Document:

Termination and License Agreement

 Exhibit 10.12 
 Portions of this exhibit marked [*] are omitted and 
 are
requested to be treated confidentially. 
 TERMINATION AND LICENSE AGREEMENT 
 THIS TERMINATION AND LICENSE AGREEMENT (“Agreement”), effective as of December 18, 2003 (“Effective Date”), is made by and
among Eli Lilly and Company, a corporation organized under the laws of the State of Indiana, having its principal place of business at Lilly Corporate Center, Indianapolis, Indiana, 46285 (hereinafter “Lilly”), Pharmaceutical Product
Development, Inc., a corporation organized under the laws of the State of North Carolina (hereinafter “PPD”), GenuPro, Inc., a wholly-owned subsidiary of PPD, and a corporation organized under the laws of North Carolina (hereinafter
“GenuPro”) and APBI Holdings, LLC, a wholly-owned subsidiary of PPD, and a limited liability company organized under the laws of North Carolina (hereinafter “APBI Holdings”). (Each party to this Agreement is hereinafter referred
to as a “Party”, or collectively, the “Parties.” All references to a Party shall be deemed to include that Party’s Affiliates). 
 Recitals 
 A. Lilly, PPD and GenuPro are parties to a Development and
License Agreement effective as of May 22, 1998 (as amended to date, the “Development Agreement”). 

 B. Pursuant to the Development Agreement, Lilly has granted GenuPro certain intellectual
property licenses related to, among other things, a pharmaceutical composition known as Dapoxetine. 
 C. As permitted by the
Development Agreement, GenuPro has sublicensed to Alza, Corporation (“Alza”) certain rights to develop and market Dapoxetine in exchange for which GenuPro is entitled to receive certain milestone, royalty and other payments from Alza.
Pursuant to the Development Agreement, Lilly is entitled to receive from GenuPro a portion of the payments received by GenuPro from Alza. 
 D. The parties now desire to, among other things, (i) terminate the Development Agreement, (ii) transfer to APBI Holdings ownership of certain Lilly patents licensed to GenuPro pursuant to the
Development Agreement and (iii) provide for an up-front cash payment to Lilly by APBI Holdings and a royalty based on Net Sales of Dapoxetine (as defined herein below), all in accordance with the terms and conditions of this Agreement.

 In consideration of the Recitals and the mutual covenants and promises contained herein, the Parties, intending to be legally bound, hereby
agree as follows: 
  

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 Article 1 
 Definitions 
 As used herein, the following terms shall have the
meaning indicated: 
 1.1 “Affiliate” means, with respect to a Party, any Person directly or indirectly
controlling, controlled by, or under common control with, such Party. For purposes of this definition, the term “controlled” (including the terms “controlled by” and “under common control with”) means the direct or
indirect ability or power to direct or cause the direction of management policies of a person or otherwise direct the affairs of such person, whether through ownership of equity, voting securities, beneficial interest, by contract or otherwise.

 1.2 “Applicable Laws” means all applicable laws, ordinances, rules and regulations of any kind whatsoever of
any governmental (including international, foreign, federal, state and local) or regulatory authority, including, without limitation, all laws, ordinances, rules and regulations promulgated by the U.S. Food and Drug Administration (“FDA”).

 1.3 “Calendar Quarter” means the three (3) month period ending on
March 31, June 30, September 30 or December 31.  
 1.4 “Calendar Year”
means the twelve (12) month period ending on December 31.  
 1.5 “Compounds” means those
compounds other than Dapoxetine covered by a Valid Claim within the scope of the Licensed Patents. 
  

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 1.6 “Confidential Information” means information received (whether
disclosed in writing, electronically, orally or by observation) by one Party (the “Receiving Party”) from the other Party (the “Disclosing Party”) that the Disclosing Party reasonably considers proprietary and confidential
unless in each case such information, as shown by competent evidence: 
 (a) was known to the
Receiving Party or to the public prior to the Disclosing Party’s disclosure, as demonstrated by contemporaneous written records; 
 (b) became known to the public, after the Disclosing Party’s disclosure hereunder, other than through a breach of the confidentiality provisions of this Agreement by the Receiving Party or any
Person to whom such Receiving Party disclosed such information; 
 (c) was subsequently disclosed to the
Receiving Party by a Person having a legal right to disclose, without any restrictions, such information or data; or 
 (d) was developed by the Receiving Party independent of the Disclosing Party’s Confidential Information. 
 1.7 “Damages” means any and all costs, losses, claims, demands for payment, government enforcement actions, liabilities, fines, penalties, expenses, court costs and

  

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reasonable fees and disbursements of counsel, consultants and expert witnesses incurred by a Party hereto (including any court-imposed interest in connection therewith). 
 1.8 “Dapoxetine” [*] 
 1.9 “Data Exclusivity Period” means the period during which the FDA (or, in countries other than the United States, an equivalent regulatory agency) prohibits reference, without
the consent of the owner, to the clinical and other data that is contained in any application for marketing or regulatory approval. 
 1.10 “Effective Date” shall have the meaning set forth in the first paragraph hereof. 
 1.11
“GAAP” means U.S. generally accepted accounting principles, consistently applied. 
 1.12 “GenuPro
Field” shall mean all therapeutic indications for use in humans (i.e. specifically excluding use in animals) within the urogenital area, including primary urinary incontinence, urge, stress and mixed incontinence, urinary urgency,
interstitial cystitis, neurogenic bladder, bladder sphincter dyssynergia and irritative symptoms of benign prostate hypertrophy, hypoactive sexual desire, hyperactive sexual desire, impotence, retarded ejaculation, premature ejaculation, delayed
orgasm and anorgasmia. 
  

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

  

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 1.13 “GenuPro Improvements” means any inventions, patentable or not,
information and/or data relating to Compound and/or Dapoxetine, including clinical trial information, processes, formulations, modes of delivery and/or other data that are owned or controlled by GenuPro (i) in the case of Dapoxetine, during the
term of this Agreement and (ii) in the case of Compounds, as of the Effective Date. 
 1.14 “GenuPro
Know-How” means any unpatented or unpatentable inventions, information, data, drawings, plans, specifications and designs relating to Dapoxetine or Compounds that is owned or controlled by GenuPro (i) in the case of Dapoxetine, during
the term of this Agreement and (ii) in the case of Compounds, as of the Effective Date including, in particular, any preclinical, clinical, toxicology, and/or ADME information or data. GenuPro Know-How shall not include GenuPro Manufacturing
Know-How or computer software. 
 1.15 “GenuPro Manufacturing Know-How” shall mean any unpatented or
unpatentable information and/or data relating to Dapoxetine and/or Compounds necessary for one skilled in the art of large scale synthetic molecule synthesis to synthesize and manufacture Dapoxetine and/or Compounds, including processes therefore,
that is owned or controlled by GenuPro (i) in the case of Dapoxetine, during the term of this Agreement and (ii) in the case of Compounds, as of the Effective Date. 
  

