Document:

rdhl_Ex4_19

		

			Exhibit 4.19

		

		

			 

		

		

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			THE SYMBOL "[****]" DENOTES PLACES WHERE PORTIONS OF THIS DOCUMENT HAVE BEEN OMIITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. SUCH MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
		

		
			 
		

		
			EXCLUSIVE LICENSE AGREEMENT
		

		
			 
		

		
			This Exclusive License Agreement (“Agreement”) made and entered into as of April 4, 2017 (the “Effective Date”), by and between Entera Health, Inc., an Iowa corporation, having its principal place of business at 2425 SE Oak Tree Court, Ankeny, Iowa 50021 (“Licensor”), and [RedHill Biopharma, Inc. a Delaware corporation, having an address at 8045 Arco Corporate Drive, Suite 120, Raleigh, North Carolina 27617, along with all Affiliates thereof (as defined below) (“Licensee”).  
		

		
			 
		

		
			RECITALS
		

		
			 
		

		
			WHEREAS, Licensor is the sole and exclusive owner of the well-known ENTERAGAM® trademark and other trademarks attached to this Agreement as Exhibit A, attached hereto and incorporated herein by reference, and rights pertaining to them (the “EnteraGam Marks”), the uniform resource locator (URL) www.enteragam.com (the “EnteraGam URL”), and related intellectual-property rights. Licensor has the exclusive right to grant to any third party rights to, including the right to use, the EnteraGam URL and ENTERAGAM® trademark and related intellectual-property rights in various countries, including the Territory (as defined below). 
		

		
			 
		

		
			WHEREAS, Licensee, through this Agreement, desires to obtain the exclusive right to use the EnteraGam URL, the EnteraGam Marks, and the related intellectual‐property rights within the Territory in connection with the use, offer for sale and sale of Licensed Products (as defined below). 
		

		
			 
		

		
			WHEREAS, Licensor is willing to grant such an exclusive license to Licensee, upon the terms and conditions set forth in this Agreement. 
		

		
			 
		

		
			AGREEMENT
		

		
			 
		

		
			NOW, THEREFORE, in consideration of the mutual promises and conditions contained in this Agreement, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows: 
		

		
			 
		

		
			I. DEFINITIONS
		

		
			 
		

		
			1.1.      “Affiliate” shall mean, for any Person, its shareholders, officers, directors, parents corporations, subsidiary corporations, partnerships, joint ventures or other entities (whether incorporated or not) under the direct or indirect control or direction of the Person or its parent and, with respect to Licensee, shall include any and all Sublicensee(s).
		

		
			 
		

		
			1.2.      “[****]” shall mean those [****] on Exhibit B, attached hereto and incorporated herein by reference.
		

		
			

		 

		

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			1.3.      “Competing Event” shall mean any event by which Licensee, Sublicensee, or any Licensee Affiliate shall [****] pursuant to the terms of this License Agreement, [****], for any entity other than Licensor, whether by acquisition, internal development or otherwise..
		

		
			 
		

		
			1.4.      “Confidential Information” shall mean secret or proprietary information of, or data maintained as confidential by, either party. It shall include, without limitation, the terms and conditions of this Agreement (except to the extent that such terms and conditions must be disclosed pursuant to the U.S. Securities and Exchange Commission, or other similar authority in any jurisdiction, requirements or the Tel Aviv Stock Exchange or other applicable stock exchange or automated quotation system rules, and if so, the parties will use commercially reasonable efforts to forgo disclosing sensitive financial information and to obtain any available confidentiality treatment from such securities regulators), information concerning products, techniques, developments, product plans, equipment, inventions, patent applications, ideas, designs, processes, methods, research, sales, licensing, customers, operations and work product of Licensor, Licensee or their respective Affiliates. Nothing shall be considered Confidential Information which (i) either party learns from other sources which have a right to that information free from confidentiality restrictions; (ii) is available to the public or readily discernible from information available to the public; (iii) enters the public domain other than through the actions or inactions of either party or any of their Affiliates or Sublicensee(s) in breach of the terms of this Agreement; or (iv) is independently developed by either party without reference to, or reliance on, the Confidential Information. In the event any item of Confidential Information is subject to required disclosure pursuant to any order, judgment, ruling or degree, despite the terms of this Agreement, the involved party shall immediately notify the other party, which shall have the right to seek a protective order or similar relief and shall reasonably cooperate with such other party in its efforts to seek such relief.
		

		
			 
		

		
			1.5.      “Contract Term” shall mean the term of this Agreement, as set forth on Exhibit C, attached hereto and incorporated herein by reference, unless sooner terminated in accordance with the terms of this Agreement. Any renewal or extension that may be granted in the future shall be deemed included in the Contract Term.
		

		
			 
		

		
			1.6.      “Contract Year” shall mean a period of twelve (12) successive months commencing on the RedHill Launch Date (as defined below).
		

		
			 
		

		
			1.7.      “Expiration Date” shall mean the date upon which the Agreement ends because of the end of the Contract Term.
		

		
			 
		

		
			1.8.      “Field” shall mean human use for any indication, in compliance with all applicable laws.
		

		
			 
		

		
			1.9.      “Licensed Product” shall mean any product, as specified in Exhibit B, attached hereto and incorporated herein by reference, for which rights are granted to Licensee under this Agreement, and which [****].  For the avoidance of doubt, [****] shall not be deemed to constitute “Licensed Product”.
		

		
			
		

		
			

		 

		

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			1.10.    “Minimum Net Sales” for any Contract Year shall mean [****] of Licensed Product [****] (in respect of all of which Licensor expects to receive the Royalty payment stipulated in this Agreement) excluding [****]. Minimum Net Sales calculations in the [****] shall not include the first fiscal quarter after RedHill Launch Date [****].
		

		
			 
		

		
			1.11.    “Net Sales” shall mean [****].
		

		
			 
		

		
			1.12.    “Other Licensor Rights” shall mean any and all [****].
		

		
			 
		

		
			1.13    “Person” shall mean any individual or any corporation, limited liability company, partnership, trust, association or other entity of any kind.
		

		
			 
		

		
			1.14    “Prime Rate” shall mean the prime rate of interest charged by J.P. Morgan Chase Bank, New York City, New York, or any successor institution, as published in the Wall Street Journal for the applicable period.
		

		
			 
		

		
			1.15.    “Product Samples” shall mean samples of the Licensed Product, and expressly excludes [****].
		

		
			 
		

		
			1.16.    “RedHill Launch Date” shall mean the first date, following the Effective Date of this Agreement, on which [****].
		

		
			 
		

		
			1.17.    “Regulatory Compliance Obligations” shall have the meaning set forth in Exhibit E,  attached hereto and incorporated herein by reference.
		

		
			 
		

		
			1.18.    “Retained Licensor Rights” shall mean any and all rights to [****], and shall also mean any and all rights of any kind, type, or nature whatsoever [****].
		

		
			 
		

		
			1.19.    “Royalty” shall mean, for [****], the amount of money Licensee (including any Sublicensee(s)) shall pay to Licensor in consideration for the grant of this license. Such amount is calculated as a percentage of Net Sales, specified in Exhibit D, attached hereto and incorporated herein by reference.
		

		
			 
		

		
			1.20.    A “Sale” in respect of any unit of Licensed Product shall occur when [****].
		

		
			 
		

		
			1.21.    [****].
		

		
			 
		

		
			1.22.    “Sublicensee” shall mean any and all Person(s) to which Licensee has granted a valid sublicense in accordance with the terms and conditions of this Agreement.  The granting of any sublicense(s) to any Person not in compliance with the provisions of this Agreement is prohibited  and all invalid sublicense(s) shall be void ab initio.
		

		
			 
		

		
			1.23.    “Termination Date” shall mean the date upon which the Agreement ends due to any other cause except expiration of the Contract Term.
		

		
			 
		

		
			1.24.    “Territory” shall mean the United States of America.
		

		
			 
		

		
			1.25.    “Transaction Documents” shall mean [****] and that certain [****] entered into by and between the Licensee and Licensor dated even herewith.
		

		
			

		 

		

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			II. APPOINTMENT; GRANT OF LICENSE
		

		
			 
		

		
			2.1      Subject to all of the terms and conditions of this Agreement, Licensor hereby grants to Licensee a royalty-bearing, nontransferable (except as set forth in this Agreement), non-assignable (except as set forth in this Agreement), non-divisible, and exclusive license, without the right to grant sublicense(s) subject to the conditions set forth in this Agreement, to use the EnteraGam Marks, the EnteraGam URL, and Other Licensor Rights, solely in the Territory and solely on or in connection with the [****] that are useful or necessary for the sale or distribution of Licensed Products and related promotional and packaging material in compliance with all applicable laws and regulations, solely in the Field, solely through the [****], during the Contract Term (such license, the “License”). In addition to all other terms and conditions set forth in this Agreement, the License herein granted shall be subject to the following terms and conditions:
		

		
			 
		

		
			(a)  This grant of the License shall be exclusive as to third parties, and even as to Entera, except as otherwise provided in this Agreement, during the Contract Term and in the Territory; provided, however, nothing contained in this Agreement shall prevent Licensor or any Licensor Affiliate from exercising any: (i) Retained Licensor Rights; and (ii) any and all other rights,  either directly or through other Licensor Affiliates or other licensees or assignees, at any time, outside the Territory, outside the [****], and/or outside the Field; provided that Licensor does not, directly or indirectly, offer for sale, sell or assist any third party to offer for sale or sell the Licensed Product in the Field in the Territory.   Licensor agrees that during the Contract Term it will not [****].  Notwithstanding the foregoing, until the RedHill Launch Date, [****].    
		

		
			 
		

		
			(b)  All Licensed Products shall bear at least one of the EnteraGam Marks, and no Licensed Products shall be sold or otherwise distributed under any marks other than the EnteraGam Marks.  Licensee shall not modify or change any [****] containing the Licensed Products provided by Licensor.  Licensor reserves all rights to the EnteraGam Marks except as specifically granted herein to Licensee and Licensor may exercise such reserved rights at any time.  
		

		
			 
		

		
			(c)  Licensee shall [****] the Net Sales of the Licensed Product pursuant to this Agreement while [****] by the EnteraGam Marks. 
		

		
			 
		

		
			(d)  During the Contract Term, Licensee may not sublicense any rights licensed to the Licensee under this Agreement without the Licensor’s prior written consent.    As a condition to any such sublicense, [****].  For the avoidance of doubt, the Licensee may not assign any rights or delegate any duties arising under this Agreement without the Licensor’s prior written consent; provided, that [****].
		

		
			 
		

		
			(e)  To the maximum extent permitted by applicable law, during the Contract Term and for a period of [****] years thereafter, Licensee or any Licensee Affiliate and any Sublicensee may not [****] without the prior written approval of Licensor.  As a material inducement to induce Licensor to enter into this Agreement and grant the License contemplated hereunder, Licensee hereby acknowledges, covenants, and agrees that the restrictions set forth in this provision are necessary to protect the 
		

		
			
		

		
			

		 

		

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			reasonable economic expectations and interests of Licensor, and that Licensee will not engage in, participate in, and initiate any challenge to the prohibitions set forth herein, whether during the Contract Term or otherwise. 
		

		
			 
		

		
			(f)  Licensee: (i) shall not contest, raise any objections to the validity of, or attack Licensor’s title to, or rights in, the EnteraGam Marks, the EnteraGam URL, or any Other Licensor Rights, (ii) shall not file any application for, or obtain or attempt to obtain ownership of, the EnteraGam Marks, the EnteraGam URL or any Other Licensor Rights, (iii) shall promptly notify Licensor if Licensee becomes aware of any attempts to do so, or any use of any material covered by any EnteraGam Marks, the EnteraGam URL, or Other Licensor Rights, by any third party, and (iv) shall take appropriate actions, and, [****], all actions reasonably requested by Licensor to prevent or avoid any misuse of the material covered by any EnteraGam Marks, the EnteraGam URL, or Other Licensor Rights or Licensed Products by any of its customers, contractors, Sublicensee(s), or suppliers. 
		

		
			 
		

		
			(g)  Licensee shall use the EnteraGam URL solely for the commercialization activities contemplated within the scope of the License.  
		

		
			 
		

		
			(h)  Licensee shall [****] in accordance with generally accepted accounting principles, and Licensee shall be responsible for [****] any financial accounting, recording, or reporting not in compliance with generally accepted accounting principles.
		

		
			 
		

		
			III. SALE OF LICENSED PRODUCTS
		

		
			 
		

		
			3.1      Licensee agrees that it will use [****] to [****] that Licensed Products, shall be distributed for sale only in compliance with the Regulatory Compliance Obligations set forth in Exhibit E, and [****].
		

		
			 
		

		
			3.3.      Licensee shall not show, distribute or sell any Licensed Product contained within any packaging and containing any labeling which has not been approved in advance by Licensor or which is, at any time, disapproved by Licensor; provided that Licensor shall not disapprove of any packaging or labeling provided by Licensor except for good reason.
		

		
			 
		

		
			IV. COMMERCIALIZATION EFFORTS; MINIMUM NET SALES
		

		
			 
		

		
			4.1      Licensee shall use commercially reasonable efforts to promote the sale of Licensed Products in the Territory.
		

		
			 
		

		
			4.2      Licensee shall use good-faith commercially reasonable efforts to provide marketing support for the Licensed Products in the Territory.
		

		
			 
		

		
			4.3      Licensee shall promote, market, and sell the Licensed Product during the Contract Term as [****].
		

		
			
		

		
			

		 

		

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			V. ROYALTY PAYMENTS
		

		
			 
		

		
			5.1      Licensee shall pay to Licensor a Royalty on Net Sales for all Sales of all Licensed Products sold by Licensee (and any and all Sublicensee(s)) during [****] based on the rates set forth on Exhibit D.  Undisputed past due payments over [****] beyond due date shall bear interest at a per annum rate of interest equal to (a) the Prime Rate [****] per annum, or (b) the maximum interest rate permissible under law, whichever is less.  All payments to Licensee will be paid in USD.
		

		
			 
		

		
			5.2      Immediately upon the occurrence of the RedHill Launch, all Royalties due to Licensor in respect of all Net Sales of Licensed Product shall begin to accrue upon the time of the Sale of such Licensed Product by Licensee and Licensee’s obligation to compute and pay Royalties to the Licensor shall commence.  Royalties shall be computed and paid on a quarterly calendar basis during the Contract Term in respect of all Net Sales occurring within each calendar quarter during the Contract Term.  The Licensee’s obligation to prepare Quarterly Statements (as defined below) will commence during [****].  All such Royalty payments shall be due and payable [****] during the Contract Term.  Reporting for and payment of the Royalties due and payable as a result of the Net Sales occurring from the time of the RedHill Launch to the end of the first calendar quarter for which a Quarterly Statement will be prepared shall be included within the first Quarterly Statement.
		

		
			 
		

		
			5.3.      Taxes.  Licensee may deduct from any amounts it is required to pay Licensor pursuant to this Agreement an amount equal to that required by applicable United States law to be withheld by Licensee for or due on account of any taxes (including VAT to the extent applicable, but other than taxes imposed on or measured by net income of Licensee) or similar governmental charge imposed by the United States based on such payments to Licensor (“Withholding Taxes”) and such payment shall be deemed as payment to Licensor in accordance with this Agreement.  Licensee will provide Licensor a certificate evidencing payment of any Withholding Taxes.
		

		
			 
		

		
			VI. SALES AND ROYALTY REPORTS
		

		
			 
		

		
			6.1.      Licensee shall supply Licensor, with a quarterly statement summarizing in reasonable detail all Sales of Licensed Products sold during each calendar quarter by the Licensee, along with and including any and all Sublicensee(s) (each, a “Quarterly Statement”). Each Quarterly Statement shall be delivered to the Licensor [****].
		

		
			 
		

		
			6.2      Quarterly Statements for the final quarter of [****] shall include, without limitation, an annual report of the foregoing for the entire Contract Year.  [****].
		

		
			 
		

		
			
		

		
			

		 

		

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			VII. ADVERTISING, MARKETING, PROMOTIONS & PACKAGING
		

		
			 
		

		
			7.1      Licensor shall be responsible for packaging, labeling, and supply of all Licensed Products pursuant to the Supply Agreement, and as may otherwise be agreed between the parties pursuant to action of the JCC.  Licensee shall not modify, change, or alter any packaging or labeling of the Licensed Product without the prior written consent of the Licensor.  For the avoidance of doubt, co-branding is not permitted without Licensor’s prior written approval.
		

		
			 
		

		
			7.2      Licensee agrees that each medium of advertising through which Licensee promotes Licensed Products and each individual media vehicle through which Licensee publishes or distributes marketing materials relating to Licensed Products shall be consistent with the [****] and no less than consistent with the [****].
		

		
			 
		

		
			7.3      Except for the [****] distribution of Product Samples, Licensed Products shall not be sold or given away by Licensee free of charge or sold or exchanged for nominal value, or authorized by Licensee to be so given away, sold or exchanged, unless written approval is granted by Licensor for a specific amount.  If Licensee desires to give away or sell for nominal value Licensed Products for the promotion of the products, services or business of any individual or entity other than Licensee, Licensee shall obtain Licensor’s written approval prior to any such arrangement and such approval shall not be unreasonably withheld.  Licensor shall have [****] in which to approve or disapprove any such plan. It is understood between the parties that if Licensee does not receive [****], the Licensor has [****] such request.
		

		
			 
		

		
			VIII. JOINT COMMERCIALIZATION COMMITTEE
		

		
			 
		

		
			8.1      Within [****] following the Effective Date, the parties shall establish a Joint Commercialization Committee (“JCC”) that shall be comprised of up to [****] representatives of each of Licensee and Licensor, which representatives shall be members of the parties’ senior management or other such senior persons responsible for the applicable functional area within each party (each, a “JCC Member”).  The initial JCC Members of each of the parties are set forth in Exhibit F, attached hereto and incorporated herein by reference.  Each party may replace its JCC Members (including the chairperson) at any time on prior written notice to the other party.  Each party will have the right from time to time to invite to JCC meetings other representatives for the purpose of addressing specific issues to be discussed at such JCC meetings.  The chairperson of the JCC shall be appointed for a [****] term by one party followed up with a [****] term by the other party and will be replaced again [****] accordingly by the parties until termination of the Agreement, it being agreed that during the [****] of the Agreement the chairperson shall be appointed by [****], and shall initially be [****].  For the avoidance of doubt, the chairperson shall not have a greater casting or deciding vote or more authority than any other JCC Member on any matter related to the JCC or this Agreement. In addition to the foregoing, the parties shall each have the right to appoint non-voting observers to the JCC.
		

		
			 
		

		
			8.2      In connection with the transactions contemplated in this Agreement and in the other Transaction Documents, Licensee shall be responsible for the [****] (the “Licensee Responsibilities”).  
		

		
			 
		

		
			
		

		
			

		 

		

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			8.3.      In connection with the transactions contemplated in this Agreement and in the other Transaction Documents, Licensor shall be responsible for the [****] (collectively, the “Licensor Responsibilities”).  The specific obligations of the Licensor Responsibilities shall be further enumerated and determined pursuant to the [****].  Licensee shall not modify, change, or alter any packaging, labeling, or package inserts provided by Licensor. Licensor shall comply with all applicable laws and regulations in performing its obligations under the Transaction Documents.  
		

		
			 
		

		
			8.4      The JCC shall act as a consultative and, to the extent expressly granted authority hereunder, a decision-making body for the purpose of designing and monitoring the implementation of, and the parties’ compliance with, the Transaction Documents in accordance with the terms thereof, and generally shall act as the forum for information-sharing between the parties with respect to the commercialization, manufacture and supply of the Licensed Product.  In particular, the JCC shall:
		

		
			 
		

		
			(a)  Exchange information (including manufacture, registration, supply, marketing and commercialization information) related to the Licensed Product and facilitate cooperation and coordination between the parties as they exercise their respective rights and fulfill their respective obligations under this Agreement;
		

		
			 
		

		
			(b)  Discuss the Licensee’s commercial plans with respect to the sales, marketing, and promotion of the Licensed Product and the manner in which the Licensed Product is to be commercialized in the Territory to the extent not set forth in such commercialization plans; 
		

		
			 
		

		
			(c)  Monitor and discuss the inventory of Licensed Product in the Licensee’s distribution channels;
		

		
			 
		

		
			(d)  Discuss strategy and proper quantities surrounding distribution of Product Samples, which the parties mutually agree is a critical part of the commercialization strategy for the Licensed Product;
		

		
			 
		

		
			(e)  Monitor Licensee’s implementation, monitoring and coordination of all activities, including scheduling and prioritization thereof, contemplated in the Transaction Documents in conformance with the Transaction Documents;
		

		
			 
		

		
			(f)  Appoint working sub-groups, as necessary, whose duties and powers shall be determined by the JCC and who shall meet as necessary to provide relevant information for the JCC to carry out its duties under the Transaction Documents;
		

		
			 
		

		
			(g)  Promptly following the Effective Date, itself or through an appointed sub-group, become the forum for the discussion and analysis of Licensee’s handling of all regulatory matters in the Territory; 
		

		
			 
		

		
			(h)  In addition, the JCC shall act as a consultative body with respect to all matters concerning intellectual property, including trademarks
		

		
			 
		

		
			
		

		
			

		 

		

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			8.5      In the [****] calendar quarter of each calendar year during the Contract Term, Licensee will submit to the Licensor a [****] for the next Contract Year. 
		

