Document:

License Agreement by and among PPD, GenuPro, Inc. and ALZA Corporation

 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 2nd day of January, 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: 

 

 1 

 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. 
  

 2 

 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. 

 

 3 

 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. 

 

 4 

 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 
  

 5 

 
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 

 

 6 

 
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. 

 

 8 

 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. 
  

 9 

 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. 

 

 10 

 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. 

 

 11 

 (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 a fraction whose denominator is the sum of Licensee’s, its Affiliates’ or sublicensees’ published sales prices in such country for equivalent dosages of all active ingredients contained in a given Combination Product,
and whose numerator is Licensee’s, its Affiliates’ or sublicensees’ published sale price in such country for equivalent dosages of the Compound contained in the Combination Product. 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 Licensee receives regulatory approval for use of a Licensed Product for an indication in the Field other than premature ejaculation (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 recoups its fully burdened development costs to obtain regulatory approval in the first country in the Territory for which regulatory approval is obtained for the New Formulation or Use. New
Formulation or Use shall include any formulation except the first formulation marketed in the Territory. 
  (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. 

 

 14 

 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). 
  

 15 

 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. 

 

 18 

 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. 

 

 19 

 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. 
  

 21 

 (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. 

 

 22 

 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 ChairmanOption License Agreement

 Exhibit 10.13 

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

OPTION AND LICENSE AGREEMENT 

THIS OPTION AND LICENSE AGREEMENT (the “Agreement”) is effective as of the
15th day of December, 2006 (the “Effective
Date”) by and among PHARMACO INVESTMENTS, INC., a Delaware corporation having a place of business at 3151 South Seventeenth Street, Wilmington, North Carolina 28412 (referred to hereinafter as “PII”), a wholly owned subsidiary of
Pharmaceutical Product Development, Inc., a North Carolina corporation having its principal place of business at 3151 South 17th Street, Wilmington, NC 28412 (“PPD”), and RANBAXY LABORATORIES LTD., a corporation incorporated, organized and
operating under the laws of India and having a place of business at Plot 90, Sector 32 Gurgaon 122001 (Haryana), India (hereinafter “RBX”). PII and RBX are sometimes referred to herein individually as a “Party” and collectively
as the “Parties.” PPD is a Party to this Agreement for the sole and limited purpose of agreeing to be bound by Section 12.19 of this Agreement. 

WITNESSETH THAT: 

WHEREAS, RBX has performed research and development with respect to a [*] identified as [*]; 

WHEREAS, PII wishes to enter into an agreement to obtain an exclusive option to acquire an exclusive license to RBX Intellectual Property (as defined
below) and to develop and market therapeutic products incorporating the Compound made in accordance therewith; and 
 WHEREAS, RBX is willing to
grant such exclusive option to acquire an exclusive license to PII under the terms and conditions set forth in this Agreement. 
 NOW,
THEREFORE, PII and RBX hereby agree as follows: 
 ARTICLE I – DEFINITIONS 

1.01. “AB Rated Product” means a product which has been approved by a Regulatory Agency having an approved application that contains
adequate scientific evidence establishing, through in vitro and/or in vivo studies, the bioequivalence of such product to a Licensed Product developed under this Agreement and which product contains the same active
pharmaceutical ingredient as such Licensed Product. 
 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. 
  

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

 1.03. “API” means active pharmaceutical ingredient. 

1.04. “Clinical Studies” means Phase I Clinical Studies, Phase II Clinical Studies, Phase III Clinical Studies, and/or Post-Registration
Studies. 
 1.05. “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. 
 1.06. “Complete” or
“Completion”, when used to describe a clinical study, shall mean the date when all data and results of such study have been collected and the final study report has been completed. 

1.07. “Compound” means: (a) [*]; (b) any pharmaceutically acceptable salt of the foregoing; (c) any active
metabolite of the foregoing; (d) any isomer of the foregoing; (e) any enantiomer of the foregoing; and (f) any prodrug of the foregoing. 

1.08. “Compound Know-How” means any Know-How, including Manufacturing Know-How, that is Controlled by RBX and is necessary for the
development of the Compound or a Licensed Product. 
 1.09. “Confidential Information” shall have the meaning set forth in
Section 9.01. 
 1.10. “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. 
 1.11. “CTM Product” means the Compound together with any formulation
ingredients in a finished pharmaceutical dosage form suitable for administration and dosing to humans in Clinical Studies, 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). 
 1.12. “Develop” or
“Development” means conducting in vitro and/or in vivo pre-clinical investigations and Clinical Studies of the Compound (including the manufacture of CTM Product and Drug Substance) and the Licensed
Products (including any placebo), and preparing, submitting and prosecuting all applications to obtain Regulatory Approval of the Licensed Products for sale in the Field in the Territory. 

 
  

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

 

 2 

 1.13. “Development Plan” means the initial plan to Develop the first Licensed Product for
the Indication, attached hereto as of the Effective Date as Schedule 1.13, as such Development Plan may be modified or updated in accordance with Section 4.01. 

1.14. “Diligent Efforts” means the carrying out by PII, its Affiliate, sublicensee or Third Party Partner of obligations or tasks in a
sustained and continuous manner consistent with the efforts a reasonable Third Party, engaged in the development and commercialization of pharmaceutical products for human use, ordinarily devotes (including meeting the timelines for development and
commercialization) to a research, development or marketing project for a pharmaceutical product or products of similar market potential, profit potential or strategic value to that of the Compound based on conditions then prevailing. Diligent
Efforts includes without limitation, using commercially reasonable efforts to sublicense the licenses granted under this Agreement to a Third Party for the continued development, manufacture and commercialization of the Compound and the Licensed
Products. Notwithstanding the foregoing, the requirement to exercise “Diligent Efforts” does not require that PII conduct Clinical Studies or other Development studies relating to the Compound of the size and scope previously conducted by
Third Party pharmaceutical companies to obtain Regulatory Approval of statin products for the Indication, except to the extent PII is otherwise required to do so by the FDA. Without limiting the Parties’ rights under Section 12.18,
the Parties understand and agree that delays resulting from the occurrence of Force Majeure events or Interfering Events shall not be grounds for RBX to claim a failure to use Diligent Efforts or that a material breach of this Agreement has
occurred; provided, however, that (i) PII uses Diligent Efforts to avoid the occurrence of such delays, and (ii) uses Diligent Efforts to reduce the impact of such delays following their occurrence. 

1.15. “Drug Substance” means the Compound suitable for administration and dosing to a human. 

1.16. “EMEA” means the European Medicine Agency. 

1.17. “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. 

1.18. “FDA” means the United States Food and Drug Administration, or any successor thereto. 

1.19. “FD&C Act” means the United States Food, Drug and Cosmetic Act, as amended and the rules and regulations of the FDA
promulgated thereunder. 
 1.20. “Field” means all human uses. 

1.21. “First Commercial Sale” means the first transaction following Regulatory Approval of a Licensed Product in which PII, its
Affiliate, sublicensee or Third Party Partner transfers physical possession and title to such 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, clinical development or testing only purposes shall not constitute the First Commercial Sale. 
  

 3 

 1.22. “Force Majeure” shall mean conditions or events that are beyond the control of
a Party or any Third Party vendors, sublicensee or Third Party Partner of PII, including, without limitation, fire, flood, earthquake, storm, war, acts of God, accident, voluntary or involuntary compliance with any regulation, law or order of any
government, civil commotion, labor strike or lock-out, epidemic, failure or default of public utilities or common carriers, explosion and/or any other cause or externally induced casualty beyond such Party’s control; provided,
however, that except as specifically provided above, Force Majeure shall not include delays caused by the conduct of Third Party vendors, sublicensees or a Third Party Partner of PII in the Development, Regulatory Approval or
commercialization of the Licensed Products, including, without limitation, manufacturers of the Licensed Products. 
  

	1.23.	“GAAP” means generally accepted accounting principles in the United States, consistently applied. 

1.24. “GMP” means the FDA’s then-current good manufacturing practices applicable to the manufacture of pharmaceutical products for
human use in the United States, the FDA’s guidance documents, and all successor regulations and guidance documents. 
 1.25.
“IND” means Investigational New Drug Application submitted to the FDA in conformance with applicable laws and regulations and the foreign equivalent of such application in non-U.S. countries of the Territory. 

1.26. “Indication” means dyslipidemia, including, without limitation, hypercholesterolemia, hyperlipidemia or hypertriglyceridemia.

 1.27. “Interfering Event” means (i) any decision ruling, directive, instructions, position, guidance or other action,
whether in writing or otherwise of a Regulatory Agency, IRB or ethics committee, any change in a Regulatory Agency, IRB or ethics committee approval processes or regulatory requirements (including Clinical Study requirements) from those in effect on
the Effective Date, or any inaction on the part of a Regulatory Agency, IRB or ethics committee, in each case that materially affects the requirements for, or the timeline of, the Development and Regulatory Approval of the Licensed Product(s) in the
U.S. or other countries in which Regulatory Approval is being, or is required to be, sought, (ii) a Licensed Product Manufacturing Failure, or (iii) a determination by PPD, in the exercise of its reasonable discretion, that data or other
information obtained during the course of, or as a result of, any Clinical Study for the Compound or Licensed Product(s) will have a material adverse affect on the safety or efficacy of the Licensed Product(s) or require that additional Development
activities be conducted (exceeding that provided in the then current Development Plan) for the Development and Regulatory Approval of the Licensed Product(s). 
  

	1.28.	“Joint Invention” shall have the meaning in Section 7.01. 

 

	1.29.	“Joint Patents” shall have the meaning in Section 7.03. 

 
  

 4 

 1.30. “Joint Patent Rights” shall have the meaning in Section 7.01. 

1.31. “Know-How” means any unpatented or unpatentable inventions, information, data, drawings, plans, specifications and designs
relating to the Compound, a CTM Product or a Licensed Product including, in particular, any marketing information, preclinical, clinical, toxicology, analytical, regulatory, ADME information and/or data. As used herein, “ADME” refers to
absorption, distribution, metabolism and excretion information and/or data of the Compound or Licensed Product. 
 1.32. “Licensed
Product” means any product: (i) which contains the Compound, or any isomer, homolog, analog or prodrug of the Compound, or (ii) which, if made, used or sold in the absence of the license granted by RBX to PII under this Agreement,
would infringe an Enforceable Claim of a RBX Patent or Joint Patent. 
 1.33. “Licensed Product Manufacturing Failure” means
any failure, disruption, delay or any other problem encountered by PII, its contract manufacturer or Third Party Partner relating to the manufacture, formulation or production of API, CTM Product or Licensed Product under the Development Plan.

