EX-10.11



 Exhibit 10.11 
 NANO-REFORMULATED COMPOUND LICENSE AGREEMENT 
 This is a
Nano-Reformulated Compound License Agreement, dated as of December 28, 2012 (the “Effective Date”), by and among iCeutica Inc. (“iCeutica Inc.”), a Delaware corporation having an address of One Kew Place, 150
Rouse Boulevard, Philadelphia, PA, 19112, its wholly owned subsidiary iCeutica Pty Ltd (“iCeutica”) (ACN 113 244 152), an Australian corporation having an address of Unit 4, 97 Hector Street, Osborne Park, Western Australia 6016,
and Iroko Pharmaceuticals Inc. (“Iroko”), a company incorporated under the laws of the British Virgin Islands having an address of Geneva Place, Waterfront Drive, PO Box 3469, Road Town, Tortola, British Virgin Islands. 

Background. iCeutica has developed a nano-reformulation of meloxicam (“Meloxicam”). Iroko is a developer and
marketer of novel reformulated and repositioned pharmaceutical products and desires to acquire an exclusive license to Meloxicam. 
 Therefore, in consideration of the promises set forth in this Agreement, the Parties agree as follows: 
  

	(1)	Definitions. As used in this Agreement: 

  

	 	(a)	“Affiliate” means an entity that is controlled by Iroko Pharmaceuticals Inc., a company incorporated under the laws of the British Virgin Islands or
iCeutica Inc., as applicable. For this purpose, “control’’ means (i) the power to direct or cause the direction of the management and affairs of the entity, whether by direct or indirect ownership of voting stock, positions on
the board of directors, contract, or otherwise; or (ii) ownership of more than fifty percent (50%) of the equity or other ownership interest of the entity. 


 

	 	(b)	“Amended and Restated Nano-Reformulated Compound License and Option Agreement” means the Amended and Restated Nano-Reformulated Compound License and
Option Agreement, effective as of June 19, 2007, and amended and restated as of the date hereof, by and among iCeutica Inc., iCeutica and Iroko Pharmaceuticals, LLC, as the same may be amended from time to time. 


 

	 	(c)	“Combination Product” means a commercial product with two (2) or more therapeutically active ingredients, one of which is Meloxicam.


  

	 	(d)	“Confidential Information” means all business, financial and technical information, data, documents and other materials, whether in electronic or
physical form or orally disclosed, provided by one Party (“Discloser”) to the other (“Receiver”), but excluding any information that Receiver can demonstrate: 


 

	 	(1)	was public knowledge at the time of disclosure to Receiver; 

  

	 	(2)	became public knowledge without fault by Receiver; 

  

	 	(3)	was rightfully in the possession of Receiver prior its disclosure by Discloser; or 









	 	(4)	was disclosed to Receiver from a source not known to Receiver to be under a duty of confidentiality to Discloser. 


 

	 	(e)	“Dollars” or “$” means U.S. dollars. 

  

	 	(f)	“FDA” means the United States Food and Drug Administration. 


 

	 	(g)	“Force Majeure” means an act, event or condition beyond the reasonable control of a Party. 


 

	 	(h)	“iCeutica IP” means Patent Rights and iCeutica Technology. 


 

	 	(i)	“iCeutica Technology” means technology owned or controlled by iCeutica and licensable to third parties relating to (i) methods and apparatus for
producing active pharmaceutical ingredients having an average particle size of 1,000 nanometers or less, including nano-milling methods and apparatus and (ii) pharmacoactive compositions of matter having an particle size of 1,000 nanometers or
less and methods for their use. 

  

	 	(j)	“Intellectual Property” or “IP” means patents, patent applications and confidential information. 


 

	 	(k)	“Invention” means any invention or discovery conceived, whether or not reduced to practice, as those terms are defined under the patent laws of the
United States. 

  

	 	(l)	“Net Sales” means revenues of Iroko and Iroko Affiliates from the sale or other disposition of (i) Meloxicam or (ii) Combination Products, as
the case may be, to a non-Affiliate less: 

  

	 	(i)	payments made or credits allowed for promotional purposes; 

  

	 	(ii)	customary allowances, rebates and trade, quantity, or cash discounts, including discounts, rebates or other payments required under Medicaid, Medicare or other
governmental medical assistance programs, to the extent allowed and taken; 

  

	 	(iii)	amounts repaid or credited for rejections or returns; and 

  

	 	(iv)	to the extent separately stated on invoices, taxes and other governmental charges levied on the production, sale, transportation, delivery, or use of a product sold by
Iroko containing Meloxicam, paid by or on behalf of Iroko or an Affiliate. 