		
			 
		

		
			8.6      Before producing, publishing or distributing any market advertising related to the transactions contemplated by the Transaction Documents or Licensed Products that is not substantially similar to materials previously approved, Licensee shall submit to the JCC for its examination and approval or disapproval, a [****].  Licensor shall have [****] in which to approve or disapprove any such materials. It is understood between the parties that if Licensee does not receive a response from Licensor within [****] after the period detailed above, Licensor has [****] such request.
		

		
			 
		

		
			8.7      The JCC shall meet at least [****] per Contract Year, which meetings may be through teleconference or other virtual means.  All meetings shall be scheduled and confirmed at least [****] in advance of the date of such meeting where feasible.  No meeting of the JCC may occur without all JCC Members present, unless waiver or proxy is given in writing by the absent JCC Members.    
		

		
			 
		

		
			8.8      The JCC Members designated by Licensee shall be responsible for preparing the minutes setting forth discussions held at each JCC meeting; provided, however, that such minutes will not become official until agreed upon by the JCC representatives designated by [****].  The JCC Members shall provide comments on such draft minutes.  [****] shall incorporate timely received agreed comments and distribute finalized minutes to all JCC Members.
		

		
			 
		

		
			8.9      Decisions of the JCC shall be taken unanimously.  In the event of a disagreement or a deadlock, the matter shall be referred to the senior executives of the parties.  In connection with any disagreement, the parties each agree that they shall participate, in good faith, in at least one (1) teleconference/virtual meeting which includes every JCC Member in an attempt to expeditiously and amicably resolve any such dispute.  If the disagreement or deadlock persists and is not resolved within [****], the parties shall have the right to cast the tie-breaking vote with respect to each matter within their respective responsibilities under the Transaction Documents, as set forth below:
		

		
			 
		

		
			(a)  Licensor shall have the right to cast a tie-breaking vote to be exercised in its reasonable judgment with respect to matters pertaining to Licensor Responsibilities.  For the avoidance of doubt, the Licensor shall have absolute control pertaining to the Licensor’s [****], except as expressly set forth in this Agreement. 
		

		
			 
		

		
			(b)  Licensee shall have the right to cast a tie-breaking vote to be exercised in its reasonable judgment with respect to matters pertaining to Licensee Responsibilities.
		

		
			 
		

		
			8.10    The JCC shall not have any authority to contravene, override, or nullify any provision of the Transaction Documents or bind or incur liability on behalf of either party hereto without such party’s express prior written authorization, and shall have only such powers as are specifically delegated to them hereunder.  The JCC shall not be construed as a statutory board of directors, or as the “governing authority” of either party or both parties pursuant to the United 
		

		
			
		

		
			

		 

		

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			States Sentencing Commission Guidelines, or give rise to the existence of fiduciary duties, either in respect of each JCC Member or in respect of the parties to this Agreement. Neither party will be required to act in accordance with decisions of the other party that contradict relevant laws or government guidelines.
		

		
			 
		

		
			8.11    Within [****] after the Effective Date, Licensor shall provide Licensee with copies of all the readily-available information in Licensor’s possession pertaining to the Licensed Product that is or in Licensor’s good faith reasonable judgment may be relevant for the commercialization of the Product; thereafter Licensor will use reasonable efforts to provide any additional relevant information pertaining to the Licensed Product within a commercially reasonable time, provided that, Licensor makes no warranty or guarantee and hereby disclaims all warranties and guarantees as to the completeness of any information provided pursuant to this Section.  In each case, such information shall be initially provided in electronic format to expedite the transition thereof, to be promptly followed up with delivery of hard copies.  During the Contract Term, Licensor shall also provide Licensee details of ongoing studies and upcoming and anticipated publications to the extent relevant to the Licensed Product and Licensee shall ensure that all such information is subject to the confidentiality provisions of this Agreement and ensure that such information is used only in compliance with applicable laws and regulations.
		

		
			 
		

		
			IX. RESEARCH & DEVELOPMENT COMMITTEE
		

		
			 
		

		
			9.1      Within [****] after the Effective Date, Licensee will establish a research & development committee comprising members of both Licensor and Licensee with a goal of exploring [****] (the “R&D Committee”). 
		

		
			 
		

		
			9.2      Within [****] after the Effective Date, Licensee will present to Licensor a [****] for consideration by the parties (the “[****]”). Notwithstanding the foregoing, either party may, at any time, for any reason, without liability, inform the other party that it does not wish to pursue [****].  Following presentation of the [****], the parties will discuss, in good faith, the plan and potential collaboration arrangements in relation to the [****].  Neither party shall commit or undertake, or be committed to undertake, or accept and/or execute any proposed [****] unless and until a [****] reached between the parties (“[****]”).  For the avoidance of doubt, neither party will be under any obligation to enter into the [****].  Terms of ownership of any intellectual property rights and/or FDA or governmental filings and approvals created by the [****] and the related work or outputs thereof shall be dictated by the [****], if applicable.  In the absence of any [****], Licensor would own all such intellectual property rights and FDA/governmental filings and approvals.  Licensee will not at any time pursue FDA marketing approval of the Licensed Product without Licensor’s prior written consent.  
		

		
			 
		

		
			9.3      Notwithstanding any other provision in this Agreement, Licensor retains the sole and absolute discretion to develop, determine and pursue a drug development plan for the Licensed Product at any time, on any terms and with any partner of its choosing, including during the Contract Term of this Agreement. Licensor shall promptly inform Licensee in writing of any such development plan and following such notification, Licensee shall be entitled to immediately terminate the License Agreement with no additional liability to Licensor except as otherwise 
		

		
			
		

		
			

		 

		

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			incidental to or arising pursuant to or as a result of this Agreement, provided that the preceding clause shall not be deemed to abrogate, cancel, or waive any provision of this Agreement.
		

		
			 
		

		
			X. ENTERAGAM MARKS & ENTERAGAM URL
		

		
			 
		

		
			10.1    During the Contract Term, Licensor shall not within the Territory grant or sanction any other party to use any mark identical with, or substantially similar to, the EnteraGam Marks, and EnteraGam URL in a manner which is in conflict with the rights granted to Licensee under this Agreement.
		

		
			 
		

		
			10.2    Licensee shall have no right, title or interest in the EnteraGam Marks, and EnteraGam URL except the licensed rights in accordance with this Agreement. Each and every part of the EnteraGam Marks, and the EnteraGam URL is, and shall remain, the sole property of Licensor. Any use by Licensee of any part of the EnteraGam Marks, and the EnteraGam URL, and the goodwill arising from them, shall inure to the benefit of Licensor.
		

		
			 
		

		
			10.3    During the Contract Term, and at any time thereafter, Licensee shall not contest, raise any objections to the validity of, or attack Licensor’s title to, or rights in, the EnteraGam Marks, or the EnteraGam URL.
		

		
			 
		

		
			10.4    During the Contract Term, and at any time thereafter, Licensee shall not file any application for any mark, or obtain or attempt to obtain ownership of any mark or trade name, in any country of the world, which refers to, or is substantially similar to, any of the EnteraGam Marks, and the EnteraGam URL, and shall promptly notify Licensor if Licensee becomes aware of any attempts to do so by third parties.
		

		
			 
		

		
			10.5    In the event that any Person (other than Licensee, or any Affiliate(s) or Sublicensee(s) thereof, or any other Person acting in cooperation or concert with any of them) asserts that the EnteraGam Marks, the EnteraGam URL, or the sale of Licensed Products (collectively, the “Rights”) infringe upon such third party’s rights in the Territory, Licensor, at its sole expense, shall take what are in Licensor’s sole discretion commercially reasonable actions to protect and validate the Rights including, without limitation, arbitration, mediation and litigation, at Licensor’s discretion. Licensor shall have the right at any time, and in its sole discretion, to reach a settlement in any action to protect and validate the Rights. If a settlement is reached, or it is determined that the Rights do infringe on such third party’s rights, then Licensor may, if it is not commercially reasonable to obtain rights for Licensee to continue to exercise its rights under this Agreement, terminate this Agreement immediately. Without derogating from any other representation and warranty provided by Licensor, Licensor represents and warrants that the Rights [****].
		

		
			 
		

		
			10.6    The parties shall promptly notify the other party in writing of any learned use that may be an infringement or imitation of the EnteraGam Marks on articles similar to the Licensed Products, and of any use which may be an infringement or imitation of any applicable related designs, design patents and copyrights in the Territory. In the event a third party is allegedly infringing or threatens to infringe the Rights in the Territory, as determined by Licensor or Licensee, Licensor shall have the first right, but not the obligation, to bring an infringement action
		

		
			
		

		
			

		 

		

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			against any actual or alleged infringer with respect to the EnteraGam Marks, or the EnteraGam URL. Licensor may, in its sole judgment and at its own expense, institute, control, settle, and defend such action and recover any damages, awards, or settlements resulting therefrom. Licensee shall reasonably cooperate and use commercially reasonable efforts to assist Licensor in any such litigation. Licensor shall reimburse Licensee for its out-of-pocket expenses incurred as a result of such cooperation.  In the event that Licensor elects not to bring any such infringement action, during the Contract Term, Licensee shall have the option, but not the obligation, to bring an infringement action against any such third party and recover any damages, awards, or settlements resulting therefrom subject to the allocations below. Licensor shall reasonably cooperate and use commercially reasonable efforts to assist Licensee in any such litigation. Licensee shall reimburse Licensor for its out-of-pocket expenses incurred as a result of such cooperation.
		

		
			 
		

		
			10.7    Any damages, award, or settlement recovered by either party in connection with   enforcement of Licensor rights against third-party infringement in the Territory shall first be used to reimburse Licensor and Licensee for all reasonable expenses incurred during said litigation.  The remainder of the damages, award or settlement that is attributable to any infringement or alleged infringement in the Territory shall be divided as follows [****].  The foregoing allocation of proceeds shall only apply to actions relating to infringement that occurs during the Contract Term.
		

		
			 
		

		
			10.8    Licensee shall take appropriate actions and, at Licensor’s expense (unless necessary to cure actions of Licensee or its Affiliate(s), in which case at Licensee’s expense), all commercially reasonable actions reasonably requested by Licensor, to prevent or avoid any misuse of the EnteraGam Marks, the EnteraGam URL, or Licensed Products by any of its customers, contractors, Sublicensee(s), suppliers, or other resources.
		

		
			 
		

		
			10.9    Licensee shall reasonably assist and cooperate with Licensor, at Licensor’s expense, in any other efforts to obtain, perfect and protect its rights to the EnteraGam Marks, and the EnteraGam URL in the Territory. Licensee shall execute any documents reasonably required by Licensor in connection with the foregoing.
		

		
			 
		

		
			10.10  Following the termination of the rights granted under this Agreement with respect to the EnteraGam Marks, or the EnteraGam URL, Licensee shall cease absolutely, and Licensee shall not thereafter offer, sell, market, promote, or utilize for any purpose whatsoever, any item branded under, or making reference to, the EnteraGam Marks, nor shall Licensee publish or display, or authorize or permit the publication or display of, further or additional quantities of any advertising or marketing materials which incorporate the EnteraGam Marks, and Licensee shall immediately cease all use of the EnteraGam URL and shall transfer all control of the EnteraGam URL back to Entera.
		

		
			 
		

		
			10.11  Licensee hereby assigns to Licensor, without the payment of additional compensation, the entire right, title and interest in and to all writing(s), formula(s), design(s), model(s), drawing(s), photograph(s), design(s) and any other invention(s) made, conceived or reduced to practice or authored by Licensee, either solely or jointly with others, during or in connection with this Agreement or which relates to, incorporates, relies upon, or is a derivative, modification, improvement or change of or to the EnteraGam Marks, the Licensed Product, and
		

		
			
		

		
			

		 

		

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			the EnteraGam URL, whether occurring prior to or after the Effective Date of this Agreement. Licensee shall promptly disclose to Licensor all work(s), writing(s), formula(s), design(s), model(s), photograph(s), drawing(s), design(s) and other invention(s) made, conceived or reduced to practice or authored by Licensor, either solely or jointly with others, during or in connection with the performance of or related to this Agreement.  Licensee shall sign, execute and acknowledge or cause to be signed, executed and acknowledged without cost, but at the expense of Licensor, any and all documents and perform any acts as may be necessary, useful or convenient for the purpose of securing to Licensor or its nominees, patent, trademark or copyright protection throughout the world upon and for all such work(s), writing(s), formula(s), design(s), model(s), drawing(s), photograph(s), design(s) and other invention(s), title to which Licensor may acquire under the terms of this Agreement.  All of the foregoing inventions, developments, and other intellectual property rights shall, once vested in the Licensor, automatically and without further action of the parties be included within the scope of the License, subject to the terms, conditions, and limitations thereof. 
		

		
			 
		

		
			XI. CONFIDENTIAL & PROPRIETARY INFORMATION
		

		
			 
		

		
			11.1    During the Contract Term, either party may provide the other with access to and/or allow them to become familiar with various aspects of their Confidential Information. Both parties shall hold all revealed Confidential Information which has been provided in strict confidence, shall not use in any way or disclose any Confidential Information directly or indirectly to any other party and such information shall be used by Licensor only in those facilities where Licensed Products are manufactured and only in connection with the manufacture, use and sale of Licensed Products. All records, files, documents, information, data and other similar items relating to either party’s business operations, regardless of who prepared them and which are not otherwise in the public domain, shall remain the exclusive property of the owning party.
		

		
			 
		

		
			11.2    Apart from the license granted herein to use the EnteraGam Marks, and the EnteraGam URL in connection with the advertising, promotion, sale, offering for sale and distribution of Licensed Products, this Agreement does not grant Licensee any rights whatsoever in the Confidential Information of Licensor under any of Licensor’s patent(s), patent application(s), trademark(s), trademark application(s), copyrights, copyright application(s), service mark(s), URL(s), website(s), or proprietary technology or any other rights in the EnteraGam Marks, or EnteraGam URL not granted herein. The use of any proprietary information outside the scope of this grant of license is considered a material breach of this Agreement. LICENSEE SHALL NOT USE ANY PROPRIETARY INFORMATION OUTSIDE THE SCOPE OF THIS GRANT OF LICENSE. LICENSOR DOES NOT GRANT LICENSEE ANY RIGHTS WHATSOEVER IN THE CONFIDENTIAL INFORMATION OF LICENSOR BY VIRTUE OF THIS AGREEMENT OR OTHERWISE. LICENSEE DOES NOT GRANT LICENSOR ANY RIGHTS WHATSOEVER IN THE CONFIDENTIAL INFORMATION OF LICENSEE BY VIRTUE OF THIS AGREEMENT OR OTHERWISE.
		

		
			 
		

		
			XII. PAYMENTS
		

		
			 
		

		
			All royalty payments required under the provisions of this Agreement are payable by wire transfer as follows: 
		

		
			 
		

		
			
		

		
			

		 

		

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			Payment Address:
		

		
			[****]
		

		
			 
		

		
			 
		

		
			XIII. NOTICES & OTHER COMMUNICATIONS
		

		
			 
		

		
			13.1    All reports, approvals, requests, demands, notices and other communications required or permitted by this Agreement shall be in writing and signed by a duly authorized officer of or such other individual designated in writing by a party.
		

		
			 
		

		
			13.2    Communications shall be duly given if delivered personally, if mailed (by certified or registered mail (air mail if sent internationally), return receipt requested) or if delivered by nationally-recognized overnight courier or mail service that requires the addressee to acknowledge, in writing, the receipt thereof, to the party concerned. Notice may also be sent by facsimile or electronic transmission, with written confirmation of receipt.
		

		
			 
		

		
			
		

		
			

		 

		

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			13.3    All Communications to Licensor shall be sent to:
		

		
			 
		

		
			Entera Health, Inc.
		

		
			2425 SE Oak Tree Court
		

		
			Ankeny, Iowa 50021
		

		
			[****]
		

		
			 
		

		
			13.4    All communications to Licensee shall be sent to:
		

		
			 
		

		
			RedHill Biopharma, Inc.
		

		
			8045 Arco Corporate Drive
		

		
			Suite 120
		

		
			Raleigh, North Carolina 27617
		

		
			[****]
		

		
			 
		

		
			with a copy to:
		

		
			 
		

		
			RedHill Biopharma Ltd.
		

		
			21 Ha'arba'a Street
		

		
			Tel-Aviv 64739
		

		
			Israel
		

		
			Fax: +972 (3) 541 3144[****]
		

		
			 
		

		
			or to such other address as the party to who notice is to be given may have furnished to the other party in writing in accordance herewith.  Any such communication will be deemed to have been given: (i) when delivered, if personally delivered; (ii) on the business day (on the receiving end) after dispatch, if sent by nationally-recognized overnight courier or mail service (third business day if sent internationally); (iii) on the [****] day following the date of mailing, if sent by mail ([****] day if sent internationally); and (iv) on [****] day (on the receiving end) after being sent by facsimile or electronic mail.  It is understood and agreed that this Section 13 is not intended to govern the day-to-day business communications necessary between the parties in performing their duties, in due course, under the terms of this Agreement.
		

		
			 
		

		
			 
		

		
			XIV. RECORDS & INSPECTION
		

		
			 
		

		
			14.1    Licensee shall maintain in the United States invoices and books of account for the sale of Licensed Products relating to this Agreement during the Contract Term for a period of [****] following the period to which they relate, with respect to inventory levels of Licensed Product within the Licensee’s distribution channels, call data (e.g. physicians which have been called on by Licensee’s sales force and prescriptions dispensed thereunder, etc.) and Sales of Licensed Product made by Licensee and by any and all Sublicensee(s). Such books of account shall be complete and accurate in accordance with generally accepted accounting practices. Licensor will have the right, at its own cost,  to have a mutually agreeable independent certified public accounting firm of internationally recognized standing and who agrees to be bound by a customary undertaking of confidentiality at least as restrictive as those in this Agreement, have
		

		
			
		

		
			

		 

		

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			access during Licensee's normal business hours, and upon reasonable prior coordination, to Licensee’s records as may be reasonably necessary to verify the accuracy of Licensee’s Quarterly Statements, during the Contract Term and for a period of up to [****] after the termination or expiration thereof; provided, however, that Licensor will not have the right to conduct more than [****] in any Contract Year, unless any audit or examination or Quarterly Statement reveals or contains any significant or material miscalculation, misstatement, or error, in which case Licensor may conduct additional audits or examinations until such miscalculations, misstatements, or errors are resolved.  The accounting firm shall not in any way be compensated (in whole or in part) contingent on the outcome of the audit. Any such audit shall not unreasonably interfere with the business of Licensee. Licensor shall provide to Licensee a copy of the audit report and any applicable audit work papers (unless such auditor will not consent to the disclosure of its audit work papers after reasonable efforts to obtain the consent of such auditor) within [****] of its receipt thereof. Without derogating from the foregoing, Licensor’s audit rights shall be conducted no later than [****] following the termination or expiration of the Contract Term. The costs of the audit are the responsibility of Licensor provided that in the event that there is a shortfall of more than [****] in the payment due, the audit costs and all related travel costs will be covered by RedHill within [****] following billing.   
		

		
			 
		

		
			14.2    If, upon any examination of Licensee’s books and records pursuant to Section 14.1 hereof, Licensor shall discover any royalty overpayment by Licensee, Licensor will make all payments required to be made to correct and eliminate such overpayment within [****] of Licensee’s demand.  If, upon any examination of Licensee’s books and records pursuant to Section 14.1 hereof, Licensor shall discover any royalty underpayment by Licensee, Licensee will make all payments required to be made to correct and eliminate such underpayment within [****] after the date on which such accounting firm’s written report is delivered to [****].
		

