the scope of this Agreement shall be determined in accordance with the applicable laws of the
countries in which such patents have issued. 
 13.10. Assignability. This Agreement and the licenses granted herein shall be
binding upon and inure to the benefit of the successors in interest of the respective Parties, whether by acquisition, merger or purchase of all or substantially all of the assets of such Party. Except as contemplated in the foregoing, neither Party
shall assign any benefit and/or burden under this Agreement without prior written consent of the other Party. Each Party agrees to grant such consent if such Party reasonably determines that the proposed assignment will not materially adversely
affect it, provided that the assignee agree in writing that it will comply with all applicable provisions of 
  

 28 

 
this Agreement. Nothing in this Section 13.10 shall be deemed to prevent Licensee from subcontracting its obligations under this Agreement to any Third Party to the extent that such
subcontracting is envisioned for the activities contemplated under this Agreement or is otherwise unanimously agreed upon by the JDC. 

13.11. Release of Information. No Party to this Agreement may release any information to any Third Party regarding the terms of this
Agreement without the prior written consent of the other Party. Without limitation, this prohibition applies to press releases, educational and scientific conferences, promotional Licensed Products, governmental filings, and discussions with public
officials and the media. This provision, however, does not apply to any publications or disclosures which may be required: (i) by law, including requests for a copy of this Agreement or related information by tax authorities; (ii) for
recording purposes; (iii) by investment bankers, lawyers, accountants and other professional advisors (provided such disclosure is made under strict confidentiality and the detail of terms disclosed is kept to the absolute minimum required by
such professionals); and (iv) by Eli Lilly and Company in connection with the Development and License Agreement. Each Party agrees that it shall fully cooperate with the other with respect to all disclosures regarding this Agreement to the
Securities and Exchange Commission and any other governmental or regulatory agencies, including requests for confidential treatment of proprietary information of either Party included in any such disclosures. 

13.12. Relationship of the Parties. The Parties are independent contractors and nothing in this Agreement is intended or shall be deemed to
constitute or create a partnership, agency or employer-employee relationship between the Parties. 
 13.13. Dollars. All
references to “dollars” hereunder are to United States dollars. 
 13.14. Jointly Prepared. This Agreement has been
prepared jointly and shall not be strictly construed against either Party. 
 13.15. Headings. The captions or headings of the
Sections are inserted only as a matter of convenience or for reference and shall have no effect on the meaning of the provisions hereof. 

13.16. Counterparts. This Agreement may be executed in one or more counterparts, each of which shall be an original, but all of which taken
together shall constitute one and the same agreement. 
 13.17. Schedules. Each Schedule attached hereto shall be incorporated
into and be a part of this Agreement. 
 IN WITNESS WHEREOF, the Parties have executed this Agreement through duly authorized representatives as
of the date first set forth herein. 
  

									
	 GenuPro, Inc.
	 		  	Alza Corporation
					
	 By:
	 	 	 		  	By:	  	 
					
	 Name:
	 	 	 		  	Name:	  	 
					
	 Title:
	 	 	 		  	Title:	  	 

  

 29 

			
	Pharmaceutical Product Development, Inc.
		
	By:	 	 
		
	Name:	 	 
		
	Title:	 	 

  

 30 

 Schedule 1.25 

[*] 
  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

 

 i 

 Schedule 3.02 

 

	1.	Drug Substance 

  

			
	 •   Dapoxetine HCl Batch 175MH1
	  	6.57 kg (GMP batch used for CTM Product)
		
	 •   Dapoxetine HCl Batch 291MH0
	  	1.567kg (GMP status not confirmed)
		
	 •   Dapoxetine HCl Batch 176MH1
	  	1.6 kg (GMP status not confirmed)

  

	2.	Formulated CTM Product 

  

							
	 Placebo
	  		  		  	
				
	 •   12 count
	  	 930 bottles
	  		  	
				
	 •   50 count
	  	 228 bottles
	  		  	
				
	 10mg Capsules
	  		  		  	
				
	 •   Bulk capsules
	  	 4366 capsules
	  		  	
				
	 •   12 count
	  	 930 bottles
	  		  	
				
	 •   50 count
	  	 613 bottles
	  		  	
				
	 20mg Capsules
	  		  		  	
				
	 •   Bulk capsules
	  	 5024 capsules
	  		  	
				
	 •   12 count
	  	 930 bottles
	  		  	
				
	 •   50 count
	  	 613 bottles
	  		  	
				
	 30mg Capsules
	  		  		  	
				
	 •   12 count
	  	 1230 bottles
	  		  	
				
	 •   50 count
	  	 316 bottles
	  		  	

  

 i 

 Portions of this exhibit marked [*] are omitted and 

are requested to be treated confidentially. 

Amendment No. 1 To LICENSE AGREEMENT  

This Amendment No. 1 to License Agreement (“Amendment No. 1”) is effective as of the 26th day of December, 2003 (the “Amendment
Effective Date”) by and among Pharmaceutical Product Development, Inc., a North Carolina corporation having a place of business at 3151 South Seventeenth Street, Wilmington, NC 28412 (hereinafter “PPD”) and its wholly owned subsidiary
GenuPro, Inc., d/b/a PPD GenuPro, a North Carolina corporation having a place of business at 3900 Paramount Parkway, Morrisville, North Carolina 27560 (hereinafter “GenuPro”), and ALZA Corporation, a Delaware corporation having a place of
business at 1900 Charleston Road, Mountain View, CA 94043 (hereinafter “Licensee”). PPD, GenuPro and Licensee are sometimes referred to herein individually as a “Party” and collectively as the “Parties.” 

WITNESSETH THAT: 

WHEREAS, GenuPro, PPD and Licensee have entered into a LICENSE AGREEMENT (the “Agreement”) effective as of the
2nd day of January, 2001 relating to the development and
commercialization of dapoxetine. 
 WHEREAS, GenuPro, PPD and Licensee wish to amend and supplement certain rights and obligations as set forth
under the terms of the Agreement under the terms and conditions set forth in this Amendment No. 1. 
 NOW, THEREFORE, GenuPro, PPD and
Licensee hereby agree as follows: 
 1. All capitalized terms used but not otherwise defined herein will have the meanings ascribed to them in
the Agreement. 
 2. Section 5.01 (License Fees) is amended by adding the following sentence to the end of that section: “Licensee
will make an additional one-time license fee payment to GenuPro of [*] within fifteen (15) days after Licensee’s receipt of this fully executed Amendment No. 1; provided, however, that such payment will be fully refunded
to Licensee in the event that Licensee terminates the Agreement prior to January 31, 2004 pursuant to Section 12.10 herein. 
 3.
Section 5.02(a)(iii) (Approval of NDA) is amended by deleting the last sentence and replacing it with the following: “Within thirty (30) days of Licensee’s receipt of such written approval, Licensee will pay GenuPro a one-time
milestone payment of [*].” 
 4. Section 5.05 (Royalty Period) is amended by adding the following sentence to the end of
the section: “Notwithstanding the foregoing and subject to the limitations below, Licensee will have no obligation to pay royalties that would otherwise be owed to GenuPro under Section 5.03 based on worldwide Net Sales of Licensed
Products for the period beginning on the date on which the first NDA approval in the United States is received for a Licensed Product and ending upon the expiration of [*] following the calendar quarter in which such first NDA approval
is 
  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

 

 1 

 received (the “Royalty Suspension Period”); provided, however, that the Royalty Suspension Period
will terminate immediately when the cumulative aggregate amount of royalties that would otherwise have been due to GenuPro pursuant to Section 5.03 and this Section 5.05 on Licensed Products, if such royalties had been paid without giving
effect to the first part of this sentence, equals the first to occur of (a) [*] on or before [*], or (b) [*] at any time thereafter. For clarity, the parties acknowledge and agree that
Licensee’s obligation to pay royalties to GenuPro under Section 5.03 shall resume immediately upon the expiration or earlier termination of the Royalty Suspension Period, but that Licensee will never have an obligation to pay royalties
that were not required to be paid during the Royalty Suspension Period. 
 5. Article V (Fees and Royalties) is amended by adding the following
new Section 5.09 to the end of the Article: 
 “5.09 [*]  

6. Section 12.05 (Residual Obligation upon Termination) is amended in that the last sentence is deleted and replaced with the following:
“Sections 5.09, 12.05, 12.06, 12.07, 12.08, 12.09, 13.01, 13.06, 13.09, 13.14, 13.15, and 13.17 and Articles I, VIII and XI shall survive any expiration or termination of this Agreement.” 

7. Article XII is amended by adding the following new Section 12.10 to the end of that Article: 

“Section 12.10 Special Right of Termination by Licensee. Licensee may terminate this Agreement on or before January 31,
2004, at its sole discretion, based on the results of in-life animal carcinogenicity studies being performed on a certain Licensed Product by providing written notice of such termination to GenuPro or PPD on or before January 31, 2004.”

 8. Section 13.11 (Release of Information) is amended in that the current existing paragraph in Section 13.11 will be referred to as
subsection (a) and the following is added as new subsection (b): 
 “(b) Notwithstanding anything in subsection
(a) above to the contrary, PPD or GenuPro may make a public disclosure regarding the Agreement that is factual and either is approved by Licensee, in its reasonable discretion, in advance or in the opinion of PPD’s or GenuPro’s
counsel is required to be made by law, provided that in each case, PPD or GenuPro shall provide Licensee a written copy of the intended disclosure at least 5 business days prior to the date of the disclosure or public announcement and that PPD and
GenuPro incorporate any changes reasonably requested by Licensee prior to making any such disclosure. 
 Except as otherwise amended herein, the
Agreement shall remain in full force and effect. 
  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

 

 2 

 IN WITNESS WHEREOF, the Parties have executed this Amendment No. 1 through duly authorized
representatives as of the date first set forth herein. 
  