 1.34. “MAA” means Marketing Authorization Application submitted to the EMEA. 

1.35. “Major Regulatory Filings” has the meaning provided in Section 4.03. 

1.36. “Manufacturing Know-How” means any Know-How that is Controlled by RBX and relates to the manufacture of the Compound or a Licensed
Product including processes and analytical methods therefore. 
 1.37. “NDA” means a New Drug Application, as defined in the
FD&C Act and applicable FDA rules and regulations, and the foreign equivalent of such application in non-U.S. countries of the Territory. 

1.38. “Net Sales” means the total gross sales (number of units shipped times the invoice price per unit) of all Licensed Products by
PII, its Affiliates, sublicensees (including sublicensees of any sublicensee), Affiliates of sublicensees and/or a Third Party Partner in the Territory to Third Parties, less the following deductions to the extent actually paid or allowed:
(i) quantity discounts, cash discounts or chargebacks actually granted, allowed or incurred in the ordinary course of business in connection with the sale of Licensed Product; (ii) sales and excise taxes, customs and any other taxes, all
to the extent added to the sale price and paid by the selling party and not refundable in accordance with applicable law (but not including taxes assessed against the income derived from such sale); (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; (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; (v) rebates or allowances actually granted or allowed to group purchasing organizations, managed health care organizations and to governments, including their agencies, or to
trade customers, in each case that are not Affiliates, sublicensees or a Third Party Partner of PII; and (vi) allowances or credits 

 

 5 

 
to customers, not in excess of the selling price of Licensed Product, on account of governmental requirements, rejection, outdating recalls or return of the Licensed Product, made in accordance
with GAAP and PII’s accounting policies. Sales between PII and its Affiliates, sublicensees and a Third Party Partner of PII shall not be treated as Net Sales hereunder. The calculation of Net Sales shall be made in accordance with GAAP and
PPD’s accounting policies. 
 1.39. “Option” shall have the meaning provided in Section 2.01 hereof.

 1.40. “Option Period” shall have the meaning provided in Section 2.02 hereof. 

1.41. “Option Termination Date” shall mean April 1, 2007. 

1.42. “Partnering Agreement” means an executed and in-force written agreement between PII and a Third Party, wherein such Third Party is
granted the right to develop (if applicable) and commercialize, alone or in collaboration with PII, a human therapeutic product that comprises the Compound. For clarity, an agreement in which PII engages a Third Party to perform, on behalf of PII,
certain obligations of PII under the Development Plan is not a Partnering Agreement. 
 1.43. “Patent” means (i) unexpired
letters patents (including inventor’s certificates) of which not all claims have 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. 
 1.44. “Phase I Clinical Study” means that portion
of the Development program that generally provides for the first introduction into humans of the Compound with the primary purpose of determining safety, metabolism and pharmacokinetic properties and clinical pharmacology of the CTM Product in
healthy patients, and generally consistent with 21 CFR §312.21(a), or its foreign equivalent in non-U.S. countries of the Territory. A Phase I Clinical Study can comprise a Phase Ia clinical study and a Phase Ib clinical study. A Phase Ia
clinical study is a study performed in healthy humans. A Phase Ib clinical study is a study performed in human patients. 
 1.45. “Phase
II Clinical Study” means a clinical trial of the Compound on patients, including possibly pharmacokinetics and dose ranging studies, the principal purposes of which are to make a preliminary determination that the Compound is safe for its
intended use and to obtain sufficient information about the Compound’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR §312.21(b), or its foreign equivalent in non-U.S. countries of the
Territory. A Phase II Clinical Study can comprise a Phase IIa clinical study and a Phase IIb clinical study. 
 1.46. “Phase III
Clinical Study” means a clinical trial involving administration of the 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 
  

 6 

 
adverse reactions that are associated with the drug or label expansion of the Compound, and to be considered as a pivotal study for submission of an NDA; and generally consistent with 21 CFR
§312.21(b), or its foreign equivalent in non-U.S. countries of the Territory. A Phase III Clinical Study can comprise a Phase IIIa clinical study and a Phase IIIIb clinical study. A Phase IIIb clinical study is performed to further define
findings found in a Phase IIIa clinical study. 
 1.47. “Post-Registration Studies” means Clinical Studies which are conducted
in a particular country after the attainment of Regulatory Approval from the appropriate Regulatory Agency in that country, which studies are conducted for a variety of purposes including, but not limited to, post-marketing surveillance and/or other
studies intended to confirm or enhance the commercial profile of the particular Licensed Product. 
 1.48. “PII Information”
means information, results and data of any type whatsoever, in any tangible or intangible form whatsoever, including without limitation, databases, inventions, practices, methods, techniques, specifications, formulations, formulae, knowledge,
know-how, skill, experience, test data including pharmacological, biological, chemical, biochemical, toxicological and clinical test data, analytical and quality control data, stability data, studies and procedures, and patent and other legal
information or descriptions produced by PII in the course of developing a Licensed Product, including PII Compound Information. 
 1.49.
“PII Patents” shall have the meaning set forth in Section 7.03(b). 
 1.50. “PII Compound Information” means
the data and results generated from the pre-clinical and clinical investigation and Development, and Clinical Studies and testing of the Compound and/or the Licensed Products during the term of this Agreement in the course of the Development Plan or
related work on the Compound or Licensed Products by PII or on behalf of PII, its Affiliates, sublicensees and/or a Third Party Partner. 

1.51. “Regulatory Agency” means the FDA or an equivalent non-U.S. regulatory agency. 

1.52. “RBX Intellectual Property” means (i) the Compound Know-How, including, without limitation, Manufacturing Know-How,
(ii) RBX Patents, and (iii) RBX’s portion of Joint Patent Rights. 
 1.53. “RBX Patents” means all Patents that
are owned or Controlled by RBX or its Affiliates during the term of this Agreement and that claim the Compounds or any Licensed Products or the Development, manufacture, intermediates made during the manufacture thereof, purification, use or
formulation thereof. RBX Patents include without limitation patents that claim RBX Intellectual Property. RBX Patents as of the Effective Date are listed in Schedule 1.53. 

1.54. “Regulatory Approval” means the product license or marketing approval necessary as a prerequisite for marketing a Licensed Product
in a particular country in the Territory, including, where applicable, pricing and reimbursement approval. 
 1.55. “Regulatory
Documentation” means all regulatory filings and supporting documents created, submitted to a Regulatory Agency (including any supra-national agency such as in the 

 

 7 

 
European Union) relating to a Licensed Product, and all data contained therein, including, without limitation, the contents of any IND(s), NDA(s), Drug Master File (“DMF”),
correspondence to and from the Regulatory Agency or governmental authority outside of the United States, minutes from meetings (whether in person or by audioconference or videoconference) with regulatory authorities, registrations and licenses,
regulatory drug lists, advertising and promotion documents shared with regulatory authorities, adverse event files, complaint files and manufacturing records. 

1.56. “Territory” shall mean all countries of the world. 

1.57. “Third Party” means any person or entity other than PII or RBX, or an Affiliate of PII or RBX. 

1.58. “Third Party Partner” means a Third Party that has entered into a Partnering Agreement. 

ARTICLE II – OPTION TO LICENSE 

2.01 License Option. In consideration for the payment by PII to RBX of the sum of [*] pursuant to the terms of a certain Letter
Agreement between the Parties dated August 2, 2006, the covenants and agreements herein contained and other good and valuable consideration, the receipt and sufficiency of which is acknowledged by RBX, subject to and upon the terms and
conditions of this Agreement, RBX hereby grants to PII an exclusive option to acquire an exclusive, royalty bearing license and sublicense rights to the RBX Intellectual Property in the Field in the Territory, all as set forth in Article I and
Articles III through XII of this Agreement (the “Option”). 
 2.02 Term of the Option. The term of the Option shall
commence on the Effective Date and shall expires at 5:00 pm Eastern Standard Time on the Option Termination Date (the “Option Period”). 

2.03 Exercise of Option. PII may exercise the Option during the Option Period by delivering written notice to RBX of PII’s exercise of
the Option on or before the expiration of the Option Period. The date on which such notice is given in accordance with Section 12.08 shall be the “Option Exercise Date” for purposes of this Agreement. If PII does not exercise the
Option on or before the expiration of the Option Period, each of the Option and this Agreement shall terminate and be of no further force and effect. 

2.04 Option Covenants. Between the Effective Date and the earlier to occur of (i) the Option Exercise Date, and (ii) the Option
Termination Date, RBX covenants that (a) it will take all reasonably necessary action to protect and maintain all right, title and interest in RBX Intellectual Property existing as of the Effective Date, and (b) it will not grant, sell,
assign, transfer, covey, option, license, sublicense, pledge or otherwise dispose of all or any part of the RBX Intellectual Property, or any rights thereto, to a Third Party, or enter into any agreement, arrangement, understanding or discussions
with a Third Party with respect thereto. 
  
  

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

 

 8 

 2.05 License Terms. Upon the timely exercise by PII of the Option in accordance with
Section 2.03, effective immediately on the Option Exercise Date and without any further action or consent by RBX or PII, the provisions set forth in Article I and Articles III – XII of this Agreement shall constitute the terms and
conditions of the license and sublicense rights granted by RBX to PII with respect to the RBX Intellectual Property in the Territory and in the Field related to Compound and Licensed Products. 

ARTICLE III – LICENSES AND EXCLUSIVITY 

3.01 License to RBX Intellectual Property. Effective as of the Option Exercise Date, subject to and upon the terms and conditions set forth
herein, RBX hereby grants PII an exclusive, royalty bearing license (with the right to sublicense as provided in Section 3.02) to RBX Intellectual Property to Develop, make, have made, use, offer for sale, sell and import the Compound and the
Licensed Products in the Territory and the Field. 
 3.02 Right to Sublicense. With respect to the licenses granted to PII in
Section 3.01 above, such licenses shall include the right of PII to sublicense all or any part of such licenses to a Third Party, provided however, that (i) such sublicense is consistent with the terms of this Agreement, and (ii) PII
shall provide prior written notice to RBX of the proposed sublicense. For clarification, PII has no obligation to obtain RBX’s consent to sublicense. Notwithstanding any sublicense by PII of its rights under Section 3.01 or elsewhere in
this Agreement, PII shall remain the primary obligor for the completion of the Development of the Compound and Licensed Products, the commercialization of the Licensed Products and all other obligations, including payment obligations, under this
Agreement and shall be responsible for any breach or failure to comply by any sublicensee or Third Party Partner of any of the obligations of PII provided in this Agreement. 

