Document:

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Exhibit 10.1
Confidential Treatment Requested by Eyenovia, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
AMENDMENT 1 TO LICENSE AGREEMENT
This AMENDMENT 1 TO LICENSE AGREEMENT (the “Amendment”) is entered into on September ___, 2021 (the “Amendment Effective Date”) by and between EYENOVIA, INC., a Delaware corporation with a place of business at 295 Madison Ave., New York, NY 10017 (“Eyenovia”), and ARCTIC VISION (HONG KONG) LIMITED, a Hong Kong company with a registered office at 19th Floor, Three Exchange Square, 8 Connaught Place, Central, Hong Kong (“Arctic Vision”). Eyenovia and Arctic Vision may be referred to herein individually as a “Party” and collectively as the “Parties”.
Recitals
WHEREAS, Eyenovia and Arctic Vision entered into that certain License Agreement dated August 10, 2020 (the “License Agreement”); and
WHEREAS, Eyenovia and Arctic Vision desire to amend the License Agreement on the terms and conditions set forth herein.
NOW THEREFORE, in consideration of the foregoing premises and the mutual covenants contained herein, the receipt and sufficiency of which are hereby acknowledged, Arctic Vision and Eyenovia hereby agree as follows:
AGREEMENT
	1.
	Any capitalized terms used in this Amendment shall have the meaning assigned to them in the License Agreement, except as otherwise amended herein.

	2.
	References in the License Agreement to “either Product” are hereby deleted and replaced with references to “any Product.”

	3.
	Section 1.4 of the License Agreement is amended and restated in its entirety as follows:

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Confidential Treatment Requested by Eyenovia, Inc.
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Pursuant to 17 C.F.R. Section 200.83

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		1.4
	“Additional Indication” means any Indication other than (a) presbyopia with respect to the MicroLine Product, (b) myopia with respect to the MicroPine Product, and (c) mydriasis with respect to the MicroStat product.

	4.
	Section 1.24 of the License Agreement is amended and restated in its entirety as follows:

		1.24
	“Competitive Combination Product” means (a) for the MicroLine Product, pilocarpine and [***], (b) for the MicroPine Product, atropine sulfate and [***], and (c) for the MicroStat Product, phenylephrine plus tropicamide fixed combination [***].

	5.
	Section 1.25 of the License Agreement is amended and restated in its entirety as follows:

		1.25
	“Competitive Senju Product” means a Senju Product for the treatment of (a) myopia (in the case of a MicroPine Product), (b) improvement in near vision or presbyopia (in the case of a MicroLine Product) or (c) mydriasis (in the case of a MicroStat Product).

	6.
	Section 1.50 of the License Agreement is amended and restated in its entirety as follows:

		1.50 
	“Initial Indications” means, with respect to (a) the MicroLine Product, presbyopia; (b) the MicroPine Product, myopia; and (c) the MicroStat Product, mydriasis.

	7.
	Section 1.58 of the License Agreement is amended and restated in its entirety as follows:

		1.58 
	“Licensed Know-How” means, subject to Section 11.2(b), all Know-How that (a) is Controlled by Eyenovia or any of its Affiliates as of the Effective Date or at any time during the Term and (b) is necessary or reasonably useful for the Development, manufacture, use, importation, offer for sale, sale, or other Commercialization of any Product in the Field, including, for the avoidance of doubt, (i) all such Know-How in any and all Improvements, (ii) Eyenovia’s and its Affiliates’ interest in any Joint Invention satisfying clauses (a) and (b) above, and (iii) MicroStat Product Gen 1 and Gen 2 new drug application filings and related Know-How.

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	8.
	Section 1.76 of the License Agreement is amended and restated in its entirety as follows:

		1.76 
	“Product” means (a) the MicroLine Product, (b) the MicroPine Product, and/or (c) the MicroStat Product, as the context dictates.