  

	 	(m)	“Party” or “Parties” means iCeutica Inc., iCeutica and/or Iroko, as applicable. 


 

	 	(n)	 “Patent Rights” means: (i) the provisional and utility patent applications listed on Exhibit A, which will be updated
periodically upon request by Iroko, to add all additional patents and patent applications included in this definition; (ii)



  
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provisional and utility patent applications relating to iCeutica Technology and owned or licensable by iCeutica on or within twenty (20) years after the Effective Date; (iii) any
patents or patent applications relating to Meloxicam; and (iv) reissues, reexaminations, renewals, extensions, divisions, continuations, continuations-in-part and foreign counterparts of and patents which issue on any of the foregoing.


  

	 	(o)	“Product Launch” means the first commercial sale of Meloxicam. 


 

	 	(p)	“Sublicense” means any sublicense or other agreement of Iroko with a non-Affiliate permitting the commercial exploitation of any iCeutica IP which is
licensed to Iroko and sublicensed by Iroko for the manufacture, use or sale of Meloxicam. 

  

	 	(q)	“Sublicense Revenues” means minimum royalties and all other royalty revenues of Iroko from Sublicenses. 


 

	 	(r)	“Sublicense Net Sales” means revenues of a Sublicensee from the sale or other disposition of (i) Meloxicam or (ii) subject to paragraph 5(e),
Combination Products, as the case may be, to an unaffiliated entity, less: 

  

	 	(1)	payments made or credits allowed for promotional purposes; 

  

	 	(2)	customary allowances, rebates and trade, quantity, or cash discounts, including discounts, rebates or other payments required under Medicaid, Medicare or other
governmental medical assistance programs, to the extent allowed and taken; 

  

	 	(3)	amounts repaid or credited for rejections or returns; and 

  

	 	(4)	to the extent separately stated on invoices, taxes and other governmental charges levied on the production, sale, transportation, delivery, or use of Meloxicam, paid by
or on behalf of a Sublicensee. 

  

	(2)	License Grant. 

  

	 	(a)	Grant to Iroko. iCeutica grants to Iroko a sole and exclusive (even as to iCeutica and iCeutica Inc.), world-wide, royalty-bearing right and license under the
iCeutica IP to develop, make, have made, use, sell, offer to sell and import Meloxicam. iCeutica retains all other rights to the iCeutica IP and has no obligations thereto to Iroko except as set forth in this Agreement. 


 

	 	(b)	Sublicenses. Iroko may grant Sublicenses, consistent with the applicable terms and conditions of this Agreement. Each Sublicense shall incorporate the substance
of paragraphs (4)(a), (6), (7)(a), (10), (11) and (12), mutatis mutandis. 


  
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	(3)	[Reserved]. 

  

	(4)	Cooperation, Development and Sublicensing Activity. 

  

	 	(a)	Diligence. Iroko will use commercially reasonable diligence to develop, commercialize, market and sell Meloxicam, itself and/or through Affiliates or
Sublicensees, subject to Force Majeure. 

  

	 	(b)	Cooperation. 

  

	 	(i)	iCeutica will make available to Iroko from time-to-time or as requested, all information and materials in its possession, including Confidential Information (but
excluding confidential information of third persons that iCeutica is not permitted to disclose), that is necessary or desirable to enable Iroko to develop, test and commercially introduce Meloxicam. 


 

	 	(ii)	Each Party shall designate a coordinator through whom all communications and cooperation for the purposes of this Agreement shall be channeled.


  

	 	(c)	Commercial Production of Meloxicam. 

  

	 	(i)	iCeutica will cooperate to transfer the iCeutica Technology in respect of Meloxicam to each applicable third party manufacturer (“TPM”), subject to a
suitable Confidentiality Agreement between iCeutica and the TPM. The respective payments under paragraph (5) will compensate iCeutica for its cooperation with the applicable TPM as to Meloxicam, except that iCeutica’s applicable
out-of-pocket costs (including any consultants engaged by iCeutica at Iroko’s request), shall be separately reimbursed by Iroko. 