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 1.16 “Licensed Patents” means those patents and patent applications listed
in Exhibit A attached hereto and any resulting issued patents arising out of or that may claim priority to such patents and patent applications and that arise from inventions disclosed therein and all national stage applications, divisionals,
continuations and continuations in part that may arise out of or may claim priority to these patents and applications and any reissues, reexaminations, extensions and supplemental protection certificates arising from such patents. 
 1.17 “Lilly Improvements” means any inventions, patentable or not, information and/or data relating to Dapoxetine
including, without limitation, processes, formulations, modes of delivery and/or other data, that are owned or controlled by Lilly during the term of this Agreement. 
 1.18 “Lilly Manufacturing Know-How” shall mean any unpatented or unpatentable information and/or data relating to Dapoxetine necessary for one skilled in the art of large scale synthetic
molecule synthesis to synthesize and manufacture Dapoxetine, including processes therefore, that is owned or controlled by Lilly, during the term of this Agreement. 
 1.19 “Lilly Know-How” means any unpatented or unpatentable inventions, information, data, drawings, plans, specifications and designs relating to Dapoxetine owned or controlled by Lilly
during the term of this Agreement including, in particular,

  

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any preclinical, clinical, toxicology and/or ADME information or data. Lilly Know-How shall not include Lilly Manufacturing Know-How or computer software. 
 1.20 “Lilly Field” shall mean all uses except for the GenuPro Field. 
 1.21 “Net Sales” means, with respect to Product, the total amount billed or invoiced by any Permitted Seller to unrelated
Third Persons for sales of Product in the Territory less the following deductions calculated in accordance with GAAP, consistently applied: 
 (i) trade, cash and quantity discounts actually taken on such; 
 (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 Permitted Seller’s accounting policies. 
 Sales between GenuPro and its Affiliates and licensees and Permitted Sellers and their Affiliates and licensees shall not be treated as Net
Sales hereunder. 
  

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 In the event the Product is sold by the Permitted Seller as part of a combination product,
the Net Sales of the Product, for the purposes of determining royalty payments, shall be determined by multiplying the Net Sales (as defined above) of the combination product by the fraction A/(A+B), where A is Permitted Seller’s published
sales price of the Product when sold separately in finished form and B is Permitted Seller’s published sales price of the other product(s) sold separately in finished form. In the event that such published sales price cannot be determined for
both the Product and the other product(s) in combination, Net Sales for purposes of determining royalty payments shall be mutually agreed by the parties based on the relative value contributed by each component, and such agreement shall not be
unreasonably withheld. 
 Such Net Sales shall be determined from the books and records of the Permitted Seller, maintained in
accordance with GAAP, consistently applied. For purposes of this definition Net Sales shall be deemed to have occurred upon invoicing of such Product or if not invoiced, then when delivered, shipped, or paid for, whichever comes first. Further, in
determining such amounts, the Permitted Seller will use its then current standard procedures and methodology. The translation of foreign currency sales into U.S. Dollars will be based on the exchange rates published in the Wall Street Journal on the
last business day of the applicable Calendar Quarter. For purposes of calculating Net Sales, in the case of a sale or other disposal of 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 Product (if higher than the stated sales price) in the country of disposition. 
  

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 1.22 “Permitted Seller” means APBI Holdings, GenuPro and any assignee,
licensee or sublicensee having the right to sell Product, including without limitation, Alza and any permitted assignee, licensee or sublicensee of Alza, but excluding Lilly. 
 1.23 “Person” means a natural person, a corporation, a partnership, a trust, a joint venture, a limited liability company,
any governmental authority, or any other entity or organization. 
 1.24 “Product” means any human
pharmaceutical composition or preparation, in any dosage strength or size, for any mode of administration, containing Dapoxetine. 
 1.25 “Royalty Term” means, with respect to each country in which the Product is sold, on a Product by Product basis, that time period beginning on the first sale of Product in such country and expiring, on a
country-by-country basis, on the later of the following: 
 (a) the [*] anniversary of the date of
first commercial sale of Product in such country; 
 (b) the expiration in such country of the
last-to-expire Licensed Patent with a Valid Claim; or 
 (c) the expiration of any applicable Data
Exclusivity Period in such country. 
  

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

  

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 1.26 “Termination Date” means the date on which Lilly receives the payment
provided for in Section 3.1(a) .  
 1.27 “Territory” means all countries of the world.  

 1.28 “Third Person” means Persons other than the Parties. 
 1.29 “Valid Claim” means a claim of an issued and unexpired Licensed Patent in a country which: (i) but for this
Agreement, would be infringed by the manufacture, importation, use, offer for sale or sale or other disposition of Product by or on behalf of GenuPro, APBI Holdings or another Permitted Seller, (ii) has not been revoked or held unenforceable or
invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and (iii) has not been abandoned, disclaimed or admitted to be invalid or unenforceable
through reissue, disclaimer or otherwise. 
 Article 2 
 Termination and Assignment 
 2.1 Termination of
Development Agreement. Lilly, PPD and GenuPro hereby terminate the Development Agreement effective as of the Termination Date. As of the Termination Date, the Development Agreement shall have no further force or

  

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effect and no party thereto shall have any further right or obligation thereunder except that: 
 a. Termination of the Development Agreement shall not release or discharge any party from the performance of any obligation, the payment of any debt or responsibility for any liability which may have
accrued prior to the Termination Date and remains to be performed, paid or discharged, as of the Termination Date. However, following the Termination Date, no further obligations under the Development Agreement shall by incurred by any party, except
as specifically provided in subparagraphs b and c below. 
 b. The obligations of confidentiality set forth in
Section 10.1 and 10.2 of the Development Agreement shall continue in effect for the period stated therein. 
 c. The obligations to indemnify set forth in Sections 14.03(a) of the Development Agreement shall continue in effect indefinitely, but only with respect to any cause of action arising prior to the Termination Date. 
 Without limiting the generality of the foregoing, following the Termination Date, Lilly shall have no further obligation to provide any
assistance of any type to PPD or GenuPro in connection with the research, development, manufacturing or sale of Dapoxetine, Product or any other product. 
  

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 2.2 Assignment of Licensed Patents. Concurrently with the execution of this
Agreement, Lilly shall execute a Patent Assignment Agreement in the form attached hereto as Exhibit B transferring to APBI Holdings ownership of the Licensed Patents effective as of the Termination Date. 
 Article 3 
 Consideration 
 3.1 Payments from APBI Holdings to Lilly. Subject to and upon the terms and conditions
of this Agreement, APBI Holdings shall make the following payments to Lilly: 
 (a) Upfront Payment to
Lilly. Concurrently with the execution of this Agreement, APBI Holdings shall transfer to Lilly by Federal Reserve wire transfer to an account designated by Lilly the sum of sixty-five million U.S. dollars ($65,000,000) in immediately available
funds. 
 (b) Royalty Payments from APBI Holdings to Lilly. APBI Holdings shall pay to Lilly a royalty of
five percent (5%) on Net Sales of Product in excess of $800 million in annual Net Sales for any Calendar Year during the Royalty Term. Net Sales of all presentations and forms of Product shall be aggregated for purposes of determining annual

  