	9.
	Section 2.6 (b) of the License Agreement is amended and restated in its entirety as follows:

(b)directly or indirectly through a Third Party, Develop or Commercialize any pharmaceutical product for the treatment of (i) myopia (in the case of a MicroPine Product), (ii) improvement in near vision or presbyopia (in the case of a MicroLine Product), or (iii) mydriasis (in the case of a MicroStat Product), in each case in such Region, except, in each case, to the extent rights to Develop or Commercialize such product in such Region are granted under the Senju License Agreement;
	10.
	Section 2.6 (d) of the License Agreement is amended and restated in its entirety as follows:

(d)supply the Optejet Dispenser Base that is compatible for use with the cartridges included as a component in a Product, or the cartridge included as a component in such Product, to any Third Party in such Region to deliver a pharmaceutical product for the treatment of (i) myopia (in the case of a MicroPine Product), (ii) improvement in near vision or presbyopia (in the case of a MicroLine Product) or (iii) mydriasis (in the case of a MicroStat Product);
	11.
	Section 2.6 (f) of the License Agreement is amended and restated in its entirety as follows:

(f) supply to any Third Party in such Region (other than a designee of Arctic Vision) (i) pilocarpine ([***]) formulated and loaded into a cartridge for use in the treatment of improvement in near vision or presbyopia, (ii) atropine sulfate ([***]) formulated and loaded into a cartridge for the treatment of myopia; or (iii) phenylephrine plus tropicamide fixed combination ([***]) formulated and loaded into a cartridge for the treatment of mydriasis; or
	12.
	Section 4.4(a) of the License Agreement is amended and restated in its entirety as follows:

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(a) Initial Indications.  Arctic Vision (either itself or through its Affiliates and Sublicensees) shall use Commercially Reasonable Efforts to Develop and Commercialize (a) the MicroLine Product for the treatment of presbyopia in the Territory and (b) the MicroPine Product for the treatment of myopia in the Territory. Arctic Vision (either itself or through its Affiliates and Sublicensees) shall use Commercially Reasonable Efforts to file for [Clinical Trial Waiver] with the CFDA not later than [***] ([***]) months following Regulatory Approval by the FDA for the MicroStat Product in the US and thereafter use Commercially Reasonable Efforts to Develop and, once approved, Commercialize the MicroStat Product for the treatment of mydriasis in the Territory.
	13.
	Section 4.10(a) of the License Agreement is amended and restated in its entirety as follows:

(a) Eyenovia Supply.  Except as provided in Section 4.10(c) below, and subject to the Parties’ execution, and the terms of, the Supply Agreement, Eyenovia shall manufacture and supply, through itself, one or more of its Affiliates, or one or more Third Party CMO(s), the Products in finished, assembled form for use in the Development and Commercialization of the Products under this Agreement.  Subject to Section 4.10(c), all Products supplied by Eyenovia to Arctic Vision under the Supply Agreement shall be at a price equal to the Supply Price for such Product set forth in Section 5.3, and Eyenovia shall source such Products, and the components thereof, from one or more manufacturers (which may be any combination of Eyenovia, any Affiliates thereof, or Third Party CMOs that Eyenovia or its Affiliate reasonably determines in good faith to be appropriately qualified for such manufacture), provided that within [***] ([***]) [***] after submitting the first MAA of a Product in the U.S., Eyenovia shall have at least two (2) manufacturers (which may be any combination of Eyenovia, any Affiliates thereof, or Third Parties) able (i.e., with all technology transfer reasonably necessary to be operational completed) to manufacture and supply for each stage of the manufacturing process of the Products (for example, two (2) manufacturers providing MicroLine Product, MicroPine Product and MicroStat Product drug substance, two (2) manufacturers manufacturing MicroLine Product, MicroPine Product and MicroStat Product cartridges, two (2) manufacturers performing drug-cartridge assembly, etc.).
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	14.
	Section 5.1 of the License Agreement is amended by adding the following new terms:

