Document:

zcor_Ex10_5

		

			Exhibit 10.5

		

		
			MANUFACTURING AND SUPPLY AGREEMENT
		

		
			This MANUFACTURING AND SUPPLY AGREEMENT (this “Agreement”) is entered into and is effective as of this 30 day of July, 2019 (the “Effective Date”), by and between Jubilant HollisterStier LLC (“Supplier”), a Delaware corporation having offices at 3525 North Regal Street, Spokane, WA 99207 and Zyla Life Science US Inc. (“Customer”), a Delaware corporation, having offices at 600 Lee Road, Suite 100, Wayne, PA 19087.  Supplier and Customer may be referred to herein individually as a “Party” and collectively as the “Parties.”
		

		
			BACKGROUND:
		

		
			WHEREAS, Supplier has the manufacturing resources and
		

		
			WHEREAS, Customer wishes Supplier to manufacture and supply to Customer, the pharmaceutical product SPRIX® (ketorolac tromethamine) Nasal Spray (the “Product”) and Supplier desires to manufacture, package and sell such Product to Customer, on the terms and subject to the conditions set out below in this Agreement
		

		
			NOW THEREFORE, in consideration of the foregoing and the mutual promises contained herein, the Parties agree as follows:
		

		
			ARTICLE I
		

		
			DEFINITIONS
		

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

		
			1.1 “Act” means the U.S. Food, Drug & Cosmetics Act (21 U.S.C. § 301 et seq.) and related U.S. regulations, including 21 Code of Federal Regulations (Chapters 210 and 211 and 610), as amended from time to time.
		

		
			1.2 “Affiliate” means, with respect to either Party, those entities controlled by, in control of, or under common control with such Party.  A corporation or non-corporate business entity shall be regarded as in control of another corporation or business entity (a) if it owns or directly or indirectly controls a majority of the voting stock or other ownership interest of the other entity, or (b) in the absence of the ownership of a majority of the voting stock or other ownership interest of such entity, if it possesses, directly or indirectly, the power to direct or cause the direction of the management and policies of such corporation or non-corporate business entity, as applicable.
		

		
			1.3 “Agreement” has the meaning set forth in the preamble of this Agreement.
		

		
			1.4 “API” means the active pharmaceutical ingredient listed on Exhibit A.
		

		
			1.5 “API Specifications” means, with respect to a given API, the specifications for such API, including chemical name, structure, reference profile, limits, impurities, physical properties,
		

		
			 
		

		
			

		 

		

			[****]  Portions omitted pursuant to a request for confidential treatment.

		

		

			 

		

		

		
			identity tests, analytical methods, storage requirements, and similar information, attached hereto as Exhibit A.
		

		
			1.6 “Applicable Laws” means all laws, statutes, ordinances, regulations, rules, judgments, decrees or orders of any Authority: (i) with respect to each party, in any jurisdiction in which such party actually operates or performs activities hereunder related to the manufacture and sale of the Product; (ii) with respect to Customer, in any jurisdictions in which API or Product are produced, marketed, distributed, used or sold; and (iii) with respect to Supplier, in any jurisdiction expressly designated in the Specifications.  The term Applicable Laws includes cGMPs.
		

		
			1.7 “Best Efforts” means the efforts that a prudent person desirous of achieving a result would use in similar circumstances to achieve that result as expeditiously as possible, provided, however, that a person required to use ‘Best Efforts’ under this Agreement will not be required to take actions that would result in a material adverse change in the benefits to such person of this Agreement and the contemplated transactions or to dispose of or make any change to its business, expend any material funds or incur any other material burden.
		

		
			1.8 “Binding Forecast” shall have the meaning set forth in Section 2.3
		

		
			1.9   “Breaching Party” shall have the meaning set forth in Section 8.2(b).
		

		
			1.10 “Business Day” means a day other than a Saturday, Sunday or a day that is a statutory holiday in the states of Pennsylvania or Washington, United States.
		

		
			1.11  “Calendar Year” means January 1 – December 31.
		

		
			1.12 “Claims” shall have the meaning set forth in Section 7.1.
		

		
			1.13 “Commercially Reasonable Efforts” means with respect to either Party, those efforts and resources that a such Party would normally devote to a product or compound owned by it or to which it has rights of the type it has hereunder, which is of similar market potential at a similar stage in its development or product life, taking into account the competitiveness of the global and local marketplace, the pricing and launching strategy for the respective product, the proprietary position of the product, the profitability and the relative potential safety and efficacy of the product and other relevant factors, including technical, legal, scientific, regulatory or medical factors then prevailing.  “Commercially Reasonable” as used herein shall be interpreted in a corresponding manner.
		

		
			1.14 “Components” means, collectively, all raw materials, ingredients and packaging components required to be used in order to produce the Product in accordance with the Specifications, other than API and those items listed as components in Exhibit B.
		

		
			1.15   “Confidential Information” means any information of a Party and/or its Affiliates that is disclosed by the disclosing Party or its Affiliates (“Disclosing Party”) to the receiving Party or its Affiliates (“Receiving Party”) during the Term relating to the obligations of either Party contemplated by this Agreement.  Notwithstanding the foregoing, any Confidential Information disclosed by visual observation during a tour, site visit, or audit of Customer’s
		

		
			
		

		
			

		 

		

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			or any of its Affiliates’ laboratories, manufacturing plants or other facilities or, reversely, any Confidential Information disclosed by visual observation during a tour, site visit, or audit of Supplier’s or any of its Affiliates’ laboratories, manufacturing plants or other facilities shall automatically be deemed Confidential Information.  Notwithstanding the foregoing, Confidential Information shall not include any information that:
		

		
			(a)     is or becomes part of the public domain without breach by the Receiving Party of this Agreement;
		

		
			(b)     was in the Receiving Party’s possession before disclosure by the Disclosing Party and was not acquired directly or indirectly from the Disclosing Party; or
		

		
			(c)     is obtained from a Third Party with no obligation of confidentiality to the Disclosing Party, who has a right to disclose it to the Receiving Party; or
		

		
			(d)     is developed independently by the Receiving Party without use of the Confidential Information of the Disclosing Party, as evidenced by the Receiving Party’s written records.
		

		
			1.16 “Conforming Product” means Product delivered by the Supplier hereunder that meets the Product Warranty.
		

		
			1.17 “Control” with respect to any intellectual property means the ability to grant a license or sublicense as provided for herein without violating the terms of any agreement or other arrangement with any Third Party and, with respect to Know-How, also means that such intellectual property is not known to the other Party prior to disclosure thereto, nor freely available from the public domain or any Third Parties.
		

		
			1.18 “Customer” shall have the meaning set forth in the preamble of this Agreement.
		

		
			1.19 “Customer Indemnitee” shall have the meaning set forth in Section 7.1.
		

		
			1.20 “Developed Intellectual Property” shall have the meaning set forth in Section 2.12.
		

		
			1.21 “Disclosing Party” shall have the meaning set forth in Section 1.14.
		

		
			1.22 “Effective Date” shall have the meaning set forth in the heading of this Agreement.
		

		
			1.23 “Failure” shall have the meaning set forth in Section 2.7.
		

		
			1.24 “Field Correction” means any action taken or changes performed affecting a distributed product to mitigate a risk to health or correct issues with misbranded or non-conforming product.
		

		
			1.25 “FDA” means the U.S. Food and Drug Administration and any successor agency thereto.
		

		
			1.26 “Force Majeure” shall have the meaning set forth in Section 10.4.
		

		
			
		

		
			

		 

		

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			1.27 “Good Manufacturing Practices” or “cGMP” means the current Good Manufacturing Practices standards as promulgated under each of the following as in effect on the date of this Agreement and as amended or revised after the date of this Agreement: (a) the Act and other FDA regulations, policies, or guidelines in effect at a particular time for the manufacture, testing and quality control of the Products; (b) the quality management systems guidance according to ICH Q10; and as amended from time to time.
		

		
			1.28 “Governmental Authority” means any nation or government, any state, local or other political subdivision thereof, and any entity, department, commission, bureau, agency, authority, board, court, official or officer, domestic or foreign, exercising executive, judicial, regulatory or administrative governmental functions.
		

		
			1.29 “Law” means each provision of any currently existing federal, state, local or foreign, civil and criminal law, statute, ordinance, order, code, rule, regulation, guideline (including cGMP) or directive or common law, promulgated or issued by any Governmental Authority, as well as any judgments, decrees, injunctions or agreements issued or entered into by any Governmental Authority.
		

		
			1.30 “Manufacturing Facility” means any facility utilized by Supplier, its agents and Affiliates in connection with the manufacture, processing, filling, testing, packaging, distribution, importation, exportation, transport or storage of any Product.
		

		
			1.31 “Maximum Transfer Prices” shall have the meaning set forth in Section 5.1(a)
		

		
			1.32 “Minimum Transfer Price” shall have the meaning set forth in Section 5.1(a).
		

		
			1.33 “Non-Breaching Party” shall have the meaning set forth in Section 8.2(b).
		

		
			1.34 “Party” or “Parties” shall have the meaning set forth in the preamble to this Agreement.
		

		
			1.35 “Patent(s)” means any claim in an issued patent including any extension, substitution, registration, confirmation, reissue, supplemental protection certificate, re-examination or renewal of such patent, to the extent said patent is valid and enforceable (and in each case any foreign counterpart thereto).
		

		
			1.36 “Permitted Recipients” shall have the meaning set forth in Section 9.1(b).
		

		
			1.37 “Product” means Sprix (ketorolac tromethamine) Nasal Spray 15.75 mg per spray
		

		
			1.38 “Product Warranty” means the warranties set forth in Sections 6.2(a), (b) and (c).
		

		
			1.39   “Purchase Order” shall have the meaning set forth in Section 2.4.
		

		
			1.40 “Quality Agreement” means the Quality Agreement executed by the Parties which shall describe the regulatory and compliance roles and responsibilities of both Supplier and Customer with respect to activities conducted hereunder. The Quality Agreement will be attached hereto as Exhibit C and incorporated herein by reference.  The Quality Agreement shall include, without limitation, provisions relating to complaint management, storage and
		

		
			
		

		
			

		 

		

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			shipment conditions and controls, product release and environmental, temperature and humidity conditions and controls, as applicable.
		

		
			1.41 “Recall” means the removal or correction of a marketed product that the FDA or other Regulatory Authority considers to be in violation of the laws it administers and against which the agency would initiate legal action (e.g., seizure) and may be conducted on a firm’s own initiative, by FDA or other Regulatory Authority request, or by FDA or other Regulatory Authority order under statutory authority.  The words ‘recalled’ ‘recalling’, etc. shall have correlative meanings.
		

		
			1.42 “Recall Costs” means all costs and expenses relating to or arising out of any Recall, Withdrawal or Field Correction including any out-of-pocket expenses incurred by either Party relative to notification, shipping, disposal and return of the Recalled or Withdrawn product and the notification and correction of any product subject to a Field Correction.
		

		
			1.43 “Receiving Party” shall have the meaning set forth in Section 4.
		

		
			1.44 “Regulatory Approvals” means, with respect to a particular country or regulatory jurisdiction, the registrations, authorizations and approvals (including reimbursement approvals), licenses, supplements and amendments, pre- and post-approvals, of any national, supra-national, regional, state or local Regulatory Authority, department, bureau, commission, council or other Regulatory Authority or Governmental Authority in such country (including, but not limited to the FDA), necessary for the development (including the conduct of clinical trials), manufacture, distribution, importation, exportation, transport, storage, marketing, promotion, offer for sale, use, or sale of a product in such country.
		

		
			1.45 “Regulatory Authority” means any national, supra-national, regional, state or local regulatory authority, department, bureau, commission, council or other Governmental Authority in such country (including, but not limited to, the FDA or any successor agencies thereto) responsible for overseeing the development (including the conduct of clinical trials), manufacture, distribution, importation, exportation, transport, storage, marketing, promotion, offer for sale, use, or sale of a Product.
		

		
			1.46   “Rolling Forecast” shall have the meaning set forth in Section 2.3.
		

		
			1.47 “Specifications” means the current approved finished product specifications for the Product attached hereto as Exhibit D, as may be updated from time to time pursuant to the terms of this Agreement.
		

		
			1.48 “Supplier” shall have the meaning set forth in the preamble of this Agreement.
		

		
			1.49 “Supplier Indemnitee” shall have the meaning set forth in Section 7.2.
		

		
			1.50 “Supplier IP” means the Supplier Know How and the Supplier Patent Rights.
		

		
			1.51 “Supplier Know How” means all Know-How Controlled by Supplier that relates to the manufacture and/or supply of a Product and all development, clinical, quality, and regulatory information associated with such Product.  For the avoidance of doubt, this includes both the
		

		
			
		

		
			

		 

		

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			Know-How Controlled by Supplier at the time of execution of this Agreement, and any future Know How Controlled by Supplier that relates to the manufacture and/or supply of Products.  Notwithstanding the foregoing, Supplier Know-How excludes Developed Intellectual Property Rights.
		

		
			1.52 “Supplier Patent Rights” all claims of any Patent that is owned or Controlled by Supplier which are necessary or useful for Supplier to manufacture and supply to Customer any of the Products that has not (a) expired or been canceled, (b) been declared invalid by an unreversed and unappealable decision of a court or other appropriate body of competent jurisdiction, (c) been admitted to be invalid or unenforceable through reissue, disclaimer, or otherwise or (d) been abandoned. For the avoidance of doubt, this includes both the Patents Controlled by Supplier at the time of execution of this Agreement, and any future Patents Controlled by Supplier that is necessary or useful for the manufacture and/or supply of Products.  Notwithstanding the foregoing, Supplier Patent Rights excludes Developed Intellectual Property Rights.
		

		
			1.53 “Term” shall have the meaning set forth in Section 8.1.
		

		
			1.54 “Territory” means worldwide
		

		
			1.55 “Third Party” means any person or entity other than the Parties or their Affiliates, whether such entity is a person, company, corporation, limited liability company, partnership or other legal entity, or a division or operating or business unit of such legal entity.
		

		
			1.56   “Transfer Price” shall have the meaning set forth in Section 5.1.
		

		
			1.57   “Withdrawal” means a removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA or other Regulatory Authority, or which involves no violation of a Law.  The words ‘withdrawn’ ‘withdrawing’, etc. shall have correlative meanings.
		

		
			ARTICLE II
		

		
			MANUFACTURE, PRODUCTION FORECASTS AND PURCHASE ORDERS
		

		
			2.1 General Agreement.  During the Term of this Agreement, except as may otherwise be provided herein (including, without limitation, the provisions contained in Section 2.7 and Section 5.1 below), Supplier agrees to manufacture and supply Product to Customer, and Customer agrees to  purchase Product from Supplier, in accordance with the terms and conditions of this Agreement.  Customer agrees to buy at least the minimum order quantity specified in Section 5.1(b) pursuant to the Binding Forecasts and Purchase Orders provided to Supplier by Customer.
		

		
			2.2 Conversion of API and Components.  Supplier shall convert API and Components into Finished Goods in accordance with this Agreement.
		

		
			(a)     API and Components.  Customer shall purchase at its sole cost and expense all API and Components and deliver API and Components to Supplier in accordance with
		

		
			
		

		
			

		 

		

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			Exhibit A.  Supplier shall visually inspect API and Components upon receipt to verify identity and quantity and shall test each shipment in accordance with the Quality Agreement and the API Specifications or Component Specifications.  Supplier shall store such API on behalf of the Customer, in accordance with API Specifications.  The parties acknowledge and agree that title to API and Components shall at all times belong to and remain the property of the Customer.
		

		
			(b)     Raw Materials.  Supplier shall purchase all other raw materials as required by and included in the product formulation and Specifications.  Supplier shall procure only raw materials that are warranted by the vendor to have been manufactured in accordance with cGMPs.  Supplier shall test all raw materials after receipt at the Manufacturing Site as required by the Specifications and the Quality Agreement.
		

		
			(c)     For each fill date on which a batch of Product is produced, Supplier shall [****].
		

		
			(d)     Supplier shall complete all inspection and packaging of each batch of Product [****].
		

		
			2.3 Rolling Forecasts.  Not later than [****], Customer shall provide Supplier with a non-binding, good faith written forecast of Customer’s expected requirements for Product during the [****] (the “Rolling Forecast”).  The Rolling Forecast shall be based on Customer’s desired Product fill schedule.  Notwithstanding the first sentence of this Section 2.3,  [****] included in each Rolling Forecast shall constitute a firm Purchase Order and binding commitment (the “Binding Forecast”).  Customer shall not be obligated to purchase nor shall it have any liability in respect of the quantities of Product set forth in the remaining [****] of any such Rolling Forecast.
		

		
			2.4 Orders.  Customer shall place binding orders for Product by written or electronic Purchase Order (each a “Purchase Order”) (or by any other means agreed to by the parties) with Supplier.  Supplier shall acknowledge and accept any Customer Purchase Order in writing [****] of its receipt thereof.  All such Purchase Orders shall be irrevocable and binding on both Parties.  Purchase Orders shall be placed at least [****] prior to the required fill date based on the Binding Forecast and include the desired date of delivery with respect to the Product ordered.  Supplier shall deliver all Product ordered by Customer under this Agreement [****] set forth in the applicable purchase order, unless otherwise agreed upon by both parties.
		

		
			2.5 Cancellation or Postponement.  Customer reserves the right to cancel or postpone any purchase order, provided that all postponements and cancellations are in accordance with each of the following terms:
		

		
			(a)     Should Customer cancel or postpone all or part of any purchase order [****].
		

		
			(b)     Should Customer cancel or postpone all or part of any purchase order [****].
		

		
			(c)     Should Customer cancel or postpone all or part of any purchase order [****].
		

		
			(d)     Should Customer cancel or postpone all or part of any purchase order [****].
		

		
			(e)     Should Customer cancel or postpone a purchase order [****].
		

		
			
		

		
			

		 

		

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			(f)     [****].
		

		
			2.6 Allocations.  Should Supplier, at any time during the course of this Agreement, have reason to believe that it will be unable to meet Customer’s requested delivery dates or the ability of Supplier to deliver Product in accordance with Customer’s forecasted requirements, Supplier will promptly notify Customer stating the reasons for the delay, the expected duration of the delay and the efforts Supplier is taking to address the cause for the delay.  In the event of any supply shortage due to the inability of Supplier to procure raw materials, production problems or other circumstances adversely impacting the manufacture and/or supply of Product (including Force Majeure), Supplier shall allocate production line fill slots among Customer and Supplier’s other customers in proportion to the aggregate production line fill slots of the last [****] of each such party.
		

		
			2.7 Failure to Supply.
		

		
			(a)     Generally.  If supplier fails to supply at least [****] of the aggregate Purchase Orders for Product (based on the number of batches ordered) and such failure continues for a period of [****] (a “Failure”).  A Failure, except in instances of Force Majeure, shall be considered a material breach of this agreement.  Supplier shall:
		

		
			(i)     Use Commercially Reasonable Efforts to work collaboratively with Customer to discuss and promptly resolve any such Failure which Commercially Reasonable Efforts shall include, but shall not be limited to: (A) making its own personnel available for consultation during the term of any such Failure; and (B) ensuring that any remedial actions recommended by Customer are considered in good faith and if accepted, promptly implemented
		

		
			(ii)    Allow Customer to purchase from a reputable third party (or itself manufacture) Product to cover the shortfall amount with respect to such accepted Purchase Order quantities and all future Product requirements until Supplier provides Customer with reasonably detailed information concerning the actions Supplier has taken to remediate the circumstances that caused Supplier’s failure to deliver and demonstrating that such circumstances have been remediated and that product supply issues are resolved.
		

		
			(b)     Effect of Remedy of a Failure.  If Customer’s manufacturing rights under this Section 2.7 become effective because of a Failure and Supplier is thereafter, during the Term of the Agreement, able to demonstrate to Customer’s reasonable satisfaction that Supplier is capable of re-establishing a satisfactory supply of Product, then Customer shall resume purchasing Product from Supplier (subject to the remainder of this Section 2.7(b) within [****] after Supplier satisfactorily demonstrates its ability to meet Customer’s Product forecasts.  Notwithstanding the foregoing, Customer shall be permitted to fulfill any then-existing contractual commitments, which are non-terminable or non-refundable, under any third party contracts entered into by Customer as a result of the Failure (if any).
		

		
			
		

		
			

		 

		

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			2.8 Compliance with Laws.  Supplier shall manufacture all Products in accordance with the applicable Specifications, the Quality Agreement, cGMP standards, the applicable Regulatory Approvals, the Act and all other applicable United States Laws.  In connection therewith, Supplier shall comply with all applicable United States Laws related to the manufacturing, labeling, packaging, storage and handling of the Product, including maintaining qualified quality facilities and procedures and shall maintain all required licenses including, but not limited to, all establishment licenses and cGMP licenses.
		

		
			2.9  Audits.  Upon reasonable prior notice to Supplier by Customer, Supplier shall allow reasonable access to the applicable Supplier facilities, the Manufacturing Facilities and records to allow Customer and any Regulatory Authority to conduct full quality and/or compliance audits or inspections relating to the manufacturing, labeling, packaging, storage and handling of the Product.  Such audits shall, to the extent requested by Customer and to the extent reasonably practical, be scheduled at mutually agreeable times upon reasonable advance written notice to Supplier, and shall be at Customer’s expense.  In connection with performing such audits, Customer shall comply with all reasonable rules and regulations promulgated by Supplier and its Third Party Contractors.  Except in the case where Customer has reasonable cause, Customer shall be limited to one audit per calendar year that consists of [****].
		

		
			2.10 Notification of Production Issues.  Supplier shall inform Customer promptly in writing, and in any case within [****] Business Days of learning thereof, of any problems that could reasonably be expected to prevent Supplier from providing timely deliveries of Product to Customer.  Supplier shall, in good faith, consider any recommendations made by Customer to resolve any problems relating to the manufacture and supply of any Product under this Agreement.  Supplier shall and shall ensure that each Third Party Contractor shall coordinate maintenance outages and shut-downs of the Manufacturing Facility to minimize any delivery disruptions.
		