									
	GenuPro, Inc.	 		 	ALZA Corporation
					
	By:	 	 	 		 	By:	 	 
					
	Name:	 	 	 		 	Name:	 	 
					
	Title:	 	 	 		 	Title:	 	 
			
	Pharmaceutical Product Development, Inc.	 		 	
					
	By:	 	 	 		 		 	
					
	Name:	 	 	 		 		 	
					
	Title:	 	 	 		 		 	

  

 3 

 AMENDMENT NO. 2 TO LICENSE AGREEMENT 

BETWEEN: 
 ALZA Corporation, a
Delaware corporation having a place of business at 700 Eubanks Drive, Vacaville, CA 95688, hereinafter also referred to as “Licensee”, 

AND: 
 Pharmaceutical Product
Development, Inc., a North Carolina corporation having a place of business at 929 North Front Street, Wilmington, NC 28401-3331 (hereinafter “PPD”) and its wholly based subsidiary GenuPro, Inc., d/b/a PPD GenuPro, a North
Carolina corporation having a place of business at 3900 Paramount Parkway, Morrisville, NC 27560 (hereinafter “GenuPro”). 
 All above
parties shall be collectively referred to as the “Parties” and individually as “Party”. 
 PPD, GenuPro and Licensee have
entered into an agreement with an Effective Date of January 2, 2001 and which was amended on December 26, 2003 by Amendment No. 1 to License Agreement (hereinafter collectively referred to as “License
Agreement”) relating to the development and commercialization of dapoxetine. PPD, GenuPro and Licensee agree to amend the License Agreement as follows: 

Delete original Section 10.02 and insert new Section 10.02 as follows: 

10.02. Limitations on Publications. 

 

	 	(a)	In General. The Parties agree that no Party shall publish Confidential Information of the other Party or the results of any clinical studies, whether conducted
by either Party or by a Third Party on behalf of either Party, relating to the Project (hereinafter “Publication”) without the prior written approval of the other Party. A Party shall provide the other Party with a copy of any proposed
Publication, including but not limited to, abstracts, presentations and manuscripts, for a reasonable period of time prior to the intended date of submission to a Third Party for publication of such Publication and agrees not to submit to a Third
Party for publication or disclose, except as otherwise permitted under this Agreement, such Publication until the other Party provides its prior written approval. Such approval shall not be unreasonably withheld. 

 

	 	(b)	Publication Review Database. The Parties agree that a Party may seek approval from the other Party to publish a proposed Publication by providing a copy of the
proposed Publication on a proprietary and confidential electronic database (hereinafter “Publication Review Database”) used by such Party for internal manuscript review. Such Party shall provide access to the Publication Review Database to
employees designated by the other Party strictly for purposes of reviewing such Publications, and such employees of the other Party shall promptly review the proposed Publication. 

 

	 	(c)	Registration of Clinical Trials on www.clinicaltrials.gov. PPD and GenuPro agree that, notwithstanding the terms of this Agreement, Licensee may, in its sole
discretion, register clinical studies sponsored by Licensee and publish results thereof via www.clinicaltrials.gov as required by U.S. Public Law 110-85 (Food and Drug Administration Amendments Act of 2007 or FDAAA), Title VIII,
Section 801 (hereinafter “Statute”) and any rules or regulations implementing the Statute. 

 This Amendment may be executed in counterparts, each of which shall be deemed an original and all together
shall be deemed to be one and the same amendment. 
 This Amendment is signed below in duplicate on the dates set forth below by an authorized
representative / authorized representatives for each of the Parties, each Party acknowledging receipt of one copy. 
  

									
	GenuPro, Inc.	 		 	ALZA Corporation
					
	 Date:
	 	16 October 2009	 		 	Date:	 	
					
	By:	 	/s/ Fred N. Eshelman	 		 	By:	 	/s/ Francesco Pannone
		 	Fred N. Eshelman	 		 		 	Francesco Pannone
	Title:	 	President	 		 	Title:	 	President

  

			
	Pharmaceutical Product Development, Inc.
		
	Date:	 	16 October 2009
		
	By:	 	/s/ Fred N. Eshelman
		 	Fred N. Eshelman
	Title:	 	Executive ChairmanForm of Consulting Agreement by and between Furiex and Fredric Eshelman

 Exhibit 10.22 

Portions of this exhibit marked [*] are requested to be treated confidentially. 

MASTER DEVELOPMENT SERVICES AGREEMENT 

THIS MASTER DEVELOPMENT SERVICES
AGREEMENT (the “Agreement”) is made and entered into as of             , 2010 (the “Effective Date”)
by and between PPD DEVELOPMENT, LP, a Texas limited partnership, with its principal executive offices located at 929 North Front Street, Wilmington, North Carolina 28401 (“PPD”), and
FURIEX PHARMACEUTICALS, INC., a Delaware corporation with its principal executive offices located at 3900 Paramount Parkway, Suite 150, Morrisville, North Carolina 27560
(“Sponsor”). 
 WHEREAS, Sponsor is engaged in the development, manufacture, distribution and sale of
pharmaceutical products; and 
 WHEREAS, PPD is a clinical research organization engaged in the business of managing clinical
research programs and providing clinical development and other related services; and 
 WHEREAS, Subject to the terms and
conditions of this Agreement, Sponsor will retain PPD from time to time to perform services in connection with certain programs Sponsor is conducting (individually, a “Project”), in which case the terms and conditions for
each such Project shall be set forth in a written agreement to be attached to this Agreement and incorporated herein by reference (individually, a “Project Addendum” and collectively, the “Project
Addenda”); and 
 WHEREAS, PPD is willing to provide such services to Sponsor in accordance with the terms and
conditions of this Agreement and the attached Project Addenda. 
 NOW, THEREFORE, for good and valuable consideration contained
herein, the exchange, receipt and sufficiency of which are acknowledged, the parties agree as follows: 
  

	1.	PREFERRED PROVIDER. 

1.1 PPD shall provide Clinical Development Activities for Sponsor and except as noted in Section 1.2, Sponsor agrees to award all
Clinical Development Activities to PPD or a PPD Affiliate. The term “Clinical Development Activities” shall mean and refer to phase I-IV clinical development services, pre-clinical services, post-approval services, program management,
general drug development consulting, biostatistics and data management services, medical communications, regulatory consulting, laboratory services, including, but not limited to, analytical, bioanalytical, central laboratory and vaccine testing
services, and such other services as Sponsor may from time to time require for drug development. 
 1.2 Notwithstanding anything
to the contrary herein, Sponsor may award Clinical Development Activities to a third party other than PPD or a PPD Affiliate in the following instances: 
  

	 	1.2.1	If after consulting with PPD and reviewing PPD’s experience and capabilities in a certain area Sponsor reasonably and in good faith concludes that PPD does not
have the expertise and capabilities to provide part or all of the Clinical Development Activities for a Project in said area, Sponsor may engage a third party to provide such Clinical Development Activities required by the Project which Sponsor has
reasonably determined that PPD cannot provide. With respect to Clinical Development Activities relating [*]. 

  

	 	1.2.2	If PPD is in material breach of its obligations to provide Services under a Project Addendum and does not cure such breach within thirty (30) days after receipt of
written notice of such breach from Sponsor (or if the breach cannot reasonably be so cured, diligent efforts to effect such cure are commenced during that period and are continued until the cure is completed within a reasonable time period), Sponsor
may terminate all or a portion of the Project Addendum and engage a third party to provide the Services covered under such Project Addendum. 

  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

 

  

1 

 PPD PROPRIETARY AND CONFIDENTIAL 

 
  

	 	1.2.3	If PPD and Sponsor mutually agree in writing that Sponsor may award Clinical Development Activities or a portion thereof to a third party. 

 

	2.	PROJECT ADDENDA AND CHANGE ORDERS 

2.1 Project Addendum. PPD and Sponsor shall execute a Project Addendum evidencing the Services to be provided by PPD. Each Project
Addendum shall be incorporated into and made a part of this Agreement by reference, and each such Project Addendum and this Agreement shall constitute the entire agreement for the applicable Services. To the extent any terms set forth in a Project
Addendum conflict with the terms set forth in this Agreement, the terms of this Agreement shall control unless otherwise specifically set forth in the Project Addendum. 

2.2 Out of Scope Services. If PPD is requested or required to perform services for a Project not specifically set forth in the
Project Addendum (“Out of Scope Services”), such Out of Scope Services and a compensation schedule therefore (the “Out of Scope Amendment”) shall be mutually agreed upon by the parties. The Out of
Scope Amendment shall be deemed an amendment to the Project Addendum. PPD shall not provide any Out of Scope Services without the authorization of Sponsor (e-mail is sufficient). Sponsor has no obligation to pay for Out of Scope Services that have
not been authorized by Sponsor (e-mail is sufficient). The terms and conditions of this Section 2.2 shall be subject to Section 7.2.6. 
  

	3.	SERVICES. 

3.1 Services to be Provided by PPD. 
  

	 	3.1.1	PPD agrees to provide to Sponsor the Clinical Development Activities identified and described in each Project Addendum or as otherwise requested by Sponsor and agreed
upon by PPD (“Services”) and provide deliverables set forth in a Project Addendum (“Deliverable”). 