		
			 
		

		
			14.3    In addition to any other remedy available to either party, if any payment not under dispute in good faith due under this Agreement is delayed for any reason beyond [****], interest shall accrue and be payable, to the extent legally enforceable, on such unpaid principal amounts from and after the date on which the same became due, at a per annum amount equal to the Prime Rate [****] or the highest amount otherwise permitted by law.
		

		
			 
		

		
			 
		

		
			XV. COMPLIANCE; REPRESENTATIONS AND WARRANTIES
		

		
			 
		

		
			15.1    Licensee shall not, in any manner, authorize or purport to authorize another, including, without limitation, any Affiliate(s), including any Sublicensee(s) of Licensee, to use the EnteraGam Marks, or the EnteraGam URL, except to the extent specifically provided herein.
		

		
			 
		

		
			15.2    Licensee and Licensor shall comply with all Regulatory Compliance Obligations set forth on Exhibit E.
		

		
			 
		

		
			15.3    As a material inducement to induce the Licensor to enter into this Agreement, Licensee hereby represents and warrants, to the Licensor, on its own behalf and, where applicable,  on behalf of all of its Affiliate(s), and its and their respective heirs, successors, and assigns (provided that the Licensee makes no representations and warranties with respect to the EnteraGam
		

		
			
		

		
			

		 

		

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			Marks, the EnteraGam URL, or the Licensed Product) that the following shall be true and correct with respect to all of them: 
		

		
			 
		

		
			(a)  the Licensee enters into this Agreement and all of the Transaction Documents freely, knowingly, voluntarily, without duress, and with the advice of counsel.
		

		
			 
		

		
			(b)  the Licensor has made no commitment, promise, or guarantee, whether verbal or written, of any amounts, revenues, or proceeds that would or may be obtained by Licensee as a result of this Agreement.
		

		
			 
		

		
			(c)  Licensee has the authority to enter into this Agreement and the other Transaction Documents, and the execution, delivery, and performance of this Agreement and all of the Transaction Documents does not conflict with any policy to which Licensee is subject or any contractual or legal obligation of Licensee, and this Agreement and the other Transaction Documents shall constitute binding obligations of the Licensee, enforceable against Licensee in accordance with its and their respective terms, subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights and judicial principles affecting the availability of specific performance and general principles of equity, whether enforceability is considered a proceeding at law or equity.
		

		
			 
		

		
			(d)  Licensee’s execution, delivery, and performance of this Agreement and all of the Transaction Documents will not violate: (i) any applicable law, rule, ordinance, regulation or order; (ii) any contracts between the Licensee and any third parties; or (iii) to Licensee’s knowledge, the rights of any Person in or to any patent, trademark, trade name, copyright, trade secret, license or other proprietary right, intellectual property right or similar right.
		

		
			 
		

		
			(e)  Licensee’s execution, delivery, and performance of this Agreement and the other Transaction Documents will not violate or infringe the rights of any Person in or to any patent, trademark, trade name, copyright, trade secret, license or other proprietary right, intellectual property right, or similar right.
		

		
			 
		

		
			(f)  Except with respect to the rights being licensed to Licensee hereunder, Licensee is the lawful owner or licensee of any software programs or other rights or material to be used by Licensee in its performance of this Agreement, and Licensee has all rights necessary to convey to the Licensor, the complete and unencumbered ownership of any and all Royalties and other deliverables contemplated hereunder.
		

		
			 
		

		
			(g)  Licensee has obtained any and all necessary approvals to enter into this Agreement including, to the extent necessary the approval of Licensee’s board of directors and shareholders.
		

		
			 
		

		
			(h)  To the best of its knowledge, Licensee and all of its personnel who will or may be used in any manner in connection with the performance of this Agreement and the other Transaction Documents has never been debarred or suspended, is not debarred or 
		

		
			
		

		
			

		 

		

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			suspended, and is not under investigation for any fact or circumstance which could result in the debarment or suspension of Licensee or any of them under any state or federal healthcare, procurement, or other programs.
		

		
			 
		

		
			(i)  To the best of its knowledge and with reasonable efforts customary in the industry, Licensee, and all of its personnel who will or may be used in any manner in connection with the performance of this Agreement and the other Transaction Documents, has not made or offered to make, and shall not improperly make, offer to make, or agree to make any loan, gift, donation or payment, or transfer of any other thing of value directly or indirectly, whether in cash or in kind, to or for the benefit of any private entities, government and public bodies, political parties, party officials, candidates for political office, local councils, judicial officers, public international organizations and their employees, institutions and officials in connection with any business activity of Licensee or any of its wholly or partially owned Affiliate.
		

		
			 
		

		
			(j)  If Licensee learns of any of the prohibited activities described above, Licensee shall promptly notify the Licensor.
		

		
			 
		

		
			(k)  Licensee is not a foreign or domestic government official nor is Licensee related to a foreign or domestic government official (as such terms are contemplated in the Foreign Corrupt Practices Act and the UK Bribery Act).
		

		
			 
		

		
			(l)  To the best of its knowledge, Licensee, and all of its personnel, have not been debarred and is not under investigation for debarment under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. §335a(a) and (b), or disqualified under any laws or regulations.  If during the term of this Agreement, Licensee (i) becomes debarred or disqualified; (ii) receives notice of an action or threat of an action with respect to its debarment or disqualification; or (iii) engages in any conduct or activity which could lead to any of the above-mentioned disqualification or debarment actions, Licensee shall notify Licensor immediately.
		

		
			 
		

		
			(m) Licensee has not and will not use in any capacity the services of any individual, corporation, partnership or association or other Person which it is aware has been debarred under 21 U.S.C. §335a(a) or (b), or disqualified under the provisions of 21 C.F.R. §312.70, and if Licensee becomes aware of the debarment, threatened debarment, disqualification or threatened disqualification of any individual, corporation, partnership, or association providing services to Licensee which directly or indirectly relate to activities under this Agreement and the other Transaction Documents, Licensee shall notify the Licensor immediately.
		

		
			 
		

		
			(n)  To the best of its knowledge, neither Licensee nor any Person affiliated with Licensee has been sanctioned by or excluded from participation in any federal health care program, including Medicare and Medicaid, and Licensee agrees that if it or any such individual associated with it should become the subject of an investigation relating to health care fraud, abuse or misconduct, or should be sanctioned by or excluded from 
		

		
			
		

		
			

		 

		

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			participation in any federal health care program, including Medicare and Medicaid, it will immediately notify Licensor.
		

		
			 
		

		
			(o)  To the best of its knowledge, Licensee is in compliance with any and all other applicable local, state, national, and international laws and regulations including, without limitation, the laws of any applicable securities exchange (including any applicable anti-retaliation and whistleblower programs) and is not under investigation for any violation of any such laws or regulations.
		

		
			 
		

		
			(p)  Licensee has in place a current and comprehensive code of conduct and ethics and maintains a corporate compliance and ethics program which is designed to detect and prevent criminal conduct in accordance with Chapter 8 of the most recent United States Sentencing Commission Guidelines.
		

		
			 
		

		
			(q)  Licensee shall conduct reasonable and adequate regulatory compliance-related due diligence of any and all third-party vendors or suppliers used in any manner in connection with the activities contemplated by the Agreement and the other Transaction Documents.
		

		
			 
		

		
			(r)  Licensee has had sufficient time to conduct due diligence of Licensor and of the Licensed Product to its satisfaction, has had unrestricted access to the management and board of the Licensor and an opportunity to ask any and all questions desired by the Licensee, and all inquiries and questions desired to be submitted or asked have been answered by the Licensor to the Licensee’s satisfaction.
		

		
			 
		

		
			(s)  Licensee and it Affiliate(s) and its Subcontractor(s) is and are Solvent (as defined below) and, after consummation of the transactions contemplated in this Agreement, will be Solvent.  “Solvent” means, as to any Person, that such Person (a) owns property whose fair salable value is greater than the amount required to pay all of its debts (including contingent, subordinated, unmatured and unliquidated liabilities); (b) owns property whose present fair salable value is greater than the probable total liabilities (including contingent, subordinated, unmatured and unliquidated liabilities) of such Person as they become absolute and matured; (c) is able to pay all of its debts as they mature; (d) has capital that is not unreasonably small for its business and is sufficient to carry on its business and the business in which it is about to engage; and (e) is not “insolvent” within the meaning of Section 101(32) of Title 11 of the United States Code.
		

		
			 
		

		
			(t)  To Licensee’s knowledge, neither this Agreement nor any certificates made or delivered in connection herewith contains any untrue statement of a material fact or omits to state a material fact necessary to make the statements herein or therein not misleading, in view of the circumstances in which they were made.
		

		
			 
		

		
			15.4    All of Licensee’s sublicense agreement(s) must comply with this Agreement including, without limitation, the provisions of this Section 15.4, provided that the preceding sentence shall not be construed to authorize the Licensee to enter into any sublicense without the 
		

		
			
		

		
			

		 

		

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			Licensor’s prior written consent.  In the event Licensee has knowledge of, has reason to believe, or should have reason to know that any Sublicensee(s) or any third-party vendors or supplier used by Licensee in connection with the activities contemplated by this Agreement or the other Transaction Documents is in breach of any provision of this Agreement, Licensee must immediately notify Licensor and Licensee shall, at its sole expense, take immediate action to rectify such breach, including, where Licensor deems it necessary, immediate termination of its relationship with such Sublicensee(s) or third-party vendor(s) or supplier(s). If Licensee fails to take immediate action or such action is not successful, Licensee will assign its rights to proceed against any such Person to Licensor and Licensor will, at Licensee’s sole expense, have the right to pursue all available remedies to protect its rights. Further, such Licensee failure shall be grounds for termination of this Agreement by Licensor. 
		

		
			 
		

		
			15.5    In addition to all other reports required by this Agreement, in order to maintain Licensor’s high standard of quality control and to ensure that appropriate measures are taken to ensure regulatory compliance, upon request by Licensor, Licensee shall provide a report to Licensor on a quarterly basis with any other relevant information regarding all Sublicensee(s) or third-party suppliers or vendors, as requested by Licensor.
		

		
			 
		

		
			15.6    As a material inducement to induce Licensee to enter into this Agreement, Licensor hereby represents and warrants, to Licensor, that the following shall be true and correct with respect as of the Effective Date:
		

		
			 
		

		
			(a)  Licensor enters into this Agreement and all of the Transaction Documents freely, knowingly, voluntarily, without duress, and with the advice of counsel.
		

		
			 
		

		
			(b)  Licensor has the authority to enter into this Agreement and the other Transaction Documents, and the execution, delivery, and performance of this Agreement and all of the Transaction Documents does not conflict with any policy to which Licensor is subject or any contractual or legal obligation of Licensor, and this Agreement and the other Transaction Documents shall constitute binding obligations of the Licensor, enforceable against Licensor in accordance with its and their respective terms, subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights and judicial principles affecting the availability of specific performance and general principles of equity, whether enforceability is considered a proceeding at law or equity.
		

		
			 
		

		
			(c)  Licensor’s execution, delivery, and performance of this Agreement and all of the Transaction Documents will not violate: (i) any applicable law, rule, ordinance, regulation or order; (ii) any contracts between the Licensor and any third parties; or (iii) to Licensor’s knowledge, the rights of any Person in or to any patent, trademark, trade name, copyright, trade secret, license or other proprietary right, intellectual property right or similar right.
		

		
			 
		

		
			(d)  Licensor’s execution, delivery, and performance of this Agreement and the other Transaction Documents and the exercise by Licensee of its rights granted under this Agreement in accordance with its terms, will not violate or infringe the rights of any 
		

		
			
		

		
			

		 

		

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			Person in or to any patent, trademark, trade name, copyright, trade secret, license or other proprietary right, intellectual property right, or similar right.
		

		
			 
		

		
			(e)  To the knowledge of Licensor, Licensor has the valid and unrestricted right to license the Licensed Product pursuant to the License.
		

		
			 
		

		
			(f)  Licensor has obtained any and all necessary approvals to enter into this Agreement including, to the extent necessary the approval of Licensor’s board of directors and shareholders.
		

		
			 
		

		
			(g)  It has and shall maintain throughout the Contract Term, all regulatory approvals necessary for the performance of its obligations hereunder.
		

		
			 
		

		
			(h)  It has not received any written notice asserting or alleging that any research or development of the Licensed Product infringed or misappropriated the intellectual property rights of any third party.
		

		
			 
		

		
			(i)  There are no pending, and to Licensor’s knowledge, no threatened, adverse actions, suits or proceedings against Licensor or its Affiliates involving the Licensed Product.
		

		
			 
		

		
			(j)  The ENTERGAM® trademark has been properly filed and registered with the U.S. Patent and Trademark Office and is valid and in full force and effect, and, Licensor has the right to use and license the ENTERA® trademark, free and clear of any liens or encumbrances.
		

		
			 
		

		
			(k)  There are no pending legal suits or proceedings involving the Licensed Product; and there are no threatened legal suits or proceedings in the Territory involving the Product. 
		

		
			 
		

		
			(l)  To the best of its knowledge, Licensor and all of its personnel who will or may be used in any manner in connection with the performance of this Agreement and the other Transaction Documents has never been debarred or suspended, is not debarred or suspended, and is not under investigation for any fact or circumstance which could result in the debarment or suspension of Licensee or any of them under any state or federal healthcare, procurement, or other programs.
		

		
			 
		

		
			(m) To the best of its knowledge and with reasonable efforts customary in the industry, Licensor, and all of its personnel who will or may be used in any manner in connection with the performance of this Agreement and the other Transaction Documents, has not made or offered to make, and shall not improperly make, offer to make, or agree to make any loan, gift, donation or payment, or transfer of any other thing of value directly or indirectly, whether in cash or in kind, to or for the benefit of any private entities, government and public bodies, political parties, party officials, candidates for political office, local councils, judicial officers, public international organizations and their employees, institutions and officials in connection with any business activity of Licensor or any of its wholly or partially owned Affiliate.
		

		
			 
		

		
			
		

		
			

		 

		

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			(n)  If Licensor learns of any of the prohibited activities described above, Licensor shall promptly notify the Licensee.
		

		
			 
		

		
			(o)  Licensor is not a foreign or domestic government official nor is Licensor related to a foreign or domestic government official (as such terms are contemplated in the Foreign Corrupt Practices Act and the UK Bribery Act).
		

		
			 
		

		
			(p)  To the best of its knowledge, Licensor, and all of its personnel, have not been debarred and is not under investigation for debarment under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. §335a(a) and (b), or disqualified under any laws or regulations.  If during the term of this Agreement, Licensor (i) becomes debarred or disqualified; (ii) receives notice of an action or threat of an action with respect to its debarment or disqualification; or (iii) engages in any conduct or activity which could lead to any of the above-mentioned disqualification or debarment actions, Licensor shall notify Licensee immediately.
		

		
			 
		

		
			(q)  Licensor has not and will not use in any capacity the services of any individual, corporation, partnership or association or other Person which it is aware has been debarred under 21 U.S.C. §335a(a) or (b), or disqualified under the provisions of 21 C.F.R. §312.70, and if Licensor becomes aware of the debarment, threatened debarment, disqualification or threatened disqualification of any individual, corporation, partnership, or association providing services to Licensor which directly or indirectly relate to activities under this Agreement and the other Transaction Documents, Licensor shall notify the Licensee immediately.
		

		
			 
		

		
			(r)  To Licensor’s knowledge, neither Licensor nor any Person affiliated with Licensor has been sanctioned by or excluded from participation in any federal health care program, including Medicare and Medicaid, and Licensor agrees that if it or any such individual associated with it should become the subject of an investigation relating to health care fraud, abuse or misconduct, or should be sanctioned by or excluded from participation in any federal health care program, including Medicare and Medicaid, it will immediately notify Licensee.
		

		
			 
		

		
			(s)  To Licensor’s knowledge, Licensor is in compliance with any and all other applicable local, state, national, and international laws and regulations including, without limitation, the laws of any applicable securities exchange (including any applicable anti-retaliation and whistleblower programs) and is not under investigation for any violation of any such laws or regulations.
		

		
			 
		

		
			(t)  To Licensor’s knowledge, Exhibit G attached hereto and incorporated herein by reference lists all past studies and publications (including name, date, author/investigator) conducted/published in the past relating to the Licensed Product.
		

		
			 
		

		
			(u)  Licensor shall conduct reasonable and adequate regulatory compliance-related due diligence of any and all third-party vendors or suppliers used in any manner in 
		

		
			
		

		
			

		 

		

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			connection with the activities contemplated by the Agreement and the other Transaction Documents.
		

		
			 
		

		
			(v)  Licensor is Solvent and, assuming the proper performance of the Transaction Documents, after consummation of the transactions contemplated in Transaction Documents, will be Solvent.
		

		
			 
		

		
			(w) Licensor has, to Licensor’s knowledge, provided Licensee with all information Licensee has requested. To Licensor’s knowledge, neither this Agreement nor any certificates made or delivered in connection herewith contains any untrue statement of a material fact or omits to state a material fact necessary to make the statements herein or therein not misleading, in view of the circumstances in which they were made. 
		

		
			 
		

		
			XVI. ASSIGNMENT; SUBLICENSE
		

		
			 
		

		
			16.1    Licensee may not and shall not sublicense or assign this Agreement or its rights and interest hereunder, or any part hereof, whether by operation of law or otherwise, except in strict compliance with the provisions of this Agreement and, as required by this Agreement, with the Licensor’s prior written consent. Any attempted or purported sale, transfer, lease, sublicense or assignment which is not in compliance with this provisions of this Agreement shall be null and void ab initio and shall, in Licensor’s sole discretion, result in the immediate termination of this Agreement.  Each and every sublicense or assignment shall require a written undertaking by each such Sublicensee and assignee that such party acknowledges and agrees to be bound by all terms and conditions of this Agreement as if such party were an original signatory to this Agreement.  No sublicense shall relieve Licensee of any of its obligations arising hereunder.  For the avoidance of doubt, all Sublicensee(s) shall be bound to and shall perform all obligations of the Licensee arising pursuant to this Agreement, notwithstanding any failure to specifically mention such Sublicensee(s) in any provisions in this Agreement giving rise to such obligations.
		

		
			 
		

		
			16.2    Licensor shall have a complete and unrestricted right to sell, transfer, lease or assign its rights and interests in this Agreement to any domestic or foreign corporation or other business entity, provided that such transferee agrees to be bound by all of the terms hereof. In the event that Licensor shall sell, transfer, lease or assign its rights and interests in this Agreement, Licensor shall notify Licensee of such event.
		

		
			 
		

		
			
		

		
			

		 

		

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			XVII. TERMINATION
		

		
			 
		

		
			17.1    This Agreement may be terminated by Licensor by written notice, immediately upon the occurrence of any of the following events:
		

		
			 
		

		
			(a)  If Licensee makes any unauthorized assertion of rights in the EnteraGam Marks, the EnteraGam URL, or the Licensed Products, which is inconsistent with the Licensor’s interest therein and fails to cure same within [****] after the written notice thereof from Licensor.
		

		
			 
		

		
			(b)  If Licensee attempts to or actually sells, transfers, leases, pledges, sublicenses, assigns or otherwise encumbers or disposes of this Agreement or any of Licensee’s rights or obligations hereunder not in strict compliance with the provisions of this Agreement and fails to cure same within [****] after the written notice thereof from Licensor. 
		

		
			 
		

		
			(c)  If Licensee ceases to engage in its business for more than [****].
		

		
			 
		

		
			(d)  If Licensee fails to offer Licensed Products for sale for a period of [****] following the RedHill Launch, other than as a result of a breach of any Transaction Document by Licensor or compliance with any applicable law or regulatory directive.
		

		
			 
		

		
			(e)  If the insurance coverage required by this Agreement should be canceled for any reason and Licensee or Licensor, as appropriate, fails to cure same within [****] after the insurer’s notice thereof to Licensee or Licensor, respectively, provided that for purposes of this provision, in order to be deemed “cured”, there may be no lapse in insurance coverage for any period during the Contract Term or thereafter as required pursuant to this Agreement.  In the event that either party is at risk of a lapse in any insurance coverage required by this Agreement, such party shall immediately notify the other party upon the discovery thereof and update such other party continuously in efforts to cure such breach.  In the event that any lapse in coverage occurs and is not curable, such breach shall be immediately deemed incurable and the non-breaching party may immediately terminate this Agreement.   
		

		
			 
		

		
			(f)  If Licensee terminates the Supply Agreement for any reason, the Licensor may immediately terminate this Agreement.
		