3.03 Exclusivity. Except as set forth in Section 3.04, during the term of this Agreement, RBX and its Affiliates will not, directly or
indirectly through or with an Affiliate, Third Party or otherwise, (i) make, use, sell or import the Compound or (ii) conduct, sponsor, fund, underwrite, initiate or otherwise participate in any development or commercialization activities
(or grant any rights to Third Parties to do so) with respect to the Compound in the Field. 
 3.04 RBX Co-Marketing Rights.

 (a) RBX reserves for itself and its Affiliates the non-exclusive right to co-market the Licensed Product(s) (i) at any
time in India, and (ii) as an AB Rated Product in any country in the Territory following the sale of an AB Rated Product by a Third Party in such country. Ranbaxy may contract with Third Parties for the distribution of the Licensed Products
pursuant to the exercise of the co-marketing rights provided herein. As used herein, RBX’s right to “co-market” means the right for RBX (either itself or through its Affiliates or a Third Party) to manufacture, sell,
distribute, promote and market Licensed Products under trademarks, tradenames, service marks, designs or names or other trade dress which are different from, and which are not confusingly similar to, any trademarks, tradenames, service marks,
designs or names (including without limitation domain names), graphics or trade dress (including without limitation product packaging and tablet characteristics) used by PII, any PII Affiliate, any

  

 9 

 
sublicensee or Third Party Partner of PII in connection with such Licensed Product. RBX agrees not to reproduce or use any text or copyrighted work covering the Licensed Product without
PII’s prior written consent. 
 (b) If RBX decides to exercise its co-marketing rights provided in Section 3.04(a)
[*]. At the time RBX decides to exercise its co-marketing rights, RBX may send to PII a written request to discuss the possibility of RBX [*]. Upon RBX’s reasonable determination that a Third Party is expected to launch within six
(6) months an AB Rated Product in a country of the Territory, RBX may at such time request [*] launch of its co-marketed product in such country upon exercise of its co-marketing right as set forth in subsection (a) of this
Section 3.04. 
 ARTICLE IV –CONDUCT OF PROJECT; DEVELOPMENT; MARKETING 

4.01 General Principle. During the term of this Agreement, as between PII and RBX, PII shall be solely responsible for the Development of
the Compound and the Licensed Product(s), including, without limitation, the conduct of the Development Plan for the Compound and the Licensed Product(s), and such other development activities in accordance with the Development Plan, and for the
marketing, manufacture and commercialization of the Compound and the Licensed Product(s) in the Territory consistent with its obligations under this Agreement. PII will use Diligent Efforts to Develop and commercialize the Compound and at least one
(1) Licensed Product for the Indication. PII shall have responsibility for, and shall exercise Diligent Efforts in, obtaining necessary Regulatory Approvals, and PII or its Affiliates, sublicensees or Third Party Partner, shall hold legal title
of any [*] for the Licensed Product(s) and shall have responsibility for all the Development, manufacture and marketing activities pursuant to and in support of such applications. RBX acknowledges that the Development Plan is an initial plan
and may change as a result of data obtained during the execution of the Development Plan, changes to Regulatory Agency guidelines and requirements and prevailing conditions in the marketplace for the Licensed Product. PII shall have the right to
modify the Development Plan in its sole and absolute discretion, but shall use Diligent Efforts to advance the Development and commercialization of the Compound and the Licensed Product. 

4.02 Development Reports. 

(a) Quarterly Development Reports. PII shall furnish to the alliance manager as may be designated from time to time by RBX
(the “Alliance Manager”) a quarterly written report detailing the progress of the Development, including successes, difficulties, milestone achievements and a comparison of the status of the Development as compared to the Development
timeline contained in the Development Plan, including (i) a description of the status of the preparation, filing and receipt of Regulatory Approvals relating for the Licensed Product(s) in the Territory, (ii) any updates or modifications
to the Development Plan, and (iii) the estimated date of the First Commercial Sale of the Licensed Products in each country of the Territory in which PII has submitted agency applications for Regulatory Approval of the Licensed Product(s). Such
reports shall constitute Confidential Information under Article IX and RBX will limit disclosure to its employees on a strict need-to-know basis. The first quarterly report shall be provided to RBX on April 1, 2007 and on the first day of each
July, October, January and April thereafter. 
  
  

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

 

 10 

 (b) Record Keeping. PII shall maintain written records of all research and development
activities under the Development Plan, such records shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the execution of the Development Plan in sufficient detail and in good scientific manner
appropriate for patent and regulatory drug development and approval purposes. RBX shall have the right to review such records annually to the extent necessary for RBX to determine that PII is fulfilling its obligations under the Agreement. The
Parties acknowledge and agree that all information in such records shall be subject to the confidentiality obligations of Article IX hereof. 

4.03 Development; Regulatory Activities and Approvals.  

(a) PII shall use Diligent Efforts and be responsible for the conduct of the Development of the Compound and the Licensed Product(s)
within the Territory in order to obtain and maintain Regulatory Approval of a [*] (“Major Regulatory Filings”) for a Licensed Product for the Indication as promptly as practicable. In executing the Development Plan, PII shall be
solely responsible for all costs and expenses relating to the Development Plan and obtaining Regulatory Approval for the Licensed Product(s). Without limiting the generality of the foregoing, PII shall be responsible for the preparation, filing and
prosecution of all agency applications for obtaining Regulatory Approvals in the Territory which are required to commercially sell or use the Licensed Product(s) in the Territory and for all subsequent related submissions. All Regulatory
Documentation and Regulatory Approvals in the Territory shall be owned and filed in the name of PII. PII shall use Diligent Efforts in preparing the Major Regulatory Filings for Regulatory Approval of the Licensed Product(s) and in causing such
agency applications to progress through the Regulatory Approval process. PII shall use Diligent Efforts for the preparation and submission of all governmental and agency applications for Regulatory Approval for a Licensed Product for the Indication
in countries of the Territory other than [*] (which are addressed separately above) in which PII determines to submit agency applications, and the receipt of such Regulatory Approvals, including, without limitation, pricing and reimbursement
approval, where applicable. 
 (b) If PII receives a written communication from a Regulatory Agency, either directly or through
a sublicensee or a Third Party Partner of PII, relating to the Compound or the Licensed Product(s) which relate to the Development, marketing, safety or efficacy of the Compound or the Licensed Products, and which would materially affect the time
for receipt of Regulatory Approval of such Licensed Product(s) or the ability of PII to Develop or market such Licensed Product(s), PII shall promptly provide RBX’s Alliance Manager (as provided in Section 4.02(a)) with a summary of such
information. Such summary shall be subject to the confidentiality obligations of Article IX hereof. 
 4.04 Launch and Marketing. 

 (a) PII, at is sole cost and expense, shall use Diligent Efforts to complete the First Commercial Sale of a Licensed
Product in [*] as soon as practicable after Regulatory Approval has been obtained for such Licensed Product, and thereafter shall use Diligent Efforts to manufacture, promote, distribute, market, advertise and sell the Licensed Product (or
cause the manufacture, promotion, distribution, marketing, advertisement and sale of the Licensed 
  

 

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

  

 11 

 
Product) to the extent reasonable in light of the market and potential market for the Licensed Product and in a manner consistent with which a Third Party engaged in the commercialization of
pharmaceutical products for human use ordinarily devotes to marketing for a pharmaceutical product having similar market potential, profit potential or strategic value to that of the Licensed Product in a particular country of the Territory. For the
sake of clarity, RBX acknowledges and agrees that, based on market conditions, including pricing conditions and environment, then existing in [*], PII may delay or elect not to manufacture, promote, distribute, market, advertise or sell the
Licensed Product in any such Country. Without limiting the foregoing, not later than 30 days following the end of each calendar year following the First Commercial Sale of any Licensed Product, PII shall provide to RBX a written report summarizing
PII’s (or its Third Party Partner’s) marketing efforts relating to the Licensed Product during such annual period. 

(b) Restrictive Covenant. Neither PII nor any of its Affiliates shall develop, license, acquire, file for Regulatory Approval,
market, promote, sell or distribute [*] other than the Compound and the Licensed Product(s) hereunder, or [*] other than the Compound and the Licensed Product(s) hereunder in combination with another active ingredient in any country of
the Territory during the term of this Agreement, except that PII and any of its Affiliates may provide services to Third Parties in connection with the preclinical and clinical development or post-marketing studies of one or more [*],
provided that (i) such services are limited to those that are usual and customary for clinical research organizations in general, and PII and its Affiliates in particular; and (ii) PII and its Affiliates shall not retain (1) any
right, title, interest or license in any such [*]; or (2) any right to receive (directly or indirectly) any consideration in connection with the subsequent development, regulatory filings, regulatory approval, promotion or sales of such
[*] (other than normal and customary fees and expenses charged by PII and its Affiliates for any such services). 
 4.05 Transfer
of Know-How. 
 (a) To facilitate PII’s accomplishment of the responsibilities set forth in this Article IV,
RBX shall supply PII with copies of all documents pertinent to the Development of the Compound which are in the possession of RBX or its Affiliates as of the Effective Date including but not limited to those documents listed in Schedule 4.05.
RBX shall use reasonable commercial efforts to provide such documents to PII within forty-five (45) days of the Option Exercise Date. RBX will provide PII with all relevant information available and known to RBX concerning the safety, handling,
use, disposal and environmental effects of Compound or as may be useful to PII to conduct the Development Plan, including but not limited to any communications with regulatory agencies. The Parties acknowledge and agree that all such
Compound-related information, including, without limitation, the Manufacturing Know-How, shall be subject to the confidentiality obligations of Article IX hereof. 

(b) Within ten (10) days of the Option Exercise Date, RBX shall make available for shipping, [*] totaling approximately [*]
and [*] that are in RBX’s possession as of the Effective Date (“RBX [*]”). PII shall pay to RBX the amount of [*] dollars ($[*]), within thirty (30) days of an invoice for the same. PII acknowledges and agrees that RBX is
providing the RBX [*] on an “as is” basis, free of any representation or warranty, including, without limitation, the warranties of merchantability or fitness for any particular purpose. 