  

	 	3.1.2	PPD shall perform the Services set forth in the applicable Project Addendum in compliance with (i) the specifications set forth in a Project Addendum,
(ii) the study protocol for the Project and any amendments thereto (“Protocol”), which shall be attached to and made a part of the Project Addendum, (iii) the terms and conditions of this Agreement, (iv) the
terms and conditions of the applicable Project Addendum, (v) PPD’s standard operating procedures (“SOPs”), which have been approved by Sponsor, or Sponsor’s SOPs if mutually agreed upon by the parties in a
Project Addendum, and (vi) all applicable laws, rules, regulations and guidelines which may apply in the location of performance of Services. Sponsor agrees that PPD is responsible only for those Services set forth on a properly executed
Project Addendum. 

  

	 	3.1.3	PPD acknowledges that timely performance and completion of Services under a Project Addendum are important for each Project. Timelines set forth in a Project Addendum
are good faith estimates and PPD shall use commercially reasonable efforts to meet such timelines. PPD shall immediately notify Sponsor when PPD becomes aware of any circumstance that could reasonably be expected to result in a delay in the
performance or completion of any Service or of PPD meeting a timeline. 

  

  

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	 	3.1.4	In the event that there is a material failure by PPD in the performance of a Service in accordance with the terms of this Agreement or a Project Addendum, PPD shall, at
Sponsor’s sole option, (i) re-perform such Services at no additional cost to Sponsor, (ii) take prompt corrective action to rectify the material failure including the use of additional resources at no additional cost to Sponsor, or
(iii) if PPD fails to cure such material failure within the applicable cure period, terminate the relevant Project Addendum pursuant to Section 8.2 and assist Sponsor in the transfer of the Project to a third party service provider
delegated by Sponsor at no additional cost to Sponsor. 

  

	 	3.1.5	PPD shall not assign, delegate or subcontract any Services to another entity without Sponsor’s prior written approval. Any such approval shall not relieve PPD of
its obligations under this Agreement or the relevant Project Addendum. 

 3.2 Sponsor Cooperation. Sponsor
will cooperate with PPD in providing information to PPD, taking action and executing documents, as appropriate, to achieve the objectives of this Agreement. Sponsor acknowledges and agrees that PPD’s performance under this Agreement is
dependant on Sponsor’s timely and effective cooperation with PPD. Accordingly, Sponsor acknowledges that any delay by Sponsor may result in PPD being released from an obligation or schedule deadline or in Sponsor having to pay extra fees in
order for PPD to meet a specific obligation or deadline despite the delay. Sponsor shall comply with all applicable laws, rules and regulations governing the performance of its obligations hereunder and the subject matter of this Agreement,
including without limitation, Sponsor’s Property (as defined below). 
 3.3 Serious Adverse Event and Medical Management
Plan. Notwithstanding anything to the contrary herein, in the event PPD and Sponsor agree upon a serious adverse event and medical management plan relating to a specific Project (“SMMP”), the parties shall comply with the
terms and conditions of any such SMMP. In the event of any conflict between the terms and conditions of the SMMP and the relevant Project Addendum, the terms and conditions of the SMMP shall control. Sponsor shall be responsible for any additional
costs associated with compliance with the SMMP.
  

	4.	MEDDRA AND WHODRUG DICTIONARY LICENSE. 

The parties acknowledge that MedDRA and Uppsala Monitoring Centre product licenses are required by all parties who wish to distribute or
receive MedDRA or WHODrug dictionary terminology. Each party represents and warrants that it possesses a current MedDRA and/or Uppsala Monitoring Centre product license. In the event Sponsor requests that PPD perform services which require
PPD to distribute MedDRA terminology or WHODrug dictionary to third parties, Sponsor shall be responsible for ensuring that all such third parties possess the necessary MedDRA and/or Uppsala Monitoring Centre product licenses. 

 

	5.	PATIENT ENROLLMENT. 

Any patient enrollment projections are good faith estimates and PPD shall exercise commercially reasonable efforts to meet such enrollment
projections. 
  

	6.	FINAL PROTOCOL. 

The parties agree that Sponsor shall be solely responsible for the final review, approval and adoption of the Protocol and PPD shall not
be liable for such Protocol. 
  

  

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	7.	COMPENSATION AND PAYMENT. 

7.1 Charges for Services. Sponsor shall pay PPD for the Services performed under this Agreement and any Project Addendum
(“Direct Fees”) in accordance with the rates or unit prices for such Services set forth in such Project Addendum. Sponsor shall also reimburse PPD for the reasonable out-of-pocket expenses incurred in connection with the
performance of the Services with respect to a Project, including, without limitation, investigator grants and fees, travel expenses, shipping and postage costs, copying and printing fees, copyright fees, third party drug storage and distribution
fees, required Institutional Review Board or similar board or committee fees, and other “pass through” expenses incurred in connection with performing the Services (collectively, the “Pass Through Costs”). PPD shall
obtain the approval of Sponsor, not to be unreasonably withheld or delayed, prior to incurring any Pass Through Costs that exceed the Pass Through Costs specified in a Project Addendum by more than [*] percent ([*]%). Except as otherwise expressly
provided in a Project Addendum, PPD shall submit to Sponsor for each Project a monthly invoice describing the Services performed on such Project, the Direct Fees due for such Services, and all Pass Through Costs. Sponsor shall pay the undisputed
portion of a monthly invoice within thirty (30) days of receipt of said invoice. In the event that Sponsor disputes an item in a monthly invoice, Sponsor shall notify PPD of the nature and amount of the dispute within thirty (30) days of
receipt of such invoice. If Sponsor fails to notify PPD of a dispute within such thirty (30) day period, all such disputes shall be deemed waived and Sponsor shall pay the invoice in full. The parties shall, promptly and in good faith,
reconcile the dispute, and Sponsor shall pay reconciled amounts within ten (10) days of reconciliation. 
 PPD shall have
no obligation to pay subcontractor costs or investigator grant payments to any subcontractor or investigator site (the “Site”) for conduct of services related to a Project until PPD has received payment of such Pass Through
Costs from Sponsor. Notwithstanding anything to the contrary contained herein, Sponsor acknowledges and agrees that certain vendor and subcontractor contracts, including without limitation, contracts for investigator meetings and patient recruitment
services, must be advanced and paid in advance by Sponsor. PPD shall be under no obligation to incur any such vendor or subcontractor fees until such fees are received by Sponsor. In addition, in certain circumstances PPD may require investigator
grants to be advanced by Sponsor at the timeframes mutually agreed upon by the parties. 
 7.2 Phase II-IV Services. The
provisions in this Section 7.2 apply only to the provision of Phase II-IV Services. “Phase II-IV Services” shall be defined as (i) all non-laboratory Clinical Development Activities relating to a phase II, phase III or phase IV
clinical trial, including, but not limited to, monitoring, data management, and biostatistics; (ii) medical communications Services and (iii) all non-laboratory consulting Services, including, but not limited to, regulatory consulting and
general drug development consulting. Phase II-IV Services shall not include any Non-Phase II-IV Services. 
  

	 	7.2.1	Project budgets; Rates. At the beginning of each year, PPD will provide Sponsor with PPD’s standard labor rates for Direct Fees and unit prices that will be
used by PPD to construct the budget in each Project Addendum for that calendar year (“Standard Pricing”). The Standard Pricing will not change during the calendar year in which such Standard Pricing was issued. Until such time as PPD has
provided the Standard Pricing for a calendar year, the budget for each Project Addendum will be based on the Standard Pricing for the previous calendar year with an adjustment based on the inflation forecast published in the Mercer’s index for
each region. PPD’s standard labor rates for Direct Fees will be applied to the mutually agreed upon unit builds for certain activities to achieve the unit prices. Sponsor and PPD agree to negotiate in good faith if it is determined that the
hours or resources used to build a unit price require modification. Unless otherwise agreed, the budget in each Project Addendum will include a breakdown of Direct Fees and Pass Through Costs into [*]. 

 

	 	7.2.2	Inflation. Subject to the inflationary adjustment noted in this Section 7.2.2, the standard labor rates for Direct Fees and unit prices specified in a
budget will remain fixed for the duration of a Project Addendum. In the event the Services in a Project Addendum extend beyond the year in which the Services were awarded, PPD will apply the inflation rates specified in each Project Addendum to the
unit prices, and to the extent the Services are not captured in unit pricing, the inflation rates shall apply to the standard labor rates for Direct Fees. If a Project Addendum does not specify an inflation rate, PPD will apply inflation to the
applicable unit prices, and to the extent the Services are not captured in unit pricing, inflation shall apply to the standard labor rates for Direct Fees, based upon the inflation forecast published in the Mercer’s index for each region.

  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

 

  

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	 	7.2.3	Discount. PPD will provide Sponsor a discount of [*] percent ([*]%) off of PPD’s Standard Pricing (“Discount”) in all Project
Addenda that apply PPD’s Standard Pricing. The Discount will be reflected as a line item in the budget of each Project Addendum. 

  

	 	7.2.4	Fixed Price. Unless otherwise provided in a Project Addendum and except as otherwise provided in this Agreement, the Direct Fees in the budget of a Project
Addendum represent the fixed price payable for the tasks specified in the budget and Sponsor is not responsible for any additional Direct Fees. This Section 7.2.4 shall not apply to Pass Through Costs. 

Notwithstanding anything to the contrary herein, PPD shall only be responsible for additional Direct Fees for [*]. 