		
			2.11 Equipment.  Supplier will use the Customer-owned equipment [****] specified in Exhibit E (the “Customer Equipment”) solely for manufacturing and supplying the Product to Customer, and may not use such equipment for any other purpose or customer.  Title to all Customer Equipment will remain solely with Customer.  Supplier will keep the Customer Equipment free and clear of any security interests, liens, pledges, claims, charges, restrictions, or other encumbrances.  All Customer Equipment will be labelled as property owned by Customer.  Supplier will perform maintenance and servicing of such Customer Equipment while located at Supplier’s facilities in accordance with the vendor’s instructions, and liable for any damage, destruction or other loss to or of the Customer Equipment caused by the negligence or misconduct of Supplier, ordinary wear and tear excepted.  Such expenses of maintenance and service will be reviewed and agreed upon by both parties and may be charged back to Customer.  Upon reasonable advanced notification, Supplier will permit Customer and its personnel and agents, and the manufacturers of the Customer Equipment, to have access to the Customer Equipment in order to monitor the operation of the Customer Equipment.  Customer acknowledges that Customer Equipment is validated in an ISO 5, multi-use area and will require significant lead time to coordinate any access to equipment.  Any transfer or seizure of equipment, upon prior written notice from Customer to Supplier authorizing such actions, will require review and coordination as well as agreed
		

		
			
		

		
			

		 

		

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			upon costs to remove from Supplier site.  With the exception of any fixed equipment, as listed in Exhibit D, Customer will have the right to require Supplier to deliver to Customer, or to permit Customer or its agents to remove from Supplier’s premises and take possession of, the Customer Equipment, and Supplier will provide all reasonable cooperation in connection therewith at Customer’s expense.  Removal of fixed equipment shall be at Supplier’ timeline (which shall be reasonable) and at Customer expense for reasonable, actual and direct costs incurred by Supplier to remove such equipment.  Removal of equipment will require a quotation to be agreed upon reasonably and in good faith and executed by both parties to cover any and all charges for the removal and an agreed upon timeline will be established to complete the work.
		

		
			2.12 Title to Intellectual Property.  All Patents, Know-How and other intellectual property generated or derived by Supplier while performing its obligations under this Agreement, to the extent it is specific to the development, manufacture, use and/or sale of the Products, is dependent on such Products, or is an improvement to or derivative of Customer’s Patents, Know-How or other intellectual property, will be the exclusive property of Customer (“Developed Intellectual Property”), and Supplier hereby irrevocably assigns to Customer, and Customer hereby accepts, all right, title and interest in and to the Developed Intellectual Property.  Supplier shall cause its employees, agents and contractors to do the same.  Subject to the preceding sentences, all right, title and interest in and to the Supplier IP shall remain vested in Supplier.
		

		
			ARTICLE III
		

		
			MANUFACTURING STANDARDS; SPECIFICATIONS; ACCEPTANCE
		

		
			3.1 Production and Manufacturing Standards.  All amendments to the Specifications (if any) will be managed in accordance with the terms of the Quality Agreement and all amendments or changes to the Specifications (if any) shall be attached to this Agreement as an Exhibit in place of the previously applicable Exhibit for such Specifications.  In the event of a conflict between the provisions of this Agreement and any of the Specifications, the provisions of this Agreement shall prevail.
		

		
			3.2 Shipping; Delivery.  Unless otherwise instructed by Customer, Supplier shall use its Commercially Reasonable Efforts to ship each lot of Product promptly upon completion of manufacturing.  All Product manufactured and supplied hereunder shall be delivered Ex-Works (INCOTERMS 2010) by freight carrier of Customer’s choice.  Customer is responsible to obtain the best commercial rates for shipping costs.  All customs duties shall be at Customer’s expense. All other costs, taxes, insurance premiums, and other expenses associated with transport and delivery shall be at Customer’s expense.  Customer shall arrange for shipping in compliance with the applicable Product requirements regarding temperature, duration and other environmental factors as required to properly preserve the Products without materially impacting their shelf life and/or integrity.
		

		
			3.3 Testing and Documentation.  Supplier shall test all Product to ensure compliance with the applicable Specifications in accordance with the Quality Agreement and pursuant to any changes thereof if such may be forthcoming due to any regulatory source(s).  Copies of all
		

		
			
		

		
			

		 

		

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			documentation and test results, including batch records, certificate of analysis, standard operating procedures, laboratory assay methods, deviation and investigation reports, appropriately signed, as are necessary to demonstrate Supplier’s cGMP compliance shall be provided to Customer in accordance with the Quality Agreement.
		

		
			3.4 Acceptance.
		

		
			(a)     Each Batch of Product delivered hereunder shall be accompanied by a Certificate of Analysis signed by a duly authorized representative of Supplier.  Customer shall have [****] from the date of receipt of Product to inspect and reject acceptance by written notice to Supplier; provided, however, that any such notice shall set forth Customer's reasons for rejection in reasonable detail and provided, further, that Customer may reject Product only if: (i) Customer claims a material breach of Supplier's representations and warranties in Article VI of this Agreement with respect to such Product; or (ii) Supplier has failed to deliver a Certificate of Analysis for such Product; (iii) the Product fails to conform to the Product Warranty.  If Supplier does not receive Customer's written notice of rejection within such [****] period, Customer shall be deemed to have accepted Product.
		

		
			(b)     In the event Customer provides Supplier with a timely notice of rejection as set forth in Section 3.4(a), Customer shall return the rejected Product to Supplier at Supplier's expense.  Supplier shall have [****] following receipt of rejected Product in which to test such Product.  If Supplier does not dispute a rejection, Supplier shall rework or replace the rejected Product promptly, at Supplier's expense (except for replacement API, which will be provided by Customer at Customer’s expense but subject to Section 3.6) and, except for Sections 4.7, and 7.1, such rework or replacement shall constitute Customer's exclusive remedy and Supplier's sole liability with respect to such rejection.  If Supplier disputes a rejection, Supplier shall provide Customer with written notice of such dispute within [****] after receiving the returned Product, and the Parties shall use commercially reasonable efforts to resolve the dispute amicably and promptly.  If the Parties are unable to reach a resolution within [****] after Customer's notice of rejection, the returned Product shall be submitted to an independent laboratory or consultant mutually acceptable to the Parties, whose decision as to the conformity of such Product with the requirements of this Agreement shall be final and binding.  The Party against whom the dispute is decided shall pay any charges for such laboratory or consultant.  If the laboratory or consultant determines that the returned Product did not conform to the standards of this Agreement, Supplier shall replace the rejected Product at no charge to Customer (except that Customer shall provide replacement API at Customer’s expense but subject to Section 3.6), and such replacement shall constitute Customer's exclusive remedy and Supplier's sole liability with respect to such rejected Product.
		

		
			3.5 Latent Defects. If, after accepting any lot or shipment of Product, Customer subsequently discovers latent material defects which were not reasonably discoverable during the acceptance period set forth in Section 3.4, Customer may revoke its acceptance of such lot or shipment by giving written notice and disclosing the nature of any defects to Supplier promptly after discovering such defects within [****] of discovery of the defect.  The existence and cause of
		

		
			
		

		
			

		 

		

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			such latent material defect will be investigated through the root cause analysis according to the procedures in the Quality Agreement. Any disputes as to whether such latent material defect was or was not ‘reasonably discoverable’ shall be referred to the Parties’ senior management for resolution.
		

		
			3.6 API.
		

		
			(a)     [****]. All such API shall conform to the API Specifications.  Title to API shall remain at all times with Customer.  Except as expressly provided otherwise in Section 3.6(b),  risk of loss of the API shall remain at all times with Customer.
		

		
			(b)     In the event any loss or damage of API (whether prior to or during processing) results from Supplier's negligent acts or omissions, as Supplier's sole liability and Customer's sole remedy with respect to such loss or damage of API, Supplier, at Customer’s option, shall (i) reimburse Customer for the documented actual direct manufacturing cost or price charged to Customer of the lost or damaged API, or (ii) allow Customer a purchase price credit equal to the documented actual direct manufacturing cost or price charged to Customer of the lost or damaged API.  The maximum liability of Supplier under this Section 3.6 during any calendar year of this Agreement for the [****].  [****].
		

		
			ARTICLE IV
		

		
			REGULATORY MATTERS
		

		
			4.1 Product Registrations.  Except as otherwise agreed upon by the Parties, Customer shall be solely responsible for obtaining and maintaining all permits, licenses, and authorizations necessary market, distribute and otherwise sell the Product.  Supplier shall be solely responsible for securing and maintaining approval of Supplier’s facility as a registered FDA facility and all licenses, permits and approvals in respect to the operation of Supplier’s business generally, the Facilities, and the performance of services of the nature of the manufacturing services to be provided under this Agreement.
		

		
			4.2 Records.  Supplier shall maintain all records relating to the manufacturing and supply of Products as specified in the Quality Agreement.  Additionally, Supplier shall maintain all records necessary to comply with all applicable Laws related to the manufacture of Product.  All such records shall be maintained for a period of not less than three (3) years from the date of expiration of each lot of Product to which said records pertain, or such longer period as may be required by Law or Supplier’s standard operating procedures.
		

		
			4.3 Supplier Production Issues.  Supplier shall promptly notify Customer of any production issues relating to the Products or other information of which Supplier becomes aware which may affect the regulatory status of or the ability of Supplier to supply Product to Customer in accordance with Customer’s forecasted requirements.  All such communications provided by Supplier shall be treated as Supplier Confidential Information.
		

		
			
		

		
			

		 

		

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			4.4 Complaints and Adverse Reactions. Customer shall have primary responsibility for safety monitoring and consumer complaint investigation; provided that Supplier shall reasonably cooperate and provide assistance as reasonably requested by Supplier in any such complaint investigation.  In connection therewith, Supplier shall provide to Customer copies of all information it uniquely has in its possession that is necessary to allow Customer to make timely reports as required by any Regulatory Authority regarding the Product.  Supplier shall notify Customer in accordance with agreed upon complaint handling procedures of any information concerning any complaint involving the possible failure of the Product to meet any requirement of applicable Laws and any serious or unexpected side effect, injury, toxicity or other reaction or any unexpected incidents associated with the use of the Product.
		

		
			4.5 Approval for Changes.  Except as otherwise permitted under the Quality Agreement, no changes may be made to any Specifications for the Product without Customer’s and Supplier’s prior written consent, as applicable.
		

		
			4.6 Inspections.  Notwithstanding anything to the contrary in the Quality Agreement, upon reasonable prior notice to Supplier, Customer or its agents shall have reasonable access to observe and inspect Supplier and its Manufacturing Facilities, records, and procedures including, without limitation, manufacturing, and environmental health and safety operations, and practices, including all analytical and manufacturing documentation related to Products, at reasonable intervals and upon reasonable notice to Supplier.
		

		
			4.7 Recalls.
		

		
			(a)     Generally.  In the event that:
		

		
			(i)      Customer determines that an event, incident, or circumstance has occurred which may result in the need for a Recall, Withdrawal Field Correction or other removal of any Product or any lot or lots thereof from the market in the Territory, or Supplier determines that an event, incident, or circumstance that could reasonably adversely affect the Product in the Territory has occurred which is reasonably likely to result in the need for a Recall, Withdrawal Field Correction or other removal of any Product, or any lot or lots thereof from the market;
		

		
			(ii)    either Party becomes aware that a Regulatory Authority is threatening or has initiated an action to remove the Product from the market in the Territory or, if such event could reasonably adversely affect the Product in the Territory, any Regulatory Authority is threatening or has initiated an action to remove the Product from the market; or
		

		
			(iii)   either Party is required by any Regulatory Authority to distribute a “Dear Doctor” letter or its equivalent regarding use of the Product in the Territory or, if such event could reasonably adversely affect Product in the Territory, any Regulatory Authority has required distribution of a “Dear Doctor” letter or its equivalent regarding use of the Product outside the Territory,
		

		
			
		

		
			

		 

		

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			then it shall promptly advise the other Party in writing with respect thereto, and shall provide to the other Party copies of all relevant correspondence, notices, and the like in the possession or Control of such Party.  In such event, Customer shall have the sole authority to determine if a recall or other removal of the Product is required in the Territory, and shall be responsible for conducting any such Recall, Withdrawal Field Correction or other removal of any Product from the Territory, whether voluntary or involuntary, or taking such other remedial action required by applicable Laws in the Territory and except as provided in Section 4.7(c), shall bear all Recall Costs therefor.
		

		
			(b)     Supplier Assistance.  At Customer’s request, Supplier shall assist Customer, at Customer’s expense, with respect to any such recall or remedial action, and shall provide Customer with all information that Customer may request in connection with its dealings with a Regulatory Authority in connection with such recall or remedial action.
		

		
			(c)     Costs Resulting from Breach.  Notwithstanding anything else contained in this Agreement to the contrary, to the extent that any Recall, Withdrawal Field Correction or other removal of any Product or any lot or lots thereof from the market in the Territory results from a breach by Supplier or its Affiliates or agents of the terms of this Agreement then Supplier shall bear Recall Costs and shall bear all costs for any assistance provided to Customer by Supplier or its Affiliates or agents in connection with such Recall, Withdrawal Field Correction or other removal. Without limiting any other rights of Customer hereunder, including under Section 3.6, Supplier is limited in such recall expenses [****].
		

		
			ARTICLE V
		

		
			FINANCIAL TERMS
		

		
			5.1 Transfer Prices; Adjustments.
		

		
			(a)     Transfer Price.  The price to be paid by Customer to Supplier for each batch of Product (the “Transfer Price”) shall be [****].
		

		
			(b)     Minimum Order Quantity.  Subject to Sections 5.1(c) and 5.1(d),  Customer agrees to place Purchase Orders for [****] of Product per full Calendar Year,  for each Calendar Year that this Agreement is in effect.  In the event the total quantity of Products actually ordered by Purchaser is [****], Customer shall pay to Supplier a compensation (the "Yearly Compensation") calculated as follows:
		

		
			[****]
		

		
			[****]
		

		
			Example: If Purchaser [****]:
		

		
			Yearly Compensation: [****]
		

		
			
		

		
			

		 

		

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			Contractor shall calculate if the minimum ordered quantity of Product has been met each Calendar Year as of December 31 of each year, and, if not, shall send an invoice for the Yearly Compensation within sixty (60) days following the end of such period.
		

		
			(c)     Supply Disruption.  If Customer has the right pursuant to Section 2.7 to purchase Product from third parties due to a Failure, each batch of Product ordered from such third parties shall be deemed a batch of Product ordered under this Agreement for purposes of satisfying the minimum order quantity in Section 5.1(b).  In addition, if during any Calendar Year, Supplier is unable to supply [****] batches of Product due to delays or supply shortages described in Section 2.6, Force Majeure, or any other reason, then the minimum order quantity requirement of Section 5.1(b) shall be waived for such Calendar Year.
		

		
			(d)     Generic Competition.  In the event that a third party commences sales of a generic version of the Product in the United States, then Customer’s obligations under Section 5.1(b) shall terminate.
		

		
			(e)     Adjustments.  Beginning [****], the then current price shall be increased by the annual percentage increase, if any, for the most recent twelve (12) month period for which final (non-preliminary) figures are available in the "Producer Price Index - Pharmaceutical Preparations" (code PCU2834) (the "PPI") published by the U.S. Bureau of Labor Statistics (the "BLS") or, if the same is no longer published, the successor index published by the BLS that is most similar thereto.  If the PPI is discontinued and not replaced with a corresponding or similar index, then the Parties shall, in good faith, agree upon a replacement PPI.  Price increases shall be effective for all purchase orders placed for manufacture dates after the applicable anniversary.
		

		
			Example calculation: If in March 2017, the PPI is 748.1 and the previous year March 2016, the PPI was 706.9, the difference is 41.2.  The difference (41.2) would be divided by the then previous year PPI (706.9) resulting in a PPI increase of 5.83%.
		

		
			[****].
		

		
			(f)     Complaint Investigations [****].
		

		
			Example calculation:  [****].   [****]  .
		

		
			5.2 Invoices; Payment Terms.  Supplier shall invoice Customer for all Product supplied to Customer at the time of delivery to Customer.  Payment to Supplier by Customer shall be made in U.S. dollars, [****] calendar days following receipt by Customer of an invoice for the Product. Any invoiced amount which is not paid by its due date may be assessed a late payment fee at the rate of [****] per month.
		

		
			5.3 Payment Information.  All payments due hereunder to Supplier shall be sent to Supplier by wire transfer of funds via the Federal Reserve Wire Transfer System to:
		

		
			[****]
		

		
			
		

		
			

		 

		

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			5.4 Taxes and Duties.  The Parties shall file required forms and provide each other with any information required by tax authorities to obtain a reduction to or an exemption from any otherwise applicable sales, use VAT or similar tax.
		

		
			5.5 Audits.  Customer shall have the right to request copies of records of Supplier with respect to the Products supplied hereunder to confirm Supplier’s compliance with the terms of this agreement.
		

		
			ARTICLE VI
		

		
			REPRESENTATIONS AND WARRANTIES
		

		
			6.1 Mutual Representations and Warranties.  Each Party represents and warrants to the other that:
		

		
			(a)     it is a legal entity duly organized, validly existing and in good standing (to the extent such concept exists under the Laws of the jurisdiction of such Party's incorporation) under the Laws of country in which it incorporated and this Agreement has been duly authorized by all necessary corporate action;
		

		
			(b)     it has all necessary corporate power and authority to enter into this Agreement and to perform all of its obligations hereunder;
		

		
			(c)     this Agreement has been duly authorized, executed and delivered by it and is the legal, valid and binding obligation of such Party, enforceable against such Party in accordance with its terms; and
		

		
			(d)     neither the execution, delivery and performance by it of this Agreement nor the consummation of the transactions contemplated hereby violate or conflict with its charter documents, any material contract, agreement or instrument to which it is a party or by which it or its properties are bound, or any judgment, decree, order or award of any court, Governmental Authority, body or arbitrator by which it is bound, or any Law applicable to it.
		

		
			6.2 Supplier Warranties. Supplier represents and warrants as follows:
		

		
			(a)     All Product manufactured and supplied under this Agreement will have been manufactured, labeled and packaged in accordance with, and the Product will conform to, the Specifications and all Applicable Laws.
		

		
			(b)     No Product manufactured and supplied pursuant to this Agreement will, at the time of delivery, be adulterated within the meaning of the Act or within the meaning of any applicable Law in which the definition of adulteration is substantially the same as that contained in the Act, as such Act and such Laws are constituted and effective at the time of delivery nor will such Product be an article which may not, under the provisions of such Act, except those relating to misbranding, be introduced into interstate commerce.
		

		
			
		

		
			

		 

		

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			(c)     Each lot of Product manufactured and supplied for Customer will at the time of delivery have the applicable shelf life set forth in the Specifications and will continue, until the applicable expiration date, conform to the Specifications and will be free from defects in materials and workmanship.
		

		
			(d)     The facilities and processes utilized by Supplier for the manufacture of the Products will, at all times, comply with all applicable FDA regulations including, without limitation, applicable cGMP, and all other Applicable Laws.
		

		
			(e)     Supplier, and all Product delivered under this Agreement are in material compliance with all applicable environmental, health, safety and transportation regulations.
		

		
			(f)     Each item of environmental, health and safety information, including but not limited to, all Material Safety Data Sheets, related to the Product, Supplier or its Third Party Contractors supplied by Supplier under this Agreement shall be complete and accurate on the date on which it is supplied to Customer.
		

		
			(g)     Supplier shall throughout the Term and for a period of [****] thereafter, maintain a system that is capable of tracking all source materials for the Product and shall, upon request, provide all such data to Customer and the applicable Regulatory Authorities.
		

		
			6.3 Customer Warranties.  Customer represents and warrants as follows:
		

		
			(a)     Neither Customer’s Technology Package, nor the use thereof by Supplier, shall infringe, violate or misappropriate the rights of any Third Party.
		

		
			(b)     Any excipients, API and other materials/components provided by Customer to Supplier shall comply with the API Specifications and shall not be adulterated or misbranded within the meaning of the Act or other applicable law.
		

		
			6.4 THE WARRANTIES SET FORTH HEREIN ARE THE SOLE AND EXCLUSIVE WARRANTIES MADE BY EITHER PARTY UNDER THIS AGREEMENT, AND NEITHER PARTY MAKES ANY OTHER WARRANTIES EXPRESS OR IMPLIED OR ARISING BY LAW, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR USE OR ARISING FROM THE COURSE OF PERFORMANCE, COURSE OF DEALING OR USAGE OF TRADE.
		

		
			6.5 EXCEPT AS NECESSARY TO SATISFY A THIRD PARTY CLAIM INDEMNIFIED UNDER ARTICLE VII OF THIS AGREEMENT, EXCEPT AS PROVIDED IN SECTIONS 3.6 AND 4.7, AND EXCEPT FOR SUPPLIER’S GROSS NEGLIGENCE, WILLFUL MISCONDUCT OR FRAUD, CUSTOMER'S SOLE AND EXCLUSIVE REMEDY, AND SUPPLIER'S SOLE AND EXCLUSIVE LIABILITY AND OBLIGATION, FOR ANY BREACH OF A REPRESENTATION AND WARRANTY SET FORTH IN SECTIONS 6.4(A)-(C) SHALL BE FOR SUPPLIER, AT ITS OPTION, EITHER TO (A) PROCESS REPLACEMENT PRODUCT AT NO COST TO CUSTOMER EXCEPT THAT, AT ITS EXPENSE (SUBJECT TO SECTION 3.6) CUSTOMER SHALL PROVIDE SUBSTITUTE
		

		
			
		

		
			

		 

		

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			API, OR (B) CREDIT OR REFUND THE PRICE TO CUSTOMER OF THE DEFECTIVE PRODUCT.
		

		
			6.6 WITHOUT LIMITING SECTION 6.5 OR ANY OTHER PROVISION OF THIS AGREEMENT, EXCEPT AS NECESSARY TO SATISFY A THIRD PARTY CLAIM INDEMNIFIED UNDER ARTICLE VII OF THIS AGREEMENT, AND/OR IN THE EVENT OF A BREACH OF THE CONFIDENTIALITY OBLIGATIONS SET FORTH IN ARTICLE IX OF THIS AGREEMENT OR A PARTY’S GROSS NEGLIGENCE, WILLFUL MISCONDUCT OR FRAUD, UNDER NO CIRCUMSTANCES WILL EITHER PARTY BE LIABLE TO THE OTHER UNDER ANY CONTRACT, TORT, STRICT LIABILITY, NEGLIGENCE OR OTHER LEGAL OR EQUITABLE THEORY, FOR COVER OF ANY INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING LOST PROFITS) IN CONNECTION WITH THE SUBJECT MATTER OF THIS AGREEMENT, INCLUDING, WITHOUT LIMITATION, WITH RESPECT TO ANY PRODUCT OR ANY SERVICES PROVIDED IN CONNECTION WITH A PRODUCT.
		