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Net Sales. APBI Holdings shall pay royalties due hereunder concurrently with the remittance of the royalty report required by Section 3.2 
 (c) Third Party Payments. APBI Holdings shall pay when due any and all milestone, royalty and other similar
obligations Lilly might be obligated to pay to a Third Party pursuant to an agreement between Lilly and such Third Party covering rights relating to any Product in accordance with the terms and conditions set forth in such agreement between Lilly
and such Third Party. Lilly hereby represents and warrants to APBI Holdings that to the best of its knowledge, no agreements imposing such Third Party obligations exist as of the Effective Date. 
 (d) Form of Payment. All amounts payable to Lilly under Section 3.1 shall be paid in U.S. dollars by Federal
Reserve electronic wire transfer in immediately available funds to an account designated in writing by Lilly (unless otherwise instructed by Lilly in writing). 
 3.2 Record Retention, Royalty Reports, and Royalty Payment Schedule. APBI Holdings shall keep (and shall require Permitted Sellers to keep) complete and accurate books and records that are
necessary to ascertain and verify royalty payments owed to Lilly. Such records shall be kept in accordance with GAAP and APBI Holdings’ or its Permitted Sellers usual internal practices and procedures, consistently applied. GenuPro shall
furnish Lilly with a quarterly report on Net Sales within sixty (60) days of the end of the first three Calendar Quarters in each Calendar Year and within seventy-five (75) days of the end of the last Calendar Quarter of each Calendar
Year. Such report shall include a written report detailing: (i) the Net Sales for the previous Calendar

  

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Quarter, broken down by country and between APBI Holdings, GenuPro and any Permitted Sellers, (ii) the royalty payment that is due and payable under Section 3.01(b) hereof if any, and
(iii) the basis for calculating such Royalty Payment. APBI Holdings will mail such report to the attention of: Eli Lilly and Company, Lilly Royalty Administration in Finance, Lilly Corporate Center, Indianapolis, Indiana, 46285. The amount of
royalty payment due to Lilly shall be paid by APBI Holdings concurrently with the remittance of each royalty report. 
 3.3
Audits. APBI Holdings will keep full and accurate books and records relating to the performance required of it under this Agreement. Lilly will have the right, during regular business hours and upon reasonable advance notice, to have such books
and records of APBI Holdings audited no more than one (1) time per Calendar Year so as to verify the accuracy of the information previously reported to Lilly. Lilly will, for purposes of such audit, utilize the services of an independent
certified public accounting firm reasonably acceptable to APBI Holdings (which need not be APBI Holdings then current independent auditing firm.) Such audit may cover the two (2) calendar years preceding the date of the request for such audit.
Such accountants will keep confidential any information obtained during such audit and will report to Lilly only their conclusions. The cost of such audit will be borne by Lilly; however, if the result of such audit shows that the amount owed to
Lilly is [*] percent [*] or more greater than the amount paid, the cost of the audit will be borne by APBI Holdings. Within thirty (30) days after Lilly and APBI Holdings have received a copy of an audit report, APBI Holdings or
Lilly, as 
  

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

  

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 appropriate, will compensate the other Party for payment errors or omissions revealed by the audit. APBI
Holdings will include in all future licenses of Licensed Patents, and any other agreements enabling a Third Person to be a Permitted Seller, an audit provision substantially similar to the foregoing requiring such Permitted Seller to keep full and
accurate books and records relating to the Product and granting APBI Holdings the right to have an independent public accounting firm audit the accuracy of the information reported by the licensee in connection therewith. At Lilly’s request,
APBI Holdings shall invoke any rights it may have to audit a Permitted Seller and make the results of such audit available to Lilly promptly. 
 3.4 Taxes And Currency. Any and all taxes levied on any payments under this Agreement shall be the liability of and paid by Lilly. If laws or regulations require the withholding of such taxes, the
taxes will be deducted by APBI Holdings from the payment and remitted by APBI Holdings to the proper tax authority, provided that APBI Holdings will furnish Lilly with a copy of the official tax receipt on such withholdings as soon as practicable
after such withholding, and give Lilly such assistance as may be reasonably necessary to enable or assist Lilly to claim exemption or take credit therefrom, provided that Lilly reimburses APBI Holdings for any out of pocket expenses incurred by it
in providing such assistance. Proof of payment shall be provided to Lilly within sixty (60) days after payment. APBI Holdings will reasonably cooperate with Lilly in pursuing tax refunds, if such refund is appropriate in Lilly’s
determination, provided that Lilly reimburses APBI Holdings for any out of pocket expenses incurred by it in providing such assistance. 
  

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 3.5 Late Payment. Any amounts not paid APBI Holdings when due under this Agreement
will be subject to interest from and including the date payment is due through and including the date upon which Lilly has collected the funds in accordance herewith at a rate equal to the lesser of (i) the sum of [*] percent [*]
plus the prime rate of interest quoted in the Money Rates (or equivalent) section of the Wall Street Journal, calculated daily on the basis of a three hundred sixty (360) day year, or (ii) the maximum interest rate allowed by law.

 3.6 Guarantee of Payment. PPD hereby unconditionally guarantees the obligations of APBI Holdings to make
payment to Lilly as provided herein. Such guarantee shall survive any transfer of ownership of APBI Holdings or any of its assets or the assignment by APBI Holdings of any of its obligations under this Agreement. 
 Article 4 
 Licenses 
 4.1 License Grants to Lilly. APBI Holdings and GenuPro, as applicable, hereby grants to
Lilly: 
 (a) A perpetual, non-cancelable, fully paid-up, royalty free, exclusive (even as to APBI Holdings)
license, with right to sublicense, under the GenuPro Know-How, GenuPro Improvements, GenuPro Manufacturing Know-How, and Licensed 
  

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

  

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 Patents to make, have made, use, sell, offer for sale, and import Dapoxetine and Product in
the Territory solely for use in the Lilly Field. 
 (b) A perpetual, non-cancelable, fully paid-up, royalty free,
non-exclusive license to use GenuPro Know-How, GenuPro Improvements, GenuPro Manufacturing Know-How and Licensed Patents for internal research purposes (which shall include the right to use with Lilly research partners) in the GenuPro Field.

 (c) A perpetual, non-cancelable, fully paid-up, royalty free, exclusive (even as to APBI Holdings) license,
with right to sublicense, under the GenuPro Know-How, GenuPro Improvements, GenuPro Manufacturing Know-How and Licensed Patents to make, have made, use, sell, offer for sale, and import Compounds in the Territory for use in the GenuPro Field and the
Lilly Field. 
 4.2 License Grants to GenuPro. Lilly hereby grants to GenuPro and APBI Holdings an exclusive (even as to
Lilly) license, with right to sublicense, under the Lilly Know-How, Lilly Manufacturing Know-How and Lilly Improvements to make, have made, use, sell, offer for sale, and import Dapoxetine and Products in the Territory solely for use in the GenuPro
Field. 
 4.3 Notification of Sublicenses. In the event either APBI Holdings, GenuPro or Lilly sublicenses any of the
license rights granted hereunder other than to an Affiliate, it shall promptly advise the others in writing of the identity of the sublicensee. 
  