 

	 	7.2.5	Material Change. Notwithstanding anything to the contrary in this Agreement, including, but not limited to Section 7.2.4, Sponsor shall be responsible for
any increases to the Direct Fees resulting from any of the following (each a “Material Change”): 

  

	 	7.2.5.1	 	[*]; 

  

	 	7.2.5.2	 	[*]; or 

  

	 	7.2.5.3	 	[*]. 

  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

 

  

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 PPD PROPRIETARY AND CONFIDENTIAL 

 
  

	 	7.2.6	[*]. 

  

	 	7.2.7	During the course of providing Services, notwithstanding the allocation of resources specified in the budget, PPD shall have the right in its sole discretion to manage
and alter its resources, including, but not limited to, study personnel labor schedules and FTEs, provided that such resourcing decisions are calculated in PPD’s reasonable discretion, to accomplish the objectives of the Project and are
consistent with Sponsor’s ability to approve substitute “Key Personnel” as provided in Section 9.1.3 and 9.1.4 of this Agreement. 

  

	 	7.2.8	Payment Schedule. Unless otherwise agreed upon by Sponsor and PPD, Direct Fees will be paid pursuant to a payment schedule incorporated into a Project Addendum.
The payment schedule shall allocate the Direct Fees as follows: [*]. Sponsor and PPD will use good faith efforts to agree upon the milestones to be incorporated into the Project Addendum and the definition of the final Deliverable to be provided by
PPD. The parties agree that milestones shall not be based upon the enrollment of subjects into a study. The payment of Pass Through Costs, including, but not limited to, investigator grants, shall not be tied to milestones or any fixed monthly
payments. 

  

	 	7.2.9	Payment Upon Completion. PPD will issue an invoice for the full value of each milestone in a payment schedule when the milestone is achieved and Sponsor shall
pay such invoices as specified in Section 7.1. There will be no reconciliation between the actual units completed and the number of units specified in the budget of a Project Addendum. Provided that the Services are not completed more than [*]
earlier than the timeline in a Project Addendum, PPD will be entitled to [*]. 

  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

 

  

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 In the event Services are completed more than [*] earlier than the timeline in a
Project Addendum (“Accelerated Project”), Sponsor shall pay PPD for the following: [*]. For each Accelerated Project, PPD shall provide Sponsor with a reconciliation of the Direct Fees upon completion of Services showing the difference (if
any) between the Direct Fees paid to PPD for the Services and the amount payable by Sponsor as noted in (i), (ii) and (iii) above. In the event the amounts in (i), (ii) and (iii) above are greater than the Direct Fees previously
paid to PPD, PPD shall invoice and Sponsor shall pay the difference. In the event the amounts in (i), (ii) and (iii) above are less than the Direct Fees previously paid to PPD, PPD will refund Sponsor the difference. 

7.3 Non Phase II-IV. The provisions in this Section 7.3 apply to the provision of all Non-Phase II-IV Services.
“Non-Phase II-IV Services” shall be defined as (i) pre-clinical Services; (ii) all laboratory Services, including, but not limited to, central laboratory Services, vaccine testing Services, bioanalytical laboratory Services and
GMP laboratory Services; and (iii) Clinical Development Activities relating to a phase I clinical trial. With respect to central laboratory Services, Sponsor shall be entitled to a [*] percent ([*]%) discount off of PPD’s standard
labor rates for Direct Fees for the year in which those Services were awarded (the “GCL Service Discount”). With respect to all other Non-Phase II-IV Services, Sponsor shall be entitled to a [*] percent ([*]%) discount off of
PPD’s standard labor rates for Direct Fees for the year in which those Services were awarded (“Additional Service Discount”). The GCL Service Discount and the Additional Service Discount will be applied at the time of the budget
proposal. In the event the Services in a Project Addendum extend beyond the year in which the Services were awarded, PPD will apply a mutually agreeable inflation rate to such Direct Fees. 

7.4 Payment after Termination. Upon termination of any Project Addendum or this Agreement pursuant to Section 8,
Sponsor shall pay PPD all Direct Fees and Pass Through Costs for all Services, and any portion of Services, performed through the termination date. In addition, Sponsor shall reimburse PPD for all future non-cancelable obligations to third parties
(where such obligations were created as a result of a Project being authorized by the Sponsor). With respect to Project Addenda with payment schedules, Sponsor pay PPD the monthly payment for any partially completed month on a pro rata basis and
shall compensate PPD for all partially complete milestones. Any funds held by PPD which are unearned at the date of termination shall be returned to Sponsor within thirty (30) days after the termination date of the Project Addendum or this
Agreement, whichever is applicable.  
 7.5 Pre-Execution Services. In the event Sponsor requests PPD to begin
providing Services for a Project prior to the execution by Sponsor of a Project Addendum, Out of Scope Amendment, or other mutually agreed upon writing, Sponsor agrees that PPD shall be compensated for Services performed at Sponsor’s request in
accordance with the PPD proposal for such Services, or, if there is no such PPD proposal, in accordance with the Rate Card. 

7.6 Payments. Unless otherwise set forth in a Project Addendum, all payments to PPD under this Agreement or any Project Addendum
shall be made as follows: 
  

			
	 If made by check, payment mailed to:
	  	PPD Development, LP
		  	12937 Collections Center Drive
		  	Chicago, Illinois 60693
		  	Tax ID# 74-2325267
		
	 If made by wire transfer, payment wired to:
	  	Bank of America
		  	Acct: 000696217456
		  	ABA: 026009593
		  	Acct Name: PPD Development, LP

  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

 

  

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 Any changes to the payee information set forth above requires a writing signed by PPD’s treasurer
or chief financial officer. 
  

	8.	TERM AND TERMINATION. 

8.1 Term. The term of this Agreement shall commence on the Effective Date and shall continue for a period of three (3) years
unless extended by mutual written agreement by the parties. 
 8.2 Early Termination. Any Project Addendum may be
terminated with or without cause by Sponsor upon thirty (30) days prior written notice. In addition, Sponsor may terminate this Agreement in the event: (i) during any consecutive twelve (12) month period, PPD on two or more occasions
fails to remedy a material breach under a Project Addendum within thirty (30) days after receipt of written notice of such breach from Sponsor (or if the breach cannot reasonably be so cured, diligent efforts to effect such cure are commenced
during that period and are continued until the cure is completed within a reasonable time), or (ii) during any consecutive twelve (12) month period, PPD on two or more occasions fails to remedy a material breach of the terms of this
Agreement (other than a material breach of PPD’s obligations to provide Services with respect to a Project Addendum which is governed by section (i) above), which is not cured within thirty (30) days after PPD’s receipt of notice
of said breach from Sponsor (or, if the breach cannot reasonably be so cured, diligent efforts to effect such cure are commenced during that period and are continued until the cure is completed within a reasonable time). 

With the exception of a material breach by Sponsor associated with the nonpayment of invoices, PPD may terminate any Project Addendum upon Sponsor’s
material breach with [*] prior written notice if Sponsor fails to cure such breach within the [*] notice period. PPD may terminate any Project Addendum upon Sponsor’s failure to pay invoices with thirty (30) days prior written notice if
Sponsor fails to cure such breach within the thirty (30) day notice period. In the event of a breach associated with the nonpayment of invoices, [*]. All Post Termination Services shall be subject to this Agreement. 

8.3 Insolvency. Either party hereto may terminate this Agreement immediately upon the occurrence of an “Insolvency
Event” with respect to the other party. For purposes of this Agreement, “Insolvency Event” shall mean (i) a party shall commence a voluntary proceeding seeking liquidation, reorganization or other relief with
respect to itself or its debts under any bankruptcy, insolvency or other similar law or seeking the appointment of a trustee, receiver, liquidator, custodian or other similar official of it or any substantial part of its property, or shall consent
to any such relief or to the appointment of or taking possession by any such official in an involuntary case or other proceeding commenced against it, or shall make a general assignment for the benefit of creditors, or shall fail generally to pay
its debts as they become due, or shall take any action to authorize any of the foregoing; (ii) an involuntary case or other proceeding shall be commenced against a party or any of its subsidiaries seeking liquidation, reorganization or other
relief with respect to it or its debts under bankruptcy, insolvency or other similar law or seeking the appointment of a trustee, receiver, liquidator, custodian or other similar official of it or any substantial part of its property, and such
involuntary case or other proceeding shall remain undismissed and unstayed for a period of sixty (60) days; or (iii) an order for relief shall be entered against a party or any of its subsidiaries under bankruptcy laws now or hereafter in
effect. 
 8.4 Effect of Termination. The termination of this Agreement by either party shall automatically terminate all
Project Addenda, unless otherwise agreed in writing. 
  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 

 

  

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 8.5 Wind Down. Upon the termination of this Agreement or a Project Addendum, PPD
shall cooperate with Sponsor to provide for an orderly wind-down of the Services provided by PPD hereunder. Upon notice of termination of a Project Addendum or this Agreement, PPD shall use commercially reasonable efforts to expeditiously conclude
or transfer any uncompleted Services as directed by Sponsor. PPD shall not perform any additional work or enter into any commitments that incur additional expenses with regard to any Service without written mutual agreement of the parties.