 
  

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

 

 12 

 4.06 Manufacturing. PII shall be solely responsible for (i) the manufacture of CTM
Product and Drug Substance as may be required to obtain Regulatory Approval of the Licensed Product(s) in the Territory and (ii) the manufacture of commercial requirements of the Licensed Product(s) for marketing and sale in the Territory. 

  

	4.07	[*]. 

 ARTICLE V –
FEES AND ROYALTIES 
 5.01 License Fee. PII shall, simultaneous with the provision of written notice to RBX exercising the
Option on the Option Exercise Date, pay to RBX a one-time non-refundable, non-creditable license fee in the amount of two hundred fifty thousand dollars ($250,000) (the “License Fee”). 

5.02 Clinical Milestone Payments. In addition to paying the License Fee, and without limiting Section 5.02(d) below, PII shall pay RBX
the following non-refundable, non-creditable additional amounts upon the first occurrence of the applicable event (individually a “Milestone Payment” and collectively the “Milestone Payments”): 

(a) Completion of [*]. PII will notify RBX in writing upon the Completion of the [*] in any country of the Territory
to be performed in the Development Plan involving CTM Product within fourteen (14) days of such Completion. Within thirty (30) days of the Completion thereof, PII will pay RBX a one-time milestone payment of [*]. For clarity, if
[*] are contemplated in the Development Plan, then Completion of the [*] shall occur upon the Completion of the [*]. In the event multiple arms of such [*] are performed using different comparitors and/or patient
populations, the Milestone Payment under this Section 5.02(a) shall be triggered upon the Completion of the last arm of such [*] (expressly excluding any requirement to complete any [*]) relating to such [*]. 

(b) Completion of [*]. PII will notify RBX in writing upon Completion of the [*] in any country in the Territory to
be performed in the Development Plan involving a CTM Product within fourteen (14) days of such Completion. Within thirty (30) days of the Completion thereof, PII will pay RBX a one-time milestone payment of [*]. For clarity, if
[*] are contemplated in the Development Plan, then Completion of the [*] shall occur upon the Completion of the [*]. In the event multiple arms of such [*] are performed using different comparitors and/or patient
populations, the Milestone Payment under this Section 5.02(b) shall be triggered upon the Completion of [*] relating to such [*] (expressly excluding any requirement to complete any [*]). 

(c) Completion of [*]. PII will notify RBX in writing upon Completion of the [*] in any country in the Territory to
be performed in the Development Plan involving a CTM Product within fourteen (14) days of such Completion. Within thirty (30) days of the Completion thereof, PII will pay RBX a one-time milestone payment of [*]. For clarity, if
[*] are 
  
  

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

  

 13 

 
contemplated in the Development Plan, then Completion of the [*] shall occur upon the Completion of the [*]. In the event multiple arms of a [*] are performed using different
comparitors and/or patient populations, the Milestone Payment under this Section 5.02(c) shall be triggered upon the Completion of [*] relating to such [*] (expressly excluding any requirement to complete any [*]).

 (d) Completion of Payments. Subject to this Section 5.02(d), PII shall only be obligated to pay the
Milestone Payments under Section 5.02(a), 5.02(b) and 5.02(c) once. For clarity, except as expressly provided below, once PII makes the Milestone Payment under either Section 5.02(a), 5.02(b) or 5.02(c) relating to the Development Plan,
PII shall have no further obligation to make any further Milestone Payments under Section 5.02(a), 5.02(b) or 5.02(c) to RBX for any future occurrence of such milestone event relating to another program for the Development of the Compound for
the Indication. In the event that PII pursues the Development of the Compound to treat an indication that is [*] (other than [*]), PII shall pay RBX the milestone payments set forth in Sections 5.02(a)-(c) upon the occurrence of
the milestone event with respect to the Development of such Compound for such [*] indication. Notwithstanding the foregoing or anything to the contrary contained in this Agreement, in the event PII pursues the Development of the Compound
(whether in a single or combination product) for the treatment of [*], the Parties shall negotiate in good faith the separate and additional milestone payments to be made by PII to RBX pursuant to such Development program; provided, however,
that such separate and additional milestone payments must exceed those provided in this Section 5.02 in the aggregate. 
 5.03 Sales
Milestones. PII shall pay to RBX sales milestone payments in accordance with the schedule set forth below with regard to the Licensed Products, based on total worldwide Net Sales of the Licensed Products for the first consecutive twelve
month period during which such sales milestone event is achieved, such payment to be made within thirty (30) days after achievement of such milestone event. Each of the milestone payments listed in this Section 5.03 shall be payable only
once under this Agreement regardless of the number of Licensed Products that individually achieve the sales milestone event in a given 12-month period or the number of times the Licensed Products achieve such sales milestone event in a given
12-month period. 
  

			
	 Sales Milestone Event
	  	 Sales Milestone Payment

	 First time that aggregate worldwide Net Sales of all Licensed Products in the aggregate in a twelve consecutive month period
exceed [*]
	  	[*]
	 First time that aggregate worldwide Net Sales of all Licensed Products in the aggregate in a twelve consecutive month period
exceed [*]
	  	[*]
	 First time that aggregate worldwide Net Sales of all Licensed Products in the aggregate in a twelve consecutive month period
exceed [*]
	  	[*]
	 First time that aggregate worldwide Net Sales of all Licensed Products in the aggregate in a twelve consecutive month period
exceed [*]
	  	[*]

  

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

 14 

 5.04 Royalties. Subject to the terms and conditions of this Agreement, PII shall pay to RBX a
royalty in the amount of [*] percent ([*]%) of Net Sales of each Licensed Product in the Territory commencing with the First Commercial Sale of the first Licensed Product. 

5.05 Royalty Period. PII’s obligation to pay royalties to RBX under Section 5.04 shall apply on a Licensed Product-by-Licensed
Product basis and shall begin, on a country by country basis, upon the date of the First Commercial Sale in such country of such Licensed Product and shall end upon termination of sale of the Licensed Product in such country. 

5.06 Payments to Third Parties. In the event PPD determines that it is necessary or desirable to seek a license or immunity from suit from
any Third Party in order for PPD to exercise its rights hereunder to Develop, manufacture, commercialize, use or exploit the Compound or a Licensed Product in a particular country of the Territory, PPD shall obtain any such license or immunity from
suit. Any upfront payment, milestone, royalty or other payment paid or payable by PPD to a Third Party in consideration for immunity from or license to such Third Party’s intellectual property rights with respect to the Compound or a Licensed
Product shall be solely for PPD’s account and RBX shall have no liability (including, without limitation, any indemnity obligation) for any such amounts. 

5.07 Method of Calculation. The calculation of the amount of royalties due under the provisions of Section 5.04 shall be subject to
and computed in accordance with the following provisions: 
 (a) Frequency. Royalties shall be calculated and paid
on a calendar quarter basis. PII shall provide RBX with a statement of royalties owed to RBX within thirty (30) days after the end of each calendar quarter and the quarterly royalty payment shall be made at the time of such statement. Each of
the quarterly statement of royalties and the annual statement provided in the following sentence shall show in reasonably specific detail, on a country-by-country basis (i) the total number of units of each of the Licensed Products sold,
(ii) the Net Sales on a Licensed Product-by-Licensed Product basis (including the detailed calculation of the deductions from gross sales of each of the Licensed Products in arriving at Net Sales); (iii) the calculation of the royalties
payable pursuant to Section 5.04 in United States dollars which had been accrued hereunder based upon Net Sales of each Licensed Product, including a detailed calculation showing the application of the applicable royalty rates under
Section 5.04 to the aggregate Net Sales for all Licensed Products; (iv) the withholding taxes, if any, required by law to be deducted with respect to such royalties and the amounts paid to the appropriate governmental authority with
respect to such royalties; (v) the date of the first Commercial Sale of each Licensed Product in each country in the Territory during the reporting period; and (vi) the exchange rates used in determining the amount of United States
dollars. In addition, at the end of each calendar year, aggregate royalties for such calendar year shall be calculated on aggregate Net Sales for all Licensed Products for such calendar year to determine additional royalty payments owed to RBX by
PII. Within sixty (60) days after the end of each calendar year, PII shall provide RBX with a statement of such additional aggregate royalty payments owed to RBX and a written report showing the method by which the royalty payments for such
calendar 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,

  
  

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

  

 15 

 
then no statement for such country shall be included in such yearly report. PII shall submit any additional aggregate royalty payments to RBX together with such statement and written report. With
respect to sales of any Licensed Products invoiced in United States dollars, the Net Sales and royalties and other payments payable hereunder shall be expressed in United States Dollars. With respect to sales of any Licensed Products invoiced in a
currency other than United States Dollars, the Net Sales and royalties and other payments payable hereunder with respect to such Licensed Products shall be expressed in the domestic currency of the party making the sale together with the United
States dollar equivalent of the royalty payment payable, and such exchange rate shall be calculated pursuant to Section 6.03. 

(b) Combination Products. PII shall pay RBX royalties on Net Sales of any Combination Product. For the purpose of
calculating royalties on Net Sales of Combination Products hereunder, Net Sales of a Combination Product shall be determined on a country by country basis by multiplying the actual Net Sales of the Combination Product by the fraction A/(A+B), where
A is the average sale price of a Licensed Product in a given country when sold separately in finished form and B is the average sale price of the other product(s) comprising the active ingredients other than the Compound sold separately in finished
form in that given country. With respect to Net Sales of Combination Products outside of the United States, where available in a given country, the most recent reference price(s) or government-regulated price(s) for the other product(s) in the given
country will be used as the average sale price. In the event that such average sale price cannot be determined for either the Licensed Product or other product(s) in the Combination Product, Net Sales for purposes of determining royalty payments
hereunder shall be calculated by multiplying the Net Sales of the Combination Product by the fraction C/(C+D), where C is PII’s, or its Affiliates’, sublicensees’ or Third Party Partner’s cost of goods of the Licensed Product and
D is PII’s, or its Affiliates’, sublicensees’ or Third Party Partner’s cost of goods of the other product(s), in each case determined in accordance with GAAP. 

