Document:

rdhl_Ex4_15

		
			Exhibit 4.15
		

		
			Confidential
		

		
			 
		

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

		
			 
		

		
			AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT
		

		
			 
		

		
			This Amendment to the Exclusive License Agreement (the "Amendment') is entered into as of September 7, 2018 (the "Amendment Effective Date") by and between Entera Health, Inc., an Iowa Corporation, having an address at 2425 SE Oak Tree Court, Ankeny, Iowa 50021 (the ''Licensor''), and RedHill Biopharma, Inc. a Delaware corporation, having an address at 8045 Arco Corporate Drive, Suite 120, Raleigh, North Carolina 27617, along with all Affiliates thereof (as defined in that certain Exclusive License Agreement dated as of April 4, 2017 between the parties hereto (the "Agreement")) ("Licensee"). Unless otherwise specifically defined in this Amendment, any term used in this Amendment which is defined in the Agreement shall have the meaning assigned to it in the Agreement.
		

		
			 
		

		
			WHEREAS, on August 16, 2018, [****] of the Agreement; and
		

		
			 
		

		
			WHEREAS, pursuant to Section 17.4 of the Agreement, Licensor may [****]; and
		

		
			 
		

		
			WHEREAS, the Licensee [****].
		

		
			 
		

		
			NOW, THEREFORE, in consideration of the premises and of the mutual covenants above, and for good and valuable consideration, the adequacy and sufficiency of which is hereby acknowledged, the parties agree as follows:
		

		
			 
		

		
			l.      Replacement of Section 1.6: The Agreement is hereby amended and modified by deleting Section 1.6 in its entirety and replacing such deleted section with a new Section 1.6 as set forth below:
		

		
			 
		

		
			1.6                        "Contract Year" shall mean: (a) until October 1, 2018, a period of twelve (12) successive months commencing on the RedHill Launch Date (as defined below); and (b) from and after October 1, 2018, each period of twelve (12) successive months.
		

		
			 
		

		
			2.    Addition of New Section 4.4: The Agreement is hereby amended and modified by adding a new Section 4.4 to the Agreement, as set forth below:
		

		
			 
		

		
			4.4         Licensee hereby agrees that the minimum amount of Licensed Product that Licensee shall purchase from Licensor in any one order shall comprise a [****] of Licensed Product, containing 30 sachets per box.
		

		
			 
		

		
			3.    Addition of New Section 4.5: The Agreement is hereby amended and modified by adding a new Section 4.5 to the Agreement, as set forth below:
		

		
			 
		

		
			
		

		
			

		 

 

		

		
			4.5  Licensee hereby agrees that, once per month, personnel of Licensee chosen at the full and sole discretion of the Licensee and who are intimately involved and familiar with Licensee's sales and commercialization efforts with respect to Licensed Product shall be available for, and participate in, monthly update teleconference calls, with personnel of Licensor. During such calls, Licensee personnel shall provide, within reason, monthly updates of sales efforts, progress, trends, forecasts, and the like, with respect to Licensed Product, and shall answer all questions reasonably related thereto submitted or asked by Licensor. The information and updates provided by Licensee shall include, without limitation, information and updates concerning the numbers of open territories, total prescriptions, new prescriptions, calls made, and sample calls made, in furtherance of the commercialization and sales activities for the Licensed Product. Licensee personnel shall participate on such calls for a duration reasonably requested by Licensor, up to one hour per monthly call. For the avoidance of any doubt, any and all operational decisions regarding the Licensed Product remain at the full and sole discretion of the Licensee and Licensor shall not intervene or attempt to intervene, in such decisions in any manner whatsoever.
		