  

	 	(ii)	iCeutica and Iroko shall work with the TPM or TPMs selected by Iroko to cause the iCeutica Technology to be scaled-up in accordance with GMP standards to a production
level sufficient to supply Iroko’s reasonable requirements of Meloxicam suitable for clinical testing and thereafter for commercial sale. 

  

	 	(iii)	Iroko will use commercially reasonable diligence (including making relevant Iroko staff and contractors available at Iroko expense when reasonably requested by
iCeutica) to assist with the scale-up and commercial production using the iCeutica Technology referred to in subparagraphs (4)(c)(i) and (4)(c)(ii). 

  

	 	(iv)	iCeutica will work with Iroko to complete the CMC section of the IND. 

  

	 	(d)	 Commercialization Plans. Within thirty (30) days after the end of each calendar year, Iroko will provide iCeutica with a detailed, written
annual research, 



  
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development and commercialization plan for Meloxicam. The commercialization plan will include any plans for any Sublicenses. 


 

	(5)	Payments. 

  

	 	(a)	Initial Payment. In consideration of the rights granted in paragraph (2), Iroko shall issue to iCeutica Inc. a promissory note in substantially the form attached
hereto as Exhibit B. 

  

	 	(b)	Royalties. In consideration of the license grants of paragraph (2), Iroko shall pay, iCeutica Inc., at Iroko’s election, made in writing, before each
applicable Product Launch, either: 

  

	 	(i)	Ten percent (10%) of Net Sales; or 

  

	 	(ii)	Five Million Dollars ($5,000,000), payable before Product Launch, and five percent (5%) of Net Sales. 


 

	 	(c)	Combination Products. Net Sales for each Combination Product shall be determined as follows: 


 

	 	(i)	If all active ingredients have separate, established market prices, Net Sales of the Combination Product shall be multiplied by a fraction, the numerator of which is
the established market price for Meloxicam in the Combination Product and the denominator of which is the sum of the established market prices for Meloxicam and the other active ingredients; or 


 

	 	(ii)	When market prices for the other active ingredients are not established, Net Sales of the Combination Product shall be multiplied by a fraction, the numerator of which
is the established market price for Meloxicam alone and the denominator of which is the established market price for the Combination Product. 

  

	 	(d)	Sublicense Revenues and Sublicensee Net Sales. As to each payment received from a Sublicensee, Iroko shall pay iCeutica Inc the lesser of:


 (i) one-half ( 1/2) of Sublicense Revenues; or 
 (ii) (A) ten percent (10%) or
(B) five percent (5%) of Sublicensee Net Sales, depending on whether option 5(d)(i) or (ii) was elected by Iroko for Meloxicam; or 
 (iii) if the option specified in section 3A is exercised, five percent (5%) of Sublicensee Net Sales. 
  

	 	(e)	Payment Terms. 


  
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	 	(i)	Notwithstanding paragraph (5)(b), the obligation to pay royalties based solely on claims of patent applications will cease for each application that is pending for over
four (4) years and resume when the application has issued as a patent. 

  

	 	(ii)	Amounts due under paragraphs (5)(b), (5)(c) and (5)(d) are payable quarterly, within sixty (60) days after each calendar quarter.


  

	 	(iii)	All payments shall be transmitted to iCeutica Inc. or iCeutica, as appropriate, by wire transfer of immediately available funds to a bank account or accounts specified
in writing by iCeutica. 

  

	 	(iv)	If any amount due to iCeutica Inc. or iCeutica is collected in a currency other than Dollars, the amount shall be converted into Dollars at the applicable exchange rate
published in The Wall Street Journal, Eastern edition, on the last business day of the calendar quarter in which the collection was made. 

  

	 	(f)	Tax Withholding. If Iroko is required by the laws of any country to withhold any tax with respect to any payment to iCeutica Inc. or iCeutica, as appropriate,
the tax will be deducted and paid to the taxing authority. Iroko will notify and promptly furnish iCeutica Inc. or iCeutica, as appropriate, with original receipts of any tax certificate or other available documentation evidencing the tax withheld.
Iroko will use commercially reasonable efforts to minimize any withholding. 

  

	(6)	Reports and Records. 

  

	 	(a)	Royalty Reports. Each royalty payment under paragraphs (5)(b), (5)(c), and (5)(d) shall be accompanied by a detailed royalty report, specifying the
computation of royalties payable and certified to be correct by the Chief Financial Officer of Iroko. 

  

	 	(b)	Books and Records. Iroko shall keep accurate books of account adequate to show amounts payable under this Agreement and the performance of the Iroko’s other
obligations hereunder for three (3) years after each applicable year. 