In addition to payments already provided to Eyenovia per terms of the License Agreement, Arctic Vision shall pay to Eyenovia a one-time upfront payment of two hundred and fifty thousand dollars ($250,000) within [***] ([***]) Business Days after the Amendment Effective Date, with Arctic Vision initiating an irrevocable wire transfer to Eyenovia therefor, and providing Eyenovia reasonable written evidence thereof.
	15.
	Section 5.2 of the License Agreement is amended by adding the following new rows 10 through 13 to the chart of Milestone Events:

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	​
	Development and Regulatory Milestone Events
	Milestone Payment

	10)
	[***]
	$[***]

	11)
	[***]
	$[***]

	12)
	[***]
	$[***]

	13)
	[***]
	$[***]

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	16.
	Section 5.5 of the License Agreement is amended to include royalty payments applicable to the MicroStat Product on the same terms and condition as applicable to the MicroPine Product and the MicroLine Product. For clarity and in accordance with the License Agreement, the royalty payments shall be calculated by multiplying the applicable royalty rate set forth in the table below by the corresponding amounts of Net Sales of such MicroPine Products, MicroLine Products or MicroStat Products, respectively, sold in the Territory in the applicable Calendar Year.

	For that portion of Net Sales of MicroPine Products, MicroLine Products or MicroStat Products in the Territory in a particular Calendar Year
	Royalty Rate

	1)
	less than or equal to
	$[***]
	[***]%

	2)
	greater than
	$[***]
	[***]%

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	but less than or equal to
	$[***]
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	3)
	greater than 
but less than or equal to
	$[***]
	[***]%

	​
	​
	$[***]
	​

	4)
	greater than
	$[***]
	[***]%

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	17.
	The introductory sentence of Section 8.1 of the License Agreement is amended as follows:

8.1 Mutual Representations and Warranties. Each Party hereby represents, warrants, and covenants (as applicable) to the other Party, as of the Amendment Effective Date, as follows:
	18.
	The introductory sentence of Section 8.2 of the License Agreement is amended as follows:

8.2 Additional Representations and Warranties. Eyenovia hereby represents and warrants to Arctic Vision that, as of the Effective Date for the MicroLine Product and the MicroPine Product and as of the Amendment Effective Date for MicroStat Product, as follows:
	19.
	Section 8.3(b) of the License Agreement is amended and restated in its entirety as follows:

(b) Eyenovia is, as of the Amendment Effective Date, in compliance in all material respects with the Senju License Agreement, and, to Eyenovia’s knowledge, the other party to the Senju License Agreement is, as of the Amendment Effective Date, not in breach or default in any respect of the Senju License Agreement pertaining to the Product.
	20.
	Section 8.4 of the License Agreement is amended and restated in its entirety as follows:

8.4 Arctic Vision Representations, Warranties, and Covenants Regarding the Senju License Agreement.  Arctic Vision represents and warrants that, as of the
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Effective Date for the MicroLine Product and the MicroPine Product and as of the Amendment Effective Date for the MicroStat Product, neither it nor any of its Affiliates is a Senju Competitor. Notwithstanding anything to the contrary, Arctic Vision shall not, and shall ensure that Sublicensees and its Affiliates do not, (i) sublicense any rights granted hereunder to any Third Party that is a Senju Competitor at the time such sublicense is granted, (ii) permit any Sublicensee to sublicense its rights to any Third Party that is a Senju Competitor at the time such sublicense is granted, or (iii) indirectly or directly sell or otherwise provide, or permit any Affiliate of Arctic Vision or Sublicensee to indirectly or directly sell or otherwise provide, any Product to any Third Party that is a Senju Competitor.
	21.
	Section 8.6 is hereby added to the License Agreement as follows:

8.6 Updated Representations, Warranties and Covenants. The Parties hereby agree and acknowledge that the representations, warranties and covenants in this Agreement were made as of the Effective Date with respect to the MicroLine Product and the MicroPine Product. The Parties hereby agree and acknowledge that the representations, warranties and covenants in this Agreement are made as of the Amendment Effective Date with respect to the MicroStat Product and as otherwise explicitly noted in this Article 8.
	22.
	Section 11.5 of the License Agreement is hereby amended by deleting the notice information for Wyrick Robbins Yates & Ponton LLP and replacing it with the following:

with a copy (which shall not constitute notice) to:
	Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. 3580 Carmel Mountain Road, Suite 300