		
			 
		

		
			4.   Replacement of Section 17.4: The Agreement is hereby amended and modified by deleting Section
		

		
			17.4 in its entirety and replacing such deleted section with a new Section 17.4 as set forth below:
		

		
			 
		

		
			17.4 Either of Licensor or Licensee may terminate this Agreement if Licensee fails to meet the Minimum Net Sales target in any Contract Year provided the terminating party delivers termination notice to the other party within [****] from the date Licensee notifies Licensor of an applicable failure. Either Licensor or Licensee may terminate this Agreement in the event of each and every such failure, and any failure to provide notice of termination within the timelines stipulated above in respect of any particular failure shall not preclude either party from later terminating such Agreement in respect of a later failure. Either Licensor or Licensee shall also be entitled to terminate this Agreement at any time, upon [****] prior written notice to the other party provided Licensor delivers termination notice to Licensee within [****] from the date Licensee provides the reports detailed below evidencing a failure to meet the sales targets provided below, if Licensee fails to meet any one or more of the following sales targets applicable to any one or more of the time periods as set forth below:
		

		
			 
		

		
			(a)   [****] of Licensed Product during [****].
		

		
			(b)   [****] of Licensed Product during [****].
		

		
			(c)   [****] of Licensed Product [****].
		

		
			(d)  [****] of Licensed Product [****].
		

		
			 
		

		
			Termination of this Agreement shall constitute the only remedy Licensor is entitled to for such commercial failures described in this Section 17.4, with no further liability by Licensee whatsoever in connection with such commercial failures.
		

		
			 
		

		
			Without limiting any other obligation of Licensee in this Agreement, Licensee shall provide reports of all
		

		
			 
		

		
			
		

		
			

		 

		

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			sales of Licensed Product made during each calendar quarter sufficient to enable Licensor to determine whether Licensee has met the foregoing sales milestones within [****] during the Contract Term.
		

		
			 
		

		
			5.   Replacement of Section 17.8 (a): The Agreement is hereby amended and modified by deleting Section 17.8(a) in its entirety and replacing such deleted section with a new Section 17.8(a) as set forth below:
		

		
			 
		

		
			(a)           Within  [****] before the Expiration Date or within [****] after the Termination Date, Licensee shall provide Licensor with a statement indicating the number and description of Licensed Products which it has on hand as of the date of expiration or termination and the amount of such inventory necessary to fill Licensee's existing customer orders with such documentation provided to Licensor. Licensee shall have the right to sell Licensed Products it has on hand to fulfill Licensee's existing customer orders, as aforesaid, under the License, subject to payment of Royalties. Furthermore, Licensee shall have the option, exercisable upon notice to Licensor within [****]following the date of expiration or termination, to require Licensor to repurchase from Licensee all such remaining Licensed Products (or the part thereof that is not needed to fulfill Licensee's existing customer orders, as aforesaid) that are in a sellable condition, meaning that all such Licensed Products: (i) are undamaged, unopened, unadulterated, unmodified, and in substantially identical condition as when such Licensed Products arrived at the Licensee's facilities; and (b) have at least [****] remaining shelf-life, at the price paid by Licensee. In  the event that any such remaining Licensed Products bear, incorporate, or embody any trademarks or other intellectual property rights of Licensee, Licensee hereby grants a perpetual, irrevocable, non-exclusive, worldwide, royalty-free, fully paid up, assignable, sublicensable license to Licensor to undertake any and all actions, including, without limitation, to sell and offer to sell such remaining Licensed Products bearing or incorporating such Licensee intellectual property rights, with respect to such remaining Licensed Products solely to the extent reasonably necessary, convenient, or advisable to enable Licensor to undertake any and all sales and commercialization activities for such remaining Licensed Products.
		

		
			 
		

		
			6.    Entire Agreement: This Amendment, together with the Agreement, constitutes the entire agreement between the parties with respect to the subject matter of the Agreement, as amended by this Amendment. The Agreement, together with this Amendment supersedes all prior agreements, whether written or oral, with respect to the subject matter of the Agreement, as amended, provided that nothing herein shall affect the Supply Agreement or any other document or instrument referenced in the Agreement, except as modified herein. Each party confirms that it is not relying on any representations, warranties or covenants of the other party except as specifically set out in the Agreement as amended. The parties hereby agree that subject to the modifications specifically stated in this Amendment, all terms and conditions of the Agreement shall remain in full force and effect. This Amendment shall be governed by the same choice of law and subject to the same venue and dispute resolution provisions as set forth in the Agreement.
		