		
			ARTICLE VII
		

		
			INDEMNIFICATION AND INSURANCE
		

		
			7.1 Supplier Indemnification.  Supplier shall indemnify, defend and hold harmless Customer, its Affiliates and each of their respective shareholders, directors, officers, employees and agents (each, an “Customer Indemnitee”) from and against all costs, losses, expenses (including reasonable attorneys’ fees) and damages resulting from all lawsuits, claims, demands, actions and other proceedings by or on behalf of any Third Party (collectively “Claims”) to the extent arising out of or resulting from: (a) the breach of any representation, warranty, covenant or material obligation of Supplier under this Agreement; (b) the gross negligence, recklessness or willful misconduct of Supplier or any of its agents or subcontractors in the performance of its obligations under this Agreement; or (c) failure of the Product to conform to the relevant Specifications.
		

		
			7.2 Customer Indemnification.  Subject to Section 7.1, Customer shall indemnify, defend and hold harmless Supplier, its Affiliates and each of their respective shareholders, directors, officers, employees and agents (each, an “Supplier Indemnitee”) from and against all Claims to the extent arising out of or resulting from: (a) the ownership, use, handling, distribution, marketing or sale of the Product, (b) the breach of any representation, warranty, covenant or material obligation of Customer under this Agreement or (c) the gross negligence, recklessness or willful misconduct of Customer or any of its agents or subcontractors in the performance of its obligations under this Agreement.
		

		
			7.3 Insurance.  Each of Customer and Supplier shall obtain and maintain, either itself or through one or more of its Affiliates, with reputable carriers, product liability insurance with limits of [****] by no later than the scheduled manufacturing date for the first Batch of Product(s) delivered as part of the first Product Development Program(s) conducted under this Agreement.  Upon request, each Party shall furnish the other Party with a certificate that such insurance is in force.  In the event of any proposed cancellation, non-renewal, or material adverse change in a Party's insurance coverage, the other Party shall be given at least [****]
		

		
			
		

		
			

		 

		

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			advance written notice thereof.  In addition, Supplier shall maintain, at its expense, at least [****] of property insurance covering all bulk, finished or in-process inventory of Product and API and Components while on Supplier’s premises or under Supplier’s control, and comprehensive general liability insurance in the amount of at [****].  Supplier shall maintain in place all insurance required by Section 7.3 for: (i) at least [****] following expiration or termination of this Agreement or, (ii) for at least [****] after the termination or expiration of this Agreement if insurance is written on a claims-made basis.
		

		
			7.4 Limitation of Liability and Claims.  Notwithstanding any other provision of this Agreement, Supplier's aggregate indemnification liability to Customer and its Affiliates for Third Party Claims shall not [****].  The foregoing shall not apply to (i) Supplier’s fraud, willful misconduct or gross negligence, (ii) any amounts due to Third Parties by Supplier as a result of Supplier’s indemnification obligations under Section 7.1, or (iii) Supplier’s breach of Article IX (Confidentiality).
		

		
			7.5 Procedures.  If any Claim covered by ARTICLE VII is brought, the indemnifying Party’s obligations are conditional upon the following:
		

		
			(a)     the indemnified Party shall promptly notify the indemnifying Party in writing of such Claim, provided, however, the failure to provide such notice within a reasonable period of time shall not relieve the indemnifying Party of any of its obligations hereunder except to the extent the indemnifying Party is prejudiced by such failure or delay;
		

		
			(b)     the indemnifying Party shall assume, at its cost and expense, the sole defense of such Claim through counsel selected by the indemnifying Party and reasonably acceptable to the indemnified Party, except that the indemnified Party may at its option and expense select and be represented by separate counsel;
		

		
			(c)     the indemnifying Party shall maintain control of such defense and/or the settlement of such Claim;
		

		
			(d)     the indemnified Party may, at its option and expense, participate in such defense, and if it so participates, the Parties shall cooperate with one another in such defense;
		

		
			(e)     the indemnifying Party will have authority to consent to the entry of any settlement or otherwise to dispose of such Claim (provided and only to the extent that an indemnified Party does not have to admit liability and such judgment does not involve equitable relief or the payment of any amounts by the indemnified party and the indemnified Party may not consent to the entry of any judgment, enter into any settlement or otherwise to dispose of such Claim without the prior written consent of the indemnifying Party (not to be unreasonably withheld or delayed); and
		

		
			(f)     the indemnifying Party shall pay the full amount of any judgment, award or settlement with respect to such Claim and all other reasonable and documented costs, fees and expenses related to the resolution thereof; provided, however, that such other
		

		
			
		

		
			

		 

		

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			costs, fees and expenses have been incurred or agreed, as the case may be, by the indemnifying Party in its defense or settlement of the Claim.
		

		
			ARTICLE VIII
		

		
			TERM AND TERMINATION
		

		
			8.1 Term. This Agreement shall become effective immediately upon execution hereof by both Parties and shall expire [****] years after the Effective Date (the “Term”) unless terminated earlier pursuant to Section 8.2 below.  The Agreement shall thereafter automatically renew for periods of [****], unless either Party shall give notice to the other to the contrary at least [****] prior to the expiration of the initial term or any renewal of the Agreement.
		

		
			8.2 Termination.  This Agreement may be terminated immediately:
		

		
			(a)     upon mutual written agreement of the Parties;
		

		
			(b)     by either Party (the “Non-Breaching Party”) upon written notice as a result of a material breach by the other Party (the “Breaching Party”) of any material obligation, condition or covenant of this Agreement (including, without limitation, the occurrence of a Failure, if such material breach shall not have been remedied, or steps initiated to remedy the same to the Non-Breaching Party’s reasonable satisfaction, within [****] calendar days after receipt by the Breaching Party of a notice thereof from the Non-Breaching Party; or
		

		
			(c)     by either Party upon written notice in the event: (i) the other Party voluntarily enters into bankruptcy proceedings, reorganization, or other insolvency proceedings; (ii) the other Party makes an assignment of all or a material portion of its assets for the benefit of creditors; (iii) a petition is filed against the other Party under a bankruptcy Law, a corporate reorganization Law, or any other Law for relief of debtors or similar Law analogous in purpose or effect, which petition is not stayed or dismissed within [****] calendar days of filing thereof; or (iv) the other Party enters into liquidation or dissolution proceedings or a receiver is appointed with respect to any assets of the other Party, which appointment is not vacated within [****] calendar days.
		

		
			8.3 Regulatory Considerations.  Customer may terminate this Agreement as to any Product and applicable portion of the Territory upon thirty (30) days’ prior written notice to Supplier in the event that (i) any Regulatory Authority takes any action or raises any objection that prevents Customer from importing, exporting, purchasing or selling such Product in all or part of the Territory, or (ii) Customer elects to discontinue selling or otherwise withdraws from the market such Product in all or part of the Territory.
		

		
			8.4 Effect of Termination.
		

		
			(a)     The expiration or termination of this Agreement shall not relieve Supplier from its obligation to deliver Product subject to the Binding Forecast prior to the effective date of such expiration or termination, nor shall expiration or termination relieve Customer from accepting and, upon acceptance, paying for any such Product or, unless Customer has terminated this Agreement
		

		
			
		

		
			

		 

		

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			pursuant to Section 8.2(b), from obligation for cancellation or postponement penalties under Section 2.5, unless otherwise agreed in writing by the Parties.
		

		
			(b)     Survival of Certain Terms.  Unless expressly provided to the contrary, the provisions of Sections 2.8, 2.10, 2.11, 3.5, 3.6, 4.2, 4.4, 4.6, 4.7, 5.1(f), 5.5, 6.2, 6.3, 6.4, 6.5, 6.6, 7, 8.4, 9, and 10 shall survive the expiration or termination of this Agreement.  Expiration or termination shall not extinguish the rights and remedies of either Party with respect to any antecedent breach of any of the provisions of this Agreement.
		

		
			ARTICLE IX
		

		
			CONFIDENTIALITY
		

		
			9.1 Confidentiality.
		

		
			(a)     Generally.  It is contemplated that in the course of the performance of this Agreement each Party may, from time to time, disclose Confidential Information to the other.  Each Party represents that it has the right to deliver the Confidential Information it discloses to the Receiving Party pursuant to this Agreement. No provision of this Agreement shall be construed so as to preclude disclosure of Confidential Information as may be reasonably necessary to secure from any Governmental Authority necessary approvals or licenses or to obtain Patents with respect to the Product.
		

		
			(b)     Use; Disclosure.  Each Party shall (a) use the Confidential Information disclosed to it solely for the performance of this Agreement and (b) not disclose such Confidential Information without the Disclosing Party’s prior written consent to any other person or entity other than those of its employees, legal advisors, accountants, contractors or agents and those of its Affiliates who: (i) have a need to know such Confidential Information in connection with the performance of the Agreement and (ii) have been informed of the confidential nature of such information and the Receiving Party’s obligations under this Agreement (collectively, “Permitted Recipients”). All Permitted Recipients shall be bound to maintain such Confidential Information in confidence, and each Party will take reasonable steps to require its Permitted Recipients to preserve such trust and confidence.  Each Party shall be responsible for any breach of this Agreement by its Permitted Recipients.
		

		
			(c)     Protection; Return.
		

		
			(i)      Each of the Parties shall in all respects treat the Confidential Information and all trade secrets (as defined by applicable Law) disclosed to it hereunder at least as carefully as such Party treats its own Confidential Information and will carry out, with respect to it, those security measures that it follows to protect its own Confidential Information, but in no event shall the Receiving Party use less than reasonable care to prevent unauthorized disclosure with respect to such Confidential Information and trade secrets.
		

		
			
		

		
			

		 

		

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			(ii)    Upon expiration or earlier termination of this Agreement and upon written request of the Disclosing Party, the Receiving Party will: (i) return to the Disclosing Party all Confidential Information (including copies) provided by the Disclosing Party under this Agreement; (ii) destroy all summaries, extracts and the like prepared by the Receiving Party that incorporate the Disclosing Party’s Confidential Information; and (iii) certify to the destruction of the same; provided, however, that: (y) the Receiving Party may retain one complete copy of the Confidential Information in its legal archives for the purpose of determining its obligations under this Agreement and as necessary to comply with Applicable Laws, and (z) Permitted Recipients may retain one copy of the reports or other materials such persons personally prepared based upon the Confidential Information (but may not retain the Disclosing Party’s Confidential Information itself) for legal, regulatory, ethical or insurance purposes.  Further, to the extent that the Receiving Party’s computer back-up or archiving procedures create copies of Confidential Information, the Receiving Party may retain such copies for the period it normally archives backed-up computer records, so long as such copies are kept confidential in accordance with the terms of this Agreement.
		

		
			(d)   Required Disclosure.
		

		
			(i)      The obligations of confidentiality set forth in this Article IX shall not prohibit the Receiving Party from disclosing any part of the Confidential Information which, in the written advice of counsel, is required to be revealed in response to a court decision or administrative order, or to comply with Laws of a Governmental Authority or rules of a securities exchange.  If the Receiving Party becomes legally compelled to disclose a Disclosing Party’s Confidential Information, the Receiving Party shall provide prompt notice to the Disclosing Party and the Parties shall cooperate so that a protective order or other appropriate remedy may be sought, unless the Disclosing Party agrees to authorize the Receiving Party to disclose such Confidential Information.  In the event that such protective order or other remedy is not obtained, or Disclosing Party waives compliance with the provisions of this Agreement, the Receiving Party shall furnish only that portion of the Confidential Information that it is required to disclose, based on the opinion of counsel, and shall take all reasonable efforts to obtain a protective order or other reasonable assurance that confidential treatment will be accorded to such Confidential Information.
		

		
			(ii)    Notwithstanding the foregoing, if either Party determines that applicable securities Laws require the disclosure of Confidential Information, Receiving Party shall promptly notify Disclosing Party and Receiving Party shall be permitted to make and issue a disclosure consistent with the requirements of such Laws.  Receiving Party shall take reasonable steps to: (i) limit the disclosure to that disclosure it has determined is required by Law and (ii) seek confidential treatment for all Confidential Information so disclosed, except to the extent such information is determined, based upon the advice of counsel, to be material and would therefore be required to be disclosed.
		

		
			
		

		
			

		 

		

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			(e)  Export.  Each Receiving Party of Confidential Information shall adhere to all applicable import and export controls and shall not export or re-export any technical data or products received from the Disclosing Party or the direct product of such technical data to any prohibited country, party or entity.
		

		
			(f)  Remedies.  In the event of any unauthorized disclosure, loss or use of Confidential Information, in whole or in part by the Receiving Party, the Disclosing Party shall be entitled to seek, upon application to any court of proper jurisdiction, a temporary restraining order or preliminary injunction to restrain and enjoin the Receiving Party or any Affiliate of the Receiving Party from such violation without prejudice as to any other remedies the Disclosing Party may have at Law or in equity.  Further, the Receiving Party acknowledges and agrees that it would be virtually impossible for the Disclosing Party to calculate its monetary damages and that the Disclosing Party would be irreparably harmed in the event of such unauthorized disclosure, loss or use of Confidential Information. If the Disclosing Party seeks such temporary restraining order or preliminary injunction, the Disclosing Party shall not be required to post any bond with respect thereto, or, if a bond is required, it may be posted without surety thereon.
		

		
			(g)     Litigation and Governmental Disclosure.  Each Party may disclose Confidential Information hereunder to the extent such disclosure is reasonably necessary for prosecuting or defending litigation, complying with applicable governmental regulations or conducting pre-clinical or clinical trials, provided that if a Party is required by Law to make any such disclosure of the other Party’s Confidential Information it will, except where impractical for necessary disclosures, for example in the event of a medical emergency, give reasonable advance notice to the other Party of such disclosure requirement and will use good faith efforts to assist such other Party to secure a protective order or confidential treatment of such Confidential Information required to be disclosed.
		

		
			(h)     Limitation of Disclosure.  The Parties agree that, except as otherwise may be required by Applicable Laws, including without limitation the rules and regulations promulgated by the United States Securities and Exchange Commission including requests for confidential treatment, and except as may be authorized in Section 9.1(g) or Section 9.1(i), no information concerning this Agreement and the transactions contemplated herein shall be made public by either Party without the prior written consent of the other.
		

		
			(i)      Publicity and SEC Filings.  Neither Party shall make any public announcement or statement concerning this Agreement, its terms or its existence without the prior written consent of the other Party.  Notwithstanding the foregoing, the Parties agree to issue a joint press release, which is subject to the review and approval of each Party, promptly following the Effective Date.  Each Party agrees that it shall cooperate fully and in a timely manner with the other with respect to all disclosures required by the Securities and Exchange Commission and any other Governmental Authority or Regulatory Authority, including requests for confidential treatment of Confidential Information of either Party included in any such disclosure.
		

		
			
		

		
			

		 

		

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			(j)      Duration of Confidentiality.  All obligations of confidentiality and non-use imposed upon the Parties under this Agreement shall expire [****] years after the expiration or earlier termination of this Agreement; provided, however, that Confidential Information which constitutes the trade secrets of a Party (including, e.g., Customer Licensed Know-How) shall be kept confidential indefinitely, subject to the limitations set forth in this Section 9.1.
		

		
			ARTICLE X
		

		
			MISCELLANEOUS ISSUES
		

		
			10.1   Relationship of the Parties.  Nothing in this Agreement is intended or shall be deemed to constitute a partnership, agency, employer-employee or joint venture relationship between the Parties.  All activities by the Parties hereunder shall be performed by them as independent contractors.  Neither Party shall incur any debts or make any commitments for the other Party, except to the extent specifically provided herein.  No right is granted by this Agreement to either Party to use in any manner the name of the other or any other trade name or trademark of the other in connection with the performance of this Agreement, except as required by Law or as expressly set forth in this Agreement.
		

		
			10.2   Assignability.  Unless otherwise expressly permitted hereunder, neither Party may assign this Agreement without the prior written consent of the other Party, except that each Party may assign any or all of its rights and/or responsibilities hereunder without the other Party’s consent as part of (a) the sale of all or substantially all of the assets or the entire business to which this Agreement relates (b) a merger, consolidation, reorganization or other combination with or into another person or entity; or (c) the transfer or assignment to an Affiliate, in each case, pursuant to which the surviving entity or assignee assumes the assigning or merging Party’s obligations hereunder without diminishing any rights of the other Party under this Agreement.  Any assignment made in violation of this Section 10.2 shall be null and void.
		

		
			10.3   Notices.  All notices and demands required or permitted to be given or made pursuant to this Agreement shall be in writing and shall be deemed given if delivered personally or by facsimile transmission (receipt verified), mailed by registered or certified mail (return receipt requested), postage prepaid, or sent by express courier service, properly addressed to the address of the Party to be notified as shown below:
		

		
			If to Supplier:
		

		
			Jubilant HollisterStier LLC
		

		
			3525 North Regal Street
		

		
			Spokane, WA  99207
		

		
			Attention:  President
		

		
			FAX:  [****]
		

		
			
		

		
			

		 

		

			24

		

		

			 

		

		

		
			With a copy to:
		

		
			Attention: Director, Business Development at same address
		

		
			If to Customer:
		

		
			Zyla Life Science US Inc.
		

		
			600 Lee Road, Suite 100
		

		
			Wayne, PA 19087
		

		
			Attention:  [****], Chief Operating Officer
		

		
			FAX: [****]
		

		
			Email (Optional): [****]
		

		
			With a copy to:
		

		
			Attention: VP, Technical Operations at same address
		

		
			or to such other address as to which either Party may notify the other.  Any notice sent by facsimile transmission shall be followed within twenty-four (24) hours by a signed notice sent by first class mail, postage prepaid.
		

		
			10.4   Force Majeure.  Neither Party shall be held liable or responsible for any loss or damages resulting from any failure or delay in its performance due hereunder (other than payment of money) caused by force majeure.  As used herein, force majeure shall be deemed to include any condition beyond the reasonable control of the affected Party including, without limitation, strikes or other labor disputes, war, riot, earthquake, tornado, hurricane, flood or other natural disasters, fire, civil disorder, explosion, accident, sabotage, lack of or inability to obtain adequate fuel, power, materials, labor, containers, transportation, supplies or equipment despite reasonable and diligent efforts to obtain the foregoing, compliance with governmental requests, laws, rules, regulations, orders or actions; inability despite commercially reasonable efforts to renew operating permits or licenses from Regulatory Authorities; breakage or failure of machinery or apparatus; national defense requirements; or supplier strike, lockout or injunction.  In the event either Party is delayed or rendered unable to perform due to force majeure, the affected Party shall give notice of the same and its expected duration to the other Party promptly after the occurrence of the cause relied upon, and upon the giving of such notice the obligations of the Party giving the notice will be suspended during the continuance of the force majeure; provided, however, such Party shall take commercially reasonable steps to remedy or mitigate the force majeure with all reasonable dispatch.  The requirement that force majeure be remedied with all reasonable dispatch shall not require the settlement of strikes or labor controversies by acceding to the demands of the opposing party.  If such non-performance continues for more than [****] days and such non-performance would be a material breach of this Agreement absent the operation of this Section 10.4, then Customer may terminate this Agreement on [****] days prior written notice, without penalty of any kind.
		

		
			10.5   Severability.  If any provision of this Agreement is determined to be illegal or unenforceable by any court of Law or any competent Government Authority, the remaining provisions shall be severable and enforceable in accordance with their terms so long as this Agreement without such terms or provisions does not fail of its essential purpose.  The Parties shall
		

		
			
		

		
			

		 

		

			25

		

		

			 

		

		

		
			negotiate in good faith to replace any such illegal or unenforceable provisions with suitable substitute provisions which will maintain as far as possible the purposes and the effect of this Agreement.
		

		
			10.6   Waiver.  Neither Party’s waiver of any breach or failure to enforce any of the terms and conditions of this Agreement at any time shall in any way affect, limit or waive such Party’s right thereafter to enforce and compel strict compliance with every term and condition of this Agreement.  Any such waiver shall be made in writing.
		

		
			10.7   Headings.  All headings, titles and captions in this Agreement are for convenience only and shall not be of any force or substance.
		

		
			10.8   Counterparts.  This Agreement may be executed in multiple counterparts, each of which shall be an original, but all of which shall constitute but one Agreement. For purposes of this Agreement and any other document required to be delivered pursuant to this Agreement, facsimiles of signatures shall be deemed to be original signatures.  In addition, if any of the Parties sign facsimile copies of this Agreement, such copies shall be deemed originals.
		

		
			10.9   Binding Effect.  This Agreement shall be binding upon and inure to the benefit of the Parties hereto and their respective successors and permitted assigns.
		

		
			10.10 Choice of Law.  The construction, validity and performance of this Agreement shall be governed in all respects by the laws of the state of Delaware, excluding its provisions regarding conflicts of law.
		

		
			10.11 Dispute Resolution.  The Parties hereto agree to perform the terms of this Agreement in good faith, and to attempt to resolve any controversy, dispute or claim arising hereunder in good faith.  Any dispute regarding the validity, construction, interpretation, or performance of this Agreement (other than provisions, hereof relating to any intellectual property rights, or the confidentiality obligations contained in Article 8 hereof) shall be (1) first attempted to be resolved between the CEO/President of each Party and failing that (2) submitted to binding arbitration in Chicago,  Illinois, U.S.A. to be conducted in accordance with the Arbitration Rules of the American Arbitration Association (“AAA”); provided, however, that nothing in this Section 10.11 shall be construed to preclude either Party from seeking provisional remedies, including, but not limited to, temporary restraining orders and preliminary injunctions, from any court of competent jurisdiction, in order to protect its rights pending arbitration, but such preliminary relief shall not be sought as a means of avoiding arbitration.  Any arbitration hereunder shall be submitted to an arbitration tribunal made up of three (3) members, one of whom shall be selected by Customer, one of whom shall be selected by Supplier, and one of whom shall be selected by the other two arbitrators and who shall serve as the chair of the panel.  All arbitration proceedings shall be conducted in English.  The arbitration panel shall provide a reasoned opinion supported by findings of fact and conclusions of law.  The order or award of the arbitrators shall be final and may be enforced in any court of competent jurisdiction.  The substantially prevailing Party in any legal or arbitration action brought by one Party against the other Party shall be entitled, in addition to any other rights and remedies it may have, to reimbursement for its expenses
		

		
			
		

		
			

		 

		

			26

		

		

			 

		

		

		
			incurred thereby, including court cost and reasonable attorney’s fees, from the substantially non-prevailing Party.
		