	San Diego, CA 92130

	Attn:
	Fred Hernandez

	Fax:
	(858) 314-1501

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	23.
	[***]

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	24.
	[***]

	25.
	[***]

	26.
	[***]

	27.
	Except as amended by this Amendment, the License Agreement shall remain in full force and effect.  This Amendment may not be modified, amended, or varied in any manner unless by a written agreement duly executed by each of the Parties.

[Signature Page Follows]
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Confidential Treatment Requested by Eyenovia, Inc.
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Pursuant to 17 C.F.R. Section 200.83

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IN WITNESS WHEREOF, Eyenovia and Arctic Vision have executed this Amendment by their respective duly authorized representatives.
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	EYENOVIA, INC.
	  
	ARCTIC VISION (HONG KONG) LIMITED

	​
	​
	​

	By:
	/s/ Tsontcho Ianchulev
	​
	By:
	/s/ Wu Hoi Ti

	​
	Name:
	Tsontcho Ianchulev
	​
	​
	Name:
	Wu Hoi Ti

	​
	Title:
	CEO
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	​
	Title:
	CEO

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	Date:
	9/14/2021
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	​
	Date:
	9/10/2021

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Exhibit 10.2
Confidential Treatment Requested by Eyenovia, Inc.
Pursuant to 17 C.F.R. Section 200.83
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
LICENSE AMENDMENT 2
This LICENSE AMENDMENT 2 (the “LA2”) by and between:
Senju Pharmaceutical Co., Ltd., a corporation duly organized and existing under the laws of Japan, having a principal place of business at 3-1-9, Kawaramachi, Chuo-ku, Osaka 541-0048, Japan (“Senju”); and
Eyenovia, Inc., a corporation organized and existing under the laws of Delaware, having a principal place of business at 295 Madison Avenue, Suite 2400, New York, NY 10017, U.S.A. (“Eyenovia”);
shall be effective as of May __, 2021 (the “LA2 Effective Date”), and where Senju and Eyenovia are each individually referred to herein as a “Party” and collectively referred to as the “Parties”.
RECITALS
WHEREAS, Senju and Eyenovia are parties to an Exclusive License Agreement dated March 18, 2015 (the “Agreement”), which remains in full force and effect; and
WHEREAS, Senju and Eyenovia are parties to a License Amendment (the “LA1”) and a letter entitled “RE: Eye Spray Exclusive License Agreement” (the “Letter”), dated April 8, 2020 and August 7, 2020 respectively, both of which remain in full force and effect; and
WHEREAS, the Parties wish to confirm their mutual understanding of the terms of the Agreement as stated in this LA2; and
WHEREAS, it is the intentions of the Parties that the terms of the Agreement be so confirmed by way of this LA2.
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Confidential Treatment Requested by Eyenovia, Inc.
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Pursuant to 17 C.F.R. Section 200.83

NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants contained herein, the Parties hereby agree as follows:
	1.
	Any capitalized terms in this LA2 shall have the meaning assigned to them in the Agreement, provided that the following terms are defined by this LA2:

		(1)
	 “China” shall mean the People’s Republic of China, and also Hong Kong, Macao, and Taiwan.

		(2)
	“LA2 Licensed Products” shall mean a Licensed Product using piezo-print technology in a microdose dispenser containing: the chemical substance atropine sulfate as its sole active ingredient and that is used for the treatment of myopia in humans; the chemical substance pilocarpine as its sole active ingredient and that is used for the treatment of presbyopia in humans; the chemical substances phenylephrine and tropicamide in combination as active ingredients that are used for pharmaceutical mydriasis in humans.

		(3)
	“LA2 Term” shall mean the period of time from the LA2 Effective Date until the end of one (1) year thereafter.