		
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			Confidential
		

		
			 
		

		
			IN WITNESS WHEREOF, the parties have entered into this Amendment to the Exclusive License Agreement as of the Amendment Effective Date by their duly authorized representatives.
		

		
			 
		

			
					
						 

					
					
						 

					
					
						 

				
	
					
						LICENSOR

					
					
						L.ICENSEE

					
					
						 

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						ENTERA HEALTH, INC.

					
					
						REDHILL BIOPHARMA, INC.

					
					
						 

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						By: /s/ Alex Walden

					
					
						By: /s/ Dror Ben-Asher

					
					
						/s/ Micha Ben Chorin

				
	
					
						Date:    Sept. 29, 2018

					
					
						Name: Dror Ben-Asher

					
					
						CFO

				
	
					
						Title: VP, Finance

					
					
						Title: CEO

					
					
						 

				
	
					
						 

					
					
						Date: Sept.27, 2018

					
					
						 

				

		
			 
		

		 

		

			4rdhl_Ex4_2

		

			Exhibit 4.2

		

		

			Confidential

		

		

			 

		

		
			AMENDMENT TO ASSET PURCHASE AGREEMENT
		

		
			 
		

		
			This Amendment to Asset Purchase Agreement (this “Amendment”) is made as of 27 February 2014 (the “Amendment Effective Date”), by and among RedHill Biopharma Ltd., an Israeli company having its principal place of business at 21 Ha’arba’a Street, Tel-Aviv 64739, Israel (“RedHill”), and Giaconda Limited ACN 108 088 517, an Australian public limited company having its registered office at Ground Floor, 44 East Street, Five Dock, NSW 2046, Australia (“Giaconda”).  Each of RedHill and Giaconda is sometimes referred to individually herein as a “Party” and collectively as the “Parties.”
		

		
			WHEREAS, Giaconda and RedHill are the parties to that certain Asset Purchase Agreement, dated as of 11 August 2010 (the “Original Asset Purchase Agreement”) , which in Section 13.2 thereof contains provisions that impose certain restraints on the ability of Giaconda and Borody (as defined below) and their respective affiliates to supply or grant certain goods, services or rights;
		

		
			WHEREAS, Professor Thomas J. Borody, of Ground Floor, 44 East Street, Five Dock, New South Wales, Australia 2046 (“Borody”), and RedHill in connection with the execution and delivery of the Original Asset Purchase Agreement and the consummation of the transactions contemplated thereby, entered into, and are now the parties to, that certain Agreement, dated as of 11 August 2010 (the “ROFR Agreement”), which in Section 4.2 thereof contains provisions that impose certain restraints on the ability of Borody and his affiliates to supply or grant certain goods, services or rights;
		

		
			WHEREAS, Borody, together with Dr. Sanjay Ramrakha, Dr. John Saxon, and Dr. Antony Wettstein (collectively, including Borody, the “Inventors”), has conducted work in the field of colonic purgatives, laxatives, and gastrointestinal cleansers and has in connection therewith developed certain know-how and intellectual property with respect thereto;
		

		
			WHEREAS, Salix Pharmaceuticals, Inc. (“Salix”) and the Inventors wish to enter into an Assignment and License Agreement simultaneously herewith, pursuant to which Salix will acquire certain rights;
		

		
			WHEREAS, RedHill and Salix are entering into an Agreement (the “Salix/RedHill Agreement”)  dated simultaneously herewith;
		

		
			WHEREAS, as required by the Salix/RedHill Agreement, RedHill has agreed to amend the Original Asset Purchase Agreement to revise the restraints it places on the ability of Giaconda, Borody and their affiliates to supply or grant certain goods, services, rights and information to Salix; and
		

		
			WHEREAS, Borody and RedHill are entering into a Deed of Variation dated simultaneously herewith that will amend the ROFR Agreement;
		

		
			 
		

		
			
		

		
			

		 

 

		

			Confidential

		

		

		
			 
		

		
			NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby amend the Original Asset Purchase Agreement as follows:
		

		
			SECTION 1.  Additional Definitions.  The following new definitions shall be inserted into the Section 1 of the Original Asset Purchase Agreement in their correct alphabetical order:
		

		
			“Designated Products” means all Products other than Purgative Products.
		