  

	 	(c)	Sublicenses. Iroko shall provide iCeutica Inc. with a copy of each Sublicense promptly after its execution. The Sublicense shall be deemed Confidential
Information. 

  

	 	(d)	 Audit Request. Iroko shall permit an independent, certified public accountant appointed and paid by iCeutica Inc. and reasonably acceptable to
Iroko to examine and make copies of applicable records and other documents of Iroko and its Sublicensees no more often than once per calendar year during regular business hours and upon two (2) weeks’ notice for the purpose of verifying
amounts and reports due from, and obligations to be performed by, each of them. The results of each examination shall be made available to iCeutica Inc. and Iroko, and shall be considered Confidential Information. Should the audit discover




  
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an underpayment equal to the greater of five percent (5%) or Twenty Five Thousand Dollars ($25,000), Iroko shall pay the cost of the audit. 


 

	 	(e)	Late Charge. All overdue payments will be paid promptly with a late charge of two percent (2%) per annum above the prime rate of J.P. Morgan Chase Manhattan
Bank, N.A., as reported in The Wall Street Journal, Eastern edition, on the last business day of the calendar quarter in which each payment was to be made. Interest shall be calculated from the last day on which the payment was payable. Any portion
of such payments that are being contested in good faith shall not be considered overdue. 

  

	(7)	Intellectual Property of Iroko. 

  

	 	(a)	 Prosecution and Maintenance of Patent Rights. iCeutica shall file, prosecute and maintain Patent Rights and pay all fees and expenses therefor.
Iroko will reimburse iCeutica for the reasonable costs of preparing, prosecuting and maintaining Meloxicam-specific patent applications and patents in countries other than the United States. If iCeutica intends to abandon any U.S. patent application
or patent of Patent Rights in a manner which will result in a forfeiture of rights, it shall notify Iroko and, if requested by Iroko and for so long as Iroko pays one-half ( 1/2) of the applicable fees and expenses, iCeutica will continue to prosecute and maintain the applicable Patent Rights. 



 

	 	(b)	Records of Inventions. Iroko shall maintain adequate and current records, in electronic or paper form, of its development of Inventions and disclose promptly to
iCeutica all Inventions and related records which relate to the iCeutica Technology or Meloxicam. 

  

	 	(c)	Grant-Back to iCeutica. Iroko assigns to iCeutica its entire right, title and interest in all IP in Inventions which (i) relate to the iCeutica Technology
(ii) are made, solely or with others, by Iroko employees and/or consultants. iCeutica grants to Iroko a royalty-free, non-exclusive, perpetual, irrevocable worldwide license with respect to IP described in the previous sentence, including the
right to grant non-exclusive Sublicenses, to utilize that IP to develop, manufacture, use and sell Meloxicam. 

  

	 	(d)	Cooperation as to IP. Iroko shall, at iCeutica’s expense and as requested, assist and cause its employees and consultants to assist iCeutica to prepare,
prosecute, procure and assert patents of Patent Rights, including the following; 

  

	 	(i)	execute and deliver all documents necessary or desirable to apply for and obtain patents on applicable Inventions of Iroko’s employees and consultants;


  

	 	(ii)	execute and deliver all documents necessary or desirable to vest iCeutica with full title to such patents, when required by this Agreement; and


  

	 	(iii)	assist iCeutica in lawsuits for the enforcement of such patents, subject only to (A) reimbursement of its reasonable out-of-pocket expenses; and



  
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 (B) compensation for employees’ and consultants’ time at a reasonable hourly
rate. 
  

	 	(e)	Publications. Iroko will provide iCeutica with a copy of each publication relating to iCeutica Technology at least forty five (45) days before the
publication date, to provide an opportunity for iCeutica to file patent applications before the publication date. Iroko will also delete from the proposed publications any Confidential Information, as reasonably requested by iCeutica.


  

	 	(f)	Data, Reports and SOP’s etc. Iroko will provide iCeutica upon request with a copy of any data, report, standard operating procedure, validation procedure,
IND submission, animal or clinical trial report or other information (“Information”) relating to Meloxicam. iCeutica shall be entitled to use such Information and shall have a license to such Information for its own regulatory,
marketing or other related purposes. 