(c) Royalty and Patents. Regardless of the number of patents that cover a Licensed Product, only one
royalty shall be payable upon sale of a Licensed Product. 
 (d) Other Consideration. In the case of a sale or
other disposal of 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. PII shall keep and shall require any Affiliates, sublicensees and Third Party Partner
selling any Licensed Product to keep proper records and books of account, in accordance with GAAP, showing the Net Sales of each Licensed Product upon which the royalty payments and Sales Milestone Payments of PII are based, and all other
information necessary for the accurate determination of royalty payments to be made hereunder. 
 6.02 Audit. On reasonable
written notice RBX, at its own expense, shall have the right, no more than once a calendar year, to have an independent certified public accountant inspect and 

 

 16 

 
audit the books and records of PII, its Affiliates, any sublicensees and Third Party Partner, including any Net Sales reports received from its Affiliates, its sublicensees and its Third Party
Partner, 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 period shall not take place
later than three years following the expiration of such period, after which royalty payments made for such fiscal periods shall be final and binding. The expense of any such audit shall be borne by RBX; provided, however, that, if the audit with
respect to a particular calendar year discloses an error in excess of five percent (5%) in favor of the PII, then PII shall pay, in addition to the amount of any underpayment, the cost of the audit. PII 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. All
payments due hereunder shall be paid in U.S. dollars, including, without limitation, royalties on Net Sales outside of the U.S. Dollar amounts shall be calculated in the foreign currency for the country in which sales are recorded and will be
translated into U.S. dollars based on the average of the average daily exchange rates for such calendar quarter as published by the Wall Street Journal for the quarter for which such payments are due. Payments in U.S. dollars shall be paid by wire
transfer to RBX. 
 ARTICLE VII – INTELLECTUAL PROPERTY 

7.01 Ownership of Patents.  

Inventorship of inventions conceived or reduced to practice in the course of the activities under the Development Plan shall be determined
by reference to United States laws pertaining to inventorship. If inventions are conceived or reduced to practice in the course of activities under the Development Plan by an individual obliged to assign patent rights to RBX and an individual
obliged to assign patent rights to PII, it shall be jointly owned (“Joint Invention”), and if one or more claims included in any issued Patent or pending Patent application which is filed in a patent office in the Territory claim such
Joint Invention, such claims shall be jointly owned (“Joint Patent Rights”). Subject to Section 3.01, during the term of this Agreement, the Parties shall not use or grant any rights under, or otherwise commercialize any Joint Patent
Rights or any Joint Invention, and the Parties shall not disclose any Joint Invention to any third Party (except to the extent each Party would be permitted to disclose Confidential Information pursuant to Article IX) without obtaining the prior
written consent of the other Party or without mutually agreeing in writing upon terms and condition, including a royalty or other compensation to the other Party. After the expiration or termination of this Agreement, the Parties may use or grant
any rights under, or otherwise commercialize, any Joint Patent Rights or any Joint Invention in the Territory, and the Parties may disclose any Joint Invention to any Third Party, all without obtaining the prior written consent of the other Party
and without any accounting obligations. If an invention is solely conceived or reduced to practice in the course of activities under the Project by an employee, consultant or agent of a Party, it shall be solely owned by such Party, and any Patent
filed claiming such solely owned invention shall also be solely owned by such Party. 
  

 17 

 7.02 Ownership of PII Information. PII shall own the entire right, title and interest in and
to any and all PII Information. 
 7.03 Patent Prosecution. 

(a) PII shall have the right and obligation to control the preparation, filing, prosecution, maintenance and defense of RBX
Patents. PII shall control the preparation, filing, prosecution, maintenance and defense of patent applications directed to Joint Patent Rights. (“Joint Patents”). In discharging its obligations under this Section 7.03(a) PII shall
exercise diligent efforts, in a sustained and continuous manner, consistent with the efforts it ordinarily devotes to the preparation, filing, prosecution, maintenance and defense of its own patents and intellectual property. RBX shall provide PII
any reasonable assistance required to perfect the RBX Patent Rights and RBX shall provide PII reasonable assistance required to perfect the Joint Patent Rights. PII shall provide RBX with drafts of all proposed patent filings (including, without
limitation, patent applications, amendments and responses to official actions) at least thirty (30) days before filing and shall take into account any comments provided by RBX to PII, to the extent reasonable, within thirty (30) days (or
such shorter period as shall be required to meet a filing deadline, but in no event less than fifteen (15) days) after RBX’s receipt of the applicable draft. If PII decides not to file or maintain any RBX Patent on a country-by-country
basis or patent family basis, PII shall give RBX reasonable notice of same and after receipt of such notice, RBX may, at its expense, file or maintain such applications or patents at its own expense. PII shall provide RBX with drafts of all proposed
patent filings relating to the Joint Patents (including, without limitation, patent applications, amendments and responses to official actions) at least thirty (30) days before filing and shall take into account any comments provided by RBX to
PII, to the extent reasonable, within thirty (30) days (or such shorter period as shall be required to meet a filing deadline, but in no event less than fifteen (15) days) after RBX’s receipt of the applicable draft. If PII decides
not to file or maintain any Joint Patent, on a country-by-country basis or patent family basis, PII shall give RBX reasonable notice of same and after receipt of such notice, RBX may at its expense, file or maintain such applications or patents, and
PII shall assign such patents and patent applications to RBX that RBX elects to file or maintain. 
 (b) PII shall have
the right to control the preparation, filing, prosecution, maintenance and defense thereof and be responsible for all costs associated with any patents relating to inventions conceived or reduced to practice in the course of the activities under the
Development Plan solely by PII’s employees or agents (“PII Patents”). RBX shall provide PII any reasonable assistance required to perfect the rights defined in Section 7.01. Subject to the last sentence in this
Section 7.03(b), if PII decides not to file or maintain any PII Patents on a country-by-country basis or patent family basis, PII shall give RBX reasonable notice of same and after receipt of such notice, RBX may, at its expense, file or
maintain such applications or patents at its own expense, and PII shall assign such patents and patent applications to RBX that RBX elects to file or maintain. The previous sentence shall not apply to any decision of PII that is based on its
determination, in its sole discretion, that the value of a particular PII invention 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. 
  

 18 

 (c) [*] shall be responsible for all patent costs (including filing fees, maintenance
fees, and outside attorney fees) with respect to each Patent within the RBX Patents and Joint Patents that covers the composition of matter, manufacture or use of the Compound. 

7.04 Notification. PII shall provide a written report to RBX every second calendar quarter summarizing the status of all RBX Patents and
Joint Patents. Such report shall constitute Confidential Information under Article IX. 
 7.05 Trademarks. PII shall own all
trademarks developed by PII used to identify a Licensed Product. 
 ARTICLE VIII – PATENTS AND INFRINGEMENT 

 8.01 Infringement of Patent Rights. Each party to this Agreement shall notify the other in writing promptly of any actual,
potential or suspected infringement (collectively “alleged infringement”) of the RBX Patents, Joint Patents or PII Patents of which such Party becomes aware and shall promptly provide the other Party with available evidence of such alleged
infringement. PII shall have the first right to take whatever action it deems appropriate to enforce the RBX Patents, Joint Patents or PII Patents, at its sole cost and expense. If PII does not, within sixty (60) days of receipt of such notice
of alleged infringement take any action, or file any suit to enforce the RBX Patents, Joint Patents and PII Patents against such infringing party in a country in the Territory, RBX may in its discretion, take such action as it deems appropriate,
including, without limitation, filing suit against any such infringing party. If RBX elects to enforce the RBX Patents, RBX shall use good faith efforts in any such proceeding against infringers, shall consult with PII during said enforcement and
shall solicit PII’s advice with respect to such enforcement. Regardless of which Party controls any such enforcement action, RBX and PII shall reasonably cooperate with each other in the planning and execution of any action to enforce the RBX
Patents, Joint Patents and PII Patents. The Party controlling any such enforcement action may not settle or consent to an adverse judgment without the express written consent of the non-controlling Party (such consent not to be unreasonably withheld
or delayed). Any damages or other amounts collected with respect to such action will first be used to reimburse each of the Parties, on a pro rata basis, for its out of pocket costs and expenses; and then, any remaining amount will be distributed
[*]% to the Party controlling the enforcement action and [*]% to the other Party. 
 8.02 Patent Marking. To the
extent permitted by applicable laws and regulations, PII agrees to mark, and to cause any Affiliate, sublicense or Third Party Partner to mark, PII’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 Licensed Products are
to be sold. 
 8.03 Third Party Infringement Actions. If RBX or any of RBX’s Affiliates or PII or any of PII’s
Affiliates, sublicensees or Third Party Partner shall be sued by, threatened to be sued by or receives a claim from, a Third Party for infringement of a Third Party Patent because of the making, using, selling, offering for sale or importing, or
having made, used, sold, offered for sale 
  
  

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

 

 19 

 
or imported, the Licensed Products in the Territory, the Party which has been sued, threatened or received a claim (or its Affiliates, or with respect to PII, its sublicensees, or Third Party
Partner, has been sued) shall promptly notify the other Party in writing thereof (each, an “Infringement Action”). If RBX shall receive notice of a certification relating to an abbreviated new drug application made pursuant to
Section 355(j)(2)(A)(viii)(IV) of the FD&C Act, it shall promptly notify PII in writing (a “Paragraph IV Challenge” and collectively with an Infringement Action, “Section 8.03 Actions”). PII shall have the obligation to
undertake control of any Section 8.03 Actions in the Territory which relate to the Compound or a Licensed Product (whether such action was brought against RBX or PII or any of its respective Affiliates or sublicensees) and RBX shall cooperate
in such defense through counsel of its choice at RBX’s expense. PII shall take into account RBX’s comments relating to such Section 8.03 Actions to the extent reasonable. PII may not settle or consent to an adverse judgment without
the expressed prior written consent of RBX (such consent not to be unreasonably withheld, delayed or conditioned). 