		(4)
	“Senju Licensed Know-How” shall mean any and all information, data, clinical studies, instructions, proprietary information, trade secrets, techniques or materials which are related to and generated by Senju’s activities (or those performed on Senju’s behalf) under the Agreement for the Licensed Product.

		(5)
	“Senju Inventions” shall mean Inventions generating from Senju’s activities (or those performed on Senju’s behalf) under the Agreement for the Licensed Product.

	2.
	LA1 shall be terminated as of the LA2 Effective Date and any rights and obligations set forth in LA1 shall be transferred to and re-stated in this LA2.  For clarification, the amount to be paid to Senju upon the execution of the arrangement with Eyenovia Designated Third Party for atropine product and pilocarpine product pursuant to Section 4.5(i)(b) has been already paid as of the LA2 Effective Date and shall not be refundable.

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Confidential Treatment Requested by Eyenovia, Inc.
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Pursuant to 17 C.F.R. Section 200.83

	3.
	For the LA2 Term and only for the LA2 Licensed Products, the Territory as stated in Section 1.15 of the Agreement shall exclude China and South Korea.  For the purpose of clarification, this exclusion shall not affect Senju’s rights to the LA2 Licensed Product outside of China and South Korea.

	4.
	If before the end of the LA2 Term, Eyenovia enters into a definitive arrangement with any third party which Eyenovia designates (“Eyenovia Designated Third Party”) for the LA2 Licensed Products in China and South Korea, then the exclusion of Section 2 of this LA2 shall continue as long as the definitive agreement with the Eyenovia Designated Third Party is in place, unless otherwise altered by agreement of the Parties.  Provided, however, that:

		(1)
	Eyenovia itself may not research, develop, commercialize, manufacture, or use the LA2 Licensed Products in China and South Korea (and accordingly it doing so would not extend the exclusion of Section 2 of this LA2); this restriction would not apply to the third party under terms of a license agreement; and

		(2)
	Subject to the terms and conditions of this LA2, and without limitation of Sections 2.1.4, 6.1.1, 7.4.3, and 7.4.4 of the Agreement, Eyenovia has a right by way of sub-license to the Eyenovia Designated Third Party, to research, develop, commercialize, manufacture, or use the LA2 Licensed Products in China and South Korea, under the Senju Licensed Know-How and Senju Inventions, as applicable.

		(3)
	Senju has a right, with a right to Sublicense in accordance with the Agreement, to research, develop, commercialize, manufacture, or use, under the Licensed Know-How and Inventions with respect to the Licensed Product generated from the Eyenovia Designated Third Party’s activities under this LA2, (a) the Licensed Products other than LA2 Licensed Products in China and South Korea, and (b) the Licensed Products in countries of the Territory other than China and South Korea.  For the purpose of clarification, Senju’s right to use the Licensed Know-How and Invention under this

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Confidential Treatment Requested by Eyenovia, Inc.
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Pursuant to 17 C.F.R. Section 200.83

Section will not increase the Running Royalty in Section 6.2 of the Agreement and/or extend Royalty Term/Term under Sections 6.3 and 7.1 of the Agreement, respectively,
		(4)
	Senju makes no representations or warranties that the Senju Licensed Know-How and/or Senju Inventions are sufficient to develop, manufacture or commercialize the Licensed Product, including LA2 Licensed Products, nor that any resulting patent applications for Senju Inventions will be granted or patents enforceable.