 8.6 Invoices. PPD shall invoice Sponsor for payments due for Services completed and for reimbursement for
non-cancelable expenses incurred in accordance with the relevant Project Addendum. If, upon the effective date of termination, Sponsor has advanced funds which are unearned by PPD, PPD shall repay such funds within thirty (30) days of the
effective date of termination. 
 8.7 Return of Materials. Within fifteen (15) days, or a period of time mutually
agreed to in writing by the parties, after the effective date of termination of this Agreement or a Project Addendum, PPD shall deliver to Sponsor all Study materials, data, Sponsor Confidential Information, Sponsor Inventions, and all other
information and documents that are Sponsor’s property as defined in this Agreement or the relevant Project Addendum. PPD agrees that this obligation is not conditioned upon Sponsor’s prior payment of amounts due or agreement to pay any
amounts in dispute. 
 8.8 Provisions Surviving Termination. The obligations of the parties contained in Sections 7.1,
7.4, 8.4, 8.5, 8.6, 8.7, 8.8, 9.3, 10, 11, 12, 15.3, and 17 hereof and herein shall survive termination of this Agreement. 
  

	9.	PERSONNEL. 

9.1 Project Personnel. 
  

	 	9.1.1	PPD shall only use appropriately qualified personnel for performance of Services under a Project Addendum. PPD shall propose personnel for performance of Services and
provide Sponsor with the credentials of each proposed person. Sponsor shall have the right to select PPD personnel to perform Services based on such credentials, such selection not to be unreasonably withheld, conditioned or delayed.

  

	 	9.1.2	The Services with respect to each Project shall be performed by PPD under the direction of the person identified as the Project Manager in the applicable Project
Addendum or such other person acceptable to Sponsor as PPD may from time to time designate as the Project Manager, such Sponsor acceptance of the designated Project Manager not to be unreasonably withheld or delayed in all instances. The Project
Manager shall be the primary contact for PPD and shall timely address all issues and concerns raised by Sponsor, as well as provide to Sponsor all information reasonably requested by Sponsor concerning this Agreement or the Services.

  

	 	9.1.3	If Sponsor requests in writing the replacement of the Project Manager or any other PPD Personnel identified in a relevant Project Addendum (“Key Personnel”)
due to performance or conduct concerns, PPD will promptly remove such person from the Project and assign a qualified and experienced person at no additional cost to Sponsor and without affecting Project timelines. Subject to Section 9.1(d), PPD
agrees to obtain the consent of Sponsor to any changes to the PPD Key Personnel, which consent shall not be unreasonably withheld, conditioned or delayed. 

  

	 	9.1.4	In the event PPD becomes aware that PPD Key Personnel on a Project plans to leave the employment of PPD, is promoted, or shall otherwise be unable to complete the
Services, PPD shall give prompt written notice of the same to Sponsor, together with the replacement personnel of similar qualification. Sponsor shall review and approve such replacement personnel, such approval not to be unreasonably withheld,
conditioned or delayed. 

  

  

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	 	9.1.5	PPD will provide Project-specific training to replace PPD personnel at its own expense. 

9.2 Personnel Retention. In the event of delays in the performance of the Study, i.e., after PPD is authorized to commence work,
that are beyond the control of PPD, and where Sponsor desires for PPD to keep PPD Study personnel assigned to the Study, in addition to any other sums payable to PPD hereunder, Sponsor agrees that Sponsor shall pay a personnel fee calculated on an
FTE-day basis. Said personnel fees shall be invoiced by PPD on a monthly basis, and shall be due and payable by Sponsor within 30 days of receipt of invoice. Such retention fee shall not be owed by Sponsor in the event PPD is unable to
replace such personnel with new personnel of equivalent quality and experience upon re-commencement of the Study. 
 9.3
Covenant Not to Interfere. Neither party will solicit for employment any employee of the other party during the term of this Agreement, or for one (1) year thereafter. As used in this section “solicit” means the initiation by a
party or its agent of a contact with any of the other party’s then current employees who are performing services under this Agreement for the purpose of offering employment to such employees, but shall not include the circumstance where any
such employee initiates a contact with the other party for the purpose of obtaining employment whether in response to a general advertisement of employment or where such contact is initiated by a third party who was not instructed to contact such
employee by the hiring party. 
  

	10.	CONFIDENTIALITY. 

10.1 Sponsor Confidential Information. Sponsor holds a proprietary interest in Study materials and in any written and oral
information that Sponsor discloses to PPD under this Agreement. Sponsor considers all such materials and information supplied to PPD by Sponsor, or generated by PPD under this Agreement to be confidential information of Sponsor (“Sponsor
Confidential Information”). As used herein, the Sponsor Confidential Information shall also include the Deliverables, Sponsor Inventions, and any other data, methods, results, conclusions, information and/or other deliverables made,
conceived, reduced to practice or otherwise generated in connection with this Agreement, whether by Sponsor or PPD. PPD shall treat all Sponsor Confidential Information as the confidential and exclusive property of Sponsor, including all tangible
and intangible forms of such information. 
 10.2 PPD Confidential Information. Sponsor shall treat all information
obtained from PPD including, without limitation, any PPD bids or proposals, standard operating procedures, personnel information, all PPD Property (as defined below) and any revisions, improvements or enhancements thereto (“PPD
Confidential Information”) as the confidential and exclusive property of PPD. In addition, any information disclosed, obtained, or observed by Sponsor during an audit of PPD or an Affiliate of PPD, or the facilities of either, with the
exception of Sponsor Confidential Information, shall be treated as confidential by Sponsor in accordance with the terms contained herein. 

10.3 Use of Sponsor Confidential Information and PPD Confidential Information. Each party shall use the other’s Confidential
Information solely for the purposes contemplated by this Agreement and for no other purpose without the prior written consent of the other party. Neither party shall publish, disseminate or otherwise disclose Confidential Information of the other to
any third party without first obtaining the written consent of such other party. Each party shall restrict the dissemination of the other’s Confidential Information with its organization to only those persons who have a need to know, and shall
ensure that all of its directors, officers, employees, agents, representatives and advisors (collectively, “Agents”) are aware of this Agreement and bound by the terms of confidentiality stated herein. 

 

  

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 PPD PROPRIETARY AND CONFIDENTIAL 

 
  

 10.4 Exceptions to Confidential Information. The above provisions of
confidentiality shall not apply to that part of disclosing party’s Confidential Information which the receiving party is able to demonstrate by documentary evidence: (i) was in the receiving party’s possession prior to receipt from
the disclosing party or is independently developed by the receiving party; (ii) was in the public domain at the time of receipt from disclosing party; (iii) subsequently becomes a part of the public domain through no fault of the receiving
party or its Agents; and (iv) is lawfully received by the receiving party from a third party having a right of further disclosure. 

10.5 Disclosure Required by Law. The non-disclosure obligations pursuant to this Agreement shall not apply to Confidential
Information that a receiving party is required to disclose pursuant to any law, stock exchange regulation, judicial action, or order of the court or other governmental agency; provided, however, that the receiving party shall make all reasonable
efforts to notify the disclosing party prior to the disclosure of Confidential Information and allow the disclosing party the opportunity to contest and avoid such disclosure, and further provided that the receiving party shall disclose only that
portion of such Confidential Information that it is legally required to disclose. 
 10.6 Return of PPD Information. Upon
the disclosing party’s written request, the receiving party shall return, and shall cause its Agents to return, all documentary, electronic or other tangible forms of Confidential Information provided by the disclosing party including, without
limitation, any and all copies thereof, or, at the disclosing party’s request, destroy all or such parts of the disclosing party’s Confidential Information as the disclosing party shall direct. Notwithstanding the foregoing, the receiving
party may retain copies of such of the disclosing party’s Confidential Information as is reasonably necessary for regulatory and business archival purposes, subject to the ongoing obligation to maintain the confidentiality of such information.

 10.7 Remedy. Each party agrees that its obligations hereunder are necessary and reasonable in order to protect the
other party and the other party’s business, and expressly agrees that monetary damages would be inadequate to compensate the other party for any breach of the terms of this Agreement. Accordingly, each party agrees and acknowledges that any
such violation or threatened violation will cause irreparable injury to the other party, and that, in addition to any other remedies that may be available, in law, in equity or otherwise, the other party shall be entitled to obtain injunctive relief
against the threatened breach of this Agreement or a Project Addendum or the continuation of any such breach, without the necessity of proving actual damages. 

10.8 Privacy Laws. All information containing personal data shall be handled in accordance with all applicable privacy laws, rules
and regulations, including, without limitation, the European Data Protection Directive [EC/95/46] and Health Insurance Portability Accountability Act (HIPAA). 
  

	11.	INTELLECTUAL PROPERTY. 

11.1 No License. Neither anything contained herein, or the delivery of any information to a party hereto, shall be deemed to grant
the receiving party any right or license under any patent or patent application or to any know-how, technology or invention of the disclosing party. 

11.2 Sponsor Property. Subject to Section 11.3 below, PPD agrees that Sponsor owns and PPD hereby assigns, without additional
consideration, to Sponsor all right, title and interest PPD or its Agents may have in any Deliverables, discoveries, developments, inventions, improvements, technology, know-how, works of authorship, mask works, ideas, information or other
intellectual property made or reduced to practice by PPD (i) a result of PPD’s provision of the Services or (ii) set forth as a deliverable under a Project Addendum (“Sponsor Inventions”). PPD shall promptly disclose Sponsor
Inventions to Sponsor. PPD agrees that any Sponsor Inventions which are works of authorship subject to copyright shall be “works made for hire” of which Sponsor shall be deemed the author and owner of the rights comprised in copyright. PPD
will execute and will cause its employees, agents and subcontractors to execute any instruments or testify as Sponsor deems necessary for Sponsor to protect Sponsor’s interest in a Sponsor Invention, at Sponsor’s sole cost and expense.