		
			10.12 Compliance with Laws.  Each Party will comply with all local, state or federal Law in any jurisdiction relevant to the activities undertaken pursuant to this Agreement or applicable to either of the Parties with respect to performing its obligations and exercising its rights hereunder.
		

		
			10.13 Non-Exclusive Remedy.  Except as otherwise set forth herein, termination of this Agreement by a Party shall not be an exclusive remedy and all other remedies will be available to the terminating Party, in equity and at Law.
		

		
			10.14 Entire Agreement.  This Agreement and the Appendices attached hereto set forth the entire agreement between the Parties with respect to the transactions contemplated hereunder, and may not be amended or modified except by written instrument duly executed by both Parties.  In the event that this Agreement conflicts with any Purchase Order, invoice or other documents, the terms and conditions of this Agreement shall apply. Any and all previous agreements and understandings between the Parties regarding the subject matter of this Agreement, whether written or oral, are superseded by this Agreement.
		

		
			[Signature Page Follows]
		

		
			 
		

		
			 
		

		
			

		 

		

			27

		

		

			 

		

		

		
			[Signature Page to Manufacturing and Supply Agreement]
		

		
			IN WITNESS WHEREOF, the Parties hereto have caused their authorized representatives to execute this Agreement by signing below:
		

			
					
						Jubilant HollisterStier LLC

					
					
						 

					
					
						Zyla Life Science US Inc.

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						Signature:

					
					
						/s/ AMIT ARORA

					
					
						 

					
					
						Signature:

					
					
						/s/ MARK STROBECK

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						Name: Amit Arora

					
					
						 

					
					
						Name: Mark Strobeck

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						Title: President

					
					
						 

					
					
						Title: EVP and Chief Operating Officer

				

		
			 
		

		
			
		

		
			

		 

		

			 

		

		

			 

		

		

		
			EXHIBIT A
		

		
			API AND API SPECIFICATIONS
		

		
			API - Ketorolac Tromethamine USP
		

		
			API Specifications:
		

		
			
		

		
			

		 

		

			 

		

		

			 

		

		

		
			EXHIBIT B
		

		
			LIST OF PRODUCT COMPONENTS
		

			
					
						 

					
					
						 

					
					
						 

				
	
					
						Description

					
					
						Use

					
					
						Supplied by

				
	
					
						[****]

					
					
						[****]

					
					
						[****]

				
	
					
						[****]

					
					
						[****]

					
					
						[****]

				
	
					
						[****]

					
					
						[****]

					
					
						[****]

				
	
					
						[****]

					
					
						[****]

					
					
						[****]

				
	
					
						[****]

					
					
						[****]

					
					
						[****]

				
	
					
						[****]

					
					
						[****]

					
					
						[****]

				
	
					
						[****]

					
					
						[****]

					
					
						[****]

				
	
					
						[****]

					
					
						[****]

					
					
						[****]

				

		
			 
		

		
			
		

		
			

		 

		

			 

		

		

			 

		

		

		
			EXHIBIT C
		

		
			QUALITY AGREEMENT
		

		
			[****] Information has been excluded from the exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
		

		
			
		

		
			

		 

		

			 

		

		

			 

		

		

		
			EXHIBIT D
		

		
			PRODUCT SPECIFICATIONS
		

		
			[****] Information has been excluded from the exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
		

		
			
		

		
			

		 

		

			 

		

		

			 

		

		

		
			EXHIBIT E
		

		
			CUSTOMER-OWNED EQUIPMENT
		

			
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						Description

					
					
						Manufacturer

					
					
						Model

					
					
						Serial #

					
					
						Supplier Equipment #

					
					
						Status

				
	
					
						[****]

					
					
						[****]

					
					
						[****]

					
					
						[****]

					
					
						[****]

					
					
						[****]

				
	
					
						[****]

					
					
						[****]

					
					
						[****]

					
					
						[****]

					
					
						[****]

					
					
						[****]

				
	
					
						[****]

					
					
						[****]

					
					
						[****]

					
					
						[****]

					
					
						[****]

					
					
						[****]

				
	
					
						[****]

					
					
						[****]

					
					
						[****]

					
					
						[****]

					
					
						[****]

					
					
						[****]

				

		
			 
		

		
			
		

		
			

		 

		

			 

		

		

			 

		

		

		
			EXHIBIT F
		

		
			API COST
		

		
			[****]EXHIBIT 10.1

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

 

Execution
Version

  

Non-Exclusive
License Agreement

  

between

  

Enteris
Biopharma, Inc.

 

and

  

CARA THERAPEUTICS,
INC.

  

Dated as of
August 20, 2019

    	 

    	 

    

Table of Contents

 

	 	 	 	Page
	 	 	 	 
	ARTICLE 1 DEFINITIONS 	4
	 	 
	ARTICLE 2 LICENSE GRANT 	13
	 	 
	2.1	 	Grant of License to Cara	13
	2.2	 	Right to Sublicense	14
	2.3	 	Rights in Bankruptcy	14
	2.4	 	Disclosure of Technology	14
	2.5	 	Retained Rights	14
	2.6	 	Use of Licensed Technology	14
	2.7	 	Negative Covenant	14
	 	 	 	 
	ARTICLE 3 DEVELOPMENT, REGULATORY AND COMMERCIALIZATION 	15
	 	 
	3.1	 	Manufacture by Enteris	15
	3.2	 	Technology Transfer by Enteris	15
	3.3	 	Cara’s Rights and Obligations	16
	3.4	 	Regulatory Responsibility	17
	3.5	 	Recalls	17
	3.6	 	Safety Information	17
	3.7	 	Reference Rights	18
	 	 	 	 
	ARTICLE 4 CONFIDENTIALITY, PUBLICITY, PUBLICATIONS 	18
	 	 
	4.1	 	Confidentiality	18
	4.2	 	Authorized Disclosure	19
	4.3	 	Employees and Consultants	20
	4.4	 	Publicity	20
	4.5	 	Public Filings	20
	4.6	 	Publications and Presentations	21
	4.7	 	Permitted Publications	21
	4.8	 	Use of Proprietary Materials	21
	 	 	 	 
	ARTICLE 5 INTELLECTUAL PROPERTY RIGHTS 	22
	 	 
	5.1	 	Enteris Rights	22
	5.2	 	Cara Rights	22
	5.3	 	Notice; Inventorship	22
	5.4	 	Third Party Infringement	23
	5.5	 	Defense of Claims	24
	5.6	 	Patent Term Extension	25
	5.7	 	Patent Marking	25
	 	 	 	 
	ARTICLE 6 CONSIDERATION 	25
	 	 
	6.1	 	Upfront Fee	25
	6.2	 	Milestone Payments	26
	6.3	 	[***]	26
	6.4	 	Notice and Payment of Milestones	26

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	 

    	 

    

	6.5	 	Payment of Royalties; Accounting and Records	27
	6.6	 	Payment Dates and Reports	28
	6.7	 	Records; Audit Rights	28
	6.8	 	Overdue Payments	29
	6.9	 	Payments; Withholding Tax	29
	6.10	 	Foreign Currency Exchange	29
	6.11	 	Cara Obligations	29
	 	 	 	 
	ARTICLE 7 REPRESENTATIONS AND WARRANTIES; COVENANTS; LIABILITY 	30
	 	 
	7.1	 	Mutual	30
	7.2	 	By Cara	30
	7.3	 	By Enteris	31
	7.4	 	Warranty Disclaimer	32
	7.5	 	Indemnification; Insurance	32
	 	 	 	 
	ARTICLE 8 TERM AND TERMINATION 	34
	 	 
	8.1	 	Term	34
	8.2	 	Expiration of Term	34
	8.3	 	Termination for Material Breach	34
	8.4	 	Termination for Challenge	35
	8.5	 	Without Cause Termination	35
	8.6	 	Consequences of Termination	35
	8.7	 	Survival	36
	 	 	 	 
	ARTICLE 9 ASSIGNMENT; SUCCESSORS AND ASSIGNS 	36
	 	 
	ARTICLE 10 GOVERNING LAW 	37
	 	 
	ARTICLE 11 DISPUTE RESOLUTION; ARBITRATION 	37
	 	 
	11.1	 	Dispute Resolution	37
	11.2	 	Arbitration of Unresolved Disputes	37
	 	 	 	 
	ARTICLE 12 MISCELLANEOUS 	39
	 	 
	12.1	 	Amendment and Modification	39
	12.2	 	Headings	39
	12.3	 	Counterparts	39
	12.4	 	Waiver	39
	12.5	 	No Third Party Beneficiaries	40
	12.6	 	Independent Relationship	40
	12.7	 	Interpretation	40
	12.8	 	Entire Agreement; Severability	41
	12.9	 	Delay Due to Force Majeure	41
	12.10	 	Further Assurances	41
	12.11	 	Expenses	41
	 	 	 	 
	ARTICLE 13 NOTICE 	42

 

Exhibits and Schedules 

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	 

    	 

    

NON-EXCLUSIVE
LICENSE AGREEMENT

This
NON-EXCLUSIVE License AGREEMENT (“Agreement”) is made August
20, 2019 (the “Effective Date”) by and between CARA THERAPEUTICS, INC., incorporated and registered in the
State of Delaware and having offices at 4 Stamford Plaza, 107 Elm Street, 9th Floor, Stamford, CT 06902, USA (hereinafter
referred to as “Cara”), and Enteris Biopharma, Inc., incorporated
and registered in the State of Delaware and having offices at 83 Fulton St., Boonton, NJ 07005, USA (hereinafter referred to as
“Enteris”). Each of Enteris and Cara is sometimes referred to individually herein as a “Party”
and collectively as the “Parties.”

RECITALS

		A.	Enteris
                                         owns or otherwise controls certain proprietary technology and patent rights (defined
                                         below as Licensed Technology) claiming or covering formulations for oral delivery of
                                         peptide active pharmaceutical ingredients with functional excipients to enhance permeability
                                         and/or solubility, including in any oral solid dosage forms, and the development and
                                         manufacture of drug products using such formulations;

		B.	Cara
                                         wishes to obtain a non-exclusive license under the Licensed Technology on the terms and
                                         conditions of this Agreement; and

		C.	Enteris
                                         is willing to grant to Cara the requested license rights and Cara is willing to accept
                                         such rights pursuant to the terms and conditions of this Agreement.

NOW
THEREFORE, in consideration of the mutual covenants contained herein, and for other good and valuable consideration, it is
hereby agreed by and between the Parties as follows:

Article
1

Definitions

In
this Agreement the following words and phrases shall have the following meanings unless the context requires otherwise:

“AAA”
shall have the meaning set forth in Article 11.

“Affiliate”
means, with respect to a particular Party, any person, company, partnership or other entity, whether or not incorporated or in
existence at the Effective Date, that directly or indirectly controls, is controlled by or is under common control with such Party
to this Agreement. The term “control” for the purposes of this definition (with correlative meanings for the
terms “controlled by” and “under common control with”) means that the applicable person, company, partnership,
or other entity owns fifty percent (50%) or more (including ownership by trusts with substantially the same beneficial interests)
of the voting and equity rights of the applicable Party, or otherwise has the legal power to direct or cause the direction of
the general management and policies of such Party.

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 4 -

    	 

    

“Agreement”
shall have the meaning set forth in the Recitals.

“Applicable
Laws” means any national, international, federal, state or local laws, treaties, statutes, ordinances, rules and regulations,
including any rules, regulations, guidance, guidelines or requirements of any national, international, regional, state or local
regulatory agency, department, bureau, commission, council or other governmental entity, national securities exchanges or securities
listing organizations, that are in effect from time to time during the Term and apply to a particular activity or obligation hereunder.

“Assist”
means knowingly providing, directly or indirectly, a Third Party with (a) any analysis of the Licensed Patent Rights or any portion
thereof; (b) prior art or analysis of any prior art to any of the Licensed Patent Rights; (c) any documents in a Party’s
possession, custody, or control relating to the Licensed Patent Rights, in whole or in part, or to any prior art to any of the
Licensed Patent Rights; or (d) financial or technical support, in each case in connection with a Challenge by such Third Party
of the Licensed Patent Rights or any portion thereof.

“Bankruptcy
Code” means, as applicable, the U.S. Bankruptcy Code, as amended from time to time, and the rules and regulations and
guidelines promulgated thereunder, or the bankruptcy laws of any other Governmental Authority, as amended from time to time, and
the rules and regulations and guidelines promulgated thereunder, or any applicable bankruptcy laws of any other country or competent
Governmental Authority, as amended from time to time, and the rules and regulations and guidelines promulgated thereunder.

“Business
Day” means any day, other than a Saturday or Sunday, on which banking institutions in New York, New York are open for
business.

“Calendar
Quarter” means the period beginning on the Effective Date and ending on the last day of the calendar quarter in which
the Effective Date falls, and thereafter each successive period of three (3) consecutive calendar months beginning on January
1, April 1, July 1, or October 1 and ending, respectively on March 31, June 30, September 30 and December 31; provided, that,
the final Calendar Quarter shall end on the last day of the Term.

“Calendar
Year” means the period beginning on the Effective Date and ending on December 31 of the calendar year in which the Effective
Date falls, and thereafter each successive period of twelve (12) months commencing on January 1 and ending on December 31; provided,
that, the final Calendar Year shall end on the last day of the Term.

“Cara
Indemnitees” shall have the meaning set forth in Section 7.5(b).

“Cara
Indemnity Claims” shall have the meaning set forth in Section 7.5(b).

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 5 -

    	 

    

“Challenge”
means to contest, or knowingly to Assist a Third Party in its contest, of the validity or enforceability of the Licensed Patent
Rights, in whole or in part, in any court, arbitration proceeding or other legal, judicial, or administrative tribunal, including
the United States Patent and Trademark Office and the United States International Trade Commission. For the avoidance of doubt,
for the purposes of this definition, the term “contest” means: (a) filing an action under 28 U.S.C. §§
2201-2202 seeking a declaration of invalidity or unenforceability of any Licensed Patent Rights; (b) citation to the United States
Patent and Trademark Office pursuant to 35 U.S.C. § 301 of prior art patents or printed publications or statements of the
patent owner concerning the scope of any of the Licensed Patent Rights; (c) filing a request under 35 U.S.C. § 302 for re-examination
of any of the Licensed Patent Rights; (d) filing, or joining in, a petition under 35 U.S.C. § 311 to institute inter partes
review of any Licensed Patent Rights or any portion thereof; (e) filing, or joining in, a petition under 35 U.S.C. § 321
to institute post-grant review of the Licensed Patent Rights or any portion thereof; (f) provoking or becoming a party to an interference
with an application for any of the Licensed Patent Rights pursuant to 35 U.S.C. § 135; or (g) filing or commencing any re-examination,
opposition, cancellation, nullity or similar proceedings against any of the Licensed Patent Rights in any country.

 

“Change
of Scope” shall have the meaning set forth in Section 3.2(c).

“CMO”
means the third party manufacturer that Cara selects for commercial Manufacturing.

“Commercialization”
or “Commercialize” means any and all activities directed to the offering for sale and sale of a Product, from
the initial launch, including (a) activities directed to marketing, promoting, detailing, distributing, Manufacturing, importing,
selling and offering to sell that Product in the Territory (including pre-approval marketing activities); (b) conducting Phase
IV clinical trials with respect to that Product; (c) interacting with Regulatory Authorities regarding any of the foregoing; and
(d) seeking pricing approvals and reimbursement approvals (as applicable) for that Product in the Territory. When used as a verb,
“to Commercialize” and “Commercializing” means to engage in Commercialization and “Commercialized”
has a corresponding meaning.

“Commercially
Reasonable Efforts” means, with respect to the applicable task or activity under this Agreement, the application of
efforts and resources that are generally consistent with those that a comparable company in the pharmaceutical industry generally
would devote to accomplish such task or activity relating to products that are at a similar stage of development and have similar
commercial potential as Product, taking into account all applicable competition, market, scientific, technical, intellectual property,
regulatory, and commercial factors (including potential and actual economic return for the product), all based on then-prevailing
conditions. 

“Completion
of Analytical Procedures Transfer” means the date of the full and complete transfer of the analytical procedures by
Enteris to the CMO designated by Cara as specified in and in accordance with Section 3.2(a), as summarized in Section I (Transfer
of Analytical Procedures) of the Project Plan.

“Completion
of Manufacturing Process Transfer” means the date of the full and complete transfer of the Manufacturing process by
Enteris to the CMO designated by Cara as specified in and in accordance with Section 3.2(a), as summarized in Section II (Transfer
of Manufacturing Process) of the Project Plan.

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 6 -

    	 

    

“Confidential
Information” means, for a particular Party, any and all confidential and proprietary information, including any Know-how,
disclosed by such Party to the other in writing, orally or in any other form in connection with this Agreement, which may include
samples, documents, drawings, specifications data, graphics, technical know-how, letters, electronically transmitted documents,
e-mails, etc. Confidential Information of a Party includes the Proprietary Materials of such Party. In the case of Enteris, Confidential
Information includes Licensed Know-how and Improvements. In the case of Cara, Confidential Information includes any information
disclosed by Cara relating to any Drug and Product(s) produced with the support of the Licensed Technology. With respect to each
Party, Confidential Information includes this Agreement and the terms of this Agreement.

“Control”
or “Controlled” means, with respect to Know-how or Patent Rights, that the applicable Party, either directly
or through any of its Affiliates, owns or has a license (or sublicense) to or under, and has the right to grant to the other Party
access to and a license or sublicense under, such Know-how or Patent Rights as provided herein without the payment of additional
consideration to, or violating the terms of any agreement or arrangement with any Third Party, and without violating any Applicable
Laws. For clarity, no Party (or Affiliate of a Party, as applicable) shall be deemed to Control any Know-how or Patent Rights
by virtue of the license grants to that Party from or by the other Party as set forth in this Agreement.

“Debarred
Entity” shall have the meaning set forth in Section 7.1(e).

“Development”
or “Develop” means, with respect to a Product, all non clinical and clinical drug development activities that
are undertaken after the Effective Date, including (a) the preparation and filing of Regulatory Filings and all regulatory affairs
related to the foregoing, (b) obtaining, maintaining or expanding Regulatory Approvals of a Product, or (c) developing the ability
to manufacture clinical and commercial quantities of a Product. This includes: (i) preclinical testing, toxicology, and clinical
trials; (ii) preparation, submission, review, and development of data or information for the purpose of submission to a Regulatory
Authority to obtain, maintain or expand Regulatory Approvals of a Product; and (iii) Manufacturing Process Development associated
with the supply of a Product for preclinical testing and clinical trials, and related quality assurance and technical support
activities. When used as a verb, “Developing” means to engage in Development and “Developed” has a corresponding
meaning. For clarity, “Development” shall not include any Commercialization activities.

“Dispute”
shall have the meaning set forth in Section 11.1.

“Drug”
means CR845 (difelikefalin), and any salt forms, esters, prodrugs, biologically active metabolites or biologically active structural
analogs, solvates, hydrates and crystalline forms thereof.

“Effective
Date” shall have the meaning set forth in the Recitals.

“EMA”
means the European Medicines Agency or any successor agency or authority thereto.

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

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“End
of Phase 2 Meeting” means the end of Phase 2 meeting with the FDA, as described in 21 C.F.R. § 312.47(b), intended
to determine the safety of proceeding to Phase 3, to evaluate the Phase 3 plan and protocols, and to identify any additional information
necessary to support a marketing application for the uses under investigation.

“Enteris
DMF” means that certain [***] and the information contained therein.

“Enteris
Indemnitees” shall have the meaning set forth in Section 7.5(a).

“Enteris
Indemnity Claims” shall have the meaning set forth in Section 7.5(a).

“FDA”
means the United States Food and Drug Administration, or any successor entity thereto having substantially the same functions.

“FDCA”
means the United States Federal Food, Drug, and Cosmetic Act, enacted in 1938 as Public Law 75-717, as such may have been amended,
and which is contained in Title 21 of the U.S. Code, Section 301 et seq., as amended, and the regulations promulgated thereunder
from time to time.

“Field”
means all fields and uses, including all prophylactic, therapeutic and diagnostic uses for all human diseases, conditions and
indications.

“Force
Majeure” means any occurrence beyond the reasonable control of a Party that (a) prevents or substantially interferes
with the performance by such Party of any of its obligations hereunder and (b) occurs by reason of any act of God, flood, fire,
explosion, earthquake, casualty or accident, or war, revolution, civil commotion, act of terrorism, blockage or embargo, or any
injunction, law, order, proclamation, regulation, ordinance, demand or requirement of any government or of any subdivision, authority
or representative of any such government.

“Generic
Competition” means and shall be deemed to exist in a particular country in the Territory with respect to a particular
Product in a given Calendar Quarter if in such country during such Calendar Quarter one or more Generic Products (other than a
Generic Product sold by Cara or its Affiliates or by a Sub-licensee under a license granted by Cara or its Affiliates) in the
aggregate account (on a units sold basis) for more than [***] of the sum of (a) the aggregate unit sales of such Product sold
by Cara or its Affiliates or Sub-licensees in such country, and (b) the aggregate unit sales of such Generic Products in such
country, each in such Calendar Quarter, based on data provided by IQVIA (formerly, Quintiles IMS Holding, Inc.), or if such data
is not available, such other reliable data source as reasonably agreed upon by Cara and Enteris. If no data is commercially available,
then the Parties shall reasonably agree upon a commercially reasonable methodology for estimating the percentage unit-based market
share of Generic Products in such country during the applicable time period.

“Generic
Product” means, with respect to a particular Product and a particular country, any pharmaceutical product (other than
the Product) that contains the same active ingredient(s) in the same or substantially the same formulation and in a comparable
quality and quantity as such Product, and is approved under an Abbreviated New Drug Application (ANDA) or any foreign equivalent
thereof.