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 Article 5 
 Intellectual Property Matters 
 5.1 Intellectual
Property Maintenance. Licensed Patents shall be filed, prosecuted and maintained worldwide by APBI Holdings or a Third Person patent counsel designated by APBI Holdings . Lilly will waive any conflict of interest that may arise as a result of
such counsel representing the interests of both licensee and licensor. APBI Holdings shall have the ultimate responsibility for and control over such matters and shall bear all expenses incurred in filing, prosecuting and maintaining Licensed
Patents. APBI Holdings or its designee shall keep Lilly reasonably informed of the filing, prosecution and maintenance of Licensed Patents, and shall furnish to Lilly copies of substantive documents (e.g., office actions, responses, etc.) relevant
to any such efforts in advance with ten (10) working days for Lilly to review and provide comments on such documents, and shall use its reasonable efforts to incorporate the comments and suggestions of Lilly, if any. If APBI Holdings decides to
allow any Licensed Patent to lapse without entry of the national phase in one or more countries designated in such application, or if APBI Holdings wishes to abandon or allow to lapse any Licensed Patent, APBI Holdings shall notify Lilly in writing
not less than thirty (30) days prior to taking such action, and if Lilly so requests, APBI Holdings shall transfer and assign to Lilly its rights under the patent or patent application in the country or countries so affected and Lilly may
assume control of the same at Lilly’s sole expense. In the event that APBI Holdings receives a restriction requirement from a patent office for a Licensed Patent that restricts out patent claims related only to Compounds, APBI Holdings shall

  

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inform Lilly in a timely manner to enable Lilly to pursue such patent claims independently of APBI Holdings, in which Lilly shall be solely responsible for all costs and expenses related thereto.

 5.2 Improvements. Each party shall promptly notify the others upon the making conceiving or reducing to practice of
any Lilly Improvement or GenuPro Improvement. Lilly shall own all Lilly Improvements and bear all patent prosecution costs related thereto and GenuPro shall own all GenuPro Improvements and bear all patent prosecution costs related thereto.

 5.3 No Fiduciary Relationship. The Parties hereby expressly agree and acknowledge that they do not intend to create
any type of fiduciary relationship as a result of the intellectual property maintenance provisions set forth in this Agreement. Without limitation or condition of the foregoing, Lilly agrees to provide APBI Holdings’ agent with any and all
powers of attorney and other instruments necessary for APBI Holdings to conduct the filing, prosecution or maintenance of the Licensed Patents as provided in this Agreement, and Lilly acknowledges that any such power of attorney will make APBI
Holdings’ agent an attorney-in-fact for Lilly with respect to the matter specified in the power of attorney or other instrument but will not create an attorney/client relationship or any other fiduciary relationship between Lilly and APBI
Holdings’ agent except to the extent the Parties share a community of interest hereunder and under law. 
  

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 5.4 Enforcement of Intellectual Property Rights. APBI Holdings and Lilly will
promptly notify the other of any infringement or suspected infringement of Licensed Patents, that may come to its notice, and will provide the other party with information with respect thereto. If a Third Person infringes any intellectual property
rights relating solely to the Licensed Patents, APBI Holdings will have the first right (but not the obligation) to pursue any and all injunctive relief, and any or all compensatory and other remedies and relief (collectively, “Remedies”),
against such Third Person. Should APBI Holdings determine not to pursue Remedies with respect to any such intellectual property within sixty (60) days after receipt of written notice from Lilly requesting APBI Holdings to do so, then Lilly will
have the right (but not the obligation) to pursue Remedies against such Third Person; provided, however, that such written notice from Lilly to APBI Holdings must state that APBI Holdings must take action on the subject matter contained within the
notice within sixty (60) days of APBI Holding’s receipt thereof. 
 5.5 Assistance and Cooperation. If a Party
pursues Remedies hereunder, the other Party will use all reasonable efforts to assist and cooperate with the Party pursuing such Remedies. Each Party will bear its own costs and expenses relating to such pursuit. Any damages or other amounts
collected will be distributed, first, to the Party that pursued Remedies to cover its out of pocket costs and expenses; and second, to the other Party to cover its out of pocket costs and expenses, if any, relating to the pursuit of such Remedies;
and any remaining amount will be distributed [*] to the Party that pursued the Remedies and [*] to the other Party. 
  

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

  

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 5.6 Settlement of Litigation. No settlement, consent judgment or other final
disposition of an action for infringement or validity of patent claims that relate in any material way to Compounds or the use of Dapoxetine in the Lilly Field, whether composition or method claims, may be entered into as to any Licensed Patent
without Lilly’s prior written consent, which consent shall not be unreasonably withheld. 
 5.7 Infringement of Third
Person Rights. If a Third Person institutes a patent, trade secret or other infringement suit against Lilly, APBI Holdings, GenuPro or a Permitted Seller during the term of this Agreement, alleging that the manufacture, marketing, sale, use or
importation of Product (in the case of APBI Holdings, GenuPro or a Permitted Seller) or Compound (in the case of Lilly) infringes one or more patent or other intellectual property rights held by such Third Person (a “Claim”), then APBI
Holdings or GenuPro will have the first right (but not the obligation), at its sole expense, to assume direction and control of the defense of such Claims as they relate to Product, and Lilly shall have the first right (but not the obligation) as
they relate to Compound. A Claim received by APBI Holdings or GenuPro related to a Compound shall be forwarded immediately to Lilly, and a Claim received by Lilly related to a Product shall be forwarded immediately to GenuPro. In the event APBI
Holdings or GenuPro is deemed to be a necessary party for any suit relating to Compound or Lilly requests any assistance from APBI Holdings or GenuPro, Lilly shall pay all out of pocket expenses, including attorney’s fees, incurred by APBI
Holdings or GenuPro. Should either Party determine not to pursue the defense of a particular Claim, such Party shall notify the other Party within five (5) days after notice from the other Party

  

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requesting it to do so, then the requesting Party will have the right (but not the obligation), at its sole expense, to assume direction and control of such claims. Neither Party will have the
right to settle or otherwise dispose of any such claim without the consent of other, which consent will not be unreasonably withheld. In the event Lilly is deemed to be a necessary party for any suit relating to Dapoxetine or APBI Holdings requests
any assistance from Lilly, APBI Holdings shall pay all out of pocket expenses, including attorney’s fees, incurred by Lilly. 
 5.8 Patent Reporting. Within sixty (60) days after each Calendar Year, APBI Holdings shall provide Lilly with a written report describing the status of all Licensed Patents, including the patent country, patent and application
numbers, filing date, issue date, expiration date, and any other relevant information requested by Lilly. Such report shall be mailed to Eli Lilly and Company, Lilly Royalty Administration in Finance, Lilly Corporate Center, Indianapolis, Indiana,
46285 with a copy to the General Patent Counsel. 
 5.9 Patent Cooperation. Each Party hereby agrees: 
 (a) to make its employees, agents and consultants reasonably available to the other Party at the other Party’s expense
to the extent reasonably necessary to enable the Party responsible for prosecuting the Licensed Patents to undertake preparation, filing, prosecution and maintenance of the Licensed Patents; 
 (b) to cooperate, if necessary and appropriate, with the other Party in gaining patent term extensions wherever applicable to
Licensed Patents; and 
  

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 (c) to endeavor to reasonably coordinate its efforts with the other Party to
minimize or avoid interference with the preparation, filing, prosecution and maintenance of the Licensed Patents. 
 5.10
Patent Marking. To the extent permitted by Applicable Laws, Lilly agrees to mark, and to cause any Affiliate or sublicensee to mark, Lilly’s 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 Lilly’s Products are to be
sold. 
 5.11 Trademarks. GenuPro or its licensee shall own all trademarks developed by GenuPro or its licensee used to
identify a Product sold by GenuPro. 
 Article 6 
 Confidentiality 
 6.1 Confidential Information.
The Parties agree that, unless the Receiving Party (as defined in the definition of “Confidential Information” in Article 1) obtains the prior written consent of the Disclosing Party (as defined in the definition of “Confidential
Information” in Article 1), at all times during the term of this Agreement and for a [*] - year period following its expiration or earlier termination, the Receiving Party will keep completely confidential, will not publish or otherwise
disclose and will not use directly or 
  