ARTICLE IX – CONFIDENTIAL INFORMATION 

9.01 Nondisclosure of Confidential Information. All information disclosed by one Party to the other Party pursuant to this Agreement shall
be “Confidential Information.” The Parties agree that during the Term, and for a period of ten (10) years thereafter, a Party receiving Confidential Information of the other Party will (i) maintain in strictest confidence such
Confidential Information to the same extent such Party maintains its own proprietary industrial information of similar kind and value (but at a minimum each Party shall use commercially reasonable efforts), (ii) not disclose such Confidential
Information to any Third Party without prior written consent of the other Party, and (iii) not use such Confidential Information for any purpose except those permitted by this Agreement. However, such obligation of confidentiality shall not
apply to any Confidential Information that: 
 (a) Is publicly disclosed by the disclosing Party, either before or after
it is disclosed to the receiving Party hereunder; or 
 (b) Was known to the receiving Party, without obligation to keep
it confidential, prior to disclosure by the disclosing Party; or 
 (c) Is subsequently disclosed to the receiving Party
by a Third Party lawfully in possession thereof and without obligation to keep it confidential; or 
 (d) Has been
published by a Third Party; or 
 (e) Has been independently developed by the receiving Party without the aid,
application or use of all or any part of Confidential Information as evidenced by the receiving Party’s written records. 
 9.02
Authorized Disclosure. A Party may disclose the Confidential Information belonging to the other Party to the extent such disclosure is reasonably necessary in the following instances: 

(a) Filing or prosecuting Patents relating to Compound; 

 

 20 

 (b) Regulatory Filings and prosecutions of the same; 

(c) Prosecuting or defending litigation; 

(d) Complying with applicable governmental regulations; and 

(e) Disclosure, in connection with the performance of this Agreement, to sublicensees, a Third Party Partner research
collaborators, employees, consultants, or agents, each of whom prior to disclosure must be bound by similar obligations of confidentiality and non-use at least equivalent in scope to those set forth in this Article IX. 

The Parties acknowledge that the terms of this Agreement shall be treated as Confidential Information of both Parties. Such terms may be disclosed by a
Party to potential Third Party Partners, investment bankers, investors, potential investors, lenders and other financing parties, provided that they are bound by similar obligations of confidentiality and non-use at least equivalent in scope to
those set forth in this Article IX. In addition, a copy of this Agreement may be filed by either Party with the Securities and Exchange Commission if such filing is required by law or regulation. In connection with any such filing, such Party shall
endeavor to obtain confidential treatment of such terms and other trade secret information to the extent permitted by the Securities and Exchange Commission. 

9.03 Limitations on Publications. The Parties shall not publish any Confidential Information received from the other Party without the
prior written approval of such Party. 
 ARTICLE X – WARRANTIES 

10.01 Warranties by RBX. RBX represents and warrants to PII as of the Effective Date and the Option Exercise Date the following:

 (a) RBX has the full right and power to grant the Option set forth in Section 2.01 and the licenses set forth in
Section 3.01 in the manner and to the extent set forth in this Agreement, free and clear of any adverse assignment, option, grant, right or other encumbrances inconsistent with such grant. 

(b) RBX or its Affiliates are the sole owners of the RBX Patents, Compound Know-How and Manufacturing Know-How. 

(c) The chemical formula listed in Section 1.07 accurately defines the compound that is the subject of RBX Intellectual
Property provided by RBX to PII. 
 (d) No claims, demands, suits, arbitrations or other adversarial proceedings have
been brought or threatened against any Third Party by RBX, which are related to the RBX Patents or Compound Know-How, or the misappropriation of any RBX trade secrets relating to the Compound. 

(e) RBX has not received any written notice by any Third Party of any pending or threatened claim, demand, suit, action,
mediation, arbitration, order or other adversarial 
  

 21 

 
proceeding: (i) alleging infringement (or other violation) by RBX of intellectual property or other rights of any Third Party; or (ii) challenging RBX’s ownership or use of, or the
validity, enforcement, registrability or maintenance of, any RBX Patent, Manufacturing Know-How or Compound Know-How owned or licensed by RBX. To RBX’s knowledge, no information contained within RBX Patents, Manufacturing Know-How or Compound
Know-How is being used or enforced in a manner that would reasonably be expected to result in the abandonment, cancellation or unenforceability of such RBX Patents, Manufacturing Know-How or Compound Know-How. 

(f) RBX has not entered into any consents, judgments, orders, indemnifications, forbearances to sue, settlement agreements,
licenses or other arrangements that: (i) restrict the RBX’s right to use any RBX Patent, Manufacturing Know-How or Compound Know-How; or (ii) restrict the development or commercialization of the Compound in order to accommodate a
Third Party’s intellectual property rights. 
 (g) Any current and former employee of or consultant to RBX
(“Researcher”) who has contributed to or participated in research and development activities of the Compound has granted to RBX on an exclusive and unrestricted basis, ownership of all intellectual property arising out of such
Researcher’s research and development activities involving the Compound. RBX has not granted or assigned to any Researcher any right to manufacture, have manufactured, assemble, import, or sell the Compound or Licensed Product. 

(h) To RBX’s knowledge, none of its current employees is obligated under any contract (including licenses, covenants or
commitments of any nature) or other agreement, or subject to any judgment, decree or order of any court or administrative agency, that would interfere or conflict with RBX’s obligations as contemplated under this Agreement. To RBX’s
knowledge, RBX has not utilized any intellectual property or trade secrets owned by any of its employees’ former employer made prior to their employment by RBX. 

(i) Schedule 1.53 is a true, accurate and complete list of all RBX Patents as of the Effective Date. 

(j) Except as described in Schedule 1.53, none of the RBX Patents have been abandoned. RBX has an existing right to file RBX
Patents with the United States Patent and Trademark Office. Except as described in Schedule 1.53, all assignment of rights necessary to vest full and complete ownership of RBX Patents in RBX have been executed by all inventors and correctly recorded
in the World Intellectual Property Organization. RBX is not aware of any inventorship disputes regarding any RBX Patents. 

(k) RBX has made available for PII’s review, all documents and certificates requested in writing by PII that have been issued
to RBX with respect to any RBX Patent, including all written documentation evidencing ownership and prosecution. 
 (l)
RBX has disclosed to PII in writing all material information in RBX’s possession that may limit the scope of patentability of RBX Patents. 
  

 22 

 (m) RBX has disclosed to PII all material information it has relating to the
Compound, its safety in animals and humans, its development status and its regulatory status. 
 (n) RBX has disclosed to
PII all material information it has requested in writing relating to the synthesis of the Compound. 
 (o) RBX is validly
existing and in good standing under the laws of the country of its organization and has the corporate and other power and authority to enter into this Agreement. This Agreement has been duly executed and delivered by RBX and constitutes the valid
and binding obligation of RBX 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 RBX, its officers and directors. 

(p) The execution, delivery and performance of this Agreement by RBX (i) are not in contravention of any provisions of the
certification of incorporation or by-laws of RBX, (ii) will not violate any law or regulation or any order or decree of any court or any government instrumentality, (iii) will not violate the terms of any indenture, mortgage, deed of
trust, lease, agreement or other instrument to which RBX is a party or by which RBX or any of its property is bound, and (iv) do not require any filing or registration with or the consent or approval of, any governmental body, agency, authority
or any other person, including, without limitation, the U.S. Federal Trade Commission or the U.S. Department of Justice under the Hart-Scott-Rodino Anti-Trust Improvements Act of 1976, as amended, which has not been made or obtained previously.

 10.02 Warranties by PII. PII represents and warrants to RBX the following: 

(a) PII is validly existing and in good standing under the laws of the state of its organization and has the corporate power and
authority to enter into this Agreement. This Agreement has been duly executed and delivered by PII and constitutes the valid and binding obligation of PII, 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 PII, its officers and directors. 
 (b) The execution,
delivery and performance of this Agreement by PII (i) are not in contravention of any provisions of the certification of incorporation or by-laws of PII, (ii) will not violate any law or regulation or any order or decree of any court or
any government instrumentality, (iii) will not violate the terms of any indenture, mortgage, deed of trust, lease, agreement or other instrument to which PII is a party or by which PII or any of its property is bound, and (iv) do not
require any filing or registration with or the consent or approval of, any governmental body, agency, authority or any other person, including, without limitation, the U.S. Federal Trade Commission or the U.S. Department of Justice under the
Hart-Scott-Rodino Anti-Trust Improvements Act of 1976, as amended, which has not been made or obtained previously. 
  

 23 

 (c) There is no (i) action, suit, dispute, proceeding or arbitration (whether by
a governmental agency, division, or otherwise) pending or threatened, or (ii) investigation (formal or informal) pending or threatened against or relating to PII or its Affiliates which, in either case, could reasonably prevent or impair PII
from carrying out its obligations under this Agreement. 
 10.03 Employee Agreements. Each Party represents and 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 XI – TERM AND TERMINATION 

11.01 Term. Unless otherwise terminated in accordance with the provisions of this Article XI, the licenses granted herein and the
obligations assumed hereunder shall commence as of the Option Exercise Date and shall expire on a country-by-country and Licensed Product-by-Licensed Product basis (the Parties agreeing that each Licensed Product shall have its own term) upon the
later to occur of (i) ten (10) years from the First Commercial Sale in such country of such Licensed Product, and (ii) the expiry of the last to expire Enforceable Claim covering such Licensed Product in such country. In the event PII does
not exercise the Option prior to the expiration of the Option Period, subject to Section 11.05, this Agreement shall terminate and be of no further legal force or effect. 

11.02 Material Breach. This Agreement may be terminated by either Party upon the material default of this Agreement by the other 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 of twenty (20) days for payment default and thirty (30) days for non-payment defaults from the date of the notice. If the Defaulting Party fails to cure the default within the applicable grace period, or if such
default is incapable of being cured within such grace period (expressly excluding payment defaults) and the Defaulting Party has failed within such period to take actions that are reasonably likely to cure such default, provided that in no event
shall such default continue beyond one hundred fifty (150) days, 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 termination 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 right to terminate this Agreement arising by reason of any subsequent
default. Notwithstanding the foregoing, PII shall not be considered in material default under this Agreement if such material default results from a Licensed Product Manufacturing Failure. 