		
			 
		

		
			17.2    This Agreement may be terminated by either party as follows: 
		

		
			 
		

		
			If either party fails to perform or fulfill any other material obligation required to be performed or fulfilled by it  in the time and manner herein provided, or any representation and warranty made by either party shall any time cease to be true and correct in all respects, whether as applicable to a party or to any other Person covered thereby and if such default shall continue for [****] after receipt of written notice thereof from the non-defaulting party, then the non-defaulting party shall have the right to terminate this Agreement immediately by written notice of termination to the defaulting party, provided that, in the event that either party violates any applicable anti-corruption or anti-bribery related laws and regulations, then the other party may terminate this Agreement 
		

		
			
		

		
			

		 

		

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			immediately. Such right to terminate this Agreement shall be in addition to and shall not be prejudicial to any right or remedies, at law or in equity, which said non-defaulting party may have on account of such default.   
		

		
			 
		

		
			17.3    This Agreement may be terminated at any time for any reason or no reason upon [****] prior written notice by Licensee without any additional liability except as otherwise incidental to or arising pursuant to or as a result of this Agreement, provided that the preceding clause shall not be deemed to abrogate, cancel, or waive any provision of this Agreement.  Any notice of termination given by Licensee pursuant to this Section 17.3 shall be irrevocable unless such requirement is waived in writing by Licensor.  In the event Licensee terminates this Agreement pursuant to this Section 17.3, Licensor may immediately enter into negotiations and, upon notice to Licensee, execute definitive agreements with any Person with respect to a license of any of the Licensor’s intellectual property rights, including, without limitation, those intellectual property rights subject to this License, subject only to the condition that such definitive agreements may not take effect until the effective date of termination specified on the Licensee’s notice of termination.    
		

		
			 
		

		
			17.4    Licensor may terminate this Agreement if Licensee fails to (i) meet the Minimum Net Sales target in any Contract Year or (ii) if the RedHill Launch does not occur within [****] after the Effective Date of this Agreement, provided Licensor delivers termination notice to Licensee within [****] from the date Licensee notifies Licensor of an applicable failure.  Licensor may terminate this Agreement in the event of each and every such failure, and any failure to provide notice of termination within the timelines stipulated above in respect of any particular failure shall not preclude Licensor from later terminating such Agreement in respect of a later breach.  Termination of this Agreement shall constitute the only remedy Licensor is entitled to for such failures described in this Section 17.4, with no further liability by Licensee whatsoever.  
		

		
			 
		

		
			17.5    Licensor may terminate this Agreement pursuant to Section 17.2 if Licensee fails to meet its obligations under Sections 2.1(c) or Section 4.  Termination of this Agreement as aforesaid shall constitute the only remedy Licensor is entitled to for the failure described in this Section 17.5 (except with respect to a breach of Section 4.3) with no further liability by Licensee whatsoever.  
		

		
			 
		

		
			17.6    Upon expiration or termination of this Agreement for any reason, the License granted hereunder shall immediately terminate and be of no further force and effect, Licensee shall immediately cease all activities with respect to or in connection with the Licensed Products, and shall not thereafter use EnteraGam Marks on the Licensed Products or on any promotional and packaging materials, labels, literature, stationary or other items bearing the EnteraGam Marks, and shall immediately cease using the EnteraGam URL and shall immediately transfer control thereof to the Licensor.  The following terms and conditions shall also apply in the event of every expiration or termination of this Agreement:
		

		
			 
		

		
			(a)  Within [****] before the Expiration Date or within [****] after the Termination Date, Licensee shall provide Licensor with a statement indicating the number and description of Licensed Products which it has on hand as of the date of expiration or termination 
		

		
			
		

		
			

		 

		

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			and the amount of such inventory necessary to fill Licensee’s existing customer orders with such documentation provided to Licensor. 
		

		
			 
		

		
			(b)  Licensor shall have the option of conducting during Licensee’s regular business hours and upon prior coordination with Licensee a physical inventory, either itself or through one or more agents, in order to ascertain or verify such inventory. 
		

		
			 
		

		
			(c)  The Licensor may itself use or license the use of EnteraGam Marks in any manner; and 
		

		
			 
		

		
			(d)  The other Transaction Documents shall immediately terminate and be of no further force and effect except as otherwise set forth therein.  
		

		
			 
		

		
			17.7    Upon expiration or termination of this Agreement for any reason, Licensor shall be entitled to all Royalties due as of the date of expiration or termination.
		

		
			 
		

		
			17.8    Within [****] after expiration or termination, Licensee shall deliver and return to Licensor any and all documents embodying Licensor’s Confidential Information.  In the event that this Agreement is terminated by Licensor pursuant to Section 17.4 and Section 17.5, Licensee shall also provide all physician-level prescription information pertaining to all Sales of Licensed Product during the [****] during the Contract Term, along with all clinical information and information relating to case studies and case series to the extent pertaining to the Licensed Product.
		

		
			 
		

		
			17.9    Neither the expiration nor earlier termination of this Agreement due to causes imputable to either party shall relieve the other party from its duty of nondisclosure provided herein, or from obligations for payments then due or accrued hereunder, or for any damage caused to either party.
		

		
			 
		

		
			17.10  Upon termination or expiration of this Agreement, all rights granted herein shall revert to Licensor, which may grant a license to others to use the EnteraGam Marks, the EnteraGam URL, and the Licensed Product in any way whatsoever. Licensee shall, thereafter, refrain from all further use of all of the foregoing.
		

		
			 
		

		
			17.11  Licensor shall have and hereby reserves all rights and remedies which it has, or which are granted to it by operation of law, to enjoin the unlawful or unauthorized use of the EnteraGam Marks, the EnteraGam URL, and the Licensed Products, to collect royalties payable by Licensee pursuant to this Agreement.
		

		
			 
		

		
			
		

		
			

		 

		

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			17.12  Bankruptcy:
		

		
			 
		

		
			(a)  If either party shall become insolvent under either the U.S. Bankruptcy Code or the Uniform Commercial Code of the State of New York, or shall make an assignment for the benefit of creditors, or files for any relief under any bankruptcy law or regulation in any jurisdiction or place, including, without limitation, the Bankruptcy Code, or shall make an assignment for the benefit of creditors, or if either party shall be made a defendant in any proceeding under bankruptcy, insolvency, reorganization or receivership law, other than an involuntary bankruptcy which is not stayed or discharged within [****] or if either party shall be adjudged bankrupt, or if a receiver or trustee for the property of either party shall be appointed, this Agreement shall hereupon terminate at the option of the other party. 
		

		
			 
		

		
			(b)  The parties hereby agree and intend that this Agreement is an executory contract governed by Section 365 of the Bankruptcy Code and, in the event of the Licensor’s bankruptcy, Licensee shall have the protection afforded to a licensee, upon rejection of the license agreement by the debtor-licensor or its representative, the option to either retain Licensee’s rights in the intellectual-property under the existing contract while continuing to pay royalties, or to treat the executory contract as terminated.  
		

		
			 
		

		
			(c)  In the event of Licensee’s bankruptcy, the parties intend that all Royalties payable under this Agreement following the commencement of a bankruptcy case shall be deemed administrative priority claims under the Bankruptcy Code because the parties recognize and agree that the bankruptcy estate’s enjoyment of this Agreement will (i) provide a material benefit to the bankruptcy estate during its reorganization and (ii) deny Licensor the benefit of the exploitation of the rights through alternate means during the bankruptcy reorganization. 
		

		
			 
		

		
			(d)  The parties acknowledge and agree that any delay in the decision of a debtor-in-possession or trustee of the bankruptcy estate to assume or reject the Agreement (the “Decision Period”) materially harms Licensor by interfering with Licensor’s ability to alternatively exploit the rights granted under this Agreement during a Decision Period of uncertain duration. The parties recognize that arranging appropriate alternative exploitation of the EnteraGam Marks, and the Licensed Product is a time-consuming and expensive process and that it is unreasonable for Licensor to endure a Decision Period of extended uncertainty. Therefore, the parties agree that the Decision Period shall not exceed [****]. 
		

		
			 
		

		
			(e)  Licensor, in its interest to safeguard its valuable interests (including, without limitation, its intellectual property rights in the EnteraGam Marks and the EnteraGam URL), has relied on the particular skill and knowledge base of Licensee. Therefore, the parties acknowledge and agree that in a bankruptcy context this Agreement is a license of the type described by Section 365(c)(1) of the Bankruptcy Code and may not be assigned without the prior written consent of Licensor in the event of any bankruptcy-related event, the actual or pending insolvency of the Licensee, or if the Licensee should enter, or during the time that the Licensee would be reasonably likely to enter, the zone of insolvency. 
		

		
			 
		

		
			
		

		
			

		 

		

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			XVIII. INDEMNITY AND DISCLAIMER
		

		
			 
		

		
			18.1    Licensor hereby agrees to indemnify and hold the Licensee, it Affiliates (including its Sublicensee(s)) and/or any of their related entities, officers, directors, employees, and/or agents (“Licensee Indemnitees”) harmless against any and all legitimate bona fide claims, demands, causes of action, damages and judgments, solely in each and every case of any third parties, to the extent arising out of: (a) the use of the EnteraGam Marks, the EnteraGam URL by the Licensee in compliance with all applicable laws and regulations and in accordance with this Agreement; (b) any material breach by Licensor of this Agreement which results in a material adverse effect on the Licensee Indemnitees, including any breach of any representation or warranty made by Licensor in this Agreement, which results in a material adverse effect on the Licensee Indemnities; or (c) Licensor’s negligence, recklessness, or willful misconduct,  provided that in each case Licensee shall give notice to Licensor within [****] after notification of each such claim, demand, cause of action or judgment and shall not, without the written consent of the Licensor (which written consent shall not be unreasonably withheld), pay, compromise or settle any such claim, demand, cause of action or judgment. Licensee’s failure to provide notice as aforesaid shall not relieve Licensor of its obligation under this Section 18 except to the extent that it can demonstrate that it has been materially prejudiced as a result of the failure. With respect to the foregoing indemnity, the Licensor agrees to indemnify and hold the Licensee Indemnitees harmless from and against reasonable attorney’s fees, expert fees and court costs. The Licensor shall have the right to undertake and conduct the defense of any claim or cause of action so brought and handle any such claim or cause of action with attorneys of its own selection and in such case the indemnified party may participate in (but not control) the defense thereof at its sole cost and expense. The provisions of this paragraph and Licensor’s obligations hereunder shall survive the expiration or termination of this Agreement for a period of [****] after the termination or expiration of this Agreement, except with respect to matters pertaining to regulatory violations, which shall survive until the expiration of all applicable statutes of limitation.  Notwithstanding anything stated in this paragraph, Licensor has no duty to indemnify or otherwise hold harmless the parties provided for herein to the extent the claims, demands, causes of action and judgments of any third parties are caused by Licensee’s (including any of Licensee’s Affiliates, any and all Sublicensee(s), and/or any of the Licensee Indemnitees’) breach of this Agreement, violation of applicable laws, or any negligence, recklessness, or willful misconduct on the part of any of them.
		

		
			 
		

		
			18.2    Licensee hereby agrees to defend, indemnify and hold the Licensor, its Affiliates, and/or any of its their related entities, officers, directors, attorneys, employees and/or agents (“Licensor Indemnitees”) harmless against from and against any and all legitimate bona fide claims, demands, causes of action and judgments of any third parties to the extent arising out of: (a) Licensee’s (and any and all Affiliate(s’)) use, import, export, distribution, shipment, advertising, promotion, offering for sale and/or sale of Licensed Products and/or the promotional and packaging material depicting such EnteraGam Marks not provided by Licensor; (b) Licensee’s negligence, recklessness, or willful misconduct; (c) any material breach by Licensee of this Agreement which results in a material adverse effect on the Licensor Indemnitees, including any breach of any representation and warranty of this Agreement which results in a material adverse effect on the Licensor Indemnitees; or (d) any claims or causes of action arising from or relating to the Licensee Responsibilities, provided that the Licensor shall give notice to the Licensee within [****] after notification of each such claim, demand, cause of action or judgment and shall not,
		

		
			
		

		
			

		 

		

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			without the written consent of the Licensor (which written consent shall not be unreasonably withheld), pay, compromise or settle any such claim, demand, cause of action or judgment. Licensor’s failure to provide notice as aforesaid shall not relieve Licensee of its obligation under this Section 18 except to the extent that it can demonstrate that it has been materially prejudiced as a result of the failure.  With respect to the foregoing indemnity, the Licensee agrees to defend and hold the Licensor Indemnitees harmless at no cost or expense to the Licensor Indemnitees whatsoever, including, but not limited to, reasonable attorney’s fees, expert fees and court costs. The Licensee shall have the right to undertake and conduct the defense of any cause of action so brought and handle any such claim or demand with attorneys of its own selection and in such case the indemnified party may participate in (but not control) the defense thereof at its sole cost and expense. The provisions of this section and Licensee’s obligations hereunder shall survive for a period of [****] after the expiration or termination of this Agreement, except with respect to matters pertaining to regulatory violations, which shall survive until the expiration of all applicable statutes of limitation. Notwithstanding anything stated in this paragraph, Licensee has no duty to indemnify or otherwise hold harmless the Licensor Indemnitees as provided for herein to the extent the claims, demands, causes of action and judgments of any third parties are caused by Licensor’s (including any of Licensor’s Affiliates, and/or any of the Licensor Indemnitees’) breach of this Agreement, violation of applicable laws, or any negligence, recklessness, or willful misconduct on the part of any of them.  
		

		
			 
		

		
			18.3    The expressed warranties, if any, contained in this Agreement are in lieu of all other warranties, guarantees, promises, affirmations or representations, express or implied, which could be deemed applicable to the License and to the Licensed Products manufactured, used or sold hereunder. NO EXPRESSED WARRANTIES AND NO IMPLIED WARRANTIES AS TO THE MERCHANTABILITY, FITNESS FOR ANY PARTICULAR PURPOSE OR USE OR OTHERWISE, OF THE LICENSED PRODUCTS OTHER THAN THOSE WHICH MAY BE EXPRESSLY SET FORTH IN THIS AGREEMENT SHALL APPLY. THE PARTIES HEREBY DISCLAIM, AND HEREBY WAIVE, ALL OTHER WARRANTIES, GUARANTEES, CONDITIONS AND LIABILITIES, EXPRESSED OR IMPLIED, ARISING BY LAW OR OTHERWISE.
		

		
			 
		

		
			XIX. INSURANCE & LOSS 
		

		
			 
		

		
			19.1    Licensee shall maintain, at its sole expense, and shall ensure that any and all of its Sublicensee(s) maintain, at their sole expense, the following insurance coverage, with a financially sound insurance company having an [****], throughout the term of this Agreement [****]: (i) [****].
		

		
			 
		

		
			19.2    Licensee shall, within [****] after execution of this Agreement, deliver to Licensor a certificate of such insurance from the insurance carriers, describing the scope of coverage and the limits of liability required by this Section 19 and providing that the policy may not be canceled or amended without [****] prior written notice to Licensor.
		

		
			 
		

		
			19.3    Licensor shall maintain, at its sole expense, the following insurance coverage, with a financially sound insurance company having [****], throughout the Contract Term [****]: [****].
		

		
			
		

		
			

		 

		

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			19.4    Licensor shall, within [****] after execution of this Agreement, deliver to Licensee a certificate of such insurance from the insurance carriers, describing the scope of coverage and the limits of liability required by this Section 19 and providing that the policy may not be canceled or amended without at least [****] prior written notice to Licensee.
		

		
			 
		

		
			XX. NO JOINT VENTURE
		

		
			 
		

		
			This Agreement does not create an agency, partnership, franchise, or joint venture. Nothing herein contained shall be so construed as constituting either party an agent of or authorizing either party to incur financial or any other obligations on the other party’s behalf without authorization in writing.  Nothing herein shall impose any fiduciary duties on either party with respect to the other party hereto.  In all respect the relationship of the parties is that of independent contractors.    
		

		
			 
		

		
			 
		

		
			
		

		
			

		 

		

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			XXI. FORCE MAJEURE
		

		
			 
		

		
			Neither party shall be liable to the other for any loss, injury, delay or damage whatsoever suffered or incurred by the other party due to causes beyond such party’s control and which are not reasonably avoidable, including but not limited to, acts of God, strikes or other labor disturbances, actions of third parties, war, act of terror, sabotage, animal disease, regulatory changes or regulatory prohibitions, and any other cause or causes, whether similar or dissimilar to those herein specified, which cannot be controlled or avoided by such party. 
		

		
			 
		

		
			XXII. CHOICE OF LAW & FORUM
		

		
			 
		

		
			22.1    This Agreement has been negotiated, prepared, executed and delivered in several jurisdictions, including the State of New York, United States of America. Accordingly, in order to establish with certainty that this Agreement will be governed by one body of well-developed commercial law, the parties hereto have expressly agreed that this Agreement shall be governed by, and construed in accordance with, the laws of the State of New York, applicable to contracts executed and fully to be performed therein, to the exclusion of any other applicable body of governing law including, without limitation, the United Nations Convention on Contracts for the International Sale of Goods.
		

		
			 
		

		
			22.2    The parties hereby consent to the jurisdiction of the United States District Court for the Southern District of New York in any dispute arising under this Agreement and agree further that service of process or notice in any such action, suit or proceeding will be effective if in writing and issued as provided in Article XIII of this Agreement.
		

		
			 
		

		
			XXIII.  WAIVER
		

		
			 
		

		
			The failure of either party at any time or times to demand strict performance by the other of any of the terms, covenants or conditions set forth herein shall not be construed as a continuing waiver or relinquishment of said rights or of any other right hereunder, and each party may at any time demand strict and complete performance by the other of any of the terms, covenants or conditions set forth herein. 
		

		
			 
		

		
			XXIV. VALIDITY
		

		
			 
		

		
			In the event that any one or more provisions or terms contained in this Agreement are found invalid or unenforceable, the validity or enforceability of this Agreement as a whole or of any remaining provisions or terms contained herein shall not in any way be affected or impaired. If any clause, term, or provision of this Agreement should be found by any court or other finder of fact or of law to be legally unenforceable, or unreasonable with respect to scope, territory, duration, or otherwise, each party hereby requests and authorizes any such court or other finder of fact or of law to reform and redraft any such provision in a manner most closely approximating the original intent of the parties, so as to render such provision legally enforceable.
		

		
			 
		

		
			
		

		
			

		 

		

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			XXV. ENTIRE AGREEMENT
		

		
			 
		

		
			25.1    This Agreement, along with the other Transaction Documents, is the entire agreement between the parties hereto with respect to the subject matter hereof. This Agreement and the License granted herein shall be binding upon and inure to the benefit of the parties and their respective successors, permitted assignees, heirs, executors and personal representatives.
		

		
			 
		

		
			25.2    The making, execution, and delivery of this Agreement has not been induced by any representations, statements or warranties, other than those expressly set forth herein. All the terms of this Agreement are herein set forth and neither this Agreement or any part hereof may be waived, modified, supplemented, or otherwise altered, unless by a writing signed by an officer of each party.
		

		
			 
		

		
			XXVI. RESERVATION OF RIGHTS
		

		
			 
		

		
			Any right not specifically granted herein to Licensee is expressly reserved by Licensor.  For the avoidance of doubt, and without limiting anything to the contrary set forth in this Agreement, this Agreement imposes no restrictions whatsoever of any kind on the Licensor or Licensee outside the Territory, and outside the Field except as expressly set forth herein in connection with a Competing Event.
		

		
			 
		

		
			XXVII. SURVIVAL
		

		
			 
		

		
			The obligations contained in I, X, XI, XIII, XIV, XVII, XVIII, XIX, XXII, XXV, XXVII, XXIX, XXX, XXXI, and XXXVI herein shall survive any termination of this Agreement. 
		

		
			 
		

		
			XXVIII. NONCIRCUMVENTION
		

		
			 
		

		
			28.1    Licensee shall engage in no activity which is designed or intended to result in the evasion or circumvention of any of Licensor’s rights arising pursuant to this Agreement.  This prohibition includes, without limitation, the use of any one or more Sublicensee(s) to reduce the amount of any Royalty that would otherwise be paid to Licensor in the absence of any applicable sublicense(s), and any scheme or artifice designed to result in any delay, deferment, or reduction of the amounts actually received by Licensee upon any sale or transfer of the Licensed Product.
		

		
			 
		

		
			28.2    Licensor shall engage in no activity which is designed, intended to, or which would result in the evasion or circumvention of any of the prohibitions imposed on Licensor pursuant to this Agreement.  This prohibition includes, without limitation, the use of any one or more Affiliate(s) to engage in any commercial or competitive activity which the Licensor is prohibited from engaging in pursuant to the terms of this Agreement.
		