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

  

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 indirectly for any purpose other than as contemplated by this Agreement any such Confidential Information of
the Disclosing Party, whether such Confidential Information was received by the Receiving Party prior to, on or after the Effective Date. 
 6.2 Limited Disclosure Permitted. Each Party may disclose Confidential Information to the extent that such disclosure is: 
 (a) made in response to a valid order or subpoena of a court of competent jurisdiction or other governmental body of a
country or any political subdivision thereof of competent jurisdiction; provided, however, that the Receiving Party will first have given notice to the Disclosing Party and given the Disclosing Party a reasonable opportunity to quash such order or
subpoena and to obtain a protective order requiring that the Confidential Information and documents that are the subject of such order or subpoena be held in confidence by such court or governmental body or, if disclosed, be used only for purposes
for which the order or subpoena was issued; provided further, however, that if a disclosure order or subpoena is not quashed or a protective order is not obtained, the Confidential Information disclosed in response to such court or governmental
order or subpoena will be limited to that information that is legally required to be disclosed in such response to such court or governmental order or subpoena; 
 (b) otherwise required by law, in the opinion of legal counsel to the Receiving Party, provided that the Receiving Party
shall advise the Disclosing Party in

  

 25 

 
advance of any such disclosure and cooperates with the Disclosing Party in limiting the disclosure required. 
 (c) made by the Receiving Party to the governmental or regulatory authority as required to obtain or maintain marketing
approval for the Product, provided that reasonable effort will be taken to ensure confidential treatment of such information; 
 (d) made by the Receiving Party to a Third Person as may be necessary or useful in connection with the manufacture, development and commercialization of the Product or Compound, provided that the
Receiving Party will in each case obtain from the proposed Third Person recipient a written confidentiality agreement containing confidentiality and non-use obligations no less onerous than those set forth in this Agreement; 
 (e) made by the Receiving Party to a United States or foreign tax authority; 
 (f) made by the Receiving Party to its representatives; provided, however, that: (i) each such representative has a
need to know such Confidential Information for purposes of this Agreement, (ii) the Receiving Party informs each representative receiving Confidential Information of its confidential nature, and (iii) the Receiving Party will be
responsible for any breach of this Article 7 by any of its representatives to the same extent as if the breach were by the Receiving Party; 
  

 26 

 (g) made by a Receiving Party or any representative of the Receiving Party
in the filing or publication of patents or patent applications relating to Licensed Patents, or any invention relating to a Compound or Product, to the extent such disclosure in the filing or publication of the patent or patent application is
reasonably necessary for support of the patent or patent application; 
 (h) made by a Receiving Party in
order to comply with applicable securities law disclosure requirements. 
 6.3 Notification. The Receiving Party will
notify the Disclosing Party immediately, and cooperate with the Disclosing Party as the Disclosing Party may reasonably request, upon the Receiving Party’s discovery of any loss or compromise of the Disclosing Party’s Confidential
Information. 
 6.4 Disclosure of Agreement. Except as contemplated herein, neither Party shall disclose this Agreement
(nor a redacted version thereof) to any Third Person without the prior written consent of the other Party. Without limitation, these prohibitions apply to press releases, annual reports, prospectuses, public statements, educational and scientific
conferences, promotional materials, governmental filings and discussions with public officials, securities analysts, investors and the media. However, subject to the requirements for review and approval that follow, this provision does not apply to
a disclosure regarding this Agreement, which counsel to a Party has advised is required by Applicable Laws, to regulatory agencies such as the FDA, Securities and

  

 27 

 
Exchange Commission (“SEC”), Federal Trade Commission or Department of Justice. This includes requests for a copy of this Agreement or related information by tax authorities.

 If any Party to this Agreement determines a release of information regarding the existence or terms of this Agreement is
required by Applicable Laws, prior to any release of such information, that Party will notify the other Party in writing as soon as practical and provide as much detail as possible in relation to the disclosure required and, where possible under
Applicable Laws, will endeavor in good faith to provide the other Party with a minimum of five (5) business days to review the proposed public statement. The Parties will then discuss what information, if any, will actually be released and that
Party shall obtain the other Party’s prior written consent or conduct any actions it may reasonably take to prevent or limit the requested disclosure. In addition, Lilly shall have the right to review and comment on a redaction of this
Agreement required by the SEC or other agencies and PPD shall use good faith in taking Lilly’s comments into account prior to releasing the redaction to the SEC or such agency. 
 Notwithstanding anything herein to the contrary, any Party to this Agreement (and each employee, representative, or other agent of such party) may disclose to any and all persons, without limitation of
any kind, and in accordance with Treas. Reg. § 1.6011 -4(b)(3), the tax treatment and tax structure of the transactions, not including confidential financial terms, contemplated by this Agreement and all materials of any kind (including
opinions and other tax analyses) that are provided to it relating to such tax treatment and

  

 28 

 
tax structure. PPD shall be required to obtain the consent of Lilly prior to issuing a press release announcing this Agreement and the transaction contemplated hereby. 
 6.5 Survival. The confidentiality and non-use obligations of this Article shall survive the termination or expiration of this
Agreement. 
 Article 7 
 Representations, Warranties, Covenants, and Disclaimers 
 7.1 No
Debarment. Each Party represents and warrants to the other that it will comply at all times with the provisions of the Generic Drug Enforcement Act of 1992 and upon request each Party will certify in writing to the other Party that neither such
Party, its employees, nor any Person providing services for such Party under this Agreement has been debarred under the provisions of such Act. 
 7.2 Corporate Existence. As of the Effective Date, each Party represents and warrants to the other that it is a company duly organized, validly existing, and, if relevant in its jurisdiction of
formation, in good standing under the laws of the jurisdiction in which it is formed. 
  

 29 

 7.3 Authority to Execute and Perform. As of the Effective Date, each Party represents
and warrants to the other that it: 
 (i) has the power and authority and the legal right to enter into this
Agreement and perform its obligations hereunder; 
 (ii) has taken all necessary action, corporate or
otherwise, on its part required to authorize the execution and delivery of this Agreement; and 
 (iii) has
duly executed and delivered this Agreement, which constitutes a legal, valid, and binding obligation of it and which is enforceable against it in accordance with this Agreement’s terms. 
 7.4 Authority to Transfer Licensed Patents. Lilly represents and warrants to APBI Holdings that Lilly is the owner of all right,
title and interest in the Licensed Patents and is transferring the Licensed Patents to APBI Holdings free and clear of all liens, encumbrances, licenses, options and similar rights, other than those created by this Agreement. This provision shall
not constitute a representation or warranty that the Licensed Patents are valid or enforceable or that practice of the Licensed Patents would not violate the intellectual property rights of others. 
 7.5 Authority to Grant Licenses. Each Party hereby represents and warrants to the other that to the best of its knowledge, it has the
full right and power to grant the licenses set forth herein, in the manner and to that extent provided herein, free and clear of any adverse assignment, grant or other encumbrance inconsistent with such grant, except