 

 24 

  11.03 Termination for Failure to Meet Key Development Milestones. RBX may terminate this
Agreement upon thirty (30) days’ written notice to PII in the event that any one or more of the following milestones have not been achieved within six (6) months of the date corresponding to such milestone as follows: 

 

					
	 	  	 Milestone
	  	 Date

			
	1.	  	[*]	  	[*]
			
	2.	  	[*]	  	 [*] 

			
	3.	  	[*]	  	 [*] 

			
	4.	  	[*]	  	 [*] 

			
	5.	  	[*]	  	 [*] 

			
	6.	  	[*]	  	[*]

  provided; however, that the period within which
a milestone must be achieved as provided above, and each subsequent milestone thereafter, will be extended to the extent of the delay in the completion of the applicable milestone that was caused by (i) RBX’s delay in compliance with its
obligations provided in Sections 4.05 and 4.07 of this Agreement, (ii) a Force Majeure event or (iii) an Interfering Event. PII shall use Diligent Efforts to achieve each of the Milestones provided above as soon as practicable and shall,
in the event of a delay, provide RBX detailed information on a monthly basis describing the reason for the delay, the actions being taken to overcome the delay and the estimated time to complete the delayed Milestone. 

11.04 Termination for Insolvency/Bankruptcy. It either PII or RBX (i) makes a general assignment for the benefit or creditors or
becomes insolvent; (ii) files an insolvency petition in bankruptcy; (iii) petitions for or acquiesces in the appointment of any receiver, trustee or similar officer to liquidate or conserve its business or a substantial part of its assets;
(iv) commences under the laws of any jurisdiction any proceeding involving its insolvency, bankruptcy, reorganization, adjustment of debt, dissolution, liquidation or any other similar proceedings for the release of financially distressed
debtors; or (v) becomes a party to any proceeding or action of the type described in (iii) or (iv) 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. 
 11.05 Voluntary Termination by PII. PII shall
have the right to terminate this Agreement in the course of Development upon giving RBX at least sixty (60) days prior written notice, if PII, in its sole discretion, determines that further Development or commercialization of Licensed Product is no
longer viable for safety, efficacy or manufacturing reasons, or, if in the opinion of PII, the Licensed Product is no longer viable for commercial reasons. In such event, PII shall, to the extent it is legally required to do so, diligently finalize
any clinical trial it has initiated and issue the corresponding final report and any other pertinent documents (including providing copies of same to RBX) in compliance with applicable regulatory requirements. In the event PII exercises the right of
termination provided in this Section 11.05 prior to the completion of any 
  

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

 

 25 

  
[*] for the Licensed Product other than (i) for safety, or efficacy reasons relating to the Licensed Product, (ii) for a material Licensed Product Manufacturing Failure, or
(iii) for breach of this Agreement by RBX, within thirty (30) days of the provision of PII’s written notice of termination to Ranbaxy as provided in this Section 11.05, PII shall remit to Ranbaxy a termination payment of one
million dollars ($1,000,000). 
  11.06 Rights of RBX Upon Early Termination. If PII terminates this Agreement pursuant to
Section 11.05 or if Ranbaxy terminates this Agreement under Sections 11.02, 11.03 and/or 11.04, PII shall: 
 (a)
irrevocably lose any and all licenses granted to PII by RBX pursuant to this Agreement, including, without limitation, pursuant to Section 3.01, which licenses shall terminate and be of no further force or effect; 

(b) be deemed to have automatically granted to RBX (without any further action required by PII) an irrevocable, fully-paid,
worldwide, exclusive license to the Joint Patent Rights and the Joint Inventions to develop, make, use and sell any Licensed Product; 

(c) be deemed to have automatically granted to RBX (without any further action required by PII) an irrevocable, worldwide,
non-exclusive license under the PII Patents to develop, make, use and sell any Licensed Product; 
 (d) promptly, but in
no event later than thirty (30) days from the effective date of termination, provide RBX with copies of all PII Information and PII shall be deemed to have automatically granted to RBX (without any further action required by PII) the right to
use such information to develop, make, use and sell (including, without limitation, obtaining Regulatory Approval) any Licensed Product(s); 

(e) PII shall be deemed to have automatically conveyed to RBX (without any further action required by PPD) all of PII’s, its
Affiliates’ and its Third Party Partner’s right, title and interest in and to any and all Regulatory Approvals (including related Regulatory Documentation) then pending or otherwise obtained by PII, its Affiliates or its Third Party
Partner relating to the Compound or any Licensed Product(s); 
 (f) PII shall execute and deliver and cause its
Affiliates and its Third Party Partner to execute and deliver, such other instruments of conveyance and transfer and take such other action as RBX may reasonably request to more effectively convey, transfer to and vest in RBX the information and
Regulatory Approvals described above; 
 (g) not later than thirty (30) days from the termination of this Agreement,
deliver to RBX (i) all original patent files relating to the RBX Patents, (ii) copies of the PII Patents (including PII Patent applications) and (iii) copies of the patent files relating to the Joint Patents, all at PII’s cost
and expense; 
 (h) destroy and not retain any copies of Confidential Information provided by RBX pursuant to this
Agreement; 
  
  

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

 

 26 

 (i) ensure that any Partnering Agreement will reflect the requirements of this
Section 11.06; and 
 In the event PII exercises its right of termination under Section 11.05, PII shall have no further liability or
obligation to RBX under the terms of this Agreement, except as set forth in Sections 11.05, 11.06 and 11.08. 
 11.07 Early Termination by
PII. If PII terminates this Agreement under Sections 11.02, 11.04 or 11.05, any license grant by RBX to PII pursuant to this Agreement, including, without limitation, as set forth in Section 3.01 shall automatically terminate and be of
no further legal force or effect. 
 11.08 Residual Obligation upon Termination. Termination of this Agreement for any reason
whatsoever will not release or discharge the Parties 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 9.01. Sections 5.07, 6.02, 6.03, 7.01, 7.02, 7.05, 8.03 (relating to any Section 8.03 Actions commended prior to the date of such termination), 11.06, 11.07, 12.01, 12.02, 12.03, 12.07, 12.09, 12.15, 12.16, and 12.17 and Article I
shall survive any expiration or termination of this Agreement. 
 11.09 Remaining Licensed Product. Upon any termination of this
Agreement, PII shall have the right for twelve (12) months 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 RBX with respect to such Licensed Product as
though this Agreement had not terminated. 
 ARTICLE XII – MISCELLANEOUS 

12.01. Indemnification. 

(a) RBX Indemnification of PII. RBX shall indemnify, hold harmless and defend PII, its permitted assignees, and its and
their officers, employees, agents, sublicensees, a Third Party Partner, Affiliates, and/or contractors against any and all claims, demands, suits, losses, damages, settlements, costs, fees and expenses of any nature whatsoever, including without
limitation reasonable attorney’s fees, expert witness fees and court costs (“Claim”) resulting from or arising out of (i) any material breach by RBX of a representation or warranty contained in this Agreement; (ii) any
material breach of this Agreement by RBX; (iii) any failure by RBX to comply in all material respects with applicable laws in connection with the performance of its obligations under this Agreement; (iv) the negligence or willful
misconduct of RBX in the performance of this Agreement; and/or (v) the development, manufacture, packaging, labeling, handling, storage, transportation, use, distribution, promotion, marketing and sale of any AB Rated Product by RBX or any of
its Affiliates or designated Third Parties for any AB Rated Product [*]; in each case except to the extent such Claims result from the gross negligence or willful misconduct of PII in the performance of this Agreement. 

 
  

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

 

 27 

 (b) PII Indemnification of RBX. PII shall indemnify, hold harmless and defend
RBX, its permitted assignees, and its and their officers, employees, agents, sublicensees, Affiliates and/or contractors against any and all claims, demands, suits, losses, damages, costs, fees and expenses of any nature whatsoever, including,
without limitation, reasonable attorney’s fees, expert witness fees and court costs (“Claim”) resulting from or arising out of (i) the Development, manufacture, packaging, labeling, handling, storage, transportation, use,
distribution, promotion, marketing and sale by PII or its Affiliates, any of their sublicensees (including sublicensees of such sublicensees), or a Third Party Partner, distributors or agents of the Compound and any Licensed Products in the
Territory and the recall of any Licensed Products; (ii) any use, handling, storage, testing, transportation, distribution, manufacturing, formulation or sale of the RBX [*]; (iii) any alleged or actual infringement or misappropriation of a
Third Party’s intellectual property in connection with the Development, manufacture and/or commercialization of the Compound or any Licensed Product including, without limitation, any amounts paid or payable to a Third Party pursuant to
Section 8.03; (iv) the manufacture of the Drug Substance, CTM Product and/or Licensed Product by PII, its Affiliates, any sublicensee, Third Party Partner of PII or Third Party; (v) any material breach by PII of a representation or
warranty contained in this Agreement; (vi) any material breach of this Agreement by PII or its Affiliates, sublicensees or Third Party Partner of PII; (vii) any injury to or death of any person from the use of any Drug Substance, CTM
Product, or Licensed Product; (viii) any failure by PII to comply in all material respects with applicable laws in connection with the performance of its obligations or the exercise or its rights under this Agreement; and/or (ix) the
negligence or willful misconduct of PII or its Affiliates, sublicensees or Third Party Partner of PII in the performance of this Agreement; in each case except to the extent such Claims result from the gross negligence or willful misconduct of RBX
in the performance of this Agreement. 
 (c) Indemnification Procedure. 

(i) If any action is brought against a party entitled to indemnification under Section 12.01(a) or 12.01(b), as applicable, (each, an
“Indemnified Party”), such Indemnified Party or Parties shall promptly notify the party obligated to provide indemnification (an “Indemnifying Party”) in writing of the institution of such action. 

(ii) Promptly upon receipt of notice pursuant to subparagraph (a) above, the Indemnifying Party shall promptly assume the defense of
such action, including, without limitation, the employment of counsel reasonably satisfactory to such Indemnified Party or Parties, and payment of expenses. An Indemnified Party or Parties shall have the right to employ its or their own counsel in
any such case, but the fees and expenses of such counsel shall be at the expense of such Indemnified Party or Parties, unless: (A) the employment of such counsel shall have been authorized in writing by the Indemnifying Party in connection with
the defense of such action; or (B) the named parties to such action include both the Indemnified Party or Parties and the Indemnifying Party and such Indemnified Party or Parties shall have reasonably concluded that there may be one or more
legal defenses available to it or them or to other Indemnified Parties which are different from, or in addition to, those available to the Indemnifying Party. In either of the foregoing events, such fees and expenses shall be borne by

  
  

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

 

 28 

 
the Indemnifying Party and the Indemnifying Party shall not have the right to direct the defense of such action on behalf of the Indemnified Party or Parties. Notwithstanding anything to the
contrary set forth herein, under no circumstances shall the Indemnifying Party be obligated to assume responsibility for the expenses for more than one counsel for all of the Indemnified Parties as a group. 