  

	 	(g)	Joint Inventions. This Agreement constitutes, in part, a ‘‘joint research agreement” between iCeutica and Iroko, as defined in the CREATE Act, 35
U.S.C. § 103(c), under which iCeutica will carry out some of its obligations pursuant to paragraph (4). Intellectual Property developed in or relating to Meloxicam or the iCeutica Technology and any other technologies that are within the scope
of the Patent Rights will be deemed made as a result of activities undertaken within the scope of the joint research agreement and subject to the CREATE Act. 


 

	(8)	Infringement. 

  

	 	(a)	Notices. Each Party shall inform the other promptly of any third party infringement of Patent Rights or misappropriation of Confidential Information of which it
has knowledge. 

  

	 	(b)	Enforcement. If and to the extent that any iCeutica IP is infringed or misappropriated by any third party products which compete with Meloxicam:


  

	 	(i)	iCeutica shall have the right, but not the obligation, at iCeutica’s expense, to bring suit for infringement or misappropriation, as applicable, of the iCeutica IP
and may join Iroko as a co-plaintiff, subject to reimbursement of reasonable fees and expenses for counsel; and 

  

	 	(ii)	Iroko shall have the right (but not the obligation), exercised within sixty (60) days after notice prior to filing of the complaint, to share equally with iCeutica
the legal fees and expenses of the suit; or 

  

	 	(iii)	If iCeutica does not initiate a suit for infringement or misappropriation of iCeutica IP, as applicable, within four (4) months after notice from Iroko (the notice
shall include detailed claim charts or evidence of misappropriation and competitive information demonstrating a substantial adverse competitive impact of the infringement or misappropriation on sales of Meloxicam), Iroko shall have the right to
initiate the suit at Iroko’s expense, and may join iCeutica as a co-plaintiff. 


  
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	 	(c)	Iroko Cooperation. In connection with any litigation involving iCeutica IP and Meloxicam, Iroko shall use reasonable diligence to make its then-present and
former employees and consultants available to iCeutica, subject to reasonable notice and payment of reasonable fees for their time and reimbursement of out-of-pocket expenses. 


 

	 	(d)	Declaratory Judgment Suits. If a declaratory judgment suit is brought against Iroko, alleging invalidity, unenforceability, or non-infringement of any patents of
the iCeutica IP, Iroko shall provide prompt notice thereof to iCeutica; and iCeutica, shall have the right, but not the obligation, within thirty (30) days after notice, to assume the defense of the suit at iCeutica’s expense.


  

	 	(e)	Recoveries. Any amounts received as awards in or license or settlement agreements entered into pursuant to any claim or suit under paragraph (8)(b) and
allocable to Meloxicam shall be distributed as follows: 

  

	 	(i)	First, to reimburse the Parties, pro rata, for their out-of-pocket legal fees and expenses incurred in connection with the claim or suit; and 


 

	 	(ii)	The balance shall be paid: 

 (1)
Fifty-fifty (50-50) if the Parties shared equally the costs of the suit; and otherwise 
 (2) Ninety percent (90%) to the
Party paying for the suit and ten percent (10%) to the other. 
 Payments shall be made within thirty (30) days after
funds are received and shall be accompanied by a report detailing the computation of the payments. 
  

	(9)	iCeutica Representations and Warranties; Changed Circumstances. Except as provided in the Amended and Restated Nano-Reformulated Compound License and Option
Agreement, iCeutica and iCeutica Inc. each represents and warrants to Iroko that: 

  

	 	(a)	Right and Power. It has the right and power to enter into and perform this Agreement in accordance with its terms, and is not now and will not become party to an
agreement in derogation of iCeutica’s obligations to Iroko in this Agreement. 

  

	 	(b)	Ownership. iCeutica owns all right, title and interest in and to the iCeutica IP, free and clear of liens, security interests, charges and other encumbrances. No
Patent Right has been abandoned. 

  

	 	(c)	No Other License. iCeutica has not granted any other license or covenant not to sue under iCeutica IP. 


 

	 	(d)	No Infringements. To the best of its knowledge, with no investigation having been made or required to be made, Iroko’s practice of the iCeutica IP will not
infringe any patent or other right of any third party. The Parties’ counsel have discussed this warranty and Iroko is comfortable with the result of the discussions. 


  
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	 	(e)	Validity. To the best of its knowledge, with no investigation having been made or required to be made, the Patent Rights are valid and enforceable and nothing
has been done, omitted, or permitted whereby any of the Patent Rights might cease to be valid and enforceable. iCeutica has taken all measures reasonably necessary or desirable to protect the iCeutica IP and all patent maintenance fees have been
duly paid. 