		
			“Designated Technology” means all Technology other than Technology that relates to the Purgative Field.
		

		
			“Designated Technology Intellectual Property” means all Technology Intellectual Property other than Technology Intellectual Property that relates to the Purgative Field.
		

		
			“Purgative Field” means the development, manufacturing, and commercialization, making, having made, using, offering to sell, selling, or importing of Purgative Products.
		

		
			“Purgative Product” means any substance or product, including the Picoconda product, intended for use as a colonic purgative, laxative or gastrointestinal cleanser (including in, or for the purpose of, the prevention, diagnosis, staging, monitoring, treatment or maintenance of any disease or condition) in humans or non-human animals, but not, for the avoidance of doubt, any of RedHill's RHB-102 (extended release anti-emetic ondansetron), Myoconda (RedHill's RHB-104 - a product containing a combination of clarithromycin, clofazamine and rifabutin) and Heliconda (RedHill's RHB-105 - a product containing a combination of rifabutin, amoxicillin and pantoprazole or omeprazole).
		

		
			SECTION 2.  Non-Competition.
		

		
			2.1       Section 13.2.1 of the Original Asset Purchase Agreement is hereby amended and replaced in its entirety by the following:
		

		
			“Restraint.  Seller agrees and undertakes that neither Seller or its Affiliates (excluding Borody and the Centre for Digestive Diseases Pty Limited (ACN 097 085 884)) (CDD) ,  will, without the prior written consent of Buyer directly or indirectly, as owner, part-owner, financier, partner, joint venturer, stockholder, employee, broker, agent, principal, corporate officer, director, licensor or in any other capacity whatever (a) supply or grant services or rights similar to or competing with the Designated Products or the Designated Technology; or (b) supply goods or services that assist any other person, entity, or organization in competing or in preparing to compete with the Designated Products or the Designated Technology. The foregoing restrictions do not prevent Seller from selling, licensing, or dealing with Hepaconda or Ibaconda provided that those patents and associated intellectual property are not the subject of the Charges.  The foregoing
		

		
			 
		

		
			
		

		
			

		 

		

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			Confidential

		

		

		
			 
		

		
			restrictions do not apply if Seller proposes to exercise or exercises its Buy Back Option. ”
		

		
			2.2       Section 13.2.5 of the Original Asset Purchase Agreement is hereby amended and replaced in its entirety by the following:
		

		
			This Section 13.2.1 does not restrict:
		

		
			a)   Seller or its Affiliates holding 1% or less of any class of stock or securities of a publicly listed company, provided that Seller or its Affiliates have no active role in that company;
		

		
			b)   Seller or its Affiliates recruiting a person through a recruitment agency (except if the agency targets Buyer’s employees) or as a response to a newspaper, web page or other public employment advertisement;
		

		
			c)   Seller or its Affiliates from selling, licensing, or dealing with Hepaconda or Ibaconda provided that those patents and associated intellectual property are not the subject of the Charges or part of the Technology Intellectual Property or licensed to Buyer under Section 4 hereto;
		

		
			d)   Seller from proposing to exercise or exercising its Buy Back Option;
		

		
			e)   Seller from enjoying the full incidents of ownership of the Relevant Therapy acquired by it as a result of exercising its Buy Back Option.
		

		
			2.3       Section 13.2.6 of the Original Asset Purchase Agreement is added as follows:
		

		
			“Notwithstanding any clause in this agreement, nothing in this agreement restricts Borody or his Affiliates from taking any action or conducting any activities with respect to Purgative Products or otherwise in the Purgative Field.”
		