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

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“Governmental
Authority” means any multi-national, national, federal, state, local, municipal, provincial or other governmental, regulatory,
administrative, judicial, public or statutory instrumentality, court or governmental tribunal, agency, commission, authority,
body or entity, or any political subdivision thereof, having legal jurisdiction over the matter or party in question.

“Improvement”
means any Invention that constitutes a specific enhancement or improvement to or modification of the proprietary Licensed Technology
(including Peptelligence® Formulation Technology), whether or not patentable.

“IND”
means (a) an Investigational New Drug Application as defined in the FDCA or any successor application or procedure required to
initiate clinical testing of the Product in humans in the United States; (b) a counterpart of an Investigational New Drug Application
that is required in any other country or region in the Territory before beginning clinical testing of the Product in humans in
such country or region; and (c) all supplements and amendments to any of the foregoing.

“Indemnified
Party” shall have the meaning set forth in Section 7.5(c).

“Indemnifying
Party” shall have the meaning set forth in Section 7.5(c).

“Infringement”
shall have the meaning set forth in Section 5.4(a)

“Infringement
Notice” shall have the meaning set forth in Section 5.4(a).

“Invention”
means any new or useful process, machine, method of manufacture, or composition of matter, whether or not patentable, or any idea,
invention, discovery, improvement, enhancement, modification or derivative work, whether or not patentable or copyrightable, including
in respect of, relating to or comprising a Product, that is conceived and/or first reduced to practice (actually or constructively),
whether or not patentable, by or on behalf of Cara (including by an Affiliate, Sub-licensee or other Third Party) in connection
with the Development, Manufacture and/or Commercialization of Products.

“Know-how”
means any and all proprietary technical and other information, whether or not patentable, including ideas, concepts, know-how,
inventions, discoveries, data, formulae, processes, trade secrets, specifications, procedures for experiments and tests and other
protocols, results of experimentation and testing, manufacturing and purification techniques and protocols.

“Licensed
Know-how” means any and all Know-how comprising, relating to or using the Peptelligence® Formulation Technology
(including any formulations developed by Enteris using the Peptelligence® Formulation Technology, and any manufacturing processes
of Enteris of drugs using such formulations), that is Controlled by Enteris, prior to or during the Term, including any Improvements,
that is necessary or useful for the Development, Manufacture, use or sale of the Product. To the extent that Cara exercises its
right to a Royalty Buyout, “Licensed Know-how” shall exclude Improvements to such Know-how that are made by Enteris
after the date on which Enteris receives a payment from Cara in connection with such Royalty Buyout.

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

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“Licensed
Patent Rights” means any and all Patent Rights that claim or cover any Licensed Know-how, including the Peptelligence®
Formulation Technology (including any formulations developed by Enteris using the Peptelligence® Formulation Technology, and
any manufacturing processes of Enteris for drugs using such formulations), that are Controlled by Enteris prior to or during the
Term, and including any Improvements, that is necessary or useful for the Development, Manufacture, use or sale of the Product;
provided, however, to the extent that Cara exercises its right to a Royalty Buyout, “Licensed Patent Rights” shall
exclude Improvements claimed or covered in any such Patent Rights that are made by Enteris after the date on which Enteris receives
a payment from Cara in connection with such Royalty Buyout.

“Licensed
Technology” means the Licensed Know-how and the Licensed Patent Rights.

“Losses”
shall have the meaning set forth in Section 7.5(a).

“MAA”
means any application for Regulatory Approval submitted to the EMA pursuant to the centralized approval procedure to obtain European
Commission approval for the marketing of the Product in the European Union, or any successor application or procedure required
to sell the Product in the European Union.

“Manufacture”
means, with respect to the Product, any activities related to the formulation, production, manufacture, processing, filling, finishing,
packaging, labeling, release, shipping, holding, conduct of Manufacturing Process Development, stability testing, quality assurance,
release testing and quality control of such Product or any intermediate thereof for Development or Commercialization, and regulatory
activities related to any of the foregoing. When used as a verb, “Manufacturing” means to engage in Manufacture.

“Manufacturing
Process Development” means the development, qualification, validation and scale-up of the process used to manufacture
the Product and analytic development and product characterization with respect thereto.

“Manufacturing
Services Agreement” means that certain Phase 2 Clinical Manufacturing Services Agreement dated July 1, 2015, by and
between Enteris BioPharma, Inc., and Cara Therapeutics, Inc., as amended from time to time.

“NDA”
means a New Drug Application, as defined in the FDCA and regulations promulgated thereunder, or any successor application or procedure
required to sell the Product in the United States.

“Net
Sales” means the gross amount billed or invoiced by Cara or any of its Affiliates or Sub-licensees (each, a “Seller”)
to Third Parties (excluding sales of Products among Cara, its Affiliates and Sub-licensees for resale to Third Parties), throughout
the Territory for sales or other dispositions or transfers for value of Products, less [***]. In addition, Net Sales are subject
to the following:

[***]

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

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In
the case of pharmacy incentive programs, hospital performance incentive program chargebacks, disease management programs, similar
programs or discounts on products, all discounts shall be allocated among products on the basis on which such discounts were actually
granted or, if such basis cannot be determined, in proportion to the respective list prices of such products.

For
purposes of this Agreement, “sale” shall mean any commercial transfer or other commercial distribution or disposition,
but shall not include transfers or other distributions or dispositions of Products at no charge (or at cost) for academic research,
preclinical, clinical, or regulatory purposes (including the use of Products in clinical trials) or in connection with patient
assistance programs or other charitable purposes or to physicians or hospitals for promotional purposes (including free samples
to a level and in an amount which is customary in the industry and/or which is reasonably proportional to the market for such
Product).

Net
Sales (including the deductions) shall be determined from the books and records of Cara, its Affiliates and its Sub-licensees,
in all cases maintained in accordance with the relevant accounting standards, consistently applied. Such amounts shall be calculated
using the same accounting principles used by Cara (or the applicable Affiliate or Sub-licensee) for other Cara (or its Affiliate
or Sub-licensee) products for financial reporting purposes.

“One
Year Royalty Buyout” shall have the meaning in Section 6.5(c)(i).

“Patent
Rights” means issued patents and pending patent applications (which, for purposes of this Agreement, include certificates
of invention, applications for certificates of invention and priority rights) in any country or region, including all provisional
applications, substitutions, continuations, continuations-in-part, divisions, renewals, all letters patent granted thereon, and
all reissues, re-examinations and extensions thereof, and all foreign counterparts of any of the foregoing, and all the rights
and interests in and to any of the foregoing.

“Peptelligence®
Formulation Technology” means Enteris’ proprietary technology relating to the methods and processes used by
Enteris concerning the formulation, development, testing, manufacturing and/or packaging of active pharmaceutical ingredients,
including: (i) the development of formulations for oral delivery of peptide active pharmaceutical ingredients in an enteric coated
capsule or tablet containing a proprietary dry blend formulation of functional excipients to enhance permeability and/or solubility,
including in any oral solid dosage forms, and/or (ii) the manufacture of drugs using such formulations. Such proprietary technology
is generally described in Exhibit C of this Agreement.

“Product”
means any drug product containing Drug in a formulation using or covered by the Licensed Technology.

“Project
Plan” means that certain project plan attached hereto as Exhibit C of this Agreement and incorporated herein, as such
plan may be amended or modified by the Parties in writing from time to time.

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

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“Proprietary
Materials” means any tangible chemical, biological or physical materials that are furnished by or on behalf of one Party
to the other Party in connection with this Agreement, whether or not specifically designated as proprietary by the transferring
Party. Proprietary Materials of Enteris shall include the Enteris DMF and all contents contained therein.

“Recipient
Party” shall have the meaning set forth in Section 4.8.

“Recipients”
shall have the meaning set forth in Section 4.1.

“Regulatory
Approval” means (a) in the United States, approval by the FDA of an NDA or similar application for marketing approval,
and satisfaction of all related applicable FDA registration and notification requirements, if any, or (b) in any other country
in the Territory, approval by Regulatory Authorities (including pricing and reimbursement approvals) having jurisdiction over
such country of a single application or set of applications comparable to an NDA and satisfaction of all related applicable regulatory
and notification requirements required for the marketing and sale of pharmaceuticals in such country.

“Regulatory
Authority” means any national, international, regional, state or local regulatory agency, department, bureau, commission,
council or other governmental entity with authority over the distribution, importation, exportation, manufacture, production,
use, storage, transport, clinical testing, pricing, sale or reimbursement of the Product in the Territory, including the FDA and
the EMA.

“Regulatory
Filing” means, collectively: (a) any IND, NDA, MAA, establishment license application, drug master file, application
for designation as an “Orphan Product(s)” under the Orphan Drug Act, for “Fast Track” status under Section
506 of the FDCA (21 U.S.C. § 356), for “Breakthrough Therapy” status under Section 506 of the FDCA (21 U.S.C.
§356), or for a Special Protocol Assessment under Section 505(b)(4)(B) and (C) of the FDCA (21 U.S.C. § 355(b)(4)(B))
and all other similar filings (including counterparts of any of the foregoing in any country or region in the Territory); (b)
all supplements and amendments to any of the foregoing; and (c) all data and other information contained in, and correspondence
relating to, any of the foregoing.

“Royalty
Buyout” or “Royalty Buyouts” shall have the meaning set forth in Section 6.5(c)(ii).

“Royalty
Term” shall have the meaning set forth in Section 6.5(a).

“Securities
Act” shall have the meaning set forth in Section 6.5(c)(iii).

“Significant
Development Event” means any of the following material Development events, a summary of which shall be included in any
summary report: (a) any material interaction and/or written correspondence between Cara and any Regulatory Authority with respect
to the Manufacture of a Product; (b) any material event with respect to any clinical trial involving the Manufacture of a Product;
and (c) any material result obtained in the conduct of any clinical trial involving the Manufacture of a Product during the period
covered by the Development report.

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

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“Stock
Purchase Agreement” means that certain common stock purchase agreement, in the form set forth in Exhibit B of
this Agreement, that is entered into by the Parties concurrently with entry into this Agreement; for clarity, the Stock Purchase
Agreement is not incorporated into or made part of this Agreement.

“Sub-licensee”
means any Third Party to which Cara grants (directly or indirectly) a sublicense in accordance with Section 2.2.

“Sublicense
Agreement” means any agreement by and between Cara and a Sub-licensee, and any agreement between any of Cara’s
Sub-licensees and a further Sub-licensee, and all additional downstream sublicense agreements thereafter, that are entered into
in accordance with Section 2.2.

“Successful
Completion” means the delivery of the meeting minutes from the FDA for the End of Phase 2 Meeting allowing for the continuation
into Phase 3 clinical trials on Product.

“Term”
shall have the meaning set forth in Section 8.1.

“Territory”
means the United States (“U.S.”) and the rest of world excluding Japan and South Korea.

“Third
Party” means any Party other than Cara and Enteris and their respective Affiliates.

“Transferring
Party” shall have the meaning set forth in Section 4.8.

“Two
Year Royalty Buyout” shall have the meaning in Section 6.5(c)(ii).

“VWAP”
shall have the meaning set forth in Section 6.1.

Article
2

License Grant

2.1             
Grant of License to Cara. Subject to the terms of this Agreement, Enteris hereby grants to Cara a non-exclusive, royalty-bearing
license, including the right to grant sublicenses through multiple tiers as provided in Section 2.2, under the Licensed Technology,
to Develop, Manufacture, and Commercialize Products in the Territory for use in the Field.

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

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2.2             
Right to Sublicense. Cara shall have the right to grant sublicenses through multiple tiers under the license granted
to it under Section 2.1 to any of Cara’s Affiliates and to any Third Parties (including the rights of Sub-licensees to grant
further sublicenses) for the Development and Commercialization of Products in the Territory in the Field, including for Manufacture
of Product by a CMO; provided that (i) Cara shall not be relieved of any of its obligations under this Agreement; (ii) Cara shall
secure all appropriate covenants, obligations and rights from any such Sub-licensee, including licenses, assignment of intellectual
property rights and confidentiality obligations, to ensure that such Sub-licensee is subject to, and complies with, all of Cara’s
applicable covenants and obligations under this Agreement; (iii) Cara shall be responsible for the performance of its obligations
under this Agreement and shall use Commercially Reasonable Efforts to enforce the obligations of each Sub-licensee under the relevant
Sublicense Agreement, including the performance of activities required, the making of all payments due and the making of any reports
under this Agreement with respect to sales of Product by such Sub-licensee, and such Sub-licensee’s compliance with provisions
of Sections 2.1, 2.6, 5.1, 5.4, 5.5, 5.7 and Article 4 of this Agreement; (iv) Cara shall require such Sub-licensee to retain
such books and records, and Cara agrees that Cara will audit the books and records of any Sub-licensee, at Enteris’ request
and expense, in accordance with the provisions of Section 6.7; (v) Cara shall provide Enteris with a copy of any such Sublicense
Agreement executed by Cara pursuant to this Section 2.2 within [***] after execution; provided, that, the financial terms and
any other confidential terms of any such Sublicense Agreement may be redacted to the extent not relevant to the determination
or enforcement of Enteris’ rights under this Agreement; and (vi) Cara shall provide written notice to Enteris of such Sub-licensee
within [***] after execution, but not in order to seek approval. All obligations of Cara under this Section 2.2 shall apply mutatis
mutandis to all Sub-licensees of Cara that further sublicense their rights and obligations under this Agreement to further
Sub-licensees, and Cara shall require each of its Sub-licensees to include appropriate provisions in such further sublicense.

2.3             
Rights in Bankruptcy. All licenses and rights to licenses granted under or pursuant to this Agreement by Enteris to
Cara are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the Bankruptcy Code, licenses of rights to “intellectual
property” as defined under Section 101(35A) of the Bankruptcy Code.

2.4             
Disclosure of Technology. Enteris shall provide periodic written notice and disclosure to Cara of any and all Licensed
Technology that is necessary or useful for the Manufacture, use or sale of the Product that is or comes under the Control of Enteris
on or after the Effective Date and during the Term of the Agreement, except in the event that Cara exercises its Royalty Buyout,
Enteris shall only provide notice to Cara under this Section 2.4 of any Licensed Technology that comes under the Control of Enteris
after the Effective Date and on or prior to the date on which Enteris receives a payment from Cara in connection with the Royalty
Buyout.

2.5             
Retained Rights. Subject to the other terms of this Agreement, Enteris hereby retains the right to use and/or practice
the Licensed Technology to develop, manufacture, or commercialize or have developed, manufactured, or commercialized any product
(other than the Product) and for any and all uses either inside or outside of the Field and to otherwise exploit the Licensed
Technology for any and all uses outside of the license grant.

2.6             
Use of Licensed Technology. Cara hereby agrees that (a) it shall not use or practice the Licensed Technology for any
purpose other than exercising its rights and performing its obligations under this Agreement; and (b) except for the rights expressly
set forth in this Agreement, Cara is not granted any rights, title or interest in or to such Licensed Technology.

2.7             
Negative Covenant. In order to preserve the economic value of the business deal in this Agreement for each Party, Enteris
covenants that during the Term, it and its Affiliates shall not grant any third party generic manufacturer of pharmaceutical or
drug products any license or other rights (such as a covenant not to sue) under the Licensed Technology to Develop, Manufacture,
or Commercialize any drug products containing the Drug in the Territory for use in the Field; provided that, the foregoing covenant
shall automatically terminate, and this Section 2.7 shall thereafter be of no force and effect, if none of Cara or its Affiliates
or Sub-licensees have launched a commercial Product by [***].

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

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Article
3

Development, Regulatory and Commercialization

3.1             
Manufacture by Enteris. Enteris shall continue to perform its obligations under the Manufacturing Services Agreement
in accordance with the terms thereof, including manufacture and supply requirements for Drug products for ongoing and (if applicable)
future Phase 1 and Phase 2 clinical trials, until termination of such agreement. For clarity, the first sentence of Section 2.5
and the first sentence of Section 4.1(b) of the Manufacturing Services Agreement are hereby terminated.

3.2             
Technology Transfer by Enteris.

(a)              
Enteris acknowledges that the transfer of all Licensed Technology existing as
the Effective Date is critical to Cara’s ability to exercise its rights and receive its benefits under this Agreement. Enteris
hereby covenants that it shall complete the transfer of all such Licensed Technology, subject, however, to the cooperation, resources
and efforts of Cara’s CMO to fully and effectively receive such technology transfer, commencing on a date as reasonably specified
by Cara, and Enteris shall use diligent, good faith efforts to complete such technology transfer, including achieving the Completion
of Analytical Procedures Transfer and Completion of Manufacturing Processes Transfer, as soon as reasonably practicable thereafter.
Cara shall cause its CMO to use diligent, good faith efforts to accept the technology transfer, and the Parties shall (and Cara
shall cause its CMO to) work collaboratively and in good faith to conduct the full, accurate, and complete technology transfer
under the Project Plan through the Completion of Analytical Procedures Transfer and Completion of Manufacturing Process Transfer.

(b)              
The Parties agree that the fee for the work as set forth under Section I of the
Project Plan as of the Effective Date (Completion of Analytical Procedures Transfer) is [***]. Prior to commencement of the transfer
of the manufacturing process, fees for all work contemplated under Section II of the Project Plan (Transfer of Manufacturing Process)
shall be proposed by Enteris and agreed to by Cara, and such fees shall be commercially reasonable and typical for similar technology
transfer work. In the event that Cara reasonably determines that additional technology transfer work by Enteris – beyond
the tasks generally set forth in the then-current Project Plan – are needed to enable the CMO successfully to complete manufacture
of amounts of Product as specified in and in accordance with the criteria in Section II (Transfer of Manufacturing Process) of
the Project Plan to achieve Completion of Manufacturing Process Transfer, then the Parties shall discuss and agree reasonably
and in good faith on such additional work required to be conducted by the Parties (and, if applicable, any CMO selected by Cara)
to satisfy all the acceptance criteria in the Project Plan, and a timeline and budget for such work (with the Enteris fees for
such additional Enteris work to be commercially reasonable and typical for similar technology transfer work), in each case in
accordance with Section 3.2(c). Notwithstanding the foregoing, any additional work performed by Enteris in furtherance of the
analytical procedures transfer under Section I of the initial Project Plan, but not set forth in Section I of the Project Plan
as of the Effective Date, shall not be included in the [***] fee, and the fee for such additional work shall be commercially reasonable
and typical for similar technology transfer work. All payments due under this Section 3.2 shall be paid upon Completion of the
Analytical Procedures Transfer or Completion of the Manufacturing Process Transfer, as applicable.

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

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(c)               
Cara shall request additional services to the Project Plan in writing, detailing
the proposed changes to the services (“Change of Scope”). Within [***] of Enteris’ receipt of such proposed
Change of Scope, Enteris shall provide Cara with a cost and time estimate for performing the additional services as proposed,
and the fees for such work, which costs and fees shall be commercially reasonable and typical for similar work. The Parties shall
jointly review and discuss the proposed Change of Scope, costs, fees and time estimate reasonably and in good faith. Such additional
services shall become part of the Project Plan upon execution by both Parties of the Change of Scope. Any disagreements with respect
to the Change of Scope shall be subject to Section 11.1.

(d)              
For purposes of this Section 3.2, Cara shall ensure that any CMO of Cara is subject
to confidentiality provisions comparable in scope to Article 4 with respect to the transfer by Enteris to Cara and its CMO of
information and Know-how under Section 3.2. Enteris does not represent or warrant that the use of, or results from, the analytical
procedures or manufacturing processes will satisfy the requirements of any Regulatory Authority at the time of submissions of
any Regulatory Filings to any such Regulatory Authority.

3.3             
Cara’s Rights and Obligations.

(a)              
Except as provided in Section 3.1, Cara shall have the sole right and responsibility,
at its sole cost and expense, and in its sole discretion, for the Development, Manufacture and Commercialization of Products for
use in the Field and in the Territory.

(b)              
Cara shall have the sole right and responsibility, at its sole cost and expense,
and in its sole discretion, during the Term to Develop, seek Regulatory Approval, and (if Regulatory Approval is achieved) Commercialize
Products in the Field in the Territory and shall, in its sole discretion, commit such resources (including employees, consultants,
contractors, facilities, funding, equipment and materials) as it determines are necessary or appropriate to conduct such Development
and Commercialization activities.

(c)               
Cara shall provide Enteris with written reports describing in reasonable summary
its Development activities and Commercialization activities with respect to the Products in the Territory and the results of such
activities on an annual basis, with the first report being due [***] after the Effective Date, which reports shall include a reasonable
summary of: (a) all Development and Commercialization activities conducted with respect to the Product (including the status of
any clinical trials) and any launch plans (including expected date of first commercial sales of Product); (b) the Regulatory Filings
with respect to such Products that Cara or any of its Affiliates have filed, sought or obtained in the prior [***] period or reasonably
expect to make, seek or attempt to obtain in the following [***] period in the Territory, and (c) any Significant Development
Events applicable to the Product. The reports shall also include a summary of all material questions asked by any Regulatory Authority
to Cara regarding the Licensed Technology and of Cara’s responses thereto. For purposes of clarity, the obligation to provide
summary reports hereunder does not affect or supersede any such reporting or disclosure obligations of Cara as set forth in the
Manufacturing Services Agreement.

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

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3.4             
Regulatory Responsibility. Cara (and including its Affiliates and Sub-licensees) shall have the sole right and responsibility,
at its and their sole discretion for (a) preparing, filing and maintaining all Regulatory Filings for Products in its own name
in the Territory; provided that Enteris shall prepare, file and solely and exclusively own the Enteris DMF and all contents therein,
and Cara shall have no ownership interest whatsoever in the Enteris DMF or the contents therein, and (b) reporting to Regulatory
Authorities all adverse events and serious adverse events occurring in any clinical trials conducted by Cara related to any Products,
to the extent required by Applicable Laws. Enteris agrees to provide Cara with all information contained in the Enteris DMF, and
in any analogous regulatory filing or documents in any other jurisdiction, to facilitate Cara’s Regulatory Filings in jurisdictions
where the Enteris DMF is not recognized, subject to Section 4.8, it being understood that such information is deemed Proprietary
Materials of Enteris.