		
			 
		

		
			XXIX. INTERPRETATION
		

		
			 
		

		
			The headings of the sections of this Agreement are for convenience only and in no way limit or affect the terms or conditions of this Agreement. As used in this Agreement, any reference to gender shall include all genders and any reference to the plural shall include the singular, and the 
		

		
			
		

		
			

		 

		

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			singular shall include the plural. The word “or” is not exclusive. When a reference is made in this Agreement to a section, such reference shall be to a section of this Agreement, unless otherwise clearly indicated to the contrary.  Whenever the words “include,” “includes” or “including” are used in this Agreement they shall be deemed to be followed by the words “without limitation.”  The words “hereof,” “herein” and “herewith” and words of similar import shall, unless otherwise stated, be construed to refer to in this Agreement as a whole and not to any particular provision of this Agreement, and annex, article, section, paragraph, exhibit, annex and schedule references are references to the annex, articles, sections, paragraphs, exhibits, annexes, and schedules of this Agreement, unless otherwise specified.  
		

		
			 
		

		
			XXX. LIMITATION OF LIABILITY
		

		
			 
		

		
			IT IS THE EXPRESS INTENT OF THE PARTIES THAT Neither Party will be liable to the other Party WHETHER in contract, in tort OR OTHERWISE for incidental or consequential damages or lost profitS, LOST INCOME, OR LOST REVENUE, HOWSOEVER ARISING, UNDER ANY THEORY, WHETHER IN LAW, EQUITY, OR CONTRACT, FOR ANY CLAIM OR CAUSE OF ACTION BROUGHT UNDER THIS CONTRACT, OR OTHERWISE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.  THE PARTIES HEREBY AGREE TO DO ANY AND ALL THINGS AND EXECUTE ANY AND ALL DOCUMENTS NECESSARY TO EFFECUATE THE INTENT AND PURPOSES OF THIS PROVISION.  
		

		
			 
		

		
			XXXI. NO THIRD-PARTY BENEFICIARIES; PARTIES IN INTEREST
		

		
			 
		

		
			No provision of this Agreement will in any way inure to the benefit of any third person so as to constitute any such person a third-party beneficiary of this Agreement or otherwise give rise to any cause of action in any person not a party hereto.  The provisions of this Agreement shall inure solely to the benefit of the named undersigned parties hereto, and shall be binding in their successors, heirs, and assigns.  
		

		
			 
		

		
			XXXII. ADVERTISING; PUBLICITY
		

		
			 
		

		
			Each party hereby agrees it will not use the name, insignia, symbol, logo or other identifying information of the other party hereto orally, writing or in electronic format in any advertising, press release, promotional materials or otherwise without the prior written consent of the other party. Neither party shall make any press release or make any public statement pertaining to the subject matter of this Agreement (but not, for the avoidance of doubt, unless reference is made to the other party or the terms of this Agreement, with respect to activities in exercise of its rights under this Agreement) without the prior written consent of the other party, which approval will not be unreasonably withheld or delayed, except solely to the minimum extent required by the applicable law, regulations or rules governing any applicable public securities exchange or automated quotation system (including a public offering prospectus), disclosures of information for which consent has previously been obtained, and information of a similar nature to that which has been previously disclosed publicly with respect to this Agreement, each of which will not require advance approval, but will be provided to the other party as soon as practicable after the release or communication thereof. For the avoidance of doubt, the parties may issue press releases regarding 
		

		
			
		

		
			

		 

		

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			the fact that this Agreement has been signed and the nature of the agreement so long as they do not describe the specific provisions hereof without approval from the other party
		

		
			 
		

		
			XXXIII. [****]
		

		
			 
		

		
			[****].
		

		
			 
		

		
			XXXIV. [****] TRANSFER
		

		
			 
		

		
			Immediately following the Effective Date, Licensor shall take all steps necessary to assign to Licensee, Licensor/s rights and obligations (with respect to the period following the assignment) the [****]. Until assignment of the aforesaid agreement to Licensee, to the maximum extent permitted by applicable law, during the Contract Term of the License Agreement, at Licensee’s request, Licensor shall transfer, at Licensor’s cost, [****] to Licensee, and to the extent necessary grant and/or assign Licensee with a license to [****]. Licensee will reasonably cooperate with Licensee’s efforts to obtain and/or maintain a [****] to permit Licensee to competitively [****].
		

		
			 
		

		
			XXXV. COUNTERPARTS
		

		
			 
		

		
			This Agreement may be executed in any number of counterparts, each of which will be an original, but all of which together will constitute one instrument.
		

		
			 
		

		
			XXXVI. FURTHER ASSURANCES
		

		
			 
		

		
			Each party will use its commercially reasonable efforts to take, or cause to be taken, all actions and to do, or cause to be done, all things necessary to consummate the transactions contemplated by this Agreement and the Transaction Documents and cure all defects in the drafting hereof and thereof.  
		

		
			 
		

		
			 
		

		
			
		

		
			

		 

		

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			IN WITNESS WHEREOF, the parties hereto have caused this License Agreement to be executed as of the Effective Date. 
		

		
			 
		

			
					
						LICENSOR

					
					
						 

					
					
						LICENSEE

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						ENTERA HEALTH, INC.

					
					
						 

					
					
						REDHILL BIOPHARMA, INC.

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						By:

					
					
						/s/ [****]

					
					
						 

					
					
						By:

					
					
						/s/ Dror Ben-Asher; /s/ Micha Ben Chorin

				
	
					
						Date:

					
					
						4/11/17

					
					
						 

					
					
						Name:

					
					
						Dror Ben-Asher; Micha Ben Chorin

				
	
					
						Title:

					
					
						[****]

					
					
						 

					
					
						Title:

					
					
						CEO; CFO

				

		
			 
		

		
			
		

		
			

		 

		

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			Exhibit A
		

		
			[****]
		

		
			 
		

		
			 
		

			
					
						 

					
					
						 

				
	
					
						 

					
						 

					
						[****]

					
					
						 

					
						 

					
						[****]

				
	
					
						 

					
						 

					
						[****]

					
					
						 

					
						 

					
						[****]

				
	
					
						 

					
						 

					
						[****]

					
					
						 

					
						 

					
						[****]

				
	
					
						 

					
						 

					
						[****]

					
					
						 

					
						 

					
						[****]

				
	
					
						 

					
						 

					
						[****]

					
					
						 

					
						 

					
						[****]

				
	
					
						 

					
						 

					
						[****]

					
					
						 

					
						 

					
						[****]

				
	
					
						 

					
						 

					
						[****]

					
					
						 

					
						 

					
						[****]

				

		
			 
		

		
			
		

		
			

		 

		

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			Exhibit B
		

		
			Authorized Licensed Products and [****]
		

		
			 
		

			
	
			
				·
			

			
	
			
			   [****]

		
			 
		

		
			
		

		
			

		 

		

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			Exhibit C
		

		
			Contract Term
		

		
			 
		

		
			The initial Contract Term shall be four (4) years from the Effective Date, and shall expire on the [****] of the Effective Date, unless renewed by action of the parties as set forth herein.
		

		
			 
		

		
			At least [****] days, but no more than [****], before the expiration of the Contract Term, Licensee may request renewal of this Agreement for [****] period, and such renewal may be granted by Licensor in its sole discretion. Licensor shall notify Licensee [****] from the receipt of the request for renewal of its decision to renew or not renew this Agreement. 
		

		
			 
		

		
			If the parties do not mutually agree to renew this Agreement, this Agreement shall expire [****] unless earlier terminated in accordance with this Agreement.  
		

		
			 
		

		
			 
		

		
			
		

		
			

		 

		

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			Exhibit D
		

		
			Royalty Rate
		

		
			 
		

		
			In consideration of the License of the EnteraGam Marks, and the EnteraGam URL and all other rights granted hereunder, Licensee (including any and all Affiliate(s)) shall pay to Licensor the following [****] (and any and all Affiliate(s)) during [****] during the Contract Term as follows: 
		

		
			 
		

		
			[****]  
		

		
			 
		

		
			The royalties that will be payable in connection with any sublicense of the License will be determined with the mutual agreement of the parties at the time that the Licensor grants consent to such sublicense.  
		

		
			 
		

		
			
		

		
			

		 

		

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			Exhibit E
		

		
			Regulatory Compliance Obligations
		

		
			 
		

		
			At all times and with respect to all matters pertaining to this Agreement and the other Transaction Documents and the transactions contemplated hereunder and thereunder, each party and any and all of its Affiliate(s), and third-party vendor(s) and supplier(s) shall comply with: 
		

		
			 
		

		
			(a)  Any and all applicable local, state, national, and international laws, regulations, requirements, and rules, including, without limitation, all applicable anti-trust, anti-bribery, anti-fraud and abuse, anti-kickback, anti-retaliation, unfair and deceptive trade practices, books-and-record, securities, tax, and import/export laws and regulations, and the listing requirements of any applicable securities exchanges.
		

		
			 
		

		
			(b)  Without limiting the generality of the foregoing, in carrying out its responsibilities under this Agreement, each party shall comply with all applicable anti-bribery laws, including, without limitation, the U.S. Foreign Corrupt Practices Act of 1977, as amended, and the UK Bribery Act. 
		

		
			 
		

		
			(c)  Without limiting the generality of the foregoing, each party represents to the other party that, in carrying out its responsibilities under this Agreement, neither the representing party nor any of its officers, directors, employees, agents or other representatives will pay, offer or promise to pay, or authorize the payment of, any money, or give or promise to give, or authorize the giving of, any services or anything else of value, either directly or through a third party, to any official or employee of any governmental authority or instrumentality, or of a public international organization, or of any agency or subdivision thereof, or to any political party or official thereof or to any candidate for political office corruptly for the purpose of: (i) influencing any act or decision of that person in his official capacity, including a decision to fail to perform his/her official functions with such governmental agency or instrumentality or such public international organization or such political party; (ii) inducing such person to use his/her influence with such governmental agency or instrumentality or such public international organization or such political party to affect or influence any act or decision thereof; or (iii) securing any improper advantage.  
		

		
			 
		

		
			(d)  No Person herein named shall, will, or may discriminate against any employee or applicant for employment because of age, race, color, creed, national origin or sex, and all Persons herein named shall comply with all applicable federal, state and local fair employment practices laws, including, without limitation, all provisions of Executive Order 11246 of September 24, 1965, the Rehabilitation Act of 1973, and the Vietnam Era Veterans Readjustment Assistance Act of 1974 and any amendments thereto. 
		

		
			 
		

		
			(e)  Each party shall ensure that all activities undertaken by all Persons herein named complies with, and that all actions to be performed by such party and any and all Persons acting on its behalf in connection with the transactions contemplated herein 
		

		
			
		

		
			

		 

		

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			shall in all respects comply with, the Federal False Claims Act, Federal Anti-Kickback Laws, the Federal Stark I-III Laws, and Section 1128G of the Social Security Act (which was added by Section 6002 of the Affordable Care Act).  
		

		
			 
		

		
			Without limiting the foregoing, each party shall immediately notify the other party upon learning that any of the foregoing covenants are breached by either such party or any of their Affiliate(s), third-party vendor(s) or supplier(s), and if any of the representations and warranties set forth in this Agreement shall at any time cease to be true and correct with respect to any of them.
		

		
			 
		

		
			 
		

		
			
		

		
			

		 

		

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			Exhibit F
		

		
			Initial JCC Members
		

		
			 
		

		
			 
		

			
	
			
				·
			

			
	
			
			   [****]

		
			 
		

		
			
		

		
			

		 

		

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			Exhibit G
		

		
			Studies and Publications
		

		
			 
		

		
			[****]
		

		
			 
		

		
			 
		

		
			 
		

		 

		

			43rdhl_Ex4_20

		
			Exhibit 4.20
		

		
			Confidential
		

		
			THE SYMBOL "[****]" DENOTES PLACES WHERE PORTIONS OF THIS DOCUMENT HAVE BEEN OMIITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. SUCH MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
		

		
			EXCLUSIVE COMMERCIALIZATION AGREEMENT
		

		
			THIS EXCLUSIVE COMMERCIALIZATION AGREEMENT is made and entered into as of August 16, 2017 (the “Effective Date”), by and between ParaPRO LLC, an Indiana company, having a place of business at 11550 North Meridian Street, Suite 290, Carmel, Indiana 46032, USA and all Affiliates thereof (“ParaPRO”) and RedHill Biopharma, Inc. a Delaware corporation, having an address at 8045 Arco Corporate Drive, Suite 120, Raleigh, North Carolina 27617 and all Affiliates thereof (“RedHill”).  RedHill and ParaPRO each may be referred to herein individually as a “Party,” or collectively as the “Parties”.
		

		
			WHEREAS,  ParaPRO owns, develops, markets and manufactures Esomeprazole Strontium delayed release capsules (49.3mg) and wishes to appoint RedHill, and RedHill wishes to accept such appointment, as the exclusive Promoter of the Product for the Field of Use in the Territory (as those terms are defined below);
		

		
			NOW THEREFORE, THE PARTIES HERETO AGREE AS FOLLOWS:
		

		
			1.         DEFINITIONS
		

		
			For purposes of this Agreement, the following terms shall have the following meanings:
		

		
			1.1       “Act” means the Federal Food, Drug and Cosmetic Act, as amended from time to time, and the rules, regulations, guidelines and requirements of the FDA as may be in effect from time to time.
		

		
			1.2       “Affiliate” of a person means any other person that, directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with such first person.  For purposes of this definition only, “control” and, with correlative meanings, the terms “controlled by” and “under common control with” will mean the possession, directly or indirectly, of the power to direct the management or policies of an entity, whether through the ownership of fifty percent or more of the voting securities or other ownership interest of a business entity (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity) of the other organization or entity or by contract relating to voting rights or corporate governance, or otherwise.
		

		
			1.3       “Applicable Laws” means all federal, state and local laws, and the rules, regulations, guidance, guidelines and requirements of governmental authorities  in effect from time to time, including those relating to the manufacture, marketing, promotion, distribution (including storage, handling and transportation) and sale of the Product in the
		

		
			 
		

		
			 
		

		
			

		 

 

		

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			Territory including the Act, the FDA Guidance for Industry – Supported Scientific and Educational Activities, “fraud and abuse”, anti-kickback, consumer protection and false claims statutes and regulations.
		

		
			1.4       “Bankruptcy Event” means a company: (i) becomes insolvent or admits its inability to pay its debts generally as they become due; (ii) becomes subject, voluntarily or involuntarily, to any proceeding under any domestic or foreign bankruptcy or insolvency law, which is not fully stayed within [****] days or is not dismissed or vacated within [****] days after filing; (iii) is dissolved or liquidated or takes any corporate action for such purpose; (iv) makes a general assignment for the benefit of creditors; or has a receiver, trustee, custodian or similar agent appointed by order of any court of competent jurisdiction to take charge of or sell any material portion of its property or business.
		

		
			1.5       “Business Day” means a day that is not a Saturday or Sunday or any other day on which banks in New York, NY and/or Israel are authorized or required by law to be closed.
		

		
			1.6       “Calendar Year” means each one-year period beginning January 1st and ending on December 31st.
		

		
			1.7       “Calendar Quarter” means each period of three consecutive months starting on January 1st, April 1st, July 1st or October 1st.
		

		
			1.8       “Commercialization Fee” has the meaning set forth in Section 9.1 of this Agreement.
		

		
			1.9       “Commercialization Plan” means the Commercialization Plan annexed hereto as  Annex A, as may be amended from time to time by the Parties which shall include the geographical territories [****] and other plans relating to commercialization of the Products as the JCC deems appropriate.
		

		
			1.10     “Detail” means any in-person sales presentation of the Product to physicians in a manner that is customary in the industry for promoting a prescription pharmaceutical product. When used as a verb, “Detail” shall mean to engage in a Detail, also known as “Detailing”.
		

		
			1.11     “FDA” means the United States Department of Health Food and Drug Administration.
		

		
			1.12     “Field of Use” means all labeled indications for the Product.
		

		
			1.13     “Generic Equivalent” means receipt by a third-party of an approval for marketing by the FDA pursuant to an abbreviated new drug application of a generic delayed-release esomeprazole strontium drug product in a strength of 49.3 milligrams referencing as bio-equivalent the Product as approved pursuant to New Drug Application 20-2342 (i.e. such drug product is approved as an “AB” therapeutic equivalent to the Product in the Approved Drug Products with Therapeutic Equivalence Evaluations published by the FDC Center for Drug Evaluation and Research)
		

		
			1.14     “JCC” shall have the meaning set forth in Section 5.1.
		

		
			
		

		
			

		 

		

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			1.15     “PIRs” means, collectively, Product Labels and Inserts and Promotional Materials.
		

		
			1.16     “Product” means Esomeprazole Strontium delayed release capsules in all formulations and strengths, and/or any other additional product(s) determined by the Parties to be subject to this Agreement following the Effective Date. Any reference to “Product” shall mean and be deemed to refer to each Product subject to this Agreement at any time.
		

		
			1.17     “Product Copyright” shall mean all copyrightable subject matter included in the PIRs and the Product training programs and materials developed and produced in accordance with this Agreement, whether or not such copyright has been registered and whether or not such materials have been published.
		

		
			1.18     “Product Label and Insert” means (a) all labels and other written, printed or graphic matter affixed to any container, packaging or wrapper utilized with the Product or (b) any written material physically accompanying the Product, including Product package inserts.
		

		
			1.19     “Product Trademarks” means (a) any Trademarks relating to the Product and the registrations thereof, (b) any pending or future Trademark registration applications relating to the Product, (c) any unregistered Trademark rights relating to the Product as may exist through use prior to or as of the date hereof, (d) any current or future modifications or variants of any of the foregoing Trademarks, and (e) any future Trademarks adopted by ParaPRO for use in connection with the Product, in each case excluding the ParaPRO Trademark and trade name.
		

		
			1.20     “Promotion” and “Promotional Activities” means those activities customary in the industry by a pharmaceutical company’s sales force to implement marketing plans and strategies aimed at encouraging the use of a prescription pharmaceutical product, including Detailing. When used as a verb, “Promote” or “Promoting” means engagement in such activities. When used as a noun, “Promoter” means a person or entity engaged in such activities.
		

		
			1.21     “Promotional Materials” has the meaning set forth in Section 3.4.
		

		
			1.22     “Regulatory Approval” means the obtaining of all necessary regulatory approvals (including the obtainment of pricing and reimbursement approval) required from all applicable Regulatory Authorities in the Territory in order to commercially sell or market the Product for human consumption in such Territory, and satisfaction of any related applicable regulatory registration and notification requirements (if any).
		

		
			1.23     “Regulatory Authority” means any applicable governmental authority regulating or otherwise exercising authority with respect to the manufacture, development and commercialization of the Product in the Territory.
		

		
			1.24     “Sample” means a standard sample unit of Product consistent with industry practices, subject to the provisions of Section 3.7.
		

		
			
		

		
			

		 

		

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			1.25     “Specialty” means gastroenterologists.
		

		
			1.26     “Tax” means, except as otherwise addressed herein, all federal, state, local, foreign and other income, gross receipts, sales, use, value added, production ad valorem, transfer, franchise, registration, profits, license, lease, service, service use, withholding, payroll, employment, unemployment, estimated, excise, severance, environmental, stamp, occupation, premium, property (real or personal), real property gains, or windfall profits, together with any interest, additions or penalties with respect thereto and any interest in respect of such interest, additions or penalties determined or assessed by a governmental authority.
		

		
			1.27     “Term” shall be as defined in Section 18.1.
		

		
			1.28     “Territory” shall mean the [****] geographical territories within the United States and a designated exclusive physician call plan for physicians in the Specialty, as well as additional geographical territories and [****] mutually agreed by the Parties as set out in the Commercialization Plan. RedHill shall, subject to the terms of this Agreement, implement its rights and obligations with respect to the geographical territories [****], provided it commences implementation with respect to [****] following the Effective Date.
		

		
			1.29     On ParaPRO’s written request given not more than [****], RedHill shall provide, a report detailing the [****]. Without derogating from the foregoing, the Parties may mutually agree to expand the Territory to other territories and/or to expand the reach to [****], as shall mutually be determined in the Commercialization Plan and/or through the JCC. Final approval for expansion will be provided by both Parties.
		

		
			1.30     “Third Party(ies)” means any party other than ParaPRO, RedHill and their respective Affiliates.
		

		
			1.31     “Trademarks” means any trademark, servicemark, trade dress, brand mark, certification marks, internet domain names, trade name, brand name, corporate name, logo, business symbol, and other indicia of source, whether or not registered, and all registrations and applications therefor including all extensions, modifications, divisions and renewals of the foregoing.
		