  

 30 

 
that, in the case of licenses granted by Lilly, such licenses are subject to the exceptions listed in Schedule 11.01 to the Development Agreement. In addition, neither Party makes any
representation or warranty that exercise of the rights granted hereunder would not violate the intellectual property rights of Third Persons. 
 7.6 DISCLAIMER OF LILLY IMPLIED WARRANTIES. EXCEPT AS EXPRESSLY PROVIDED IN THIS ARTICLE, LILLY MAKES NO REPRESENTATION OR WARRANTY AS TO THE LICENSED PATENTS, LILLY KNOW-HOW, LILLY IMPROVEMENTS OR
LILLY MANUFACTURING KNOW-HOW, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, STATUTE, OR OTHERWISE, INCLUDING ANY ASSURANCE THAT THE LICENSED PATENTS ARE VALID OR THAT THE MANUFACTURE OR SALE OF PRODUCTS WILL NOT VIOLATE ANY INTELLECTUAL
PROPERTY RIGHTS OF ANY PERSON. LILLY SPECIFICALLY DISCLAIMS ANY AND ALL IMPLIED OR STATUTORY WARRANTIES INCLUDING WARRANTIES OF MERCHANTABILITY AND OF FITNESS FOR A PARTICULAR PURPOSE. Without limiting the foregoing, APBI Holdings acknowledges that
it has not and is not relying upon any implied warranty of merchantability or of fitness for a particular purpose or otherwise, or upon any representation or warranty whatsoever as to the prospects (financial, regulatory or otherwise), validity, or
likelihood of success of Product after the Effective Date. 
  

 31 

 7.7 DISCLAIMER OF APBI HOLDINGS, GENUPRO AND PPD IMPLIED WARRANTIES. EXCEPT AS
EXPRESSLY PROVIDED IN THIS ARTICLE, APBI HOLDINGS, GENUPRO AND PPD MAKE NO REPRESENTATION OR WARRANTY AS TO THE LICENSED PATENTS, GENUPRO KNOW-HOW, GENUPRO IMPROVEMENTS OR GENUPRO MANUFACTURING KNOW-HOW, EXPRESS OR IMPLIED, EITHER IN FACT OR BY
OPERATION OF LAW, STATUTE, OR OTHERWISE, INCLUDING ANY ASSURANCE THAT THE LICENSED PATENTS ARE VALID OR THAT THE MANUFACTURE OR SALE OF PRODUCTS BY LILLY WILL NOT VIOLATE ANY INTELLECTUAL PROPERTY RIGHTS OF ANY PERSON. APBI HOLDINGS, GENUPRO AND PPD
SPECIFICALLY DISCLAIM ANY AND ALL IMPLIED OR STATUTORY WARRANTIES INCLUDING WARRANTIES OF MERCHANTABILITY AND OF FITNESS FOR A PARTICULAR PURPOSE. Without limiting the foregoing, Lilly acknowledges that it has not and is not relying upon any implied
warranty of merchantability or of fitness for a particular purpose or otherwise, or upon any representation or warranty whatsoever as to the prospects (financial, regulatory or otherwise), validity, or likelihood of success of a Product sold by
Lilly after the Effective Date. 
 7.8 DISCLAIMER OF INCIDENTAL AND CONSEQUENTIAL DAMAGES. NEITHER PARTY WILL BE LIABLE
TO THE OTHER PARTY FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, OR SPECIAL DAMAGES, INCLUDING BUT NOT LIMITED TO LOST PROFITS ARISING FROM OR

  

 32 

 
RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. NOTHING IN THIS SECTION IS INTENDED TO LIMIT OR RESTRICTS THE INDEMNIFICATION RIGHTS OR
OBLIGATIONS OF ANY PARTY. 
 7.9 DILIGENCE. Neither Party shall have any obligation, either express or implied, to
develop, market or sell any Product or Compound, or to otherwise exploit or commercialize any licenses granted hereunder. 
 Article 8 
 Indemnification 
 8.1 Indemnification. 
 (a) GenuPro’s Obligation. Except to the extent such Damages are due to negligence, gross negligence or willful misconduct by Lilly, or its officers, directors, employees or agents, GenuPro
shall defend, indemnify and hold harmless Lilly and its officers, directors, employees and agents against any and all Damages resulting from or arising out of: 
 (i) any breach of any representation or warranty made by GenuPro, APBI Holdings or PPD in this Agreement or any documents
executed in connection herewith; 
 (ii) the handling, possession, development, marketing, distribution,
promotion, sale or use of Product by APBI Holdings, GenuPro or a Permitted Seller; 
  

 33 

 (iii) any product liability or other claim arising out of any allegation of
injury caused by any person’s use of Product which Product is distributed or sold by APBI Holdings, GenuPro or any Permitted Seller or their respective agents or contractors; 
 (iv) the exercise of any right(s) under the Licensed Patents or Lilly Know-How, Lilly Improvements or Lilly Manufacturing
Know-How, by APBI Holdings, GenuPro, its Permitted Seller and any other sublicensees; or 
 (v) APBI
Holdings’ or GenuPro’s failure to comply in all material respects with Applicable Laws in connection with the performance of their respective obligations or the exercise of their respective rights hereunder. 
 (b) Lilly’s Obligation. Except to the extent such Damages are due to negligence, gross negligence or willful
misconduct by APBI Holdings, GenuPro, or their officers, directors, employees or agents, Lilly shall defend, indemnify and hold harmless APBI Holdings, GenuPro, and their respective officers, directors, employees and agents against any and all
Damages resulting from or arising out of any breach of: 
 (i) any breach of any representation or warranty made
by Lilly in this Agreement or any document executed in connection herewith; 
 (ii) the handling, possession,
development, marketing, distribution, promotion, sale or use of Product or Compound by Lilly; 
 (iii) any
product liability or other claim arising out of any allegation of injury caused by any person’s use of Product or Compound, which Product or Compound is distributed or sold by Lilly or its sublicensees, agents or contractors; 
  

 34 

 (iv) the exercise of any right(s) under the Licensed Patents or GenuPro
Know-How, GenuPro Improvements or GenuPro Manufacturing Know-How, by Lilly or its sublicensees; or 
 (v)
Lilly’s failure to comply in all material respects with Applicable Laws in connection with the performance of its obligations or the exercise of its rights hereunder. 
 8.2 Notice and Opportunity To Defend. 
 (a) Notice. Promptly after receipt by a Party hereto of notice of any claim which could give rise to a right to indemnification pursuant to this Article, such Party (the “Indemnitee”)
will give the other Party (the “Indemnifying Party”) written notice describing the claim in reasonable detail. The failure of an Indemnitee to give notice in the manner provided herein will not relieve the Indemnifying Party of its
obligations under this Article except to the extent that such failure to give notice materially prejudices the Indemnifying Party’s ability to defend such claim. 
 (b) Defense of Action. In case any action that is subject to indemnification under this Agreement shall be brought
against an Indemnitee and it shall give written notice to the Indemnifying Party of the commencement thereof, the Indemnifying Party shall be entitled to participate and, if it so desires, to assume the defense with counsel of the Indemnifying
Party’s choice, which counsel shall be reasonably satisfactory to such Indemnitee. After notice from the Indemnifying Party to the Indemnitee of its election to assume the defense, the Indemnifying Party shall not be liable to such Indemnitee
for any