3.5             
Recalls. If any Regulatory Authority issues or requests a recall or takes similar action in connection with any Product
in the Territory, or if Cara (or and its Affiliate or Sub-Licensee) reasonably believes that an event, incident or circumstance
has occurred that may result in the need for a recall, market withdrawal or other corrective action regarding the Product, Cara
shall promptly advise Enteris thereof by telephone or facsimile. Following such notification, Cara (or and its Affiliate or Sub-Licensee)
shall decide and have control of whether to conduct a recall or market withdrawal (except in the event of a recall or market withdrawal
mandated by a Regulatory Authority, in which case it shall be required) or to take other corrective action in any country and
the manner in which any such recall, market withdrawal or corrective action shall be conducted; provided, that, Cara shall keep
Enteris regularly informed regarding any such recall, market withdrawal or corrective action. All expenses incurred by Cara in
connection with any such recall, market withdrawal or corrective action (including, without limitation, expenses for notification,
destruction and return of the affected Product and any refund to customers of amounts paid for such Product) shall be the sole
responsibility of Cara.

3.6             
Safety Information. Each Party shall disclose to other Party any and all information of which that Party (or its Affiliate)
becomes aware relating to any safety issues for formulations using or based on the Licensed Technology, which reasonably may impact
the safety of Product, such disclosure to be made promptly after the Party becomes aware thereof.

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 17 -

    	 

    

3.7             
Reference Rights. Cara (and its Affiliates and Sub-Licensees) shall have (i) the right of reference to the Enteris
DMF and the information therein, and (ii) the right to reference the information contained in the Enteris DMF in all of Cara’s
(and its Affiliates and Sub-Licensees) Regulatory Filings in jurisdictions where the Enteris DMF is not recognized, in each case
solely for the purpose of exercising, using and practicing the licenses and other rights granted to Cara pursuant to this Agreement,
provided that Cara shall bear any expenses (including expenses of Enteris) in respect of exercising any such right of reference.

 

Article
4

Confidentiality, Publicity, Publications

4.1             
Confidentiality. Each Party agrees that, during the Term and for a period of [***] thereafter, it and its Affiliates
shall keep confidential and shall not publish or otherwise disclose to any Third Party and shall not use for any purpose other
than to exercise its rights or perform its obligations under this Agreement or the Project Plan any Confidential Information furnished
to it or its Affiliate by the other Party or its Affiliate pursuant to this Agreement or the Project Plan, except to the extent
expressly authorized by this Agreement or the Project Plan, or as otherwise agreed to in writing by the Parties. Each Party shall
further require its Affiliates, and its and their respective directors, officers, employees, agents, consultants, sublicensees,
contractors, partners, acquirors, assignees, and distributors (collectively, “Recipients”) who receive the
other Party’s Confidential Information to agree, in writing, to be bound by duties and obligations of confidentiality and
non-use no less stringent than those contained in this Section 4.1. The foregoing confidentiality and non-use provisions will
apply over any preceding obligations of confidentiality between Enteris and Cara, including those set forth in the Manufacturing
Services Agreement. The foregoing confidentiality and non-use obligations do not apply to any particular portion of the disclosing
Party’s Confidential Information that the receiving Party can demonstrate by competent written proof:

(a)              
was already known to or otherwise in the possession of, the receiving Party, other
than under an obligation of confidentiality, prior to the time of disclosure by the disclosing Party or its Affiliate, as evidenced
by contemporaneous writing;

(b)              
was part of the public domain at the time of its disclosure to the receiving Party
or any of its Recipients;

(c)               
became part of the public domain after its disclosure and other than through any
act or omission of the receiving Party or any of its Recipients in breach of this Agreement;

(d)              
was disclosed to the receiving Party on a non-confidential basis by a Third Party
who, to the receiving Party’s knowledge after due inquiry, had a legal right to make such disclosure; or

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 18 -

    	 

    

(e)               
was independently discovered or developed by the receiving Party or its Affiliate
without aid, application, reference to or use of the disclosing Party’s Confidential Information, as evidenced by a contemporaneous
writing dated prior to the time of disclosure by the disclosing Party or its Affiliate.

4.2             
Authorized Disclosure. Notwithstanding the obligations set forth in Section 4.1, a Party or its Affiliate may disclose
the other Party’s Confidential Information and the terms of this Agreement to the extent:

(a)              
such disclosure is reasonably necessary (i) for the filing or prosecuting of Patent
Rights as contemplated by this Agreement; (ii) to comply with the requirements of Regulatory Authorities with respect to obtaining
and maintaining Regulatory Approval of a Product or submission of information to tax or other Governmental Authorities; (iii)
for prosecuting or defending litigation as contemplated by this Agreement; or (iv) complying with Applicable Law;

(b)              
such disclosure is reasonably necessary to its officers, directors, employees,
agents, consultants, contractors, licensees, sublicensees, attorneys, accountants, sources of debt or equity financing, insurers
or licensors who need to know such information in order for such Party to perform its obligations or exercise its rights under
this Agreement, and to potential acquirers, merger partners, strategic partners, or sources of debt or equity financing, and their
professional advisors, for use in diligence and related activities in the proposed transaction(s); provided that in each case,
the disclosees are bound by written obligations of confidentiality and non-use, or by equivalent professional ethical obligations,
no less stringent than those of this Agreement with a reasonable duration based on customary terms;

(c)               
such disclosure is reasonably necessary to any bona fide potential or actual investor,
acquiror, merger partner or other financial or commercial partner for the sole purpose of evaluating an actual or potential investment,
acquisition or other business relationship; provided that, in each case, the disclosees are bound by written obligations of confidentiality
and non-use no less stringent than to those of this Agreement with a reasonable duration based on customary terms, and further
provided that in the case of any such disclosure of Confidential Information to any actual or potential competitor of either Party,
all competitively sensitive information (including, for the avoidance of doubt, all financial information) herein shall be redacted
until, subject to Applicable Laws, the execution of a definitive agreement with such actual or potential competitor to implement
a transaction with the receiving Party is imminent; or

(d)              
such disclosure is reasonably necessary to comply with Applicable Laws, including
regulations promulgated by applicable security exchanges, court order, administrative subpoena or other order.

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 19 -

    	 

    

(e)               
Notwithstanding the foregoing, if a Party or its Affiliate is required to make
a disclosure of the other Party’s Confidential Information pursuant to Section 4.2(a)(iii)-(iv) or 4.2(d), then such Party
shall (i) promptly notify the other Party of such required disclosure, (ii) give the other Party an opportunity to seek confidential
treatment and, upon the other Party’s request, such Party and its Affiliates shall use reasonable efforts to obtain, or
to assist the other Party in obtaining, a protective order preventing or limiting the required disclosure and (iii) if the other
Party is unsuccessful in its efforts pursuant to subsection (ii), disclose only that portion of the Confidential Information that
such Party is legally required to disclose.

4.3             
Employees and Consultants. Enteris and Cara each hereby represents that all of its employees and consultants, and all
of the employees and consultants of its Affiliates, who have access to Confidential Information of the other Party are or will,
prior to having such access, be bound by written obligations to maintain such Confidential Information in confidence. Each Party
agrees to use, and to cause its Affiliates to use, Commercially Reasonable Efforts to enforce such obligations and to prohibit
its employees and consultants from using such information except as expressly permitted hereunder. Recipient party will be liable
to the other for any disclosure or misuse by its employees of Confidential Information of the disclosing Party.

4.4             
Publicity. The Parties shall, upon the execution of this Agreement, issue a joint press release with respect to this
Agreement in a form mutually agreeable by both Parties, and each Party may make subsequent public disclosure of the contents of
such press release without further approval of the other Party. After release of such press release, if either Party or its Affiliate
desires to make a public announcement concerning the existence or terms of this Agreement, or any clinical or regulatory announcements,
early notification of such public announcement by the proposing Party shall be given in writing to the other Party at least [***]
before the proposed disclosure date and a draft of such public announcement shall be sent to the commenting Party for its review
and comment at least [***] before the proposed disclosure date, but subject to Section 4.5. Under no circumstances shall any competitively
sensitive information contained in this Agreement (including all financial information, including total value of this Agreement)
be disclosed, except as otherwise provided in Section 4.5.

4.5             
Public Filings. The Parties acknowledge that either or both Parties may be obligated to file under Applicable Laws
a copy of this Agreement with the U.S. Securities and Exchange Commission or other Governmental Authorities. Each Party shall
be entitled to make such a required filing, provided that it requests confidential treatment of the commercial terms and sensitive
technical terms hereof and thereof to the extent such confidential treatment is reasonably available to such Party. In the event
of any such filing, each Party will provide the other Party with a copy of this Agreement marked to show provisions for which
such Party intends to seek confidential treatment and shall reasonably consider and incorporate the other Party’s reasonable
comments thereon to the extent consistent with the legal requirements, with respect to the filing Party, governing disclosure
of material agreements and material information that must be publicly filed. Further, each Party acknowledges that the other Party,
or its successor, may be required by Applicable Laws to make public disclosure of events or results of activities under this Agreement,
and that such disclosures may be made, if required by such Applicable Laws, prior to the expiration of the notice periods in Section
4.4., provided that a Party (or successor) shall not, in any such public disclosure, disclose any of the other Party’s
Confidential Information, unless such Party is required by Applicable Law to make such a public disclosure of such particular
information.  In such event, such Party shall submit the proposed disclosure in writing to the other Party as far in advance
as reasonably practicable so as to provide a reasonable opportunity to comment thereon, and such Party required to make the disclosure
shall consider all comments from such other Party in good faith, and shall in any event only disclose such information of the
other Party as is required by Applicable Law to be disclosed publicly in such manner.

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 20 -

    	 

    

4.6             
Publications and Presentations. Except for disclosures permitted pursuant to Section 4.4 or Section 4.5, if a Party
wishes to make a publication relating to activities conducted under this Agreement or the results of such activities hereunder,
and such publication would disclose Confidential Information of the other Party, (a) it shall deliver to the other Party a copy
of any such proposed written publication or an outline of a proposed oral disclosure at least [***] prior to submission for publication
or presentation, (b) the reviewing Party shall have the right to require a delay of up to [***] in publication or presentation
in order to enable patent applications to be filed protecting such reviewing Party’s rights in potentially patentable inventions
that are owned by such Party and that would be publicly disclosed by the publication of the information in such publication, and
(c) such reviewing Party shall have the right to prohibit disclosure of any of its Confidential Information in any such proposed
publication or presentation. In any such publication or presentation by a Party, the other Party’s contribution shall be
duly recognized, in accordance with customary industry standards. For clarity, Cara is free to make publications about its (and
its Affiliates’ and Sub-licensees’) activities under this Agreement, and results of such activities, without review
by Enteris, provided that such publications do not disclose Confidential Information of Enteris. Further, Enteris covenants that
it and its Affiliates shall not publish (or permit publication of) any non-public information relating to Cara’s (and its
Affiliate’s and Sub-licensee’s) activities under this Agreement, or the results of such activities, without the prior
written consent of Cara, such consent not to be unreasonably withheld.

4.7             
Permitted Publications. Notwithstanding Sections 4.4 through 4.6, either Party may include in a public disclosure or
in a scientific or medical publication or representation, without prior delivery to or approval by the other Party, any information
which has previously been included in a public disclosure or scientific or medical publication that has been approved or otherwise
made pursuant to Section 4.4 or 4.5 or reviewed pursuant to Section 4.6 or published or publicly disclosed by the other Party.
A Party relying on this Section 4.7 shall bear the burden of establishing that information has previously been included in a public
disclosure or scientific or medical publication that has been approved pursuant to Section 4.4 or 4.5 or reviewed pursuant to
Section 4.6 or published or publicly disclosed by the other Party. For clarity, Cara (and its Affiliates and Sub-licensees) retain
the full rights to publish clinical and other data and results relating to Drug or Product without consent of or comment by Enteris,
provided that such publications do not disclose Enteris Confidential Information. Cara and Enteris each may further disclose or
publish that Cara and Enteris are parties to this Agreement and the general scope of the rights granted hereunder, but excluding
any financial terms or the total value of the Agreement.

4.8             
Use of Proprietary Materials. From time to time during the Term, one Party (the “Transferring Party”)
may supply the other Party (the “Recipient Party”) with Proprietary Materials of the Transferring Party for
use in the Manufacture or Development of a Product. In connection therewith, each Recipient Party hereby agrees that: (a) it shall
not use such Proprietary Materials for any purpose other than exercising its rights or performing its obligations hereunder; (b)
it shall use such Proprietary Materials only in compliance with all Applicable Laws; (c) it shall not transfer any such Proprietary
Materials to any Third Party without the prior written consent of the Transferring Party, except for (i) the transfer of Products
for use in clinical trials or (ii) in a transaction expressly permitted hereby (such as transfer by Cara to its CMO); (d) the
Recipient Party shall not acquire any right of ownership or title in or to such Proprietary Materials as a result of such supply
by the Transferring Party; and (e) upon the expiration or termination of this Agreement, the Recipient Party shall, if and as
instructed by the Transferring Party, either destroy or return any such Proprietary Materials that are not the subject of the
grant of a continuing license under this Agreement.

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 21 -

    	 

    

Article
5

Intellectual Property Rights

5.1             
Enteris Rights. Enteris shall own all rights, title, and interest on a worldwide basis in and to the Licensed Patent
Rights and Licensed Know-how, including any Improvements (including any Patent Rights claiming or covering such Improvements)
regardless of inventorship, used to formulate, develop or otherwise exploit the Drug or Product, and Enteris retains all rights
to prosecute and maintain the Licensed Patent Rights at its sole discretion and sole expense. Cara shall cooperate with and assist
Enteris in all reasonable respects, at Enteris’ expense, in connection with Enteris’ preparation, filing, prosecution
(including review and comments regarding responses to office actions and/or official actions from worldwide patent offices) and
maintenance of such Licensed Patent Rights, including by obtaining assignments to reflect chain of title consistent with the terms
of this Agreement, gaining United States patent term extensions, supplementary protection certificates and any other extensions
that are now or become available in the future wherever applicable to such Licensed Patent Rights.

5.2             
Cara Rights. Cara shall own all rights, title, and interest on a worldwide basis in and to any Inventions, other than
Improvements, including any Patent Rights claiming or covering any such Invention, and Cara shall retain all rights to prosecute
and maintain such Patent Rights in its sole discretion and sole expense. Further, and notwithstanding the foregoing, Cara shall
own the overall formulation of the Product, provided that Enteris shall retain ownership of all Licensed Technology that
claims or is incorporated in such formulation. Notwithstanding the foregoing, Cara acknowledges that a license shall be required
with respect to any formulation to the extent that the formulation uses or practices issued patents or Confidential Information
of Enteris in the Licensed Technology (excluding any Confidential Information that is subject to any of the exceptions in subsections
4.1(a)-(e)).

5.3             
Notice; Inventorship. Cara hereby agrees to promptly notify Enteris of the conception or reduction to practice of any
Improvements made by or on behalf of Cara and to promptly execute any documents that may be necessary to perfect Enteris’
ownership and rights in and to any such Improvements. In case of a dispute between the Parties over whether any particular Invention
is an Improvement, such dispute shall be resolved according to U.S. patent law pursuant to Article 11, with an arbitration (if
conducted) by patent counsel mutually selected by the Parties who (and whose firm) is not at the time of the Dispute, and was
not at any time during the [***] prior to such Dispute, performing services for either of the Parties. Expenses of the patent
counsel shall be shared equally by the Parties. With respect to any Inventions that are Improvements, Cara, its Affiliates and
Sub-licensees, and their respective employees, subcontractors and contractors, and agents, shall assign, and do hereby irrevocably
and perpetually assign, to Enteris, all worldwide rights, title and interest in and to all such Improvements (including all Patent
Rights or other intellectual property rights relating thereto).

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 22 -

    	 

    

5.4             
Third Party Infringement.

(a)              
Notice. If either Party becomes aware
of any suspected infringement or misappropriation of any Licensed Technology that cover the Development, Manufacture or Commercialization
of the Product anywhere in the Territory (each, an “Infringement”), that Party shall promptly notify the other
Party within [***] and provide it with all details of such Infringement of which it is aware, excluding privileged information
(each, an “Infringement Notice”).

(b)              
Enteris Right to Enforce. Enteris
shall have the first right, but not the obligation, to address such Infringement in the Territory that involves such Licensed
Technology by taking reasonable steps, which may include the institution of legal proceedings or other action, and to compromise
or settle such Infringement (each, an “Infringement Response”); provided, that: (A) Enteris shall keep Cara
fully informed about such Infringement Response and Cara shall provide, at Enteris’ expense all reasonable cooperation to
Enteris in connection with such Infringement Response; (B) Enteris shall not take any position with respect to, or compromise
or settle, any such Infringement in any way that is reasonably likely to directly and adversely affect the scope, validity or
enforceability of any such Licensed Technology, without the prior consent of Cara, which consent shall not be unreasonably withheld,
conditioned or delayed; and (C) if Enteris does not intend to prosecute or defend an Infringement, or ceases to diligently pursue
an Infringement Response with respect to such an Infringement, it shall inform Cara in such a manner that such Infringement Response
will not be prejudiced and Section 5.4(c) shall apply. [***]

(c)               
Cara’s Right to Enforce. If
(A) Enteris informs Cara in writing that it does not intend to prosecute any Infringement Response with respect to any such Infringement,
(B) within [***] after the receipt of notice of any such Infringement, Enteris has not commenced to take any Infringement Response
with respect thereto, or (C) if Enteris does not diligently pursue any such Infringement Response, then, unless Enteris provides
Cara with a commercially reasonable justification for its delay of such Infringement Response, and provided that such delay
will not adversely affect the scope, validity or enforceability of the Licensed Technology subject to the Infringement and will
not materially affect Cara’s Commercialization of Product, Cara shall have the right, at its own expense, upon written notice
to Enteris to take appropriate action to address such Infringement, including by initiating an Infringement Response or taking
over prosecution of any legal proceedings initiated by Enteris. In that event, Cara shall keep Enteris fully informed about such
Infringement Response and shall consult with Enteris before taking any major steps during the conduct of that Infringement Response.
Enteris shall provide reasonable cooperation to Cara in connection with that Infringement Response. Cara shall not take any position
with respect to, or compromise or settle, such Infringement in any way that is reasonably likely to directly and adversely affect
the scope, validity or enforceability of such Licensed Technology. [***]

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 23 -

    	 

    

(d)              
Right to Representation. Each Party
shall have the right to participate and be represented by counsel that it selects, in any Infringement Response instituted under
Section 5.4(b) or 5.4(c) by the other Party. If a Party with the right to initiate an Infringement Response under Section 5.4
to eliminate an Infringement lacks standing to do so and the other Party has standing to initiate such action, then the Party
with the right to initiate an action under Section 5.4 may name the other Party as plaintiff in such action or may require the
Party with standing to initiate such Infringement Response at the expense of the other Party.

(e)               
Cooperation. In any Infringement Response
instituted under this Section 5.4, the Parties shall cooperate with and assist each other in all reasonable respects. Upon the
reasonable request of the Party instituting that Infringement Response, the other Party shall join such Infringement Response
and shall be represented using counsel of its own choice, at the requesting Party’s expense.

(f)               
Allocation of Recoveries. Any settlements,
damages or monetary awards (“Recovery”) recovered by either Party pursuant to any Infringement Response shall,
after reimbursing the Parties for their reasonable out-of-pocket expenses in making such recovery (which amounts shall be allocated
pro rata if insufficient to cover the totality of such expenses), [***].

5.5             
Defense of Claims. If any action, suit or proceeding is brought against either Party or any Affiliate of either Party
alleging the infringement of the Know-how or Patent Rights of a Third Party by reason of the Development, Manufacture or Commercialization
of any Product, such Party shall notify the other Party within [***] of the earlier of (a) receipt of service of process in such
action, suit or proceeding, or (b) the date such Party becomes aware that such action, suit or proceeding has been instituted,
and the Parties shall meet as soon as possible to discuss the overall strategy for defense of such matter. Except as otherwise
agreed in writing by the Parties, the Party alleged to have infringed, or whose Affiliate or Sub-licensee is alleged to have infringed,
shall have the obligation to defend such action, suit or proceeding at its sole expense, and in its sole discretion; the other
Party shall have the right to separate counsel at its own expense in any such action, suit or proceeding, provided that
its intellectual property rights are actually at issue in the action or proceeding, and that it shall not interfere or compromise
the defending Party’s defense of such action. In any such action or proceeding, the Parties shall cooperate with each other
in all reasonable respects in the defense of any such action, suit or proceeding. All such expenses with respect to any such action,
suit or proceeding in the Territory shall be borne solely by the Party defending such action, suit or proceeding. Each Party shall
promptly furnish the other Party with a copy of each communication relating to the alleged infringement that is received by such
Party including all material documents filed in any related litigations as to such infringement that are reasonably needed by
the other Party, but excluding confidential or privileged communications or documents.

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 24 -

    	 

    

5.6             
Patent Term Extension. The Parties shall cooperate with each other in obtaining patent term extensions or supplemental
protection certificates or their equivalents in any country in the Territory where applicable to Licensed Patent Rights. Such
cooperation shall include diligently and timely conferring and coordinating with respect to such matters to ensure compliance
with applicable filing deadlines, and agreeing on procedures to be followed by the Parties to ensure such compliance. In the event
that elections with respect to obtaining such patent term extension are to be made, Enteris shall have the right to make the election
with respect to Licensed Patent Rights.

5.7             
Patent Marking. Cara agrees to mark, and to cause its Affiliates and Sub-licensees to mark, Products sold in the U.S.
with all applicable U.S. patent numbers in issued Patent Rights that claim the Product (or its manufacture), and to mark Products
shipped to or sold in other countries, in each case to comply with the patent laws and practices of the countries of manufacture,
use and sale. Such marking may be on the packaging for the Products, if permitted by Applicable Laws.