		
			1.32     “[****]” means a [****]. For the avoidance of doubt, each [****], will be considered a “[****]” for the purpose of this Agreement. [****].
		

		
			1.33     [****](collectively, the  "Data Source").
		

		
			1.34     Interpretation. As used in this Agreement, any reference to gender shall include all genders and any reference to the plural shall include the singular, and the singular shall include the plural. When a reference is made in this Agreement to a section, such reference shall be to a section of this Agreement, unless otherwise clearly indicated to the contrary.  Whenever the words “include,” “includes” or “including” are used in this Agreement they shall be deemed to be followed by the words “without limitation.”  The words “hereof,” “herein” and “herewith” and words of similar import shall, unless otherwise stated, be
		

		
			
		

		
			

		 

		

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			construed to refer to in this Agreement as a whole and not to any particular provision of this Agreement, and annex, article, section, paragraph, exhibit, annex and schedule references are references to the annex, articles, sections, paragraphs, exhibits, annexes, and schedules of this Agreement, unless otherwise specified.  The captions contained in this Agreement are for convenience only and shall not be deemed a part hereof or affect the interpretation or construction of any provision hereof.
		

		
			2.         APPOINTMENT AND GRANT OF RIGHTS
		

		
			2.1       Appointment; Grant of Rights.  ParaPRO hereby appoints RedHill, together with its Affiliates, and grants to RedHill and its Affiliates, the exclusive (including as to ParaPRO) right and license to Promote and commercialize the Product to physicians in the Specialty in the Territory and the non-exclusive right and license to promote and market the Product in the Field of Use.
		

		
			2.2       Limitations on Grant of Other Rights. ParaPRO shall not, and shall not permit or authorize any Third Party to market, commercialize or otherwise Promote the Product (and/or Esomeprazole Strontium delayed release capsules in any other dosage) in the Specialty in the Territory. ParaPRO shall have the right to Promote and otherwise market the Product within the Specialty and outside the Territory (i.e., in geographic territories [****] not included in the Territory) or outside the Specialty. Furthermore, throughout the Term, ParaPRO will continue to supply Product to [****] and other customers in the ordinary course of business according to orders received.
		

		
			2.3       Continued Development; Regulatory Authorities. ParaPRO shall (i) use commercially reasonable efforts to continue development of the Product and (ii) contact and communicate with applicable Regulatory Authorities regarding the Product (including market authorization). All regulatory matters regarding the Product, that relates to the commercialization of the Product during the term of this Agreement, as well as all filings in connection therewith, shall be the obligation and responsibility solely of ParaPRO, subject to the participation by RedHill as requested by the JCC and RedHill’s right to contact and communicate directly with Regulatory Authorities with respect to matters relating to RedHill and its performance under this Agreement. Each Party shall promptly provide the other Party with copies or a description of all communications received from any Regulatory Authority concerning the Product and shall promptly submit to the other Party copies of all communications and filings concerning the Product made to any Regulatory Authority during the Term. Without derogating from the foregoing, ParaPRO shall keep RedHill informed of the regulatory status of the Product and all developments related thereto, by periodic written reports as well as additional reports provided promptly following any material changes in regulatory status and material occurrences regarding development of the Product and shall authorize RedHill to access all regulatory data/correspondence relevant to the Product.
		

		
			
		

		
			

		 

		

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			3          COMMERCIALIZATION PLAN; PROMOTIONAL ACTIVITIES
		

		
			3.1       Commercialization Plan. The Parties have developed the initial commercialization plan annexed hereto as Annex A (the “Commercialization Plan”). For the avoidance of doubt, RedHill’s undertakings in relation to the number of territories and related promotion activities pursuant to the Commercialization Plan are subject to availability of, among other things, [****], as provided herein, as well as availability of [****] and adequate [****]  to support such activities.
		

		
			3.2       Promotional Activities. During the Term, RedHill shall be responsible for the Promotion and commercialization of the Product for the Field of Use in the Specialty in the Territory and RedHill shall utilize its commercially reasonable efforts to aggressively market the Product [****]. In the event [****], the Parties, through the JCC,  will discuss such situation to arrive at a mutually agreeable course of action. RedHill shall deploy sales professionals in the Territory in accordance with the Commercialization Plan and shall be responsible for all Promotional activities in relation to its own sales professionals. RedHill shall not be prohibited from undertaking Promotional Activities with respect to the Product that are in excess of those for which RedHill is responsible under the then current Commercialization Plan, provided that such excess Promotional Activities are not inconsistent with the Commercialization Plan and are in compliance with Applicable Laws. In implementing the Commercialization Plan, Promoting the Product in the Territory and otherwise exercising its rights and fulfilling its obligations under this Agreement, RedHill shall have full discretion with respect to [****] (including with respect to [****]). RedHill may engage Third Parties for the performance of all or any of RedHill's obligations hereunder provided that RedHill shall provide ParaPRO with at least [****] prior notice thereof and RedHill shall remain liable to ParaPRO for performance of its obligations hereunder. RedHill may provide RedHill’s sales representatives with sales bonuses as incentives for meeting performance goals, all as determined by RedHill in its sole discretion.
		

		
			3.3       Generic Equivalent. Notwithstanding anything in this Agreement to the contrary, in the event of the sale into the Territory of a Generic Equivalent for the Product, RedHill shall may, in its sole discretion, limit or discontinue all or any part of its ongoing Promotional activities.
		

		
			3.4       Promotional Materials. ParaPRO shall, at its own expense, provide RedHill in a timely manner with the necessary promotional materials and quantities thereof as outlined in the Commercialization Plan that may include: [****] (“Promotional Materials”) that are consistent with the then current Commercialization Plan and that are consistent with any such materials provided to ParaPRO sales personnel. ParaPRO shall own all rights, including copyrights in such Promotional Materials. ParaPRO shall ensure that all Promotional Materials are in strict compliance with all Applicable Laws. The Parties may mutually agree on the transfer to RedHill of responsibilities related to Promotional Materials.
		

		
			
		

		
			

		 

		

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			3.5       Statements. Each Party shall make, and shall permit its representatives to make, only such statements and claims regarding the Product, including as to efficacy and safety, as are consistent with the PIRs. Without limitation to the foregoing, each Party shall not, and shall not permit its representatives, to make any untrue or misleading statements or comments about the Product, and/or take any action that jeopardizes or could reasonably be expected to jeopardize the goodwill or reputation of the other Party or its products, including the Product.
		

		
			3.6       Training. ParaPRO shall train RedHill’s sales managers and trainers to assist RedHill in the fulfillment of its obligations under this Agreement. Such training provided by ParaPRO shall comply with all Applicable Laws. In connection therewith, ParaPRO shall provide such trainers and lecturers as RedHill may deem reasonably necessary. RedHill shall have the right to review and comment on training materials from medical, legal and regulatory perspectives. ParaPRO shall, in addition to the aforementioned training of RedHill’s sales managers and trainers, designate and make available during regular business hours at least [****] to respond to inquiries from RedHill's sales managers and trainers. ParaPRO shall provide RedHill with such training materials as is reasonably required to adequately train RedHill’s sales managers and trainers to Promote the Product and in such quantities as RedHill shall reasonably require and request.All RedHill employees engaged in the promotion of the Product within the Territory will be trained to meet competency standards relating to their knowledge of the Product and all promotional materials and receive reasonable additional training from ParaPRO to maintain said competence to Promote the Product.
		

		
			3.7       Samples. ParaPRO shall make available to RedHill any sampling program it utilizes in the Promotion of the Product.  Initially, such sampling program is anticipated to provide a [****] of the Product to [****]. If any alterations to the sampling program are enacted, RedHill will be consulted and must approve alterations that impact the Specialty in the Territory.
		

		
			3.8       Savings Clause. Neither Party shall be required to perform any obligation under this Agreement or the Commercialization Plan, or use any Promotional Materials or otherwise engage in any promotional activity, to the extent that such Party believes, in its reasonable judgment and in good faith, that such obligation, use of Promotional Materials or other promotional activity: (i) violates any Applicable Law; (ii) violates a written corporate policy of such Party; or (iii) would have a material adverse effect on the business, assets, properties, liabilities (actual or contingent), operations, condition (financial or otherwise) or prospects, of such Party. Each Party shall promptly notify the other Party if and when it formulates such a belief and the Parties shall discuss, in good faith, how best to alter the relevant obligation, Promotional Material or other promotional activity so that it does not have the effect described in item (i), (ii) or (iii) above.
		

		
			
		

		
			

		 

		

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			4.         Trademark License.
		

		
			4.1       ParaPRO hereby grants RedHill the [****] to use any Product Trademarks and Product Copyrights in the Territory in connection with the Promotion of the Product, subject to the provisions of this Agreement.  RedHill may include its name on Promotional Materials in coordination with ParaPRO.
		

		
			4.2       Whenever RedHill uses any Product Trademarks in promotion or in any other manner in connection with the Product, RedHill shall provide ParaPRO adequate time to review and approve promotional materials, subject to relevant laws and regulations, and to ensure that they clearly indicate ParaPRO's ownership of such Product Trademarks and future Product Trademarks. When using any Product Trademarks under this Agreement, RedHill undertakes to comply with all laws and regulations pertaining to trademarks in force at any time in the Territory. RedHill shall not at any time do, cause to be done, or permit any act or thing inconsistent with, contesting or in any way impairing such ownership. RedHill acknowledges and agrees that ParaPRO or its Affiliates, as the case may be, are the owners of all rights, title and interest in and to any Product Trademarks and the goodwill now and hereafter associated therewith and RedHill agrees that all use of any Product Trademarks shall inure to the benefit of and be on behalf of ParaPRO. RedHill acknowledges that nothing in this Agreement shall give RedHill any right, title or interest in or to any Product Trademarks other than the right to use such Product Trademarks in accordance with Section 4.1 hereof.
		

		
			4.3       RedHill (upon written request of ParaPRO) shall assist ParaPRO in safeguarding its full rights, title and interest in and to any Product Trademarks, Product Copyrights and all other intellectual property relating to the Product.
		

		
			4.4       RedHill shall not undertake any action to register or renew any of the Product Trademarks (or any Trademark similar thereto).
		

		
			5.         JOINT COMMERCIALIZATION COMMITTEE
		

		
			5.1       Within [****] following the Effective Date, the Parties shall establish a joint commercialization committee (“JCC”), with up to [****] members being appointed by ParaPRO, of which one shall be designated the “ParaPRO Project Leader”, and up to [****] members being appointed by RedHill, of which one shall be designated the “RedHill Project Leader”. All such representatives shall be individuals of suitable authority and seniority with significant and relevant experience and expertise. Each Party may remove any member appointed by it for any reason or no reason and appoint another member in his or her stead. Any appointment or removal shall be notified to the other Party in writing.
		

		
			5.2       The JCC shall be responsible for ensuring full cooperation between the Parties in implementing this Agreement and for monitoring compliance with the Agreement and the Commercialization Plan. The JCC shall discuss, inter alia, marketing, promotion and sales strategy for the Promotion of the Product in the Territory.
		

		
			
		

		
			

		 

		

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			5.3       The ParaPRO Project Leader and the RedHill Project Leader shall facilitate the flow of information and otherwise promote communications and collaboration within and among the Parties, the JCC, and any other sub-committees or teams that the JCC may appoint or constitute.
		

		
			5.4       The JCC shall hold meetings at such times and places as agreed between the members of the JCC, but in no event less frequently than following every Calendar Quarter to examine the number of [****] and the Commercialization Fee payable. The JCC may conduct meetings in person or by teleconference or videoconference or other means. Meetings shall be chaired alternatively by the ParaPRO Project Leader and the RedHill Project Leader. Each Party shall only be responsible for its own costs related to the JCC and meetings. The Project Leader conducting the meeting also will be responsible for taking and distributing the minutes.  At and between meetings of the JCC, each Party shall keep the other fully and regularly informed as to its progress with its respective tasks and obligations under the Agreement and shall make themselves available to the other members of the JCC for communication purposes.
		

		
			5.5       At each JCC meeting, at least [****] appointed by RedHill and [****] appointed by ParaPRO present in person, by teleconference or videoconference or by other means shall constitute a quorum. Each Party shall have equal voting power, whether represented by [****] committee members, on all matters before the JCC and, unless specifically determined otherwise, ParaPRO will have the final tie breaking vote on all topics and activities under its responsibility and RedHill will have a final tie breaking vote on all topics and activities under its responsibility.
		

		
			5.6       By mutual consent of the members appointed by both Parties, such consent not to be unreasonably withheld, conditioned or delayed, either Party may invite other, non-voting, persons to attend appropriate meetings of the JCC.
		

		
			5.7       The JCC may act without a meeting if prior to such action the JCC members agree regarding such action and a written consent thereto is signed by both Project Leaders.
		

		
			5.8       The JCC may amend or expand upon the foregoing procedures for its internal operations by unanimous written consent.
		

		
			5.9       The JCC shall not have any power to amend this Agreement or bind or incur liability on behalf of either Party hereto without such Party’s express prior written authorization, and shall have only such powers as are specifically delegated to them hereunder.
		

		
			5.10     Notwithstanding the regular meeting schedule of the JCC, a meeting of the JCC may be called by either Party on [****] written notice to the other, unless such notice is waived by the other Party. In the event of any meeting called pursuant to a notice under this Section 5.10, the Party calling the meeting shall provide with the notice an agenda for the meeting together with the information that such Party believes is relevant for the items to be discussed. Neither Party shall call more than [****] additional meetings per Calendar Year for the JCC under this Section 5.10 without the other Party’s consent.
		

		
			
		

		
			

		 

		

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			5.11     The JCC shall, among its other authorities, have the authority to establish and appoint sub-committees, as the JCC deems necessary. All decisions of a subcommittee are subject to approval by the JCC. The JCC may prescribe rules of procedure for the foregoing subcommittees. In the event that any such other subcommittees fail to reach agreement on an issue within its respective area of oversight, the matter shall be referred to the JCC.
		

		
			5.12     Unless otherwise expressly stated, nothing contained in this Agreement may be deemed to make any member of the JCC a partner, agent or legal representative of the other, or to create any fiduciary relationship for any purpose whatsoever. No member of the JCC shall have any authority to act for, or to assume any obligation or responsibility on behalf of, any other member of the JCC, or the other Party.
		

		
			6.         SALE, MANUFACTURE AND SUPPLY OF PRODUCT
		

		
			6.1       During the Term, ParaPRO shall continue to be responsible to take all actions in relation to the commercialization of the Product in the Territory (other than Promotion of the Product which is RedHill’s responsibility pursuant to this Agreement), including:
		

		
			6.1.1    [****].
		

		
			6.1.2    [****].
		

		
			6.1.3    [****].
		

		
			6.1.4    [****].
		

		
			6.2       All sales of the Product in the Territory shall be invoiced by [****].
		

		
			6.3       All terms of sale, including policies concerning pricing, credit terms, cash discounts and returns and allowances, shall be set by [****] consistent with its normal internal selling and past practices [****]. Without derogating from the foregoing, [****] ParaPRO shall inform RedHill of  [****] at approximately the same time.
		

		
			6.4       [****] shall not accept any customer orders for the Product. All customer orders for the Product shall be received and executed by [****] or its designee. If [****] receives any orders, it shall promptly refer such to [****].
		

		
			6.5       [****] shall supply the Product during the Term in sufficient quantities to timely satisfy orders for the Product in the Territory. [****] shall maintain reasonable inventory levels of the Product in order to ensure its ability to fulfill its obligations hereunder. All orders for Product shall be subject to acceptance by [****], which acceptance shall not be unreasonably withheld.
		

		
			6.6       In the event that [****] fails to supply the Product through the wholesaler channel and available for retail ordering, as required pursuant to this Agreement for any reason or no reason, which failure results in lost sales in the Territory, the Parties shall meet and attempt to negotiate a mutually agreeable and commercially reasonable solution. If the Parties cannot reach such an agreement within a reasonable period, the matter shall, at the request of either Party, be referred to a designated senior executive of each Party for
		

		
			
		

		
			

		 

		

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			resolution. In the event that such senior executives are unable to reach agreement within [****] of the date of referral, the matter shall be resolved, at the request of either Party, by a third party acceptable to both Parties or some other mechanism agreed by both Parties.
		

		
			6.7       [****] shall have the sole responsibility and right to accept any returned Product in accordance with [****] returns policy. [****] shall not solicit the return of any Product and shall not receive or accept any returned Product. In the event that any such Product is inadvertently returned to [****], [****] shall promptly ship such Product to [****], along with any documentation or explanation [****] receives regarding the reason for the return, at [****] cost and expense.
		

		
			6.8       ParaPRO shall be responsible for all aspects of managed care in connection with the Product, including [****]. ParaPRO shall communicate with RedHill sales management on a Calendar Quarterly basis regarding such managed care activities.
		

		
			6.9       For the avoidance of doubt, ParaPRO shall be responsible for all costs and expenses of its performance under this Agreement.  For the avoidance of doubt, RedHill shall be responsible for all costs and expenses of its performance under this Agreement.
		

		
			6.10     If there is a change in market conditions, which materially affects the economics of this Agreement, the Parties will discuss modifications to this Agreement in good faith to address such changed market conditions. For the avoidance of doubt, the discussions will not be held in the framework of the JCC and neither Party is required to agree to any modifications to the terms of this Agreement.
		

		
			7.         INFORMATION; REPORTING; RECALLS
		

		
			7.1       Information.  Each Party shall promptly notify the other Party of receipt of information from a Regulatory Authority that: (i) raises any material concern regarding the safety or efficacy of the Product, or would affect the Product Label and Insert, Promotion and/or sale of the Product; (ii) indicates a potential material liability for either Party relating to the Product; (iii) is reasonably likely to lead to a recall or market withdrawal of the Product; or (iv) is reasonably likely to impact the manner in which a Party satisfies its obligations hereunder.
		

		
			7.2       Adverse Experience Reporting. RedHill shall give ParaPRO notice of any Product complaint it receives, including but not limited to any adverse drug experience (as defined in 21 CFR 314.80 or any successor provision thereto) of which RedHill obtains information in accordance with the following procedure:
		

		
			7.2.1    Information concerning any adverse drug experience associated with the Product shall be reported to ParaPRO’s designated medical liaison within [****] Business Days after initial receipt of such information by calling the Adverse Event number (855-628-7622) or completing the MKT-010-FRM1-003 form;
		

		
			7.2.2    RedHill's report to ParaPRO shall contain: (i) the date the report was received by RedHill; (ii) the name of the reporter; (iii) the address and telephone number
		

		
			
		

		
			

		 

		

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			of the reporter; (iv) occupation; (v) patient information including identifier, age or date of birth at the time of event, sex and weight; (vi) product information and (vii) an indication of the adverse drug experience; and
		

		
			7.2.3    All other Product complaints not covered by 7.2.1 above shall be reported to ParaPRO by calling the Product complaint number (855-628-7622) within [****] Business Days after initial receipt of such complaint.
		

		
			7.3       ParaPRO shall be responsible for all activities relating to medical surveillance within the Territory, including [****]. Without derogating from the foregoing, ParaPRO shall investigate all adverse drug experiences and non-clinical complaints associated with the Product, including those reported to ParaPRO by RedHill, and, as appropriate, report such information to the FDA. In addition, ParaPRO shall provide RedHill with a summary of all adverse drug experiences and clinical complaints received by ParaPRO, during each Calendar Quarter and all material comments of the FDA with respect thereto within [****] days after the end of such Calendar Quarter; provided, however, that ParaPRO shall provide RedHill prompt written notice of any adverse side effect experienced in response to the use of the Product.
		

		
			7.4       Product Recall and Withdrawal. ParaPRO shall have the sole responsibility with respect to any recall or withdrawal of the Product, and shall bear all costs and expenses relating thereto, except to the extent such recall or withdrawal is as a result of a breach by RedHill of the terms of this Agreement, or the gross negligence, willful misconduct, bad faith or fraud of RedHill. At ParaPRO’s request, where the Product has been recalled or withdrawn from the market, RedHill shall, as soon as reasonably practical and in accordance with Applicable Law, assist ParaPRO in obtaining the return of any Product not in the direct possession or control of ParaPRO by notifying physicians who have received Samples from RedHill and by returning to ParaPRO Samples still in the possession of RedHill, and ParaPRO shall reimburse RedHill for all costs and expenses incurred in taking such actions.
		