(iii) Notwithstanding anything contained in this Section 12.01(c) to the contrary, the Indemnifying Party shall not be liable for
any settlement of any such Claim or action effected without its written consent, which consent shall not be unreasonably withheld. The Indemnifying Party shall have the right to settle or compromise any action, or permit a default or consent to the
entry of judgment in, or otherwise seek to terminate, any pending or threatened action, in respect of which indemnity may be sought hereunder (whether or not any Indemnified Party is a party thereto), provided such settlement, compromise, consent,
or termination includes a disclaimer of any fault of the Indemnified Party and an unconditional release of each Indemnified Party from all liability in respect of such action. In the event such an unconditional release is not obtainable for each
Indemnified Party, then the Indemnifying Party must obtain the prior written consent of any Indemnified Party not so released before the Indemnifying Party may enter into such settlement, compromise, consent or termination, which consent shall not
be unreasonably withheld or delayed. 
 (d) Limitation on Liability. IN NO EVENT SHALL EITHER PARTY OR ITS
AFFILIATES, OR THEIR DIRECTORS, OFFICERS, EMPLOYEES OR AGENTS BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY OR CONSEQUENTIAL DAMAGES, WHETHER BASED UPON A CLAIM OR ACTION OF CONTRACT, WARRANTY, NEGLIGENCE, STRICT
LIABILITY OR OTHER TORT, OR OTHERWISE ARISING OUT OF THIS AGREEMENT; PROVIDED, HOWEVER, THAT THIS LIMITATION WILL NOT LIMIT THE INDEMNIFICATION OBLIGATIONS OF SUCH PARTY UNDER THE PROVISIONS OF THIS ARTICLE XII FOR SUCH DAMAGES CLAIMED BY A THIRD
PARTY (EXPRESSLY EXCLUDING ANY SUBLICENSEE, AFFILIATE OR THIRD PARTY PARTNER OF PII). 
 (e) Payment of
Indemnification. Upon the final, nonappealable determination of liability and the amount of the indemnification payment under this Article, the indemnifying Party will pay such amount to the Indemnified Party in immediately available funds
within thirty (30) days after such determination. 
 12.02. Product Recalls and Insurance. 

(a) Product Recalls. PII shall oversee and handle, at its own cost and expense, all physical aspects relating to any
withdrawal or recall of the Licensed Products sold by PII or its Affiliates, their respective sublicensees or a Third Party Partner in the Territory; 

(b) Insurance. During the term of this Agreement and for a period of five (5) years after its expiration or earlier
termination, each Party shall obtain, at its sole cost and expense, product liability insurance, or shall set up, at its sole cost and expense, a self insurance arrangement, that meets the following requirements: 

(i) the insurance shall insure such Party against all liability related to the Products (whether that Party’s liability arises from
its own conduct or by virtue of its participation in this Agreement), including liability for bodily injury, property damage, wrongful death, and any contractual indemnity obligations imposed by this Agreement; and 

 

 29 

 (ii) the insurance shall be in amounts, respectively, that are reasonable and customary in
the United States in the pharmaceutical industry, but in no event shall the product liability insurance maintained by each Party cover less than [*] per occurrence (or claim) and an annual aggregate of [*]. Each Party shall provide written
proof of the existence of such insurance to the other Party upon request. 
 12.03. Arbitration. 

(a) Pre-Arbitration Efforts. If a dispute arises between the Parties as to the interpretation or performance of any of the
provisions of this Agreement or as to matters related to but not covered by this Agreement, then the Parties shall consult initially to try to resolve the matter amicably. If they shall not be capable of resolving the matter within thirty
(30) days of the dispute arising, the matter shall be dealt with in accordance with the provisions of Section 12.03(b). 

(b) Arbitration Procedures. All disputes arising out of or in connection with the Agreement shall be settled by final and
binding arbitration by the American Arbitration Association (“AAA”), under its commercial rules then in effect except as provided herein. The arbitration will be conducted in New York, NY or such other geographically neutral site within
the United States that is mutually agreed by the Parties. All proceedings shall be held in English and a transcribed record prepared in English. The parties shall choose, by mutual agreement, one arbitrator within twenty (20) days of the filing
of an arbitration demand with the AAA. If the parties are unable to appoint an arbitrator within the time herein provided or any extension of time that is mutually agreed on, one arbitrator will be appointed by PII, one arbitrator will be appointed
by RBX, and the third arbitrator will be appointed by the two arbitrators within thirty (30) days of the date on which the initial period for appointment of a sole arbitrator by mutual agreement lapsed. The award rendered by the arbitrator
shall include all costs of arbitration, reasonable attorneys’ fees and reasonable costs for expert and other witnesses, and judgment on such award may be entered in any court having jurisdiction thereof. Nothing in this Agreement shall be
deemed as preventing either party from seeking injunctive relief (or any other provisional remedy) from any court having jurisdiction over the Parties and the subject matter of the dispute as necessary to protect either Party’s name,
proprietary information, trade secrets, know-how or any other proprietary right. If the issues in dispute involve scientific or technical matters, any arbitrator chosen hereunder shall have educational training and/or experience sufficient to
demonstrate a reasonable level of knowledge in the field of biotechnology. 
 12.04. Amendment. This Agreement may not be amended,
supplemented or otherwise modified except by an instrument in writing signed by an authorized representative of the Parties. 
  

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

 30 

 12.05. 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, this 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. 
 12.06. 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. 
 12.07. Waiver. The waiver of a
breach hereunder may be affected only by a writing signed by the waiving Party and shall not constitute a waiver of any other breach. Any delay in enforcing a Party’s rights under this Agreement or any waiver as to a particular default or other
matter shall not constitute a waiver of such Party’s rights to the future enforcement of its rights under this Agreement, excepting only as to an express written and signed waiver as to a particular matter for a particular time period.

 12.08. 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:
	    	Pharmaco Investments, Inc.
		    	3151 South 17th Street
		    	Wilmington, NC 28412
		    	Facsimile: (910) 343-5920
		    	 Attn: Chief Executive Officer

		
		    	With a copy to:
		    	Pharmaco Investments, Inc.
		    	3151 South 17th Street
		    	Wilmington, NC 28412
		    	Facsimile: (910) 343-5920
		    	 Attn: General Counsel

		
	 For:
	    	Ranbaxy Laboratories Ltd.
		    	Plot 90 Sector 32
		    	Gurgaon 1222001 (Haryana) India
		    	Facsimile:
		    	 Attn:

  

 31 

 12.09. Governing Law. This Agreement shall be governed by, and construed in accordance with,
the laws of the State of New York, United States, except any choice of law shall be determined in accordance with the applicable laws of the countries in which patents encompassed within the scope of this Agreement have issued. Any action, suit or
other legal proceeding which either party may commence to resolve any matter arising under or relating to any provision of this Agreement shall be commenced only in the state or federal courts located in the State of New York, United States, and the
parties hereby consent to the jurisdiction of such court with respect to any such action, suit or proceeding. 
 12.10.
Assignability. This Agreement and the licenses granted herein shall be binding upon and inure to the benefit of the Parties and their respective successors in interest, 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 this Agreement or any benefit and/or burden hereunder without prior written consent of the other Party, provided that either Party will have the
right to assign this Agreement and its benefits and burdens hereunder to an Affiliate, or to a successor in interest (whether by acquisition, merger or sale of all or substantially all its assets), without obtaining the consent of the other party.
Nothing in this Section 12.10 shall be deemed to prevent PII from subcontracting its obligations under this Agreement to any Third Party, which PII shall have the right to do in its discretion subject to Section 3.02. 

12.11. Release of Information. Unless otherwise mutually agreed by the Parties, the Parties agree to issue, within two (2) business
days from the Option Exercise Date, a mutually agreed press release relating to the transactions contemplated by this Agreement. No Party to this Agreement may otherwise 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; and (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). 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. 
  

 32 

 12.12. 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. 

12.13. Dollars. All references to “dollars” hereunder are to United States dollars. 

12.14. Jointly Prepared. This Agreement has been prepared jointly and shall not be strictly construed against either Party. 

12.15. 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. 
 12.16. Counterparts. This Agreement may be executed in one or more
counterparts, including by facsimile, each of which shall be an original, but all of which taken together shall constitute one and the same agreement. 

12.17. Schedules. Each Schedule attached hereto shall be incorporated into and be a part of this Agreement. 

12.18. Force Majeure. Both Parties, and any Third Party vendors or any sublicensee or Third Party Partner of PII, shall be excused from the
performance of their obligations under this Agreement to the extent that such performance is prevented, in whole or in part, by Force Majeure events and the nonperforming Party promptly provides notice of the prevention to the other Party. Such
excuse shall be continued so long as the condition constituting Force Majeure continues and the nonperforming Party takes reasonable efforts to remove the condition; provided, however, the obligation to make payment of any payment that
is due and owing hereunder shall not be delayed by the payer because of a Force Majeure affecting the payer. 
 12.19. PPD
Guarantee. PPD hereby unconditionally and irrevocably guarantees to RBX the performance of all of the obligations of PII under this Agreement, including, without limitation, the due and prompt payment by PII of any amounts payable under
Article V. 
 12.20. No Third Party Beneficiary. No Third Party is or shall be construed to be a third party beneficiary of any
provision of this Agreement. 
 IN WITNESS WHEREOF, the Parties have executed this Agreement through duly authorized representatives as of the
date first set forth herein. 
 [The Next Page is the Signature Page] 

 

 33 

							
	PHARMACO INVESTMENTS, INC.	    	RANBAXY LABORATORIES LTD.
				
	By:	 	  
	    	By:	 	  

				
	Name:	 	  
	    	Name:	 	  

				
	Title:	 	  
	    	Title:	 	  

 PPD, by its signature
below, executes and delivers this Agreement to RBX for the sole and limited purpose of agreeing to be bound by Section 12.19. 

PHARMACEUTICAL PRODUCT DEVELOPMENT, INC. 
  

			
	By:	 	  

		
	Name:	 	  

		
	Title:	 	  

  

 34 

 SCHEDULE 1.13 

DEVELOPMENT PLAN 

[*] 
  

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

 SCHEDULE 1.53 

RBX PATENTS 
 [*] 

  
  

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

 SCHEDULE 4.05 

RBX Know-How 
 [*]

  
  

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

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00173-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00173-of-00352.parquet"}]]