 

Article
6

Consideration

6.1             
Upfront Fee. In consideration of the grant by Enteris to Cara of the license in Section 2.1, Cara shall pay Enteris
or Enteris’ designees (as contemplated by the Stock Purchase Agreement) a non-refundable, non-creditable upfront fee in
an aggregate amount equal to eight million dollars ($8,000,000), fifty percent (50%) of which shall be payable by transfer of
immediately available funds, within five (5) days of execution of this Agreement, in accordance with the wire transfer instructions
set forth in Exhibit A, attached hereto and incorporated herein, and the invoice provided in writing by Enteris to Cara
prior to the Effective Date, and the other fifty percent (50%) of which shall be paid in Cara stock issued by Cara to Enteris,
or its designee, pursuant to the terms of the Stock Purchase Agreement.

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 25 -

    	 

    

6.2             
Milestone Payments. Cara shall make the following non-refundable, non-creditable one-time payments to Enteris within
[***] after the first achievement of each of the following milestone events with respect to Cara’s first Product (or Products,
cumulatively, in the case of sales milestones) (whether such milestone is achieved by Cara or its Affiliate or Sub-licensee) utilizing
the Licensed Technology, regardless of indication:

			Milestone
    Event	 	 	Payment
    
($ U.S. Dollars)	 
	Milestone #1	 	 	[***]	 	 	$	[***]	
	Milestone #2	 	 	[***]	*		$	[***]	
	Milestone #3	 	 	[***]	 	 	$	[***]	
	Milestone #4	 	 	[***]		 	$	[***]	
	Milestone #5	 	 	[***]		 	$	[***]	
	Milestone #6	 	 	[***]		 	$	[***]	
	Milestone #7	 	 	[***]		 	$	[***]	

 

*[***]

6.3             
[***]

 

6.4             
Notice and Payment of Milestones. Cara shall provide Enteris with prompt written notice, in any event within [***]
thereafter, upon Cara’s knowledge of the occurrence of each milestone event set forth in Section 6.2. If Enteris believes
any such milestone event has occurred and has not received a written notice of same from Cara, it shall so notify Cara and shall
provide to Cara documentation or other information that support its belief. Any dispute under this Section 6.4 that relates to
whether or not a milestone event has occurred shall be resolved by discussion and, if needed, arbitration in accordance with Article
11. If Cara determines that there is a reasonable likelihood of a particular milestone event being achieved on or about a particular
date, Cara shall use reasonable efforts to provide advance notice thereof to Enteris, which notice shall be provided solely for
Enteris’ planning purposes and shall not be construed as a representation, warranty or covenant by Cara that such milestone
event will occur when anticipated, or at all. Each milestone payment under Section 6.2 shall only be payable once, and, for clarity,
the total amount of milestones payable under Section 6.2 shall not exceed $[***].

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 26 -

    	 

    

6.5             
Payment of Royalties; Accounting and Records.

 

(a)              
Payment of Royalties. Cara shall pay
Enteris a tiered royalty on the applicable amount of Net Sales of Products in each Calendar Year (or partial Calendar Year) at
the following rates:

	Aggregate Amount of Net Sales in a 

Calendar Year for All Products in All Indications	 	Royalty Rate (%)	 
	Amount of annual Net Sales [***] 
	 	 	[***]	%
	Amount of annual Net Sales [***]	 	 	[***]	%

 

[***]

(b)              
Royalty Reductions. For sales of Product
in countries where there is no valid claim in an issued patent in the Licensed Patent Rights that covers the Product, royalties
for such Product in such country will be paid on Net Sales of such Product in such country at [***] of the royalty rate otherwise
applicable to such Net Sales in the above schedule.

(c)               
Royalty Buyout.

     (i)                
On or before the first (1st) anniversary of the Effective Date, Cara shall have
the right, but not the obligation, to terminate its obligation to pay any royalties by paying to Enteris or Enteris’ designees
(as contemplated by the Stock Purchase Agreement) the sum of [***] payable in cash (the “One Year Royalty Buyout”).

     (ii)              
After the first (1st) anniversary of the Effective Date but on or before
the second (2nd) anniversary of the Effective Date, Cara shall have the right, but not the obligation, to terminate its obligation
to pay any royalties by paying to Enteris or Enteris’ designees (as contemplated by the Stock Purchase Agreement) the sum
of [***] payable in cash (the “Two Year Royalty Buyout”, collectively with the One Year Royalty Buyout, the
“Royalty Buyouts”, and each a “Royalty Buyout”).

     (iii)            
If either (x) Cara is a “well-known seasoned issuer,” as such term
is defined in Rule 405 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), as of the
date of the exercise of the Royalty Buyout, or (y) (i) the staff of the Division of Corporation Finance of the U.S. Securities
and Exchange Commission has issued to Cara a no-action letter regarding the commencement of the holding period under Rule 144(d)
promulgated under the Securities Act for such shares of Cara stock as are otherwise issuable at the election of Cara as partial
payment of the Royalty Buyout as permitted under this Section 6.5(c)(iii), and such no-action letter permits tacking of such holding
period back to the date of this Agreement, and (ii) sufficient time has passed since the date of this Agreement (and all other
requirements under Rule 144 are met) to permit the holders of the stock to be issued by Cara in relation to the Royalty Buyout
to sell all such shares on the date of Cara’s exercise of such option in compliance with Rule 144 under the Securities Act
without any restrictions, then Cara shall have the option, but not the obligation, to pay fifty percent (50%) of the Royalty Buyout
amount by issuing Cara stock to Enteris or its designee pursuant to the Stock Purchase Agreement.

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 27 -

    	 

    

     (iv)            
In order to exercise a Royalty Buyout, Cara shall notify Enteris and, if the option
to partially pay in Cara stock as permitted by Section 6.5(c)(iii) above is exercised by Cara, EBP Holdco LLC and any designees
of Enteris and EBP Holdco LLC, in writing that it is paying the Royalty Buyout and shall pay such Royalty Buyout within [***]
of such notice. For avoidance of doubt, upon Enteris’ receipt of the Royalty Buyout under this Section 6.5(c), no royalties
shall thereafter be due to Enteris under this Agreement and the Royalty Term (and the provisions of this Section 6.5) shall end
immediately. For the avoidance of doubt, the expiration of the Royalty Term, including due to payment of a Royalty Buyout, shall
not affect Cara’s obligation to pay Enteris milestones pursuant to Section 6.2 of this Agreement, including milestone events
based on [***]. In the event that Cara provides Enteris with a notice that it is exercising the Royalty Buyout but no payment
is received by Enteris within the [***] period (other than solely due to an issue with Enteris or its bank), then the Royalty
Buyout is deemed to not have been exercised. Such failure to pay the Royalty Buyout amount within that [***] period is not subject
to cure.

6.6             
Payment Dates and Reports. Cara shall make all royalty payments due hereunder within [***] after the end of each Calendar
Quarter in which the sale of such Product shall occur. Cara shall provide, within [***] after each Calendar Quarter in which a
sale of such Product shall occur, a report showing: (a) the Net Sales of each Product by type of Product and country in the Territory;
(b) an itemization of the deductions permitted to determine Net Sales; (c) a calculation of the amount of royalty due to Enteris,
if applicable; and (d) [***]. Payment of all milestone events due hereunder, including the milestones on [***], shall be made
in accordance with Section 6.2. The Parties agree that, notwithstanding anything to the contrary in the Manufacturing Services
Agreement, Cara has and shall have no further obligation under Section 4.1(b) of the Services Agreement to pay any additional
License Access Fees (as defined in the Manufacturing Services Agreement), and any such obligation going forward is hereby terminated.

6.7             
Records; Audit Rights. Cara and its Affiliates and Sub-licensees shall keep
and maintain, for [***] from the date of (x) each payment of royalties under this Agreement and (y) each milestone owed, complete
and accurate records of gross sales and Net Sales by Cara and its Affiliates and Sub-licensees, in sufficient detail to allow
royalties and milestones on Net Sales to be determined accurately. All such records required to be maintained under this Section
6.7 shall include the information contained in the reports required under Section 6.6. Enteris shall have the right for a period
of [***] after receiving any such payments to appoint at its expense an independent certified public accountant reasonably acceptable
to Cara to audit such records of Cara, or its Affiliates, to verify that the amount of any such payment was correctly determined.
Cara and its Affiliates shall each make its records available for audit by such independent certified public accountant during
regular business hours at such place or places where such records are customarily kept, upon [***] written notice from Enteris.
Such audit right shall not be exercised by Enteris more than once in any Calendar Year or more than once with respect to sales
of a particular Product in a particular period or with respect to an individual milestone. All records made available for audit
shall be deemed to be Confidential Information of Cara. The results of each audit, if any, shall be binding on both Parties absent
manifest error. In the event there was an underpayment by Cara under this Agreement, Cara shall promptly (but in any event no
later than [***] after Cara’s receipt of the report so concluding) make payment to Enteris of any shortfall together with
interest as provided in Section 6.8 from the date such payment was due to the date paid in full. Enteris shall bear the full cost
of such audit unless such audit discloses a variance to the detriment of Enteris of five percent 5% or more from the amount of
the original payment calculation in which case Cara shall bear all reasonable cost of the performance of such audit.

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 28 -

    	 

    

6.8             
Overdue Payments. All payments not made by Cara to Enteris when due under this Agreement shall bear interest at a rate
equal at [***] (as quoted in The Wall Street Journal or its successor on the day after the payment is due) calculated from
the due date to the date paid in full. Any such overdue payment shall, when made, be accompanied by, and credited first to, all
interest so accrued.

6.9             
Payments; Withholding
Tax.

(a)              
Payments in Dollars. All payments made by Cara under this Section shall
be made by wire transfer from a banking institution in United States Dollars in accordance with instructions given in writing
from time to time by the other Party.

(b)              
Withholding Taxes. If Applicable Laws require withholding of income or
other taxes imposed upon any payments made by Cara to Enteris under this Agreement, Cara shall (i) make such withholding payments
as may be required, (ii) subtract such withholding payments from such payments, (iii) submit appropriate proof of payment of the
withholding taxes to Enteris within a reasonable period of time, and (iv) promptly provide Enteris with all official receipts
with respect thereto. Cara shall render Enteris reasonable assistance in order to allow Enteris to obtain the benefit of any present
or future treaty against double taxation which may apply to such payments.

6.10         
Foreign Currency Exchange. If, in any Calendar Quarter, Net Sales are made in any currency other than United States
Dollars, such Net Sales shall be converted into United States Dollars by applying the exchange rate conversion consistently used
by Cara in its audited consolidated accounts making use of a publicly available foreign exchange rate source.

6.11         
Cara Obligations. Cara shall be solely responsible for all amounts it owes to any Third Party in connection with the
Development, Manufacture, or Commercialization of Products in the Field in the Territory.

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 29 -

    	 

    

Article
7

Representations and Warranties; COVENANTS; Liability

7.1             
Mutual. Enteris and Cara each represents and warrants to the other Party, as of the Effective Date, as follows:

(a)              
It is a corporation or company duly organized, validly existing and in good standing
under the laws of the jurisdiction of its organization, and has all requisite power and authority, corporate or otherwise, to
execute, deliver and perform this Agreement.

(b)              
The execution and delivery of this Agreement and the performance by it of the
transactions contemplated hereby have been duly authorized by all necessary corporate action and will not violate (a) such Party’s
certificate of incorporation or bylaws, (b) any agreement, instrument or contractual obligation to which such Party is bound in
any material respect, (c) any requirement of any Applicable Laws, or (d) any order, writ, judgment, injunction, decree, determination
or award of any court or governmental agency presently in effect applicable to such Party.

(c)               
This Agreement is a legal, valid and binding obligation of such Party, enforceable
against it in accordance with its terms and conditions, subject to all bankruptcy and other debtor laws and protections and to
equitable principles.

(d)              
It is not under any obligation, contractual or otherwise, to any other person
or entity that conflicts with or is inconsistent in any respect with the terms of this Agreement or that would impede the diligent
and complete fulfillment of its obligations hereunder.

(e)               
Such Party has never been, and is not currently, a Debarred Entity. Each of the
Parties further warrants and represents that no Debarred Entity has performed or rendered, any services or assistance on its behalf
relating to activities contemplated or rights granted pursuant to this Agreement. Each Party certifies and covenants that it shall
not use, in any capacity, a Debarred Entity in the performance of this Agreement. “Debarred Entity” for purposed
of this Section 7.1(e) means a corporation, partnership or association that has been debarred by the FDA pursuant to 21 U.S.C.
§335a (a) or (b) from submitting or assisting in the submission of any abbreviated drug application, or an employee, partner,
shareholder, member, subsidiary or affiliate of a Debarred Entity.

7.2             
By Cara. Cara represents, warrants, and covenants to Enteris that:

(a)              
All of its activities and the activities of its Affiliates and its Sub-licensees,
related to its use and practice of the Licensed Technology and all Development, Manufacture and Commercialization of the Products
pursuant to this Agreement, shall to its knowledge comply in all material respects with all Applicable Laws.

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 30 -

    	 

    

(b)              
Cara, its Affiliates, and to its knowledge its Sub-licensees, shall not encumber,
with liens, mortgages, or security interests, the Licensed Technology, except as otherwise expressly permitted in this Agreement.

7.3             
By Enteris.

(a)              
Enteris owns or has license rights to all the Licensed Technology existing as
of the Effective Date. Enteris is entitled to grant the licenses specified in this Agreement. The Licensed Patent Rights existing
as of the Effective Date constitute all of the Patent Rights owned by or licensed to Enteris or its Affiliate as of the Effective
Date that are necessary or reasonably useful to Develop, Manufacture, sell and otherwise Commercialize the Product. The Licensed
Know-how existing as of the Effective Date constitute all of the Licensed Know-how owned by or licensed to Enteris or its Affiliate
as of the Effective Date that are necessary or reasonably useful to Develop, Manufacture, sell and otherwise Commercialize the
Product.

(b)              
To Enteris’ knowledge, there is no actual or threatened infringement of
the Licensed Technology in the Field by any Third Party;

(c)               
To Enteris’ knowledge, the Licensed Patent Rights existing as of the Effective
Date are subsisting and are not invalid or unenforceable, in whole or in part. As of the Effective Date, there are no claims,
judgments, or settlements against, or amounts with respect thereto owed by, Enteris or any of its Affiliates relating to the Licensed
Patent Rights that would have a material adverse effect on the license rights granted to Cara under this Agreement or on Cara’s
ability to use or practice such license rights;

(d)              
As of the Effective Date, no claim or litigation has been brought against Enteris
or, to Enteris’ knowledge, against any Third Party or, to Enteris’ knowledge, threatened, alleging that (A) the Licensed
Patent Rights are invalid or unenforceable; or (B) the Licensed Patent Rights or the licensing or exploiting of such Licensed
Patent Rights violates, infringes, or other conflicts or interferes with any intellectual property or proprietary right of any
Third Party, nor is there any reasonable basis for any such claim; or (C) the Licensed Know-how has been misappropriated; or (D)
the Licensed Know-how or the licensing or exploiting of such Licensed Know-how violates, misappropriates, or otherwise conflicts
or interferes with any intellectual property or proprietary right of any Third Party;

(e)               
The practice or use of the Licensed Technology (including in the Manufacture or
Commercialization of Products) does not, and to the knowledge of Enteris shall not, result in any payment obligation by Cara (of
any royalty, milestone payment or other license fee), other than the payments due to Enteris under this Agreement, to any Third
Party;

(f)               
Neither Enteris, nor any of its Affiliates, has granted any mortgage, pledge,
claim, security interest, encumbrance, lien, or other charge of any kind (collectively, “liens” and each a
“lien”) on any of the Licensed Technology anywhere in the Territory, and the Licensed Patents and Licensed
Know-how are free and clear of all liens in the Territory; except with respect to (i) any such liens on the Licensed Technology
that are junior in priority to the rights of a licensee in ordinary course of business, or (ii) liens on revenue received under
this Agreement.

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 31 -

    	 

    

(g)              
Within [***] of the Effective Date of this Agreement, Enteris shall have provided
to Cara all material documentation, data, and information under its control requested by Cara relating to the Licensed Know-how
and the use thereof in formulations, including all material safety information. All information and data provided by or on behalf
of Enteris to Cara as set forth in this Section 7.3(g) in contemplation of this Agreement or the transactions contemplated hereby
is, to Enteris’ knowledge, true, accurate and complete in all material respects, and Enteris shall not knowingly fail to
disclose any material information or data in Enteris’ (or its Affiliate’s) control that could be reasonably expected
to cause the Enteris information or data that has been disclosed to Cara to be misleading in any material respect.

7.4             
Warranty Disclaimer. EXCEPT FOR THE EXPRESS WARRANTIES PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY WARRANTY,
EXPRESS OR IMPLIED, WITH RESPECT TO ANY KNOW-HOW, PATENT RIGHTS OR OTHER SUBJECT MATTER OF THIS AGREEMENT, AND EACH PARTY HEREBY
DISCLAIMS ALL SUCH OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE
AND NONINFRINGEMENT.

7.5             
Indemnification; Insurance.

(a)              
Cara shall indemnify, defend and hold harmless Enteris and its Affiliates, and
their respective directors, officers, employees and agents, and their respective successors, heirs and assigns (collectively,
the “Enteris Indemnitees”), against all liabilities, damages, losses and expenses (including reasonable attorneys’
fees and expenses of litigation) (collectively, “Losses”) incurred by or imposed upon the Enteris Indemnitees,
or any of them, as a direct result of claims, suits, actions, demands or proceedings (“Claims”) brought by
a Third Party against Enteris Indemnitees, including, personal injury and product liability claims (collectively, “Enteris
Indemnity Claims”), to the extent arising out of (i) the Development, Manufacture and/or Commercialization of any Product
by Cara or any of its Affiliates, Sub-licensees and/or agents in the Territory, including warranty claims or Product recalls;
(ii) any breach of this Agreement by Cara or any of its Affiliates, Sub-licensees or agents; (iii) any tort claims for the death,
personal injury, or illness of any person or claims relating to any damage to any property related in any way to the rights granted
under this Agreement or activities conducted by or on behalf of Cara, its Affiliates or Sub-licensees and their respective directors,
officers, employees and agents, in connection with this Agreement; except, in each case, to the extent such Claim or Loss is caused
by a breach by Enteris of its representations, warranties, covenants or obligations in this Agreement, or the gross negligence
or willful misconduct of any Enteris Indemnitee; or (iv) the gross negligence or willful misconduct of any Cara Indemnitee, or
agent of Cara; but excluding any Enteris Indemnity Claim or Losses to the extent that Enteris has an obligation
to indemnify Cara Indemnitees pursuant to Section 7.5(b), as to which Claim or Losses each Party shall indemnify the other to
the extent of their respective liability for such Losses.

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 32 -

    	 

    

(b)              
Enteris shall indemnify, defend and hold harmless Cara, its Affiliates and Sub-licensees,
and their respective directors, officers, employees and agents, and their respective successors, heirs and assigns (collectively,
the “Cara Indemnitees”), against all Losses incurred by or imposed upon the Cara Indemnitees, or any of them,
as a direct result of claims, suits, actions, demands or proceedings brought by a Third Party against Cara Indemnitees, including
personal injury and product liability claims (collectively, “Cara Indemnity Claims”) to the extent arising
out of (i) any breach of this Agreement by Enteris or any of its Affiliates or agents, except, in each case, to the extent such
Claim is caused by a breach by Cara of its representations, warranties, covenants or obligations in this Agreement, or the gross
negligence or willful misconduct of any Cara Indemnitee; or (ii) the gross negligence or willful misconduct of any Enteris
Indemnitee; or (iii) infringement or violation of Third Party intellectual property rights to the extent due to the use or practice
of the Licensed Technology; but excluding any Cara Indemnity Claim or Losses to the extent that Cara has an obligation
to indemnify any Enteris Indemnitees pursuant to Section 7.5(a) as to which Claims or Losses each Party shall indemnify the other
to the extent of their respective liability for such Losses.

(c)               
Upon receipt of notice of any Loss, or of any claim, suits, action, demand or
proceeding, that may give rise to a right of indemnity from the other Party hereto, the Party seeking indemnification (the “Indemnified
Party”), either on behalf of itself or, as applicable, for a member of its group entitled to such indemnity (an “Indemnified
Member”), shall give prompt written notice to the other Party (the “Indemnifying Party”) of the Loss
(or related claim, action, or allegation) for which indemnification is sought (a “Claim”). Provided that the
Indemnifying Party is not contesting its obligation to indemnify as to the noticed Claim under this Article 7, the Indemnified
Party (and the Indemnified Member, as applicable) shall permit the Indemnifying Party to control any the defense of such Claim
and any litigation relating to such Claim and all related Losses and the disposition of such Claim and Losses. The Indemnifying
Party shall (i) act reasonably and in good faith with respect to all matters relating to the settlement or disposition of such
Claim and all related Losses as the settlement or disposition relates to such Indemnified Party and (ii) not settle or otherwise
resolve such Claim and related Losses in a way that would adversely impact the Indemnified Party (or the Indemnified Member, as
applicable) without the prior written consent of such Indemnified Party (which consent shall not be unreasonably withheld, conditioned
or delayed). Each Indemnified Party (and all applicable Indemnified Members) shall cooperate with the Indemnifying Party in its
defense of any such Claim and related Losses in all reasonable respects and shall have the right to be present in person or through
counsel at all legal proceedings with respect to such Claim and Loss. If the Indemnifying Party does not assume and conduct the
defense of the Claim and Loss as provided above, (a) the Indemnified Party may defend against, consent to the entry of any
reasonable judgment, or enter into any reasonable settlement with respect to such Loss in any manner the Indemnified Party may
deem reasonably appropriate (and the Indemnified Party need not consult with, or obtain any consent from, the Indemnifying Party
in connection therewith), and (b) the Indemnifying Party shall remain responsible to indemnify the Indemnified Party as provided
in this Article 7.

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 33 -

    	 

    

(d)              
Limited Liability. EXCEPT FOR LIABILITY
ARISING FROM A PARTY’S BREACH OF CONFIDENTIALITY OBLIGATIONS HEREUNDER, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY
OR ANY OF ITS AFFILIATES FOR ANY SPECIAL, PUNITIVE, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING LOST PROFITS OR LOST
REVENUES, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION
7.5(d) IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION 7.5(a) OR
7.5(b).