		
			7.5       Product Medical Inquiries.  ParaPRO shall have the exclusive right and obligation, consistent with Applicable Law, to respond to all questions or requests for information about the Product made by any medical professionals or any other person to RedHill's representatives that warrant a response beyond the information included in the PIRs (all such questions or requests being referred to as “Product Medical Inquiries”). RedHill shall direct its representatives to direct all Product Medical Inquiries to ParaPRO’s Medical Call Center (855-628-7622) or provide ParaPRO’s Medical Information request form KA-001-FRM1-006 to be completed and emailed to parapro@medcomsol.com or Faxed to (510) 595-8183.
		

		
			7.6       Third Party Actions and Communications. ParaPRO shall be solely responsible for: (i) taking all actions and conducting all communication with all Third Parties in respect of the Product (other than Promotional Activities performed by RedHill in accordance with the terms hereof), including responding to all [****]. Moreover, ParaPRO shall timely, and in good faith, [****].
		

		
			
		

		
			

		 

		

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			8.         REPORTS
		

		
			8.1       Reports.  On a [****] basis, within [****] days following the publishing of  data by the Data Source for the end of each of [****], ParaPRO shall deliver to RedHill a report in the English language with respect to the relevant Calendar Month (each, a “Monthly Report”) showing: [****].
		

		
			8.2       Additional Information. In addition, to allow RedHill to execute and monitor its Promotional activities, ParaPRO shall, at its expense, provide RedHill, on the earlier of [****], depending on availability of information, access to its Data Source information. RedHill will allow ParaPRO access to its [****] (if from another source/tool) to validate accurate data is in use. The Parties acknowledge that at the Effective Date both Parties are using [****]. In addition, ParaPRO shall provide RedHill with [****] in a timely manner. Should any discrepancies of data arise, the JCC will look to provide a remedy. All final payments related to Product [****] will be governed based on ParaPRO’s Data Source data reports.
		

		
			8.3       Final Report and Payment. Upon termination of this Agreement for any reason, ParaPRO shall deliver a final report, in the English language and the associated Commercialization Fee payment to RedHill within [****] days after the end of the then current Calendar Month.
		

		
			9.         FINANCIAL PROVISIONS
		

		
			9.1       Commercialization Fee Payments.  In respect of each Calendar Month, or part thereof, during the Term, ParaPRO shall pay RedHill an amount equal to [****] less any [****] for (ii) (a) [****] (or similar program implemented by the JCC), if RedHill participates in such Sampling Program, attributable to [****] in the Field of Use in the Specialty in the Territory and (b) any [****] costs, such costs including but not limited to [****] in the Field of Use in the Specialty in the Territory (the “Commercialization Fee”). ParaPRO will make all reasonable efforts to allocate costs to RedHill only for those [****] subject to [****] in the Field of Use in the Specialty in the Territory. Furthermore, allocation of costs between the Parties pursuant to (a) and (b) above, if any, will be mutually and openly discussed in good faith between the Parties. To the extent any measuring period is less than a [****], the Commercialization Fee shall be based on the number of [****] during the Calendar Month in question. Notwithstanding the foregoing, in the event that the net selling price of the Product shall increase by [****] on the Effective Date, [****] shall be [****] by [****] of any such increase above [****].
		

		
			9.2       The Parties acknowledge that ParaPRO anticipates that RedHill will participate in the [****] Program for a minimum of [****] to establish the Product in the Territory in the Field, provided that RedHill is not obligated to participate in such program.  RedHill shall have the right to provide input on the business terms of the Sampling Program.
		

		
			9.3       ParaPRO represents that it is currently not a party to any [****] or other [****] with third-party [****] to maintain the Product on the [****] and it has no plans to pursue
		

		
			
		

		
			

		 

		

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			any such agreement. Prior to entering into a [****], ParaPRO will seek input from RedHill’s [****] to negotiate the most effective agreement.
		

		
			9.4       Monthly Reports and Payments. All payments due pursuant to the provisions of this Section 9 shall be due and payable to RedHill on [****] following the date for submission of the relevant Monthly Report, all against the receipt of an appropriate invoice from RedHill for same. If ParaPRO fails to provide the respective Monthly Report in a timely fashion as set forth in Section 9.1, RedHill shall be entitled to invoice its best estimate of the amount due not to exceed the amount of the preceding Monthly period with payment of such invoice to serve as a down payment being subject to the specific calculation under the Monthly Report yet to be provided by ParaPRO. ParaPRO shall make any additional payments (if any) in accordance with the Monthly Report, following its submission.  RedHill shall promptly reimburse ParaPRO for any down payment made by ParaPRO in excess of the actual amount owing.
		

		
			9.5       Payment Method.  Any amounts due to RedHill under this Agreement will be paid in US Dollars, by wire transfer in immediately available funds to an account designated in writing in an appropriate invoice at least [****] in advance by RedHill, as the case may be.
		

		
			9.6       Currency; Foreign Payments.  If any currency conversion will be required in connection with the calculation of any payment hereunder, such conversion will be made by using the average exchange rate for the purchase of the relevant currency as published in The Wall Street Journal, Eastern Edition, on the date of the payment.
		

		
			9.7       Taxes.  All payments shall be net of all Taxes other than taxes imposed on or measured by net income of RedHill or similar governmental charge imposed by any jurisdiction.
		

		
			9.8       Exclusivity. During the term of this Agreement, without prior consent from ParaPRO which shall not be unreasonably withheld, delayed or conditioned, RedHill will exclusively promote the Product and will [****].  In addition, for a period of [****] following [****] for any reason [****], without prior consent from ParaPRO which shall not be unreasonably withheld, delayed or conditioned, RedHill will not engage in [****].
		

		
			10.       RECORDS RETENTION AND AUDIT
		

		
			10.1     Record Retention.  Throughout the Term and for a term of [****], ParaPRO will maintain (and will ensure that its Affiliates maintain) complete and accurate books, records and accounts that fairly reflect sales of the Product in the Territory, in sufficient detail to confirm the accuracy of Monthly Reports and Commercialization Fee payments made hereunder, which books, records and accounts will be retained for [****] the end of the period to which such books, records and accounts pertain.
		

		
			10.2     Audit.  RedHill will have the right, for a period of [****] following the expiration or termination of this Agreement for any reason to have an independent certified public accounting firm of nationally recognized standing, reasonably acceptable to ParaPRO and who agrees to be bound by a customary undertaking of confidentiality, have access during
		

		
			
		

		
			

		 

		

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			ParaPRO's normal business hours, and upon reasonable prior written notice, to ParaPRO’s records as may be reasonably necessary to verify the accuracy of ParaPRO's Monthly Reports in respect of any period; provided, however, that except as set forth in Section 10.3, RedHill will not have the right to conduct more than [****] in any Calendar Year.  The accounting firm shall not in any way be compensated (in whole or in part) contingent on the outcome of the audit.  Any such audit shall be completed within a reasonable time.  The costs of the audit are the responsibility of RedHill provided that in the event that there is a shortfall of more than [****] in the payment due, the audit costs and all related travel costs will be covered by ParaPRO within [****] of billing.  In the event there is a shortfall of more than [****], RedHill shall be permitted, at its sole discretion and with due notice to ParaPRO, to conduct a subsequent audit in the same Calendar Year.
		

		
			10.3     Payment of Additional Amounts.  If the audit report shows that additional payments are owed by ParaPRO under this Agreement, ParaPRO shall make such additional payments plus interest at the rate prescribed in Section 10.4 hereof within [****] following RedHill's demand. RedHill shall have the right to conduct additional follow-up audits in the same Calendar Year to ensure that there are no further shortfalls.
		

		
			10.4     Interest. All late payments under this Agreement shall bear interest from the date due until paid at a rate equal to [****] as of the date that such payment was due, or, if lower, the highest rate permitted under Applicable Law, calculated on the number of days such payment is delinquent.
		

		
			10.5     Confidentiality.  RedHill will treat all information subject to review under this Section 10 in accordance with the confidentiality provisions of Section 14 below.
		

		
			11.       REPRESENTATIONS AND WARRANTIES
		

		
			11.1     By the Parties.  Each Party hereby represents, warrants and covenants to the other Parties as of the Effective Date as follows:
		

		
			11.1.1  Such Party (a) has the power and authority and the legal right to enter into this Agreement and perform its obligations hereunder, and (b) has taken all necessary action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder. This Agreement has been duly executed and delivered on behalf of such Party and constitutes a legal, valid and binding obligation of such Party and is enforceable against it in accordance with its terms subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights and judicial principles affecting the availability of specific performance and general principles of equity, whether enforceability is considered a proceeding at law or equity.
		

		
			11.1.2  Such Party has obtained all necessary consents, approvals and authorizations of all Regulatory Authorities and other authorities and parties required to be obtained by such Party in connection with the execution and delivery of this Agreement and the performance of its obligations hereunder.
		

		
			
		

		
			

		 

		

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			11.1.3  The execution and delivery of this Agreement and the performance of such Party’s obligations hereunder (a) do not conflict with or violate any requirement of Applicable Law or any provision of the articles of incorporation, bylaws or any similar instrument of such Party, as applicable, in any material way and (b) do not conflict with, violate, or breach or constitute a default or require any consent not already obtained under, any contractual obligation or court or administrative order by which such Party is bound.
		

		
			11.2     By ParaPRO.  ParaPRO hereby further represents, warrants, and covenants to RedHill as follows:
		

		
			11.2.1  It has the sole legal and/or beneficial title to and ownership of the Product, all as is necessary to fulfill its obligations under this Agreement and to grant all rights granted to RedHill pursuant to this Agreement. ParaPRO is not aware of any FDA communication or action suggesting its ability to market or sell the Product in the Territory can or will be diminished or compromised or eliminated.
		

		
			11.2.2  It has not and during the Term shall not grant any rights to Third Parties in the Field of Use in the Specialty in the Territory (and those geographic territories occupied by RedHill or stated in the Commercialization Plan as being assigned to RedHill) that conflict with the rights granted to RedHill hereunder.
		

		
			11.2.3  The manufacture, use and sale of the Product by ParaPRO, and the exercise by RedHill of its rights granted under this Agreement, do not, and during the Term, will not infringe or otherwise violate any patent, trademark, copyright, trade secret or other intellectual property right of a Third Party.
		

		
			11.2.4  It has and shall maintain throughout the Term, all Regulatory Approvals necessary for the performance of its obligations hereunder.
		

		
			11.2.5  Product: (i) shall be manufactured in conformance with all applicable federal, state and local statutes, ordinances and regulations, (including the Act), as the same may be amended from time to time; (ii) at the time of shipment by ParaPRO shall not be adulterated or misbranded within the meaning of the Act; and (iii) at the time of shipment by ParaPRO shall not be a product which would violate any section of the Act if introduced into interstate commerce.
		

		
			11.2.6  It has not received any written notice from any Third Party asserting or alleging that any research or development of the Product prior to the Effective Date infringed or misappropriated the intellectual property rights of such Third Party.
		

		
			11.2.7  There are no pending, and to ParaPRO’s knowledge, no threatened, adverse actions, suits or proceedings against ParaPRO or its Affiliates involving the Product.
		

		
			11.2.8  The Product Trademarks have been properly filed and registered with the U.S. Patent and Trademark Office and are valid and in full force and effect, and ParaPRO has the right to use and license the Product Trademarks, free and clear of any liens or encumbrances.
		

		
			
		

		
			

		 

		

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			11.2.9  To ParaPRO’s knowledge, there are no pending legal suits or proceedings involving the Product; and to there are no threatened legal suits or proceedings in the Territory involving the Product.
		

		
			11.2.10 There are no current pending, or to ParaPRO’s knowledge, threatened in writing, product liability, warranty or other similar claims by any Third Party (whether based in contract or tort and whether relating to personal injury, including death, property damage or economic loss) arising from the marketing or sale of the Product.
		

		
			11.2.11 It will not act in a manner that is intended to and has the effect of materially and detrimentally affecting the operations, prospects, or reputation of RedHill.
		

		
			11.3     By RedHill.  RedHill hereby further represents, warrants, and covenants to ParaPRO that:
		

		
			11.3.1  RedHill will conduct any activities under this Agreement in compliance with all federal, state and local statutes, ordinances and regulations (including the Act), as the same may be amended from time to time. Additionally, RedHill will comply with any law, regulations, rules or requirements of the Laws of Israel that may impact the performance of RedHill under this Agreement.
		

		
			11.3.2  RedHill and any RedHill personnel have not been, and will not knowingly use in any capacity in the performance of this Agreement, the services of any person or entity, currently or ever debarred under 21 U.S.C. § 335a or convicted of a felony for conduct relating to the regulation or handling of any drug product. RedHill shall insure adequate staffing and training of all personnel assigned to the territories, including continuing training and instruction or certification with regard to ParaPRO products.
		

		
			11.3.3  It shall notify ParaPRO promptly if, during the term of this Agreement, it becomes aware that RedHill or any RedHill personnel comes under investigation by the FDA for debarment or disqualification or is debarred or disqualified.
		

		
			11.3.4  It will not act in a manner that is intended to and has the effect of materially and detrimentally affecting the operations, prospects, or reputation of ParaPRO.
		

		
			11.3.5  RedHill shall, in good faith, assure compliance with any applicable statutory or regulatory requirements of a foreign entity to do business in the United States, including payment of all taxes, license fees and other requirements that may be levied on a foreign based entity doing business in the United States or through a subsidiary.
		

		
			11.4     Except as otherwise expressly set forth in this Agreement, neither Party MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
		

		
			
		

		
			

		 

		

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			12.       LIMITATION OF LIABILITY
		

		
			EXCEPT IN THE CASE OF A FRAUD OR WILLFUL MISREPRESENTATION, BREACH OF APPLICABLE LAWS, BREACH OF CONFIDENTIALITY, INTELLECTUAL PROPERTY INFRINGEMENT, PRODUCT LIABILITY, RECALL, CONTAMINATION OR EXTORTION AS WELL AS ANY CRIMINAL, CIVIL OR ADMINISTRATIVE PROCEEDING INVOLVING THE PRODUCT, NEITHER PARTY SHALL BE LIABLE TO THE OTHER OR ANY OF ITS AFFILIATES FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES (INCLUDING LOST PROFITS, BUSINESS OR GOODWILL) SUFFERED OR INCURRED BY SUCH OTHER PARTY OR ITS AFFILIATES, WHETHER BASED UPON A CLAIM OR ACTION OF CONTRACT, WARRANTY, NEGLIGENCE OR TORT, OR OTHERWISE, ARISING OUT OF THIS AGREEMENT.
		

		
			13.       Intellectual Property- Enforcement
		

		
			13.1     Infringement Notice.  If either Party determines that a Third Party is wrongfully marketing, Promoting or selling the Product or infringing any intellectual property of ParaPRO or its Affiliates or licensors relating to the Product, including actual, potential or suspected wrongful marketing, Promoting or selling the Product or infringement, and that such activities could affect the exercise of the rights granted under this Agreement by the other Party, it will notify the other Party in writing without undue delay.
		

		
			13.2     Enforcement. ParaPRO will have the sole, exclusive and first right, but not the obligation, to remove such wrongful marketing, Promotion, selling, infringement and/or misappropriation and to control all litigation to remove such wrongful marketing, Promotion, selling, infringement and/or misappropriation, all as it shall deem appropriate in its sole discretion, and to settle or compromise any such possible infringement by taking such action as ParaPRO or its Affiliates may determine in their sole and absolute discretion; provided, however, that ParaPRO shall not settle any such potential infringement in a manner that materially adversely affects the rights granted to RedHill hereunder, except with RedHill's prior written consent (which consent shall not be unreasonably withheld). ParaPRO shall be solely responsible for all costs and expenses of such litigation. In the event ParaPRO does take any action to remove such wrongful marketing, Promotion, selling, infringement or misappropriation activity, ParaPRO will keep RedHill informed of the progress of such action and consider any comments made by RedHill. Furthermore, RedHill shall have the right to participate in (but not control) such proceedings with counsel of its choice at its own cost and expense. If ParaPRO decides not to take any action to remove such wrongful marketing, Promotion, selling, infringement or misappropriation activity, it shall notify RedHill in writing and RedHill shall be entitled to do so at its own cost and expense upon giving written notice to ParaPRO within [****] of the date of ParaPRO's notice. In the event RedHill does, at its discretion, undertake any action to remove such wrongful marketing, Promotion, selling, infringement or misappropriation activity, RedHill will provide ParaPRO with copies of all relevant documentation so that
		

		
			
		

		
			

		 

		

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			ParaPRO will be informed of the continuing action and may comment upon such documentation sufficiently in advance of any initial deadline for filing a response, provided, however, that if ParaPRO has not commented upon such documentation in a reasonable time for RedHill to sufficiently consider ParaPRO’s comments prior to a deadline, or RedHill must act to preserve the action, RedHill will be free to act without consideration of ParaPRO’s comments, if any.
		

		
			13.3     Co-operation. The Parties will provide reasonable assistance to each other (at no charge or expense, other than with respect to reasonable out-of-pocket expenses), including providing access to relevant documents and other evidence, making its employees available at reasonable business hours, and joining the action to the extent necessary to allow the prosecuting Party to maintain the action.
		

		
			13.4     Recovery.  Any amounts recovered in connection with or as a result of any action contemplated by Section 13.2, whether by settlement or judgment, will be used to reimburse the Parties for their reasonable documented costs and expenses in such action (which amounts will be allocated pro rata in accordance with the respective costs and expenses if insufficient to cover the totality of such expenses), and any remainder will be the property of [****].
		

		
			13.5     Infringement of Third Party Rights.  In the event that either Party is sued by a Third Party alleging that the Promotion, manufacture, marketing, use or offer to sell of the Product in the Territory infringes upon any intellectual property rights of such Third Party, the Party being so sued shall immediately give the other Party notice of same and the Parties shall thereafter proceed as provided in Section 16.
		

		
			14.       CONFIDENTIALITY
		

		
			14.1     Disclosure and Use Restriction.  The Parties agree that, during the Term and thereafter, each Party will keep completely confidential and will not publish, submit for publication or otherwise disclose, and will not use for any purpose except for the purposes contemplated by this Agreement, any Confidential Information (as such term is defined below) received from the other Party. This Article 14 replaces and supersedes the Confidentiality Agreement entered into by the Parties dated July 7, 2017.
		

		
			14.2     Confidential Information.  “Confidential Information” shall mean all information and know-how and any tangible embodiments thereof provided by or on behalf of one Party to another Party either in connection with the discussions and negotiations pertaining to this Agreement or in the course of performing this Agreement, which may include data; knowledge; practices; processes; ideas; research plans; engineering designs and drawings; research data; manufacturing processes and techniques; scientific, manufacturing, marketing and business plans; and financial and personnel matters relating to the disclosing Party or to its present or future products, sales, suppliers, customers, employees, investors or business. Notwithstanding the foregoing, information or know-how of a Party shall not be deemed Confidential Information of such Party for purposes of this Agreement if such information or know-how:
		

		
			
		

		
			

		 

		

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			(i)        was already known to the receiving Party, other than under an obligation of confidentiality or non-use, at the time of disclosure to such receiving Party;
		

		
			(i)        was generally available or known to parties reasonably skilled in the field to which such information or know-how pertains, or was otherwise part of the public domain, at the time of its disclosure to such receiving Party;
		

		
			(ii)       became generally available or known to parties reasonably skilled in the field to which such information or know-how pertains, or otherwise became part of the public domain, after its disclosure to such receiving Party through no breach of this Agreement by the receiving Party;
		

		
			(iii)      was disclosed to such receiving Party, other than under an obligation of confidentiality or non-use, by a Third Party who had no obligation not to disclose such information or know-how to others; or
		

		
			(iv)      was independently discovered or developed by such receiving Party, as evidenced by their written records, without the use of Confidential Information belonging to the disclosing Party and prior to any subsequent disclosure by the receiving Party.
		