  

  

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 11.3 PPD Property. PPD possesses certain inventions, processes, technology,
know-how, trade secrets, improvements, other intellectual property and assets, including, without limitation, those related to business or product plans or proposals, marketing strategies, standard operating procedures, data, composition of matter,
research, experimental results, personnel data, financial information and conditions, pricing information, customer information, supplier/vendor information, raw materials, data collection and data management processes, laboratory analyses,
analytical, biotechnology and clinical methods, procedures and techniques, computer technical expertise and software (including code) which have been independently developed without the benefit of any information provided by Sponsor (collectively,
“PPD Property”). Sponsor and PPD agree that any PPD Property or revisions, improvements or enhancements thereto shall be the sole and exclusive property of PPD, and Sponsor shall have no rights, title and interest to such PPD
Property. PPD hereby grants to Sponsor a perpetual, fully paid, non-exclusive license, with the right to sublicense, to use any PPD Property contained in a Deliverable solely in connection with the use of such Deliverable as necessary for the full
development and commercialization of the subject matter of the Project. Sponsor shall enforce the terms of any such sublicense as agreed upon by the PPD and Sponsor or as otherwise reasonably necessary to limit the use of the PPD Property as stated
herein and/or to protect PPD’s interest in the PPD Property. 
  

	12.	INDEMNIFICATION. 

12.1 Sponsor Indemnity. Sponsor shall indemnify, defend, and hold harmless PPD, PPD Affiliates (as that term is defined in
Section 17.11), and their Agents (“PPD Indemnitees”) from and against any and all damages, liabilities, losses, fines, penalties, settlement amounts, costs and expenses of any kind or nature whatsoever,
including, without limitation, reasonable attorneys’ fees, expert witness fees, court costs, and amounts incurred by PPD Indemnitees under indemnity obligations imposed upon it by a third party provider to a Project where such third party
provider has been approved by Sponsor, incurred in connection with any claim, demand, action, proceeding, investigation or hearing (collectively, a “Claim”) directly or indirectly relating to or arising from this Agreement or
any Services provided by PPD Indemnitees hereunder, including but not limited to, Project related services provided by PPD at the request of Sponsor yet prior to finalization of the relevant Project Addendum; provided however, that Sponsor shall
have no obligation of indemnity hereunder to the extent any Claim arose from the negligence, intentional misconduct or material breach of Agreement on the part of PPD or its Agents. 

12.2 PPD Indemnity. PPD shall indemnify, defend and hold harmless Sponsor and its Agents from and against any and all damages,
liabilities, losses, fines, penalties, settlement amounts, cost and expenses of any kind or nature whatsoever, including, without limitation, reasonable attorney’s fees, expert witnesses and court costs, incurred in connection with any Claim
arising from the negligence, intentional misconduct, or material breach of Agreement of PPD or its Agents; provided however, that PPD shall have no obligation of indemnity hereunder to the extent any Claim arose from the negligence, intentional
misconduct or material breach of Agreement on the part of Sponsor or its Agents. 
 12.3 Indemnification Procedure. Each
indemnified party shall give the indemnifying party prompt notice of any Claim for which indemnification is sought hereunder. The indemnifying party shall have the right to control the defense and settlement of a Claim, provided the indemnifying
party shall act reasonably and in good faith with respect to all matters relating to the settlement or disposition of the Claim, and the indemnified party shall reasonably cooperate in the investigation, defense and settlement of such Claim. Any
indemnified party shall have the right to participate in, but not control, the defense and settlement of a Claim and to employ separate legal counsel of its own choice; provided, however, that such employment shall be at the indemnified party’s
own expense, unless (i) the employment thereof has been specifically authorized by the indemnifying party, or (ii) the indemnifying party has failed to assume the defense and employ counsel (in which case the indemnified party shall
control the defense and settlement of such Claim). The costs and expenses, including reasonable fees and disbursements of counsel, incurred by any indemnified party in connection with any Claim shall be reimbursed on a monthly basis by the
indemnifying party subject to refund in the event the indemnifying party is ultimately held not to be obligated to indemnify the indemnified party. 
  

  

12 

 PPD PROPRIETARY AND CONFIDENTIAL 

 
  

	13.	REPRESENTATIONS AND WARRANTIES. 

 

	 	13.1.	PPD covenants, represents and warrants to Sponsor that as of the Effective Date: 

 

	 	13.1.1	PPD has full power and authority to enter into and perform this Agreement; 

 

	 	13.1.2	neither PPD’s entering or performing this Agreement will violate any right of or breach any obligation to any third party under any agreement or arrangement
between PPD and such third party; 

  

	 	13.1.3	no licenses, permissions or releases of third party rights are necessary for PPD’s development of or Sponsor’s production or distribution of any work product,
including but not limited to any Deliverable, generated under the Project Addenda or other currently anticipated exercise of its rights hereunder in accordance with the terms of this Agreement (the parties acknowledge that this representation and
warranty in no way relates to Sponsor’s use of any compound in any Project, including, but not limited to, any Sponsor proprietary compound); 

  

	 	13.1.4	with respect to all copyrightable matter licensed or assigned hereunder that was created by persons who were employees of PPD at the time of creation, no third party
has or will have “moral rights” or rights to terminate any assignment or license with respect thereto; 

  

	 	13.1.5	the work under this Agreement will be performed in a professional and workman-like manner; 

 

	 	13.1.6	PPD has and will obtain agreements with its employees and Agents sufficient to allow it to provide Sponsor with the assignments and licenses to Sponsor Inventions;

  

	 	13.1.7	performance of the Services hereunder will not result in any third party acquiring any rights, title or interest in or to any Sponsor Inventions or Deliverable
generated by PPD pursuant to this Agreement; and 

  

	 	13.1.8	all PPD employees, Agents related to performance of Services under this Agreement and Project Addenda have not been or are not currently debarred, and has not been
convicted of a crime which could lead to debarment, under the Generic Drug Enforcement Act of 1992, 21 U.S.C. § 335a(a) or disqualified as a testing facility under the provisions of 21 C.F.R. Part 58, Subpart K; or disqualified as a
clinical investigator under the provisions of 21 C.F.R. § 312.70 or equivalent laws or regulations outside the US. If PPD or any of its Agents who perform Services for a Project is debarred or receives notice of an action or threat of action of
debarment, PPD shall immediately notify Sponsor of same. The debarment of PPD or any of its Agents (which are providing services to Sponsor on a Project under this Agreement) that remains in place for a period of at least thirty (30) days shall
be deemed to be a material breach of this Agreement, unless, with respect to the debarment of an Agent providing services to Sponsor hereunder, PPD is able to replace the Agent within such 30-day period, in which case the debarment of the replaced
Agent shall not be a material breach of this Agreement. In addition, PPD represents and warrants to Sponsor that upon the effective date of delivery of a Service or Deliverable hereunder, such Service and/or Deliverable does not, to PPD’s
actual knowledge, infringe the intellectual property rights of any third party. 

 13.2 Representative.
With regard to any Study conducted under this Agreement, Sponsor represents and warrants that it shall not name any PPD employee or other PPD representative on Line 15 of Form FDA 1571 or as the Senior Medical Officer in Canada on Line 87 of Form
HC/SC 3011 or in any similar capacity for clinical trials conducted in other countries. Sponsor acknowledges and understands that if Sponsor desires PPD to be responsible for review and evaluation of information relevant to the safety of the drug,
Sponsor will have to enter into a separate contract with PPD for the provision of these services. 
  

  

13 

 PPD PROPRIETARY AND CONFIDENTIAL 

 
  

	14.	LIMITATION OF LIABILITY. 

EXCEPT FOR CLAIMS OF PATENT INFRINGEMENT, BREACHES OF SECTION 10 AND THE INDEMNIFICATION PROVIDED ABOVE IN SECTION 12, NEITHER PARTY
SHALL BE LIABLE FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL OR INDIRECT DAMAGES OF THE OTHER PARTY, ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT (OR THE TERMINATION HEREOF) OR ANY PROJECT ADDENDUM, INCLUDING, WITHOUT LIMITATION, LOSS OF
PROFITS OR ANTICIPATED SALES. 
  

	15.	RECORD STORAGE. 

15.1 Record Maintenance during Project. During the term of this Agreement, PPD shall maintain all materials and all other data
obtained or generated by PPD in the course of providing the Services hereunder, including all computerized records and files, in accordance with applicable laws and guidelines. PPD shall cooperate with any reasonable internal review or audit by
Sponsor and make available to Sponsor for examination and duplication, during normal business hours and at mutually agreeable times, all documentation, data and information relating to a Project. 

15.2 Record Maintenance after Expiration or Termination. Upon the expiration or termination of this Agreement other than for
Sponsor’s breach of required payment hereunder, all materials and all other data and information obtained or generated by PPD in the course of providing the Services hereunder (collectively, the “Records”) shall, at
Sponsor’s option, be (i) delivered to Sponsor at its expense and risk to its offices identified herein in such form as is then currently in the possession of PPD, (ii) retained by PPD for Sponsor for a period of ten (10) years,
or (iii) disposed of at Sponsor’s expense, as directed by written request of Sponsor, unless the Records are otherwise required to be stored or maintained by PPD under applicable law. If PPD is required or requested to maintain and/or
store the Records for a period beyond three (3) years after the termination or expiration of this Agreement, Sponsor shall reimburse PPD for its maintenance and storage costs. In no event shall PPD dispose of Records without first giving
Sponsor sixty (60) days prior written notice of its intent to dispose of the Records. PPD shall be entitled at its expense to retain copies of the Records reasonably necessary for regulatory purposes or to demonstrate the satisfaction of its
obligations hereunder, all subject to the confidentiality obligations set forth in Section 10 above. 
 15.3 Specimen
Maintenance after Expiration or Termination. Any study specimen sent to PPD will be maintained as directed by Sponsor during the course of providing the Services. Three (3) months after final data transfer, or termination of the Services,
all study specimens will be returned to Sponsor, or destroyed upon Sponsor’s written request, in either instance at Sponsor’s sole expense and risk, unless the relevant Project Addenda provide for a different agreed upon duration, and
compensation therefore. In no event shall PPD dispose of study specimens without first giving Sponsor sixty (60) days prior written notice of its intent to dispose of the specimens. 