  

 35 

 
fees of other counsel or any other expenses, in each case subsequently incurred by such Indemnitee in connection with the defense. 
 (c) Indemnitee’s Separate Counsel. Notwithstanding the foregoing, the Indemnitee shall have the right to employ
separate counsel and to participate in the defense of such action, and the Indemnifying Party shall bear the reasonable fees, costs and expenses of such separate counsel if: (i) the use of counsel chosen by the Indemnifying Party to represent
the Indemnitee would present such counsel with a conflict of interest, and the Indemnifying Party does not elect to engage new counsel without such a conflict; (ii) the Indemnifying Party shall not have employed counsel reasonably satisfactory
to the Indemnitee to represent the Indemnitee within a reasonable time after notice of the institution of such action; or (iii) the Indemnifying Party shall authorize the Indemnitee to employ separate counsel at the Indemnifying Party’s
expense. 
 (d) Settlement. If an Indemnifying Party assumes the defense of such action, no compromise or
settlement thereof may be effected by the Indemnifying Party without the Indemnitee’s written consent, which consent shall not be unreasonably withheld or delayed, unless there is no finding or admission of any violation of law or any violation
of the rights of the Indemnitee and no effect on any other claims that may be made against the Indemnitee. In any event, the Indemnitee and the Indemnifying Party may participate, at their own expense, in the defense of such asserted liability.

 (e) Provision of Documents. If the Indemnifying Party chooses to defend any claim, the Indemnitee will
make available to the Indemnifying Party any books, records or other documents within its control that are necessary or appropriate for such defense; provided, however, any such books, records or other documents within the control of the

  

 36 

 
Indemnitee which are made available to the Indemnifying Party hereunder will be held in confidence by the Indemnifying Party in accordance with this Agreement and will be disclosed by the
Indemnitee to the Indemnifying Party only to the extent that such books, records or other documents relate to the claim. 
 (f) Conduct of Defense. Notwithstanding anything to the contrary in this agreement, the Party conducting the defense of a claim will (1) keep the other Party informed on a reasonable and
timely basis as to the status of the defense of such claim (but only to the extent such other Party is not participating jointly in the defense of such claim), and (2) conduct the defense of such claim in a prudent manner. 
 8.3 Indemnification Payment. Upon the final, unappealable 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) business days after such determination. 
 8.4 Survival. The provisions of this Article will survive any termination or expiration of this Agreement. Each Indemnified
Party’s rights under this Article will not be deemed to have been waived or otherwise affected by such Indemnified Party’s waiver of the breach of any representation, warranty, agreement or covenant contained in or made pursuant this
Agreement, unless such waiver expressly and in writing also waives any or all of the Indemnified Party’s right under this Article. 
  

 37 

 Article 9 
 Term and Termination 
 9.1 Term. The term of
this Agreement will begin upon the Effective Date and, unless sooner terminated under this Article, will continue in full force and effect until the later of (i) the expiration of all Licensed Patents, (ii) the date of expiration of any
patent encompassed within GenuPro Improvements or Lilly Improvements claiming inventions that would prevent in whole or in part the making, using, selling or importing of Product or Compound, or (iii) the date on which APBI Holdings has no
remaining royalty payment obligations to Lilly under Section 3.1(b) . 
 9.2 Termination for Material Breach. Lilly
may terminate this Agreement upon material breach thereof by APBI Holdings, PPD or GenuPro. APBI Holdings, PPD or GenuPro may terminate this Agreement upon material breach thereof by Lilly. The Party seeking to terminate this Agreement shall provide
[*] days notice of termination to the defaulting Party, except in the case of monetary defaults, in which case [*] days notice shall be provided. This Agreement shall be deemed terminated as of the expiration of such [*] day
period in the case of monetary defaults or [*] day period in the case of non-monetary defaults, unless prior thereto the defaulting Party has cured the default. If in the case of a non-monetary default such default is not capable of being
cured within such [*] day period, and the defaulting Party is diligently pursuing the cure of such default, the defaulting party shall be given an additional [*] day period in which to cure such default. If the default remains uncured
after such additional period, then this Agreement shall be deemed terminated. Any failure by APBI Holdings to make any payment to Lilly 
  

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

  

 38 

 required by Article 3, or any development of Dapoxetine by GenuPro for use outside the GenuPro Field, shall
be deemed material breaches of this Agreement. Any development of Dapoxetine by Lilly for use inside the GenuPro Field (other than solely for research purposes as permitted under the licenses granted to Lilly in Article 4) shall be deemed a material
breach of this Agreement. 
 Article 10 
 Miscellaneous 
 10.1 Independent Contractor. It is understood and
agreed that the Parties shall have the status of an independent contractor under this Agreement and that nothing in this Agreement shall be construed as authorization for any of APBI Holdings, GenuPro or PPD, on the one hand, or Lilly, on the other
to act as agent for the other. 
 10.2 No Benefit to Others. The representations, warranties, covenants and agreements
contained in this Agreement are for the sole benefit of the Parties and their legal representatives, successors and assigns, and they shall not be construed as conferring any rights to any Third Person. 
 10.3 Amendment. This Agreement may not be amended, supplemented, or otherwise modified except by an instrument in writing signed by
authorized representatives of the Parties. 
  

 39 

 10.4 Entire Agreement. This Agreement constitutes the entire agreement and
understanding relating to the subject matter of this Agreement and supersedes all previous communications, proposals, representations and agreements, whether oral or written, relating to the subject matter of this Agreement. 
 10.5 Severability. If any provision of this Agreement is held to be illegal, invalid, or unenforceable under present or future laws
effective while this Agreement remains in effect, the legality, validity and enforceability of the remaining provisions will not be affected thereby. 
 10.6 Waiver. Any term or provision of this Agreement may be waived at any time by the Party entitled to the benefit thereof only by a written instrument executed by such Party. No delay on the part
of any Party in exercising any right, power or privilege hereunder will operate as a waiver thereof, nor will any waiver on the part of any Party of any right, power or privilege hereunder operate as a waiver of any other right, power or privilege
hereunder nor will any single or partial exercise of any right, power or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, power or privilege hereunder. 
 10.7 Notices. All notices required or permitted to be given under this Agreement shall be in writing and shall be deemed given upon
receipt if delivered personally or by facsimile transmission (receipt verified), telexed, mailed by registered or

  

 40 

 
certified mail (return receipt requested), postage prepaid, or sent by prepaid express courier service, to the Parties at the following addresses (or at such other address for a Party as shall be
specified by the Party; provided, that notices of a change of address shall be effective only upon receipt thereof): 
 For GenuPro, PPD and
APBI Holdings: 
 3151 South 17th Street 
 Wilmington, NC 28412 
 Fax No. (910) 772-6951 
 Attn: CEO 
 With a copy to the
attention of the General Counsel at the same address. 
 For Lilly:     Eli Lilly and Company 
 Lilly Corporate Center 
 Indianapolis, IN 46285 
 United States of America 
 Attention: General Counsel 
 10.8 Governing Law. This Agreement shall be governed by, and construed in accordance with, the laws of the State of Indiana, United States, excluding any choice of law rules which may direct the application of the law of any other
jurisdiction. However, the scope, validity and enforceability of any patents encompassed within the scope of this Agreement shall be determined in accordance with the applicable laws of the countries in