  

	 	(f)	Third Person Payments. No statutory or other amount is or will be owed to any other person in connection with any iCeutica IP. 


 

	 	(g)	No Claims. No claim has been asserted or threatened by any third party alleging that (i) any of the Patent Rights is invalid or unenforceable, or
(ii) the development, manufacture, use or sale of Meloxicam infringes the rights of any third person and iCeutica is not aware of any reason why such claims should be asserted or threatened by any third party. 


 

	 	(h)	No Other Warranties. Except as set forth in paragraphs (9)(a) to (9)(g), iCeutica makes no other representations or warranties whatsoever, and there is no
warranty of merchantability or fitness for a particular purpose. The warranties of paragraphs (9)(d), (9)(e) and (9)(g) are made as of the Effective Date and not continuing. 


 

	 	(i)	Changed Circumstances. iCeutica shall notify Iroko promptly of any changed circumstances with respect to paragraphs (9)(a), (9)(b), (9)(c), and (9)(f).
 

  

	(10)	Iroko Representations and Warranties. Iroko represents and warrants to iCeutica that: 


 

	 	(a)	Right and Power. It has the right and power to enter into and perform this Agreement in accordance with its terms. 


 

	 	(b)	Agreements with Inventors. Iroko has, and will maintain during the term of this Agreement, contracts with all of its employees and consultants requiring them,
during and after their employment or other engagement by Iroko and during and after the term of this Agreement, to cooperate fully, if requested, in all prosecution or litigation of iCeutica IP acquired from Iroko or relating to Meloxicam, subject
only to payment of reasonable fees for their time and reimbursement of out-of-pocket expenses. 

  

	(11)	Indemnification; Insurance. 

  

	 	(a)	 Iroko Indemnity. Iroko shall indemnify, defend, and hold harmless iCeutica and iCeutica Inc. and each of their Affiliates, officers, directors,
employees, agents, successors, and assigns (the “iCeutica Indemnitees”) against any claim, demand, liability or expense (including reasonable attorneys’ fees and expenses, whether incurred as the result of a third party claim
or a claim to enforce this provision) incurred by or imposed upon any of the iCeutica Indemnitees in connection with any third party claims, suits, or judgments arising out of any theory of liability (including tort, warranty, or strict liability
suits or claims and whether or not such 



  
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suit or claim has a factual basis) concerning Meloxicam (collectively, “Claims”), except to the extent that the damages claimed were caused by iCeutica Indemnitees.


  

	 	(b)	iCeutica Indemnity. iCeutica shall indemnify, defend, and hold harmless Iroko and its Affiliates, officers, directors, employees, agents, successors, and assigns
(the “Iroko Indemnitees”), against any claim, demand, liability or expense (including reasonable attorneys’ fees and expenses, whether incurred as the result of a third party claim or a claim to enforce this provision) incurred
by or imposed upon any of the Iroko Indemnitees in connection with any third party claims, suits, or judgments arising out of any theory of liability (including tort, warranty, or strict liability suits or claims and whether or not such suit or
claim has a factual basis) with respect to any breach of any representation or warranty set forth in paragraph (9). 

  

	 	(c)	Procedure. The iCeutica Indemnitees or the Iroko Indemnitees, as applicable, shall provide the indemnitor with prompt written notice of each Claim for which
indemnification is sought. The indemnitor, at its expense, shall defend any such Claim. The Indemnitees shall cooperate fully in such defense and permit the indemnitor to conduct and control the defense and the disposition of the Claim (including
all decisions relative to appeal, and settlement); provided, however, that any Indemnitee shall have the right to retain its own counsel, at the Indemnitee’s expense. The indemnitor shall keep the other Party informed of the
progress in the defense and disposition of any Claim and shall consult with the other Party with regard to any proposed settlement. The indemnitor shall obtain the written consent, which shall not unreasonably be withheld, of the other Party to any
settlement which would adversely affect the other party. 

  

	 	(d)	Insurance. 

  

	 	(i)	Iroko and each Sublicensee shall maintain in full force and effect at all times from the Product Launch for the term of this Agreement and four (4) years
thereafter with a reputable commercial insurance carrier, commercial general liability insurance of a type as may be necessary to protect their interests and fulfill its obligations under this Agreement, including without limitation contractual
liability insurance, covering the marketing, sale, distribution, use and performance of products sold by Iroko containing Meloxicam in an amount of at least Ten Million Dollars ($10,000,000) per occurrence and Twenty Million Dollars ($20,000,000) in
the aggregate. 