		
			14.3     Authorized Disclosure. Notwithstanding the provisions of Section 14.1 above, a Party shall be entitled to disclose the Confidential Information of another Party hereto to the extent that such disclosure is:
		

		
			(i)        made in response to a valid order of a court of competent jurisdiction; provided,  however, that such Party will first (to the extent practicably possible and permitted by such order) have given notice to such other Party and given such other Party a reasonable opportunity to quash such order, at such Party’s sole cost and expense, and to obtain a protective order, at such Party’s sole cost and expense, requiring that the Confidential Information and documents that are the subject of such order be held in confidence by such court or agency or, if disclosed, be used only for the purposes for which the order was issued; and provided further that if a disclosure order is not quashed or a protective order is not obtained, the Confidential Information disclosed in response to such court or governmental order will be limited to that information which is legally required to be disclosed in response to such court or governmental order;
		

		
			(ii)       otherwise required by Applicable Law or the rules of a stock exchange; provided, however, that the receiving Party will provide the disclosing Party with notice of such disclosure in advance thereof to the extent practicably possible, and to the extent permitted seeks confidential treatment of the information disclosed and reasonably cooperates with any efforts of disclosing Party to seek confidential treatment of the information disclosed and discloses only that portion of the Confidential Information required;
		

		
			
		

		
			

		 

		

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			(iii)      made by such Party to a Regulatory Authority as necessary for the development or commercialization of a medicinal product, including the Product, in a country, as required in connection with any filing, application or request for Regulatory Approval or as required by applicable securities laws and regulations, subject to the limitations in Section 14.3(ii);
		

		
			(iv)       made by such Party, in connection with the performance of this Agreement and on a need to know basis only in connection therewith, to Affiliates, directors, officers, employees, consultants, representatives or agents, each of whom prior to disclosure must be bound by obligations of confidentiality and non-use at least equivalent in scope to those set forth in this Agreement; or
		

		
			(v)        made by such Party in the course of submitting financial accounts to relevant authorities as per local statutory requirements or to existing or potential acquirers; existing or potential collaborators; investment bankers; existing or potential investors, merger candidates, venture capital or private equity firms or other financial institutions or investors for purposes of obtaining financing; or, bona fide strategic potential partners; each of whom prior to disclosure must be bound by obligations of confidentiality and non-use at least equivalent in scope to those set forth in this Agreement.
		

		
			15.       PRESS RELEASES
		

		
			Press releases or other similar public communication by any Party during the Term and until [****] following the expiration or termination of this Agreement for any reason relating to the terms of this Agreement (but not, for the avoidance of doubt, unless reference is made to any of the other Parties or the terms of this Agreement, with respect to activities in exercise of its rights under this Agreement) will be shared in advance with the other Party, and subject to such other Party’s approval which approval will not be unreasonably withheld, conditioned or delayed, except for those communications required by Applicable Law, regulation or securities exchange rules, disclosures of information for which consent has previously been obtained, and information of a similar nature to that which has been previously disclosed publicly with respect to this Agreement, each of which will not require advance approval but will be provided to the other Party as soon as practicable after the release or communication thereof.  For the avoidance of doubt, the Parties may issue press releases regarding the fact that this Agreement has been signed and the nature of the agreement so long as they do not describe the specific economic provisions hereof without approval from the other Party, unless required under Applicable Law, regulation or securities exchange rules, as aforesaid.
		

		
			16.       INDEMNIFICATION
		

		
			16.1     Indemnification ParaPRO. ParaPRO will defend and hold RedHill, its respective Affiliates, and their respective directors, officers, employees and agents (“RedHill’s Indemnified Persons”) harmless, from and against any and all liability, damages, suits,
		

		
			
		

		
			

		 

		

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			investigations, claims, demands, actions, judgments, costs and expenses (including reasonable and documented attorneys’ fees and expenses) (“Losses”)  to which the RedHill Indemnified Persons may become subject arising from any Third Party claim, demand, suit, action or proceeding to the extent arising out of or in connection with this Agreement or otherwise in connection with any actions taken by RedHill hereunder; except that ParaPRO shall not be required to indemnify RedHill to the extent any Loss arises from or occurs as a result of the: (i) relevant  negligence, willful misconduct, bad faith or fraud on the part of a  RedHill Indemnified Person; or (ii) breach by a RedHill Indemnified Person of any relevant representations, warranties or covenants set forth in this Agreement. Without derogating from the foregoing, ParaPRO shall be responsible for all the costs, fees, expenses and control in connection with any litigation instituted by a Third Party relating to a claim or claims of infringement of intellectual property against either of the Parties, relating to or arising from the manufacturing, marketing, use, sale or offer to sell of the Product in the Territory and shall indemnify RedHill and its Indemnified Persons in respect of all Losses in connection therewith, subject to the foregoing clauses (i) and (ii).
		

		
			16.2     Indemnification RedHill. RedHill will defend and hold ParaPRO, its respective Affiliates, and their respective directors, officers, employees and agents (“ParaPRO’s Indemnified Persons”, and, together with “RedHill Indemnified Persons”,  “Indemnified Persons” ) harmless, from and against any and all Losses to which the ParaPRO Indemnified Persons may become subject arising from any third party claim, demand, suit, action or proceeding to the extent arising out of or in connection with this Agreement or otherwise in connection with any actions taken by ParaPRO hereunder to the extent arising from or occurring as a result of or in connection with: (a) the negligence, willful misconduct, fraud or bad faith on the part of RedHill in performing any activity contemplated by this Agreement; and/or (b) any breach by a ParaPRO Indemnified Person of any representations, warranties, or covenants set forth in this Agreement.
		

		
			16.3     Conditions to Indemnity.  Each Party’s agreement to indemnify and hold the other harmless is conditioned upon the Indemnified Person: (i) providing written notice to the indemnifying Party of any claim, demand or action arising out of the indemnified activities within [****] after the Indemnified Person has knowledge of such claim, demand or action; (ii) permitting the indemnifying Party to assume full responsibility to investigate, prepare for and defend against any such claim or demand; and (iii) assisting the indemnifying Party, at the indemnifying Party’s reasonable expense, in the investigation of, preparation of and defense of any such claim or demand. The indemnifying Party shall not compromise or settle such claim or demand without the indemnified Party’s prior written consent, unless such settlement includes as an unconditional term thereof the giving by the claimant or plaintiff to such indemnified Party a complete release from all liability in respect of such claim or litigation.  If the Party entitled to indemnification fails to notify the indemnifying Party without undue delay pursuant to the foregoing clause (i), the indemnifying Party shall only be relieved of its indemnification obligation to the extent it is materially prejudiced by such failure and provided further that the indemnified Party is not obligated to notify the indemnifying Party of claims, demands and/or actions made directly against the
		

		
			
		

		
			

		 

		

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			indemnifying Party only. Notwithstanding the foregoing, if in the reasonable judgment of the indemnified Party, such suit or claim involves an issue or matter which could have a materially adverse effect on the business, operations or assets of the indemnified Party, the indemnified Party may waive its rights to indemnity under this Agreement and control the defense or settlement thereof, but in no event shall any such waiver be construed as a waiver of any indemnification rights such indemnified party may have at law or in equity.
		

		
			16.4     Participation in Defense. If the indemnifying Party defends the suit or claim, the indemnified Party may participate in (but not control) the defense thereof at its sole cost and expense; provided, however, that the indemnifying Party shall pay the reasonable and documented fees and costs of any separate counsel to the extent such separate representation is due to a conflict of interest between the Parties.
		

		
			16.5     Settlement. No Party shall, without the consent of the other Party, which shall not be unreasonably withheld, conditioned or delayed, enter into any settlement or compromise or consent to any judgment in respect of any claim related to the rights and liabilities under this Agreement, unless such settlement, compromise or consent includes an unconditional release of the other Party from all liability arising out of the claim and does not otherwise limit or impair the other Party’s rights.
		

		
			17.       INSURANCE
		

		
			17.1     Each Party hereto shall maintain, for the Term and thereafter, insurance sufficient to cover its obligations under this Agreement and under law as it customarily maintains for similar activities in the regular course of its business.
		

		
			17.2     Without derogating from the generality of the aforesaid, ParaPRO shall effect and maintain for the duration of this Agreement and thereafter for [****]. RedHill and its respective directors, officers, employees and shareholders shall be added to the policy as additional insured. The policies shall apply retroactively at least as of the Effective Date and will contain [****] reporting period and cross-suits coverage. The products liability policy shall be primary and non-contributory to any insurance effected by RedHill and will contain [****] provision in favor of RedHill. ParaPRO will provide RedHill with a certificate of insurance on the Effective Date and every 12 months thereafter.
		

		
			17.3     Each party waives its rights against the other for all claims to the extent covered by the insurance of each party and each party shall require their insurers to waive subrogation consistent with the above with regard to general third party products and automobile liability insurance policies.
		

		
			18.       TERM AND TERMINATION
		

		
			18.1     Term.  Unless earlier terminated in accordance with the provisions of this Article 18, the term of this Agreement (the “Term”) shall be for the period of four (4) years commencing upon the Effective Date, following which the Term shall be renewed for additional [****]
		

		
			
		

		
			

		 

		

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			periods upon mutual agreement between the Parties with such agreement to be reached no later than [****] prior to the expiration of the contract term, or any renewal term, then in effect after which time the Contract shall terminate.
		

		
			18.2     Termination for Cause. Without derogating from any other remedies that either Party may have under the terms of this Agreement or at law, each Party hereto shall have the right upon [****] prior written notice to terminate this Agreement forthwith upon the occurrence of any of the following:
		

		
			18.2.1  the commission of a material breach by any other Party hereto of its obligations hereunder, and such other Party’s failure to remedy such breach to the reasonable satisfaction of the other Party within [****] after being requested in writing to do so;
		

		
			18.2.2  the commission by the other Party of a violation of Applicable Law in connection with such Party’s actions in connection with this Agreement; or
		

		
			18.2.2  the occurrence of a Bankruptcy Event in respect of another Party.
		

		
			18.3     Termination for Convenience.
		

		
			18.3.1  Without derogating from the foregoing, RedHill shall be entitled, to terminate this Agreement in its entirety or [****] by providing [****] prior written notice to ParaPRO.  Upon ParaPRO’s written request, Territories terminated as aforesaid for a period of [****] or longer will be reassigned back to ParaPRO for active promotion by the ParaPRO Sales team unless within [****] following such request RedHill notifies ParaPRO of RedHill’s decision to reinstate such Territory and to continue promotional activities therein. [****].
		

		
			18.3.2  After the initial [****] Term of this Agreement, ParaPRO shall be entitled, in its sole discretion, to terminate this Agreement with respect to [****] at any time by providing [****] days prior written notice to the RedHill.
		

		
			18.3.3  The Party terminating for convenience shall not incur any liability and shall not be required to pay any compensation by reason of exercise of the rights of termination of this Agreement described above; provided, however, that such termination shall not act as a waiver of any breach of this Agreement and shall not act as a release of either Party from any liability for past or future obligations under this Agreement.
		

		
			18.4     Continuation following ParaPRO’s Bankruptcy. The Parties agree that in the event that ParaPRO becomes insolvent or makes a filing under bankruptcy or similar laws in any jurisdiction, RedHill shall have the protection afforded to the licensee under the United States Bankruptcy Code, including but not limited to, the protections set forth in 11 U.S.C §365(n) or its equivalent in any other jurisdiction which allows the licensee, upon rejection of the license agreement by the debtor-licensor or its representative, the option to either retain the licensee’s rights in the intellectual property under the existing contract for the balance of the term thereof while continuing to pay royalties, or to treat the executory contract as terminated.
		

		
			
		

		
			

		 

		

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			18.5     Consequences of Termination
		

		
			18.6.1  License.  Upon termination of this Agreement, all rights granted to RedHill under Section 2 will automatically terminate and all such rights shall automatically revert to ParaPRO.
		

		
			18.6.2  Return of Information and Materials.  Upon termination of this Agreement, each Party will return to the other all Confidential Information of the other Party (except one copy of which may be retained for archival and compliance purposes), provided that any such retained copy shall continue to be subject to the confidentiality provisions of this Agreement.
		

		
			18.6.3  Accrued Rights. Termination or expiration of this Agreement for any reason will be without prejudice to any rights or financial compensation that will have accrued to the benefit of a Party prior to such termination or expiration.  Such termination or expiration will not relieve a Party from obligations that are expressly indicated to survive the termination or expiration of this Agreement, whereas “accrued” shall mean the creation and/or maturity of a claim.
		

		
			18.6.4  Survival. Sections 1, 8.3, 10, 12, 13.5, 14, 15, 16, 17, 18 and 19 of this Agreement will survive expiration or termination of this Agreement for any reason.
		

		
			19.       MISCELLANEOUS
		

		
			19.1     Assignment.  Without the prior written consent of the other Party, neither Party shall sell, transfer, assign, delegate, pledge or otherwise dispose of, whether voluntarily, involuntarily, by operation of law or otherwise, this Agreement or any of its rights or duties hereunder; provided, however, that a Party may assign or transfer this Agreement and its rights or obligations hereunder without the consent of the other Party to any Affiliate and to any Third Party successor in interest with which it has merged or consolidated, or to which it has transferred all or a substantial part of its assets or stock to which this Agreement relates; provided such Third Party assumes and agrees, in advance, to assume the obligations of the transferring party under this Agreement.
		

		
			19.2     Severability.  Should any term or provision of this Agreement be or become invalid or unenforceable or should this Agreement contain an omission, the validity or enforceability of the remaining terms or provisions shall not be affected. In such case, subject to the next following sentence, the Parties shall immediately commence to negotiate in good faith in order to replace the invalid or unenforceable term or provision by such other valid or enforceable term or provision which comes as close as possible to the original intent and effect of the invalid or unenforceable term or provision, or respectively, to fill the omission by inserting such term or provision which the Parties would have reasonably agreed to, if they had considered the omission at the date hereof. In the event that any term or provision as aforesaid is invalid, void or unenforceable by reason of its scope, duration or area of applicability or some similar limitation as aforesaid, then the court making such determination shall have the power to reduce the scope, duration, area or applicability of
		

		
			
		

		
			

		 

		

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			the term or provision so that they shall be enforceable to the maximum scope, duration, area or applicability permitted by Applicable Law which shall not exceed those specified in this Agreement or to replace such term or provision with a term or provision that comes closest to expressing the intention of the invalid or unenforceable term or provision.
		

		
			19.3     Governing Law. This Agreement and all matters arising out of or relating to this Agreement, are governed by, and construed in accordance with, the substantive laws of the State of Delaware, USA, without reference to any rules of conflicts of laws the extent such rules would require or permit the application of the laws of any jurisdiction other than those of the State of Delaware.
		

		
			19.4     Jurisdiction.
		

		
			19.4.1  Subject to Section 6.6, any legal suit, action or proceeding arising out of or related to this Agreement shall be instituted exclusively in the United States District Court for the District of Delaware, and each party irrevocably submits to the exclusive jurisdiction of such court in any such suit, action or proceeding. Service of process, summons, notice or other document by mail to such party’s address set forth herein shall be effective service of process for any suit, action or other proceeding brought in any such court.
		

		
			19.4.2  Each party irrevocably and unconditionally waives any right it may have to a trial by jury in respect of any legal action arising out of or relating to this Agreement or the transactions contemplated hereby.
		

		
			19.4.3  Notwithstanding the foregoing, the Parties agree prior to the filing of any action pursuant to Subsection 1 hereof, to submit, within [****] of notice by one Party to the other of a dispute, to mediation of the dispute in Dover, Delaware with a certified mediator experienced in commercial disputes.  The Parties shall endeavour, in good faith, to reach settlement of the dispute prior to filing any legal proceeding.  If agreement is not reached within [****] of mediation of the dispute, this condition precedent to litigation shall be deemed to be satisfied.  Notwithstanding the foregoing, and anything in this Section 19 to the contrary, either party may bring an action for interim, provisional, injunctive or other equitable relief in connection with any alleged breach of a material nature in the United States District Court for the District of Delaware, however neither party shall have waived its rights to mediation as herein set forth.
		

		
			19.5     Notices.  All notices or other communications that are required or permitted hereunder will be in writing and delivered personally with acknowledgement of receipt, sent by electronic mail (provided receipt is acknowledged), facsimile (and promptly confirmed by personal delivery, registered or certified mail or overnight/express courier as provided herein), sent by nationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:
		

		
			
		

		
			

		 

		

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			If to ParaPRO, to:
		

		
			ParaPRO LLC.
		

		
			11550 North Meridian Street,
		

		
			Suite 290
		

		
			Carmel Indiana 46032 USA
		

		
			Attention: [****]
		

		
			Telephone: [****]
		

		
			Fax: 317-810-0216
		

		
			Email: [****]
		

		
			If to RedHill, to:
		

		
			RedHill Biopharma, Inc.,
		

		
			c/o RedHill Biopharma Ltd.
		

		
			21 Ha'arba'a Street
		

		
			Tel-Aviv 64739
		

		
			Israel
		

		
			Attention: [****]
		

		
			Fax: +972 (3) 541 3144
		

		
			Email:[****]
		

		
			or to such other address as the Party to who notice is to be given may have furnished to the other Party in writing in accordance herewith.  Any such communication will be deemed to have been given: (i) when delivered, if personally delivered; (ii) on the Business Day (on the receiving end) after dispatch, if sent by nationally-recognized overnight/express courier ([****] Business Day if sent internationally); (iii) on the [****] Business Day following the date of mailing, if sent by mail (fifth Business Day if sent internationally); and (iv) on the [****] Business Day (on the receiving end) after being sent by facsimile or electronic mail.  It is understood and agreed that this Section 19.5 is not intended to govern the day-to-day business communications necessary between the Parties in performing their duties, in due course, under the terms of this Agreement.
		

		
			19.6     Entire Agreement; Modifications.  This Agreement sets forth and constitutes the entire agreement and understanding between the Parties with respect to the subject matter hereof and all prior agreements, understanding, promises and representations, whether written or oral, with respect thereto are superseded hereby, including the Term Sheet between the Parties dated August 7, 2017.  Each Party confirms that it is not relying on any representations or warranties of the other Party except as specifically set forth herein. No amendment, modification, release or discharge will be binding upon the Parties unless in writing and duly executed by authorized representatives of both Parties; this shall also apply to any change of this clause.
		

		
			
		

		
			

		 

		

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			19.7     Relationship of the Parties.  It is expressly agreed that the Parties will be independent contractors of one another and that the relationship between the Parties will not constitute a partnership, joint venture or agency.
		

		
			19.8     Waiver.  Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver will be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition.  Any such waiver will not be deemed a waiver of any other right or breach hereunder.
		

		
			19.9     Counterparts. This Agreement may be executed in two (2) or more counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument, and shall become effective when counterparts have been signed by each of the Parties and delivered to the other Parties; it being understood that all Parties need not sign the same counterparts.  The exchange of copies of this Agreement and of signature pages by facsimile transmission, by electronic mail in “portable document format”  (“.pdf”) form, or by any other electronic means intended to preserve the original graphic and pictorial appearance of a document, or by combination of such means, shall constitute effective execution and delivery of this Agreement as to the Parties and may be used in lieu of the original Agreement for all purposes. Signatures of the Parties transmitted by facsimile shall be deemed to be their original signatures for all purposes.
		

		
			19.10   No Third Party Beneficiaries.  The representations, warranties, covenants and agreements set forth in this Agreement are for the sole benefit of the Parties hereto and their successors and permitted assigns, and they will not be construed as conferring any rights on any other parties.
		

		
			19.11   Expenses. Except as expressly provided herein, each party shall each bear its own legal, accounting, brokerage and other costs and expenses in connection with this Agreement and the transactions contemplated hereby.
		

		
			19.12   Further Assurances.  Each Party will duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary to carry out the provisions and purposes of this Agreement.
		

		
			19.13   Force Majeure.  No party shall be responsible to the other for failure or delay in performing any of its obligations under this Agreement or for other non-performance hereof but only to the extent that such delay or non-performance is occasioned by a cause beyond the reasonable control and without fault or negligence of such party, including earthquake, fire, flood, explosion, discontinuity in the supply of power, court order, or governmental interference, act of God, general strike or other general labor trouble, act of war or terrorism and provided that such party will inform the other party as soon as is reasonably practicable and that it will entirely perform its obligations immediately after the relevant cause has ceased its effect.  If any such force majeure event continues for a
		

		
			
		

		
			

		 

		

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			continuous period of three (3) months, a Party whose performance is not prevented by such event may terminate this Agreement thereafter so long as the force majeure event continues, with immediate effect by providing the other Parties with written notice.
		

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

			
					
						RedHill Biopharma, Inc.

					
					
						ParaPRO LLC

				
	
					
						 

					
					
						 

				
	
					
						By: /s/ Dror Ben-Asher

					
					
						By: /s/ : [****]

				
	
					
						Name: Dror Ben-Asher

					
					
						Name: [****]

				
	
					
						Title: CEO

					
					
						Title:  [****]

				
	
					
						By: /s/ Micha Ben Chorin

					
					
						 

				
	
					
						Name: Micha Ben Chorin

					
					
						 

				
	
					
						Title: CFO

					
					
						 

				

		
			
		

		
			

		 

		

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			ANNEX A
		

		
			COMMERCIALIZATION PLAN
		

		
			[****]
		

		 

		

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