15.4 Regulatory Inspection. If any governmental or regulatory authority notifies PPD that it will inspect PPD’s records,
facilities, equipment, or procedures, or otherwise take action related to this Agreement or a Project Addendum, PPD shall notify Sponsor within two (2) business days and prior to the inspection or action, allow the authority to conduct an
inspection or take other legal action, allow Sponsor to be present at the inspection or participate in any response to the action, and provide Sponsor with copies of any reports issued by the authority and PPD’s proposed response for
Sponsor’s prior review and approval, such approval not to be unreasonably withheld. 
 15.5 Study Investigators. If
PPD becomes aware of any material issues related to the performance of a Study investigator or other Study staff, including without limitation any governmental or regulatory authority notification to a Study investigator that it will inspect the
study investigator’s records, facilities, equipment, or procedures, or otherwise take action related to a Sponsor study, PPD shall notify Sponsor within two (2) business days and prior to the inspection or action, and will cooperate with
Sponsor regarding responsive action. 
  

  

14 

 PPD PROPRIETARY AND CONFIDENTIAL 

 
  

	16.	CURRENCY MANAGEMENT. 

16.1 Direct Fees. All Direct Fees owed to PPD for Services performed under this Agreement or any Project Addendum shall be invoiced
to and paid by Sponsor in the “Contract Currency”, which shall be defined as United States Dollars (“USD”) unless otherwise agreed upon by the parties. 

In the event PPD provides Services in a region in which the PPD rates are in a currency other than USD, PPD shall specify in the
applicable proposal and associated contract the exchange rate or rates (“Exchange Rate”) used to prepare the budget or payment schedule for such Project Addendum. This Exchange Rate will be the one used for the preparation of
each invoice for Services and payment by the Sponsor. 
 16.2 Pass Through Costs. Where PPD incurs Pass Through Costs in
a currency other than the Contract Currency, PPD shall, for Sponsor invoicing and payment purposes, convert such costs to the Contract Currency based on an average exchange rate between the local currency and the Contract Currency for the month in
which such costs were incurred. 
 16.3 Investigator Fees. PPD shall pay investigator fees in the currency specified in
the investigator agreements. For Sponsor invoicing and payment purposes, PPD shall convert all investigator fees that are to be paid in a currency other than the Contract Currency to the Contract Currency. The conversion to the Contract Currency
shall be based on an average exchange rate between the currency specified in an investigator agreement and the Contract Currency for the month prior to the month the Sponsor invoice is issued. All amounts invoiced to Sponsor will be based upon an
accrual of costs owed to investigators. At the end of the project a reconciliation will be completed between the estimated exchange rate used for the purposes of billing on the basis of the accrued costs versus the exchange rate when the actual
payment is made to the sites, and any variation will be billed or credited to the Sponsor as applicable. 
  

	17.	MISCELLANEOUS. 

17.1 Independent Contractor Relationship. The parties hereto are independent contractors, and nothing contained in this Agreement
is intended, and shall not be construed, to place the parties in the relationship of partners, principal and agent, employer/employee or joint venturer. Neither party shall have any right, power or authority to bind or obligate the other, nor shall
either hold itself out as having such right, power or authority. 
 17.2 Publicity. Neither party shall mention or
otherwise use the name, insignia, symbol, trademark, trade name or logotype of the other party (or any abbreviation or adaptation thereof) in any publication, press release, promotional material or other form of publicity without the prior written
approval of the other party in each instance, except that Sponsor shall have the right to identify PPD as its contract research organization. The restrictions imposed by this Section shall not prohibit a party from making any disclosure identifying
the other party that is required by any applicable law, rule or regulation. 
 17.3 Publication. PPD may not publish any
articles or make any presentations relating to the Services provided to Sponsor hereunder with respect to a Project or referring to data, information or materials generated as part of the Services without the prior written consent of Sponsor.

 17.4 Insurance. Sponsor and PPD each will maintain insurance in types and amounts reasonably adequate to cover any
liabilities arising out of its obligations hereunder, and, upon request, each party will provide to the other party a certificate of insurance showing that such insurance is in place, which certificate shall demonstrate the amounts, exclusions and
deductibles of such insurance coverage. 
  

  

15 

 PPD PROPRIETARY AND CONFIDENTIAL 

 
  

 17.5 Force Majeure. If either party shall be delayed, hindered, or prevented from
the performance of any act required hereunder by reason of strike, lockouts, labor troubles, restrictive governmental or judicial orders or decrees, riots, insurrection, war, acts of God, inclement weather, or other cause beyond such party’s
reasonable control (each, a “Disability”), then performance of such act shall be excused for the length of time necessary to cure such Disability and resume performance. A party shall not be liable for any delays resulting
from a Disability, and any affected timelines shall be extended for a period at least equal to that of the Disability. The party incurring the Disability shall provide notice to the other of the commencement and termination of the Disability.

 17.6 Notices. Any notice required or permitted to be given hereunder by either party hereto shall be in writing and
shall be deemed given on the date delivered if delivered (i) personally, (ii) on the first business day after the date sent if sent by recognized overnight courier, (iii) on the date transmitted if sent via facsimile (with
confirmation of receipt generated by the transmitting machine), or (iv) on the second business day after the date deposited if mailed by certified mail, return receipt requested, postage prepaid. All notices to each party shall be sent to the
address for said party set forth in the applicable Project Addendum. If no address is provided in the Project Addendum, then notices shall be sent to the following address: 

 

			
	If to PPD:	  	PPD Development, LP
		  	929 North Front Street
		  	Wilmington, North Carolina 28401
		  	Attention: CEO
		  	Tel: (910) 251-0081
		  	Fax: (910) 762-5820
		
	If to Sponsor:	  	Furiex Pharmaceuticals, Inc.
		  	3900 Paramount Parkway, Suite 150
		  	Morrisville, North Carolina 27560
		  	Attention: CMO
		  	Tel: (919) 456-7800
		  	Fax:_______________

 Either party may change its notice
address by notice to the other party hereto in the form and manner provided in this Section 17.6. 
 17.7 Governing
Law. This Agreement and the rights and obligations of the parties hereunder shall be governed by and construed in accordance with the laws of the State of North Carolina without reference to its conflicts of laws provisions. 

17.8 Severability. If any provision of this Agreement or any Project Addendum is held to be illegal, invalid or unenforceable
under any present or future law, and if the rights or obligations of any party hereto under this Agreement or such Project Addendum will not be materially or adversely affected thereby, (a) such provision will be fully severable, (b) this
Agreement or such Project Addendum will be construed and enforced as if such illegal, invalid or unenforceable provision had never compromised a part hereof, (c) the remaining provisions of this Agreement or such Project Addendum will remain in
full force and effect and will not be affected by the illegal, invalid or unenforceable provision or by its severance herefrom, and (d) in lieu of such illegal, invalid or unenforceable provision, there will be added automatically as a party of
this Agreement or such Project Addendum, a legal, valid and enforceable provision as similar in terms as to such illegal, invalid or unenforceable provision as may be possible and reasonably acceptable to the parties herein. 

 

  

16 

 PPD PROPRIETARY AND CONFIDENTIAL 

 
  

 17.9 Waiver. Any term or condition of this Agreement or a Project Addendum may be
waived at any time by the party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the party waiving such term or condition. No waiver by any party
hereto of any term or condition of this Agreement or a Project Addendum, in any one or more instances, shall be deemed to be or construed as a waiver of the same or any other term or condition of this Agreement or such Project Addendum on any future
occasion. 
 17.10 Amendments. No amendment, change or modification to this Agreement or any Project Addendum shall be
effective unless in writing and executed by the parties hereto. 
 17.11 Assignment and Subcontracting. This Agreement
and any Project Addendum may not be assigned or transferred by either party without the prior written consent of the other party; provided, however, that (i) a party hereto may assign this Agreement or a Project Addendum hereunder to a
successor-in-interest to the party’s business and (ii) PPD may assign this Agreement or a Project Addendum or subcontract all or part of the Services to be performed hereunder to PPD Affiliates. “PPD Affiliates” shall mean
entities which can provide the Services and which controls, is controlled by or is under common control with PPD or PPD’s parent company Pharmaceutical Product Development, Inc. In the event the Services shall be performed by a PPD Affiliate,
such PPD Affiliate may be the contracting party to any Project Addendum for the Services. 
 17.12 Arbitration.

  

	 	17.12.1	 	Except for disputes regarding breaches of Section 10 and the right to pursue the remedies set forth in Section 10.7 above, the parties hereby agree to submit
any dispute, claim or controversy arising hereunder to binding arbitration pursuant to the Non-Administered Arbitration Rules then in effect of the International Institute for Conflict Prevention and Resolution (“CPR”) (available at
http://www.cpradr.org), or successor, except where those rules conflict with these provisions, in which case these provisions control. The arbitration shall be conducted in Raleigh, North Carolina. 