  

 41 

 
which such patents have issued. In the event of any dispute involving this Agreement, the parties, before seeking any judicial relief, shall submit the matter to an executive officer of GenuPro,
APBI Holdings and PPD and a Lilly executive at the executive director or higher level. If such executives are unable to resolve the matter within fifteen (15) days of the date on which the matter was referred to them, then either party shall be
free to seek judicial relief. Notwithstanding the foregoing, either party may seek immediate judicial relief in the event it believes that it will suffer irreparable injury. 
 10.9 Assignability. During the term of this Agreement, none of the Parties shall assign any benefit or burden under this Agreement
without prior written consent of the other Parties, which shall not be unreasonably withheld, except that (i) each Party may assign its rights and obligations under this Agreement to (A) an Affiliate, (B) to any Person with which it
may merge or consolidate, (C) to any Person to whom it may transfer substantially all of its assets to which this Agreement relates, or (D) to any Person which may acquire such Party (including, in each case, any company created as a new
vehicle upon any such merger, transfer or acquisition), and (ii) APBI Holdings, GenuPro or Lilly may transfer any and all of its rights to a sublicensee as provided by this Agreement, and (iii) APBI Holdings may assign the Licensed Patents
to any Person, provided, however, that in the case of (iii) APBI Holdings shall remain liable for all financial obligations to Lilly, including payment of the royalty provided for in Section 3.1(b), and the assignee shall assume all
obligations under this Agreement relating to patent maintenance and cooperation on patent litigation and related matters. 
  

 42 

 10.10 Jointly Prepared. This Agreement will be deemed to have been drafted by the
Parties and will not be construed against any Party as the draftsperson hereof. 
 10.11 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. It shall not be necessary in making proof of this Agreement or any counterpart hereof to
produce or account for any of the other counterparts. 
 10.12 Schedules, Exhibits and Attachments. All schedules,
exhibits and attachments referred to herein are intended to be and hereby are specifically made part of this Agreement. However, if there is a conflict between a term or condition of such schedules, exhibits and attachments and this Agreement, the
terms and conditions of this Agreement shall prevail. 
  

 43 

 IN WITNESS WHEREOF, the Parties by their respective authorized representatives, have
executed this Agreement. 
  

			
	Pharmaceutical Product Development, Inc.
		
	By:	 	  

		 	Name
		 	Title
	
	GENUPRO, INC.
		
	By:	 	  

		 	Name
		 	Title
	
	APBI HOLDINGS, LLC
		
	By:	 	  

		 	Name
		 	Title
	
	ELI LILLY AND COMPANY
		
	By:	 	  

		 	John C. Lechleiter
		 	Executive Vice President
		 	 Pharma Products/Corporate Development
 Pharma Products Administration

  

 44 

 EXHIBIT A 
 LICENSED PATENTS 
 [*] 
  

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

  

 45 

 EXHIBIT B 
 ASSIGNMENT 
 WHEREAS Eli Lilly and Company, an
Indiana corporation having its principal place of business at Lilly Corporate Center, Indianapolis, Indiana 46285, (hereinafter “Lilly”) is the assignee of all right, title and interest in inventions that are the subject of patents and
patent applications (“Applications”) as listed herein below; and  
 WHEREAS APBI Holdings, LLC, a
wholly-owned subsidiary of Pharmaceutical Product Development, Inc., and a limited liability company organized under the laws of the State of North Carolina (hereinafter “APBI Holdings”), wishes to acquire the entire interest in
Applications;  
 NOW, THEREFORE, in consideration of the mutual benefits as set forth in the Termination and
License Agreement, effective December 18, 2003, by and between Lilly and APBI Holdings, and other good and valuable consideration, the receipt of which is hereby acknowledged, Lilly assigns to APBI Holdings, its successors and assigns, its
entire right, title and interest in, to and under Applications, including all priority rights for other countries arising therefrom, all inventions therein disclosed, and any and all present or future patent applications applicable to such
inventions that may be filed in any country, inclusive of, but not limited to, continuations, continuations-in-part, divisions, substitutions, reexaminations, reissues, international applications filed under the PCT, United States provisional patent
applications, subsequent United States provisional patent applications claiming some or all of this invention, certificates of addition, utility models, petty patents, and including any, supplementary protection certificates and related patent term
extensions which may be granted for Letters Patent with respect to Applications; all of the above to be held and enjoyed by APBI Holdings for its own use

  

 46 

 
and enjoyment to the full end of the term or terms for which such Letters Patent and related intellectual property rights may be granted, as fully and entirely as the same would have been held
and enjoyed by Lilly had this Assignment to APBI Holdings not been made. 
 PATENTS AND PATENT APPLICATIONS ASSIGNED: 
 [*] 
 Lilly
covenants that no assignment, sale, agreement or encumbrance has been or will be made or entered into which would conflict with this Assignment. 
 Lilly further covenants and agrees with APBI Holdings that upon request Lilly will, without further consideration than that now paid, but at the sole expense of APBI Holdings (including reasonable charges
for the time of Lilly personnel), provide reasonable (i) cooperation in the further prosecution of Applications, as for example facilitating the execution of related documents, facilitating communication of facts relating to such inventions or
the histories thereof; (ii) cooperation in any interference proceedings, litigation discovery proceedings and depositions, oppositions, cancellation proceedings, priority contests, public use proceedings, administrative agency proceedings,
litigation and other court actions and the like; (iii) facilitation of the execution and delivery of any related application papers, affidavits, declarations, assignments, or other related instruments; and (v) facilitation of all other
acts which, in the opinion of counsel for Lilly, may be necessary or desirable to secure the grant of Letters Patent and related intellectual property to APBI Holdings or its nominees, in the United States and in all other countries where APBI
Holdings may desire to have such inventions, patented. 
 IN WITNESS WHEREOF Lilly, by its authorized representative, has
executed this assignment on the date indicated below. 
  

					
			
	  
	 		 	  

			
	Date	 		 	John C. Lechleiter
		 		 	Executive Vice President
		 		 	Pharma Products/Corporate Development
		 		 	Pharma Products Administration

  

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

  

 47 

 UNITED STATES OF AMERICA 
  

					
	STATE OF INDIANA	 	)	  	SS:
		 	)	  	
	COUNTY OF	 	)	  	

 Before me, a Notary Public for
             County, State of Indiana, personally appeared              and acknowledged the
execution of the foregoing instrument this              day of             , 2003. 
  

	
	
	  

	Notary Public

 ACKNOWLEDGED
BY APBI Holdings’ authorized representative: 
  

					
			
	  
	 		 	  

			
	Date	 		 	Name
		 		 	Title

 UNITED STATES OF AMERICA 

  

			
	STATE OF NORTH CAROLINA	 	)
		 	) SS:
	COUNTY OF              )

 Before me, a Notary Public for              County, State of North
Carolina, personally appeared              and acknowledged the execution of the foregoing instrument this
             day of             , 2003. 
  

	
	
	  

	Notary Public

  

 48Option and 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) [*] 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. 
  
  

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

  

 24 

 11.03 Termination for Failure to Meet Key [*] 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
[*]. 
 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.

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