(e)               
Cara shall procure and maintain insurance, including product liability insurance,
or shall self-insure, in each case in a manner adequate to cover its obligations under this Agreement and consistent with normal
business practices of prudent companies similarly situated at all times during the Term and for a period of [***] thereafter.
Such insurance shall provide that the policy is primary and not in excess or contributory with regard to other insurance Enteris
may have. Cara shall provide Enteris with written evidence of such insurance or self-insurance upon request. Cara shall provide
Enteris with written notice at least [***] prior to the cancellation, non-renewal or material change in such insurance.

The
terms of this Article 7 shall survive termination of this Agreement for whatever reason. 

Article
8

Term and Termination

8.1             
Term. This Agreement shall commence on the Effective Date, and shall continue in full force and effect until the earlier
of (i) the expiration of the Agreement upon the expiration or termination of all payment obligations under this Agreement with
respect to the last Product in all countries in the Territory, or (ii) the termination of this Agreement by either Party pursuant
to Sections 8.3 through 8.5, inclusive (the “Term”).

8.2             
Expiration of Term. Upon expiry of the Term pursuant to clause (i) of Section 8.1, all rights and licenses granted
to Cara under this Agreement in respect of Products shall become fully paid-up and irrevocable with respect to all countries in
the Territory.

8.3             
Termination for Material Breach. A Party may terminate this Agreement by notice in writing to the other Party if such
other Party materially breaches its obligations under the Agreement, and does not cure such breach, in accordance with the following:
In the case of such material breach, the non-breaching Party may provide the breaching Party with a written notice specifying
in reasonable detail the nature of the material breach, and stating its intention to terminate this Agreement if such breach is
not cured. If the material breach is not cured within sixty (60) days (or thirty (30) days with respect to a material breach of
a payment obligation) after the receipt of such notice, the non-breaching Party shall be entitled, without prejudice to any of
its other rights under this Agreement, and in addition to any other remedies available to it by law or in equity, to terminate
this Agreement by providing written notice to the other Party, such notice to be provided no later than [***] after the end of
the cure period (and subject to Article 11).

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 34 -

    	 

    

8.4             
Termination for Challenge. Enteris shall have the right to terminate this Agreement upon written notice to Cara, if
all the following criteria are met: (a) Cara or any of its Affiliates formally Challenges the validity of any Licensed Patent
Rights or Assists a Third Party in initiating a Challenge of any Licensed Patent Rights, and (b) Enteris provides Cara written
notice that it intends to terminate this Agreement as a result of such Challenge by Cara (or its Affiliate), or of such Assist
by Cara of a Third Party Challenge. Such termination by Enteris shall become effective thirty (30) days after notice of termination
to Cara (but subject to Article 11), unless Cara has withdrawn such Challenge of such Licensed Patent Rights or ceased providing
such Assist to the Third Party (as applicable). The notice provided by Enteris must provide the details of Enteris’ belief
that Cara has initiated, or has Assisted in the initiation of, such a Challenge. If a Sub-licensee of Cara, or a Sub-licensee
of Cara’s Sub-licensee, initiates a Challenge of any Licensed Patent Rights, then Cara shall, upon written notice from Enteris,
terminate such sublicense or direct Cara’s Sub-licensee to do so, unless such Sub-licensee has ceased such Challenge within
thirty (30) days of such written notice.

8.5             
Without Cause Termination. Cara may terminate this Agreement for any reason or no reason: (a) prior to receipt of first
Regulatory Approval for a Product in the United States for any indication upon thirty (30) days prior written notice to Enteris
or (b) on or after receipt of first Regulatory Approval for a Product in the United States for any indication upon sixty (60)
days prior written notice to Enteris.

8.6             
Consequences of Termination. Upon early termination of this Agreement pursuant to clause (ii) of Section 8.1 for any
reason (but not upon expiration of the Term pursuant to clause (i) of Section 8.1), in addition to any remedies available to a
Party at law or in equity, the following provisions shall apply, as applicable:

(a)              
all licenses and rights granted by Enteris to Cara pursuant to this Agreement,
including the licenses and rights granted to Cara under Section 2.1 shall terminate as of the effective date of termination;

(b)              
Cara shall not use or practice any issued Licensed Patent Rights or, to the extent
consisting of Enteris Confidential Information, any Licensed Know-how that, in each case, are incorporated into any Product for
any purpose;

(c)               
Cara shall cease all Commercialization and Development activities with respect
to the Products (except as otherwise provided in this Section) and shall diligently wind down, according to good clinical practice,
any clinical trials of such Product(s) that are ongoing at the time of notice of such termination or expiration, to the extent
any such activities would use or practice issued claims in the Licensed Patent Rights, or Enteris Confidential Information or
Licensed Know-how that is not subject to the exceptions in subclauses (a) – (e) of Section 4.1;

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 35 -

    	 

    

(d)              
all reference rights granted by Enteris to Cara under this Agreement shall cease,
including Cara’s right to reference the Enteris DMF, the contents therein, and any set of documents referencing the Enteris
DMF, in any Regulatory Filings, and (1) such Regulatory Filings referencing the Enteris DMF or the contents therein shall immediately
be withdrawn with appropriate notification to the Regulatory Authority, and (2) all copies (in any form, including electronic)
of documents referencing the Enteris DMF which have been provided to Third Parties shall be sequestered until the applicable retention
period of the Regulatory Authority expires and shall thereafter be promptly destroyed; and

(e)               
each Party shall cease use of, and promptly return, all Confidential Information
of the other Party that are not subject to a continuing license hereunder; provided, that, each Party may retain one (1) copy
of the Confidential Information of the other Party in its archives solely for the purpose of establishing the contents thereof
and ensuring compliance with its obligations hereunder.

(f)               
Except in the event Enteris terminates this Agreement pursuant to this Article
8, Cara and its Affiliates and Sub-licensees shall be entitled, during the [***] period following such termination, to continue
to sell any commercial inventory of such terminated Product(s) so long as Cara pays to Enteris the amounts applicable to said
subsequent sales in accordance with the terms and conditions set forth in this Agreement. Any drug substance, clinical supplies
and finished forms of such terminated Product(s) remaining following such [***] period shall be destroyed.

8.7             
Survival. Termination or expiration of this Agreement for any reason shall be without prejudice to: (a) any obligations
of the Parties that arose or accrued prior to the effective date of such termination; (b) the survival of rights specifically
stated in this Agreement to survive; (c) the rights and obligations of the Parties provided in Article 1, Article 4, Article 5,
Article 10, Article 11, Article 13, Sections 3.5, 3.6, 6.5, 6.7, 6.8, 6.9, 6.10, 6.11, 7.5, 8.2, 8.6, 8.7, 12.1-12.8
(including all other Sections referenced in any such Section), all of which shall survive such termination except as provided
in this Article 8; and (d) any other rights or remedies provided at law or equity which either Party may otherwise have.

Article
9

Assignment; Successors and assigns

Neither
Party shall be entitled to assign, transfer, charge or in any way make over the benefit and/or the burden of this Agreement without
the prior written consent of the other, which consent shall not be unreasonably withheld, conditioned or delayed, except that
(a) each Party shall be entitled without the prior written consent of the other Party to assign this Agreement and the rights,
obligations and interests thereunder to (i) an Affiliate, provided that the assigning Party shall remain liable and responsible
to the non-assigning Party for the performance and observance of all such duties and obligations by such Affiliate, or (ii) its
successor in interest in connection with a sale, merger, or acquisition of all or substantially all of the assets of its business
to which this Agreement relates and (b) Enteris shall be entitled without the prior written consent of Cara to (i) pledge, grant
a security interest, lien or charge in, or other encumbrance upon, any of its rights or interests in this Agreement (and may assign
this Agreement or the rights hereunder, in whole or in part in connection with any of the foregoing), including without limitation
pursuant to the terms of any secured indebtedness (and any amendment, restatement, replacement or refinancing thereof) and any
related documents, and (ii) assign all or a portion of its rights and interests to receive any payments pursuant to Article 6
to its current or former shareholders, provided, however, in such event, Cara shall, in accordance with Article 6, continue to
make such payments directly to Enteris (who shall receive such payments on behalf of, and as agent for, such current or former
shareholders, to the extent of the payment rights and interests so assigned). Any attempted assignment in violation of this Article
9 shall be null and void.

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 36 -

    	 

    

The
terms and conditions of this Agreement shall be binding on and inure to the benefits of permitted successors and assigns of each
Party.

Article
10

Governing Law

This
Agreement shall be construed, governed and interpreted in accordance with the laws of the State of New York without regard to
the application of its principles of conflict of law.

Article
11

DISPUTE RESOLUTION; Arbitration

11.1         
Dispute Resolution.  If a dispute or issues arises between the Parties regarding any matter under this Agreement,
including interpretation of a provision of the Agreement or performance or breach of an obligation hereunder, (a “Dispute”)
then on notice from either Party detailing such Dispute, the senior executive officers of each Party shall promptly meet and discuss
and seek to resolve, reasonably and in good faith, such Dispute, for a period of up to [***] from the date of receipt of such
notice. Any resolution by the Parties of such a Dispute shall be set forth in writing acknowledged by the Parties. Neither Party
shall initiate any court or other legal proceeding to resolve or enforce its rights as to, any Dispute except as provide in this
Article 11.

11.2         
Arbitration of Unresolved Disputes. For any Dispute that is not resolved by the Parties pursuant to Section 11.1 above,
such Dispute shall be resolved, at the election of either Party, by binding arbitration before a panel of three (3) neutral, fully
independent arbitrators in accordance with the rules of the American Arbitration Association (“AAA”) in effect
at the time the proceeding is initiated, by such Party providing written notice of the arbitration, such notice setting forth
in detail the Dispute to be resolved. In any such arbitration, the following procedures shall apply:

(a)              
The panel will be comprised of one arbitrator chosen by Cara, one by Enteris and
the third, who shall act as the chairman of the panel, by the two co-arbitrators. If either Party fails or both Parties fail to
choose an arbitrator or arbitrators within [***] after receiving notice of commencement of arbitration or if the two arbitrators
fail to choose a third arbitrator within [***] after their appointment, then either or both Parties shall immediately request
that the AAA select the remaining number of arbitrators to be selected, which arbitrator(s) shall have the requisite scientific
background, experience and expertise. All such arbitrators must have no current or prior relationship with or to either Party
and all its respective Affiliates, be neutral and unbiased as to the subject matter of the Dispute, and have significant experience
in the creation and interpretation of license agreements similar to this Agreement. The place of arbitration shall be New York,
New York. The language of the arbitration shall be English.

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 37 -

    	 

    

(b)              
Either Party may apply to the arbitrators for interim injunctive relief until
the arbitration decision is rendered or the Dispute is otherwise resolved. Either Party also may, without waiving any right or
remedy under this Agreement, seek from any court having jurisdiction any injunctive or provisional relief necessary to protect
the rights or property of that Party pending resolution of the Dispute pursuant to this Section 11.2. The arbitrators shall have
no authority to award punitive or any other type of damages not measured by a Party’s compensatory damages.

(c)               
The award of the arbitrators shall be final and binding on the parties (except
for those remedies expressly set forth in this Agreement). Judgment on the award rendered by the arbitrators may be entered in
any court having jurisdiction thereof. Notwithstanding anything in this Section 11.2 to the contrary, each Party shall have the
right to institute judicial proceedings against the other Party or anyone acting by, through or under such other Party, in order
to enforce the instituting Party’s rights hereunder through specific performance, injunction or similar equitable relief.

(d)              
Each Party shall bear its own costs and expenses and attorneys’ fees in
connection with any such arbitration; provided, that, the arbitrators shall be authorized to determine whether a Party is the
prevailing Party, and if so, to award to the prevailing Party reimbursement for its reasonable attorneys’ fees, costs and
expenses (including, for example, expert witness fees and expenses, photocopy charges and travel expenses).

(e)               
Unless otherwise agreed by the parties, Disputes relating to patents and non-disclosure,
non-use and maintenance of Confidential Information shall not be subject to arbitration, and shall be submitted to a court of
competent jurisdiction.

(f)               
The arbitration shall be confidential. Except to the extent necessary to confirm
an award or decision or as may be required by Applicable Laws, neither Party nor any arbitrator may disclose the existence or
results of any arbitration without the prior written consent of both parties. In no event shall any arbitration be initiated after
the date when commencement of a legal or equitable proceeding based on the Dispute would be barred by the applicable New York
statute of limitations.

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 38 -

    	 

    

(g)              
In the event of a Dispute involving the alleged breach of this Agreement (including
whether a Party has satisfied its diligence obligations hereunder), (i) the running of the time periods as to which a Party must
cure a breach of this Agreement shall be tolled during the period the breach that is the subject matter of the Dispute is being
arbitrated, and (ii) if the arbitrators render a decision that a breach of this Agreement has occurred, the arbitrators shall
have no authority to modify the right of the non-breaching Party to terminate this Agreement in accordance with Section 8.3. Any
disputed performance or suspended performance, pending the resolution of a Dispute that the arbitrators determine to be required
to be performed by a Party, shall be completed within a reasonable time period following the final decision of the arbitrators.

(h)              
Any monetary payment to be made by a Party pursuant to a decision of the arbitrators
shall be made in U.S. dollars, free of any tax or other deduction.

Article
12

Miscellaneous

12.1         
Amendment and Modification. This Agreement may only be amended, modified, or supplemented by an agreement in writing
signed by each Party hereto.

12.2         
Headings. Section and subsection headings are inserted for convenience of reference only and do not form a part of
this Agreement.

12.3         
Counterparts. This Agreement may be executed simultaneously in two or more counterparts, each of which shall be deemed
an original and both of which, together, shall constitute a single agreement. Each Party may execute this Agreement by facsimile
transmission or in AdobeTM Portable Document Format (“PDF”) sent by electronic mail. In addition, facsimile or
PDF signatures of authorized signatories of any Party will be deemed to be original signatures and will be valid and binding,
and delivery of a facsimile or PDF signature by any Party will constitute due execution and delivery of this Agreement. This Agreement
may be amended, modified, superseded or canceled, and any of the terms of this Agreement may be waived, only by a written instrument
executed by each Party or, in the case of waiver, by the Party or parties waiving compliance. The delay or failure of either Party
at any time or times to require performance or to exercise any right arising out of any provisions shall in no manner affect the
rights at a later time to enforce the same.

12.4         
Waiver. Any waiver by a Party of a particular provision or right shall be in writing, shall be as to a particular matter
and, if applicable, for a particular period of time and shall be signed by such Party. No single or partial exercise of any right,
power or privilege will preclude any other or further exercise of such right, power or privilege or the exercise of any other
right, power or privilege. No waiver by either Party of any condition or of the breach of any term contained in this Agreement,
whether by conduct, or otherwise, in any one or more instances, shall be deemed to be, or considered as, a further or continuing
waiver of any such condition or of the breach of such term or any other term of this Agreement. Except as otherwise expressly
set forth in this Agreement, all rights and remedies available to a Party, whether under this Agreement or afforded by Applicable
Law or otherwise, will be cumulative and not in the alternative to any other rights or remedies that may be available to such
Party.

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 39 -

    	 

    

12.5         
No Third Party Beneficiaries. Except as set forth in Sections 7.5(a) and 7.5(b) and in Article 9, no Third Party (including
employees of either Party) shall have or acquire any rights by reason of this Agreement.

12.6         
Independent Relationship. The Parties understand and agree that the relationship between the Parties to this Agreement
is purely contractual and is limited to the activities, rights and obligations as set forth in this Agreement. Nothing in this
Agreement shall be construed (a) to create or imply a general partnership between the parties, (b) to make either Party the agent
of the other for any purpose, (c) to alter, amend, supersede or vitiate any other arrangements between the Parties with respect
to any subject matter not covered hereunder, (d) to give either Party the right to bind the other, (e) to create any duties or
obligations between the parties except as expressly set forth herein, or (f) to grant any direct or implied licenses or any other
rights other than as expressly set forth herein.

12.7         
 Interpretation. The Parties acknowledge and agree that: (a) each Party and its counsel reviewed and negotiated the
terms and provisions of this Agreement and have contributed to its revision; and (b) the rules of construction to the effect that
any ambiguities are resolved against the drafting Party shall not be employed in the interpretation of this Agreement. In addition,
unless a context otherwise requires, wherever used, the singular shall include the plural, the plural the singular, the use of
any gender shall be applicable to all genders, the word “or” is used in the inclusive sense (and/or) and the word
“including” is used without limitation and means “including without limitation”. Unless otherwise specified,
references in this Agreement to any Section shall include all Sections, subsections and paragraphs in such Section, references
to any Section shall include all subsections and paragraphs in such Section, and references in this Agreement to any subsection
shall include all paragraphs in such subsection. The words “herein,” “hereof” and “hereunder”
and other words of similar import refer to this Agreement as a whole and not to any particular Section or other subdivision. All
references to days in this Agreement shall mean calendar days, unless otherwise specified. Unless the context requires otherwise,
(i) any definition of or reference to any agreement, instrument or other document herein will be construed as referring to such
agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions
on such amendments, supplements or modifications set forth herein or therein), (ii) any reference to any Applicable Laws herein
will be construed as referring to such Applicable Laws as from time to time enacted, repealed or amended, (iii) any reference
herein to any person will be construed to include the person’s successors and permitted assigns, (iv) any reference herein
to the words “mutually agree” or “mutual written agreement” will not impose any obligation on either Party
to agree to any terms relating thereto or to engage in discussions relating to such terms except as such Party may determine in
such Party’s sole discretion, (v) all references herein to Sections or Exhibits will be construed to refer to Sections and
Exhibits to this Agreement, (vi) except as otherwise expressly provided herein all references to “$” or “dollars”
refer to the lawful money of the U.S., and (vii) the words “copy” and “copies” and words of similar import
when used in this Agreement include, to the extent available, electronic copies, files or databases containing the information,
files, items, documents or materials to which such words apply. This Agreement has been prepared in the English language and the
English language shall control its interpretation. In addition, all notices required or permitted to be given hereunder, and all
written, electronic, oral or other communications between the parties regarding this Agreement shall be in the English language.

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 40 -

    	 

    

12.8         
Entire Agreement; Severability. This Agreement and the Stock Purchase Agreement set forth the entire agreements between
the Parties with respect to the subject matter of this Agreement and of such Stock Purchase Agreement and supersede all other
agreements and understandings between the Parties with respect to such subject matter. There are no covenants, promises, agreements,
warranties, representations, conditions or understandings, either oral or written, between the Parties with respect to the subject
matter of this Agreement other than as are set forth in this Agreement and any other documents delivered pursuant hereto or thereto.
If any provision of this Agreement is or becomes invalid or is ruled invalid by any court of competent jurisdiction or is deemed
unenforceable, it is the intention of the parties that the remainder of the Agreement shall not be affected.

12.9         
Delay Due to Force Majeure. A Party shall not be liable for failure of or delay in performing any of its obligations
set forth in this Agreement, and shall not be deemed in breach of such obligations, if such failure or delay is due to a Force
Majeure. In the event of such Force Majeure, the Party affected shall use Commercially Reasonable Efforts to cure or overcome
the same and resume performance of its obligations hereunder. Notice of a Party’s failure or delay in performance due to
Force Majeure must be given to the other Party within thirty (30) days after the affected Party becomes aware of its occurrence.
All delivery dates under this Agreement that have been affected by Force Majeure shall be tolled for the duration of such Force
Majeure. If a Force Majeure persists for more than ninety (90) days, then the Parties will discuss in good faith the reasonable
modification of the Parties’ respective obligations under this Agreement in order to mitigate the delays caused by such
Force Majeure and the impacts of such delays.

12.10     
Further Assurances. Each of Enteris and Cara, upon the reasonable request of the other Party, whether before or after
the Effective Date, will do, execute, acknowledge, and deliver or cause to be done, executed, acknowledged or delivered all such
further reasonable acts, deeds, documents, assignments, transfers, conveyances, powers of attorney, instruments and assurances
as may be reasonably necessary to effect complete consummation of the transactions contemplated by this Agreement, and to do all
such other reasonable acts, as may be necessary or reasonably needed in order to carry out the purposes and intent of this Agreement.
The Parties agree to execute and deliver such other reasonable documents, certificates, agreements and other writings and to take
such other reasonable actions as may be reasonably necessary in order to consummate or implement expeditiously the transactions
contemplated by this Agreement.

12.11     
Expenses. Each of the Parties will bear its own direct and indirect expenses incurred in connection with the negotiation
and preparation of this Agreement and, except as set forth in this Agreement, the performance of the obligations contemplated
hereby and thereby.

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 41 -

    	 

    

Article
13

Notice

 

Any
notice or other documents to be given under this Agreement shall be in writing and shall be deemed to have been duly given if
sent by registered post, courier, facsimile or other electronic media to a Party or delivered in person to a Party at the address
or facsimile number set out below for such Party or such other address as the Party may from time to time designate by written
notice to the other(s):

Address
of Enteris:

 

Enteris
Biopharma, Inc., 83 Fulton St., Boonton, NJ 07005, USA

Facsimile:
[***]

E-mail:
[***]

For
the attention of the President & CFO

 

Address
of Cara:

 

Cara
Therapeutics, Inc.

4
Stamford Plaza

107
Elm Street, 9th Floor

Stamford,
CT 06902

 

Facsimile:
[***]

E-mail:
[***]

For
the attention of: Chief Executive Officer

With
a copy to:

Cara
Therapeutics, Inc.

4
Stamford Plaza

107
Elm Street, 9th Floor

Stamford,
CT 06902

 

Facsimile:
[***]

E-mail:
[***]

For
the attention of: General Counsel

Any
such notice or other document shall be deemed to have been received by the addressee seven (7) working days following the date
of dispatch of the notice or other document by post or, where the notice or other document is sent by hand or is given by facsimile
or other electronic media or transmission, simultaneously with the transmission or delivery. 

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 42 -

    	 

    

IN
WITNESS WHEREOF, the hands of the duly authorized representatives of the Parties have caused this License Agreement to be
executed effective as of the Effective Date.

	Signed for and on behalf of	 	 
	 	 	/s/ Brian Zietsman
	 	 	 
	ENTERIS BIOPHARMA, INC.	 	 
	 	NAME   	Brian Zietsman
	 	TITLE	President & CFO
	 	 	 
	Signed for and on behalf of	 	 
	CARA THERAPEUTICS, INC.	 	 
	 	 	/s/ Derek Chalmers
	 	NAME	Derek Chalmers
	 	TITLE	CEO

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE
INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED.

    	- 43 -

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