  

	 	(ii)	The insurance of subparagraph (11)(d)(i): (A) shall be issued by an insurer licensed to practice in Pennsylvania and otherwise in the countries in which Iroko
undertakes activities in connection with the exercise of its rights, or an insurer pre-approved by iCeutica, such approval not to be unreasonably withheld; (B) shall be endorsed to include product liability coverage; and (C) shall require
thirty (30) days’ written notice to iCeutica before any cancellation or material change. 


  
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	 	(iii)	Iroko shall, upon request, provide iCeutica with a copy of the Certificate of Insurance and the underlying policy(ies) evidencing compliance with this paragraph
(11)(d). 

  

	(12)	Confidential Information. During the term of this Agreement and for three (3) years thereafter, each Receiver will: 


 

	 	(a)	use commercially reasonable efforts, but no less than the protection given to its own confidential information, to maintain in confidence all Confidential Information,
including without limitation the financial terms of this Agreement; and 

  

	 	(b)	disclose Confidential Information only: 

  

	 	i)	to the Receiver’s employees, consultants and legal, financial and business advisors who reasonably need to know such information for the Receiver to perform its
obligations or otherwise conduct its activities hereunder; or 

  

	 	ii)	as required by court order, statute, governmental regulation or securities exchange rule, upon at least five (5) days prior notice to the Discloser.


  

	(13)	Termination. 

  

	 	(a)	Duration of this Agreement. Unless terminated pursuant to paragraph (13)(b) or (13)(c), the term of this Agreement shall continue on a country-by-country
basis until expiration of the last-to-expire of the Patent Rights in that country and, if there is no granted iCeutica patent in any country, for twenty (20) years from the Product Launch date for that country. 


 

	 	(b)	Termination by iCeutica. iCeutica may terminate this Agreement if Iroko breaches any material provision (other than the payment obligations contained in
paragraph (5), for which iCeutica’s sole remedy shall be the pursuit of monetary damages) of this Agreement and has not cured the breach within ninety (90) days after notice from iCeutica specifying the nature of the breach in reasonable
detail; provided, however, that a breach of a Sublicense by a Sublicensee shall not be deemed to be a breach of this Agreement. 

  

	 	(c)	Termination by Iroko. Iroko may terminate this Agreement if iCeutica breaches any material provision of this Agreement and has not cured the breach within ninety
(90) days after notice from Iroko specifying the nature of the breach in reasonable detail. 

  

	 	(d)	Bankruptcy. All rights and licenses granted under or pursuant to this Agreement by iCeutica to Iroko are, for all purposes of paragraph 365(n) of Title 11 of the
United States Code (“Title 11”) or other relevant bankruptcy or insolvency law (collectively, “Law”), licenses of rights to “intellectual property,” as defined in Title 11 or such other Law.



  
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	 	(e)	Effects of Termination. 

  

	 	(i)	Nothing herein will release any Party from any obligation that matured prior to the effective date of any termination of this Agreement. Subject to the foregoing,
paragraphs (6), (7), (8) (as to litigation then in process), (11), (13)(d), (15) and (16) will survive termination of this Agreement. 

  

	 	(ii)	Iroko may, after termination, sell all Meloxicam then in inventory or work-in-process. 


 

	 	(iii)	All Sublicenses shall remain in full force and effect after termination of this Agreement for any reason; and the Sublicensee shall pay directly to iCeutica all
post-termination payments that Iroko would otherwise have been obligated to make hereunder. 

  

	 	(f)	Return of Information. Upon termination of this Agreement, each Receiver will return all applicable Confidential Information supplied to Receiver, except that
Receiver’s counsel may keep one archival copy. 

  

	(14)	General Compliance with Laws. 

  

	 	(a)	Compliance with Laws. iCeutica shall comply with all local, state, federal, and international laws and regulations relating to its performance under this
Agreement, including but not limited to the development, manufacture, use, and sale of Meloxicam, including export control laws. Without limiting the generality of this paragraph, Iroko shall be responsible for the preparation and submission of all
applications relating to any required regulatory approval of any Meloxicam, whether by the FDA or other regulatory body. 