 

	 	17.12.2	 	The panel shall consist of three arbitrators chosen from the CPR Panels of Distinguished Neutrals (unless the parties agree on the selection of the arbitrators) each of
whom shall be a lawyer with at least fifteen (15) years experience with a law firm or corporate law department of over twenty-five (25) lawyers or who was a judge of a court of general jurisdiction. In the event the aggregate damages
sought by the claimant are stated to be less than $5 million, and the aggregate damages sought by the counterclaimant are stated to be less than $5 million, and neither side seeks equitable relief, then a single arbitrator shall be chosen, having
the same qualifications and experience specified above. Each arbitrator shall be impartial and independent of the parties and shall abide by the Code of Ethics for Arbitrators in Commercial Disputes (available at
http://www.adr.org/EthicsAndStandards). 

  

	 	17.12.3	 	In the event the parties cannot agree upon selection of the arbitrator(s), the CPR will select arbitrator(s) as follows: CPR shall provide the parties with a list of no
less than twenty-five (25) proposed arbitrators (15 if a single arbitrator is to be selected) having the credentials referenced above. Within 15 days of receiving such list, the parties shall rank at least 65% of the proposed arbitrators on the
initial CPR list, after exercising cause challenges. The parties may then jointly interview the five candidates (three if a single arbitrator is to be selected) with the highest combined rankings for no more than one hour each and, following the
interviews, may exercise one peremptory challenge each. The panel will consist of the remaining three candidates (or one, if one arbitrator is to be selected) with the highest combined rankings. In the event these procedures fail to result in
selection of the required number of arbitrators, CPR shall select the appropriate number of arbitrators from among the members of the various CPR Panels of Distinguished Neutrals, allowing each side challenges for cause and one peremptory challenge
each. 

  

  

17 

 PPD PROPRIETARY AND CONFIDENTIAL 

 
  

	 	17.12.4	 	The parties agree to cooperate (i) to attempt to select the arbitrator(s) by agreement within twenty-five (25) days of initiation of the arbitration,
including jointly interviewing the final candidates, (ii) to meet with the arbitrator(s) within twenty-five (25) days of selection and (iii) to agree at that meeting or before upon procedures for discovery and as to the conduct of the
hearing which will result in the hearing being concluded within no more than six (6) months after selection of the arbitrator(s) and in the award being rendered within thirty (30) days of the conclusion of the hearings, or of any post
hearing briefing, which briefing will be completed by both sides within twenty (20) days after the conclusion of the hearings. 

  

	 	17.12.5	 	In the event the parties cannot agree upon procedures for discovery and conduct of the hearing meeting the schedule set forth in paragraph 17.12.4 above, then the
arbitrator(s) shall set dates for the hearing, any post hearing briefing, and the issuance of the award following the paragraph 17.12.4 schedule as closely as practical. The arbitrator(s) shall provide for discovery according to those time limits,
giving recognition to the understanding of the parties that they contemplate reasonable discovery, including document demands and depositions, but that such discovery will be limited so that the paragraph 17.12.4 schedule may be met without
difficulty. In no event will the arbitrator(s), absent agreement of the parties, allow more than a total of ten days for the hearing or permit either side to obtain more than a total of forty (40) hours of deposition testimony from all
witnesses, including both fact and expert witnesses, or serve more than twenty (20) individual requests for documents, including subparts. There shall be no requests for admission or interrogatories. Multiple hearing days will be scheduled
consecutively to the greatest extent possible. The arbitrator(s) shall have power to exclude evidence on grounds of hearsay, prejudice beyond its probative value, redundancy, or irrelevance and no award shall be overturned by reason of any ruling on
evidence. A transcript of the testimony adduced at the hearing shall be made and shall, upon request, be made available to either party. 

  

	 	17.12.6	 	The arbitrator(s) are expressly empowered to decide dispositive motions in advance of any hearing, including but not limited to motions to dismiss and motions for
summary judgment, and shall endeavor to decide such motions as would a Federal District Judge sitting in the jurisdiction whose substantive law governs as set forth in clause 17.12.7 below. 

 

	 	17.12.7	 	The arbitrator(s) shall decide the issues presented in accordance with the substantive law of North Carolina and may not apply principles such as “amiable
compositeur” or “natural justice and equity.” The arbitrator(s) shall render a written opinion stating the reasons upon which the award is based. To the extent possible, the arbitration hearings and award will be maintained in
confidence. 

  

	 	17.12.8	 	In the event the award exceeds $2 million in monetary damages, or grants any form of equitable relief, or rejects a claim in excess of that amount or for equitable
relief, then the losing party may obtain review of the arbitrators’ award or decision by a single appellate arbitrator (the “Appeal Arbitrator”) selected from the CPR Panels of Distinguished Neutrals by agreement or, failing agreement
within ten (10) working days, pursuant to the selection procedures specified in paragraph 17.12.4 above. If CPR cannot provide such services, the parties will together select another provider of arbitration services that can. No Appeal
Arbitrator shall be selected unless he or she commits to adhering to the time limits provided in paragraph 17.12.9. Any such review must be initiated by written notice to the other party or parties within twenty (20) days following the
rendering of the award referenced in 17.12.7 above. Such notice will suspend the effect of the award, which will not be considered a final award unless the appeal is subsequently abandoned. 

 

  

18 

 PPD PROPRIETARY AND CONFIDENTIAL 

 
  

	 	17.12.9	 	The Appeal Arbitrator will review the award applying the same standards of review that the U.S. Court of Appeals of the Circuit applicable to the jurisdiction whose
substantive law governs as set forth in section 17.12.7 would apply to a judgment rendered by a district court after a bench trial. The Appeal Arbitrator may modify, vacate or affirm the award, or remand to the arbitrator(s) for further
proceedings. The Appeal Arbitrator will consider only the award, pertinent portions of the hearing transcript and evidentiary record as submitted by the parties, opening and reply briefs of the party pursuing the review, and the answering brief of
the opposing party, plus a total of no more than four (4) hours of oral argument evenly divided between the parties. The party seeking review must submit its opening brief within fifty (50) and any reply brief within ninety (90) days
from the date of the award under review, whereas the opposing party must submit its responsive brief within seventy-five (75) days of that date. Oral argument shall take place within three (3) months after the date of the award under
review, and the Appeal Arbitrator shall render a decision within thirty (30) days following oral argument. The decision of the Appeal Arbitrator will be considered the final award in the arbitration and will not be subject to further review,
except pursuant to the Federal Arbitration Act. 

  

	 	17.12.10	 	The parties consent to the jurisdiction of the Federal District Court for the district in which the arbitration is held for the enforcement of these provisions and the
entry of judgment on any award rendered hereunder (including after review by the Appeal Arbitrator where such an appeal is pursued). Should such court for any reason lack jurisdiction, any court with jurisdiction may act in the same fashion.

  

	 	17.12.11	 	Each party has the right before or, if the arbitrator(s) cannot hear the matter within an acceptable period, during the arbitration to seek and obtain from the
appropriate court provisional, injunctive, or equitable remedies such as attachment, preliminary or temporary injunction, replevin, etc. to avoid irreparable harm, maintain the status quo, or preserve the subject matter of the arbitration.

  

	 	17.12.12	 	The decision of the arbitrator or arbitration panel shall be final and binding upon the parties hereto and shall be enforceable by any court of competent jurisdiction.

 17.13 Construction. Except where the context otherwise requires, wherever used the singular shall
include the plural, the plural the singular, the use of any gender shall be applicable to all genders and the word “or” is used in the inclusive sense. The captions of this Agreement are for convenience of reference only and in no way
define, describe, extend or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement. The language of this Agreement shall be deemed to be the language mutually chosen by the parties and no rule of
strict construction shall be applied against either party hereto. 
 17.14 Counterparts and Facsimile Signatures. This
Agreement, and any subsequent amendment(s), may be executed in counterparts and the counterparts, together, shall constitute a single agreement. A facsimile transmission of this signed Agreement bearing a signature on behalf of a party shall be
legal and binding on such party. 
  

  

19 

 PPD PROPRIETARY AND CONFIDENTIAL 

 
  

 17.15 Use of Copyrighted Materials. If in connection with Services, Sponsor
requests PPD to make and/or distribute copies of copyrighted materials such as journal articles or excerpts from publications, Sponsor agrees to pay the cost of any copyright fees incurred by PPD that are necessary for PPD to produce and distribute
such copies. Sponsor shall indemnify PPD for any and all damages, losses, costs, including, without limitation, reasonable attorneys’ fees, which PPD incurs as a result of making and/or distributing copyrighted material pursuant to
Sponsor’s request. 
 17.16 Entire Agreement. This Agreement constitutes the entire agreement between the parties
and supersedes all prior negotiations, representations or agreements, either written or oral, with respect to the subject matter hereof. 

IN WITNESS WHEREOF, this Agreement has been executed and delivered by the parties hereto by their duly authorized officers as of the date
first above written. 
  

									
	 PPD DEVELOPMENT, LP
	 		 	FURIEX PHARMACEUTICALS, INC.
	 By:
	 	PPD GP, LLC	 		 		 	
	 Its:
	 	General Partner	 		 		 	
					
	 By:
	 	  
	 		 	By:	 	  

					
	 Name:
	 	  
	 		 	Name:	 	  

					
	 Title:
	 	  
	 		 	Title:	 	  

 

  

20

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