		
			2.4       Release The Buyer irrevocably and unconditionally releases and forever discharges the Seller and its Affiliates from any and all claims (including any present or future causes of action, expenses, including legal fees, claim, liabilities, damages, declaration, demand, loss or suit whether arising in contract, tort, statue, equity or otherwise whether known or unknown) that the Buyer or its Affiliates may have in connection with any acts or omissions of Borody or CDD relating to Section 13.2 of the Original Asset Purchase Agreement prior to the amendment of Section 13.2 under this Agreement.
		

		
			SECTION 3.  Confidentiality.  Section 14.2 of the Original Asset Purchase Agreement is hereby amended by adding a new sentence at the end thereof reading as follows:
		

		
			“Notwithstanding anything in this Article 14 to the contrary, nothing in this Article 14 shall operate to limit or qualify the right and ability of Seller, Borody, CDD and their respective Affiliates to use and to disclose to Salix Pharmaceuticals, Inc. information, including information that would otherwise constitute Confidential
		

		
			 
		

		
			
		

		
			

		 

		

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			Confidential

		

		

		
			 
		

		
			Information subject to the restrictions and limitations set forth in this Article 14, to the extent (but only to the extent) the same relates to Purgative Products or the Purgative Field.”
		

		
			SECTION 4.  Condition Precedent.  The parties agree and acknowledge that this Amendment is interdependent with those agreements and deeds set forth on Annex 1 hereto (the “Interdependent Documents”) and that, except as may otherwise be agreed by the parties in writing, (a) no provision of this Amendment other than this Section 4 will come into effect until a counterpart of each of the other Interdependent Documents has been duly executed and delivered by all parties thereto but (b) simultaneously with the execution and delivery by each party thereto of a counterpart of each of the other Interdependent Documents all provisions of this Amendment shall, without further action by any of the parties, come into full force and effect.
		

		
			SECTION 5.  Effective Date; Incorporation of Terms; Continuing Effect.  Subject to Section 4, this Amendment shall be deemed effective for all purposes as of the Amendment Effective Date.  The amendment set forth in this Amendment shall be deemed to be incorporated in, and made a part of, the Original Asset Purchase Agreement, and the Original Asset Purchase Agreement and this Amendment shall be read, taken and construed as one and the same agreement (including with respect to the provisions set forth in Article 18 of the Original Asset Purchase Agreement, which shall, as applicable, be deemed to apply to this Amendment (including with respect to the governing law)).  Except as otherwise expressly amended by this Amendment, the Original Asset Purchase Agreement shall remain in full force and effect as so amended in accordance with its terms and conditions and does not prejudice any accrued rights or obligations which the parties to the Original Asset Purchase Agreement have under that agreement.
		

		
			SECTION 6.  Counterparts.  This Amendment may be executed in any number of counterparts, each of which shall be deemed to be an original, and all of which, taken together, shall constitute one and the same instrument.  This Amendment may be executed by the electronic or telephonic delivery of a facsimile of an executed signature page hereof with the same effect as the delivery of the original of such executed signature page.
		

		
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			IN WITNESS WHEREOF, the parties, intending to be bound, have caused this Amendment to be executed on their behalf by their duly authorized agent to be effective as of the Amendment Effective Date.
		

		
			 
		

			
					
						RedHill Biopharma Ltd.

					
					
						    

					
					
						 

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						By:

					
					
						/s/ Dror Ben-Asher

					
					
						 

					
					
						/s/ Ori Shilo

				
	
					
						 

					
					
						Name: Dror Ben-Asher

					
					
						 

					
					
						Ori Shilo

				
	
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
					
						Title: CEO

					
					
						 

					
					
						Deputy CEO

				
	
					
						 

					
					
						February 26, 2014

					
					
						 

					
					
						February 26, 2014

				
	
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						Executed by Giaconda Limited ACN 108 088 517 in accordance with Section 127 of the Corporations Act 2001

					
					
						 

					
					
						 

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						/s/ Thomas Borody

					
					
						 

					
					
						/s/ Christopher Robert Bilkey

				
	
					
						Signature of director

					
					
						 

					
					