		(5)
	In consideration for the exclusion of Section 2 of this LA2, Eyenovia shall pay to Senju the following compensation upon and after the execution of the arrangement with Eyenovia Designated Third Party:

		(i)
	Non-Royalty License Revenue:

		(a)
	$250,000 representing the entirety of the lump-sum payment received from Eyenovia Designated Third Party if Eyenovia licenses the phenylephrine plus tropicamide combination product;

		(b)
	[***] percent ([***]%) of any lump-sum payment received from Eyenovia Designated Third Party if Eyenovia licenses any other LA2 Licensed Product, including, without limitation, any signing fee and, upfront;

		(c)
	[***] percent ([***]%) of any lump-sum payment received from Eyenovia Designated Third Party if Eyenovia licenses any LA2 Licensed Product for milestones; and

		(d)
	[***] percent ([***]%) of any net revenue obtained from contract research and/or development for the LA2 Licensed Product; and

		(e)
	[***] percent ([***]%) of any net revenue obtained from contract manufacture for the device of the LA2 Licensed Product.

In the case of contract manufacturing, Net Revenue is defined as [***].
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Confidential Treatment Requested by Eyenovia, Inc.
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Pursuant to 17 C.F.R. Section 200.83

In the case of contract research and or development, Net Revenue is defined as [***].
Senju must receive a minimum of [***] United States Dollars (US$[***]) in payments for Non-Royalty License Revenue under this Section 3. (3) (i).
		(ii)
	Revenue from running royalty based on sales:

[***] percent ([***]%) of all sales royalty revenues received by Eyenovia for the sale or commercialization of the LA2 Licensed Product in China and South Korea by Eyenovia Designated Third Party.
		(iii)
	At the request of Senju, Eyenovia shall deliver to Senju a true and accurate report setting out in detail the information necessary to calculate the payments and revenues due under Section 3(3), including all deductions made under Net Revenues.  Eyenovia shall retain records pertaining to such payments and revenues, which will be open for inspection by an auditor chosen by Senju, for the purpose of verifying the amounts payable by Eyenovia hereunder.  Such inspections shall be at the expense of Senju, unless a variation or error producing an underpayment in amounts payable exceeding five percent (5%) of the amount paid for any period covered by the inspection is established, in which case, all reasonable costs relating to the inspection for such period and any unpaid amounts that are discovered shall be paid by Eyenovia.

	5.
	In the event that Eyenovia fails to enter into such a definitive arrangement with Eyenovia Designated Third Party for the LA2 Licensed Product in China and South Korea during the LA2 Term, then the exclusion of Section 2 of this LA2 shall end at the end of the LA2 Term.  In the event that such arrangement was to be entered into during the LA2 Term, but then expire or otherwise terminate thereafter, then the exclusion of Section 2 of this LA2 shall end upon such expiration or termination.  In either such case, Senju would regain and retain full rights to the LA2 License Product in China and South Korea.

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Confidential Treatment Requested by Eyenovia, Inc.
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Pursuant to 17 C.F.R. Section 200.83

	6.
	Any material breach by Eyenovia of the terms of this LA2 shall be grounds for Senju to terminate this LA2 upon notification to Eyenovia and after Eyenovia is given sixty (60) days to address any such material breach. If Eyenovia remains in such material breach after that time, Senju may terminate this LA2 and the rights and obligations stated herein.

	7.
	The Parties agree and acknowledge that “LA Licensed Product” in the Letter shall be replaced in its entirety to “LA2 Licensed Product.”

	8.
	The remaining terms and conditions of the Agreement shall remain unchanged, and in full force and effect.

	9.
	This LA2 may be executed in counterparts and signature pages may be delivered by facsimile or scanned (“PDF”) form, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

 [Signature Page Follows]
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Confidential Treatment Requested by Eyenovia, Inc.
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Pursuant to 17 C.F.R. Section 200.83

IN WITNESS WHEREOF, Eyenovia and Senju have executed this LA2 by their respective duly authorized representatives.
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	EYENOVIA, INC.
	SENJU PHARMACEUTICAL CO., LTD.

	​
	​

	​
	(“Senju”)

	​
	​

	/s/ Tsontcho Ianchulev
	By:
	/s/ Shuhei Yoshida

	​
	Name:
	Tsontcho Ianchulev
	​
	Name:
	Shuhei Yoshida

	​
	Title:
	CEO
	​
	Title
	President

	​
	Date:
	9/14/2021
	​
	Date:
	5/14/2021

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