  

	 	(b)	Marking. Iroko shall mark the packaging and/or product inserts for Meloxicam with the number of each applicable patent of the Patent Rights. Iroko shall provide
iCeutica with written notice of compliance with this paragraph by December 31 of each year. 

  

	(15)	Governing Laws; Venue; Severability. 

  

	 	(a)	Delaware Law. This validity and interpretation of this Agreement shall be governed by Delaware law, without regard to conflicts of laws principles.


  

	 	(b)	Consent to Service. Each Party consents to service of process by prepaid next-business-day delivery service at its last known address identified by proper
notice. 

  

	 	(c)	Severability. If any provision of this Agreement is held invalid, unenforceable, void or unconscionable, that provision shall be enforced to the greatest extent
permitted by law and the remainder of this Agreement and such provision shall remain in full force and effect. 


  
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	(16)	Miscellaneous. 

  

	 	(a)	Negotiation of Disputes. If any dispute arises under or related to this Agreement, senior executives of the parties, with decision-making authority, will meet in
Philadelphia, PA within ten (10) days after notice and enter into good faith negotiations, for a period not to exceed twenty (20) days, aimed at resolving the dispute. 


 

	 	(b)	Notices. Any notices or other communications required or permitted by this Agreement shall be in writing and delivered (i) personally, (ii) via
electronic mail, or (iii) sent by prepaid express courier service, signature requested. Notices shall be effective upon receipt. Notices shall be sent to the addresses of the Parties specified on the first page of this Agreement or such other
address as given by proper notice; provided, that notices to Iroko shall be sent to One Kew Place, 150 Rouse Boulevard, Philadelphia, PA, 19112. 

  

	 	(c)	Entire Agreement. This Agreement contains the entire agreement of the Parties with respect to its subject matter, and supersedes all previous agreements and
understandings, written or oral, express or implied. This Agreement may only be amended by a writing signed by the Parties. 

  

	 	(d)	Successors and Assigns. This Agreement is binding upon the Parties and their successors and permitted assigns. Neither Party may assign its rights or obligations
under this Agreement without the prior written consent of the other, except that: 

  

	 	(i)	iCeutica may assign its rights to receive payments hereunder and may pledge its IP, subject to the rights granted to Iroko in this Agreement; 


 

	 	(ii)	Iroko may assign its rights and obligations hereunder to an Affiliate, with written notice thereof to iCeutica Inc.; provided, however, that in the event
of an assignment under this paragraph 16(d)(ii), notices shall be delivered pursuant to paragraph 16(b) hereof and the assignee and the assignor shall be jointly and severally liable for all of Iroko’s obligations under this Agreement;


  

	 	(iii)	Iroko may assign all or a portion of its rights to an acquirer of all or substantially all of Iroko’s assets in which event the successor and iCeutica shall enter
into an agreement as to Meloxicam, substantially the same as this Agreement, mutatis mutandis; and 

  

	 	(iv)	Iroko or iCeutica may assign all of its rights to a successor by (A) merger, (B) acquisition of all or substantially all of the shares, members’
interests or other indicia of ownership of a Party, (C) as to Iroko, purchase of all or substantially all of Iroko’s assets relating to Meloxicam, or (D) as to iCeutica, purchase of all or substantially all of iCeutica’s assets
relating to iCeutica Technology. 


  
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	 	(e)	Counterparts. This Agreement may be signed in two or more counterparts, each of which will be deemed an original, but all of which together will constitute one
and the same instrument. Signed signature pages may be exchanges by fax or e-mail and shall complete this Agreement, and shall be followed by the exchange of paper copies of the signed documents. 


 

	 	(f)	Headings. The headings contained in this Agreement are for reference purposes only and will not affect in any way the meaning or interpretation of this
Agreement. 

  

	 	(g)	Acknowledgment. The Parties acknowledge and agree that the provisions of this Agreement are intended to be read in conjunction with the provisions in the Amended
and Restated Nano-Reformulated Compound License and Option Agreement; provided, however, that, in the event of a conflict with respect to Meloxicam, the provisions of this Agreement should be read as controlling.


 [Signature page follows] 

  
 15 









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

 iCeutica Inc. 
 iCeutica
Pty Ltd. 
  

			
	By	 	/s/ MATT CALLAHAN
		 	Matt Callahan, their CEO
	
	Iroko Pharmaceuticals Inc.
		
	By	 	
		 	                , its Director

 SIGNATURE PAGE TO MELOXICAM
LICENSE AGREEMENT