						Signature of director/company secretary

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
					
						 

					
					
						Name of director/company secretary:

				
	
					
						Name of director: Thomas Borody

					
					
						 

					
					
						Christopher Robert Bilkey

				

		
			 
		

		
			 
		

		
			 
		

		
			

		 

		

			Signature Page to Amendment to Asset Purchase Agreement

		

 

		

			 

		

		

		
			 
		

		
			ANNEX 1
		

		
			 
		

		
			Interdependent Documents
		

		
			 
		

		
			Core Transactional Documents
		

		
			1.   Assignment and License Agreement by and among Professor Thomas J. Borody, Dr Sanjay Ramrakha, Dr John Saxon, and Dr Antony Wettstein and Salix Pharmaceuticals, Inc.
		

		
			2.   Agreement between RedHill Biopharma Ltd. and Salix Pharmaceuticals, Inc.
		

		
			Giaconda / Redhill Arrangements
		

		
			3.   This Amendment to Asset Purchase Agreement by and between RedHill Biopharma Ltd. and Giaconda Limited ACN 108 088 517
		

		
			4.   Deed of Waiver, Confirmation, Termination, and Amendment by and between Giaconda Limited ACN 108 088 517, Centre for Digestive Diseases Pty Limited ACN 097 085 884, Professor Thomas Julius Borody, RedHill Biopharma Ltd., and Salix Pharmaceuticals, Inc.
		

		
			Borody / RedHill Arrangements
		

		
			5.   Deed of Variation by and between RedHill Biopharma Ltd. and Professor Thomas J. Borody
		

		
			6.   Deed of Termination by and between RedHill Biopharma Ltd and Centre for Digestive Diseases Pty Limited ACN 097 085 884
		

		
			7.   Deed of Termination by and between RedHill Biopharma Ltd and Professor Thomas J. Borody
		

		
			General Facilitating Documents
		

		
			8.   Deed of Waiver and Confirmation by and among Centre for Digestive Diseases Pty Limited ACN 097 085 884, Professor Thomas Julius Borody, and Salix Pharmaceuticals, Inc.
		

		
			9.   Deed of Waiver and Confirmation by and between Pharmatel Research & Development Pty Ltd as trustee for the Pharmatel Research & Development Trust ACN 104 997 328 and Salix Pharmaceuticals, Inc.
		

		
			10. Research Services Agreement by and between Centre for Digestive Disease Pty Limited ACN 097 085 884 and Salix Pharmaceuticals, Inc.
		

		
			11. Deed of Waiver and Confirmation, between Giaconda Limited ABN 108 088 517 and Centre for Digestive Diseases Pty Limited ABN 54 097 085 884
		

		
			12. Letter agreement, between Giaconda Limited ACN 108 088 517 and Salix Pharmaceuticals, Inc.
		

		
			Giaconda / Borody/ Salix Arrangements
		

		
			 
		

		
			
		

		
			

		 

		

			 

		

 

		

			 

		

		

		
			 
		

		
			13. Deed of Waiver and Confirmation by and among Giaconda Limited ACN 108 088 517, Professor Thomas Julius Borody, and Salix Pharmaceuticals, Inc.
		

		
			14. Ibaconda Assignment Agreement by and between Giaconda Limited ACN 108 088 517 and Salix Pharmaceuticals, Inc.
		

		
			Rosenhain Arrangements
		

		
			15. Releases for Salix Deed, dated 23 December 2013, by and between Mrs. Norma Rosenhain, CIPAC Limited, and Salix Pharmaceuticals, Inc.
		

		
			16. Deed of Assignment and License, dated on or about 25 January 2013, between Professor Thomas Julius Borody and CIPAC Limited
		

		
			17. Letter agreement, dated 23 December 2013, between Mrs. Norma Rosenhain and CIPAC Limited
		

		
			18. Termination Deed, dated 23 December 2013, between Professor Thomas Julius Borody, Centre for Digestive Diseases Pty Limited ACN 097 085 884, and Mrs. Norma Rosenhain

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