Document:

ex_182422.htm

Exhibit 10.48

 

AMENDMENT NO. 1 

TO

PAYMENT RESTRUCTURING AGREEMENT

 

This Amendment No. 1 to Payment Restructuring Agreement (this “Amendment”) is made by and between Windtree Therapeutics, Inc., a corporation organized and existing under the laws of the state of Delaware, having its principal place of business at 2600 Kelly Road, Suite 100, Warrington, PA 18976 USA (“Windtree”), and Battelle Memorial Institute, through its Corporate Operations, a corporation organized and existing under the laws of the state of Ohio, having its principal place of business at 505 King Avenue, Columbus, OH 43201-2693 USA (“Battelle”). This Amendment is effective as of the date of the last signature below (the “Amendment Effective Date”).

 

WHEREAS, Windtree and Battelle are parties to that certain Payment Restructuring Agreement made and entered into as of December 7, 2018 (as amended through the Amendment Effective Date, the “Agreement”); and

 

WHEREAS, Windtree and Battelle now desire to amendment the Agreement as provided herein.

 

NOW, THEREFORE, in consideration of the covenants and promises contained in this Amendment and intending to be legally bound, Windtree and Battelle hereby agree to modify, replace, supplement or amend the terms of the Agreement, as the case may be, as follows:

 

	 	
			1.

				
			Definitions. All capitalized terms used herein and not otherwise defined herein shall have the meanings ascribed to them in the Agreement.

			

 

	 	
			2.

				
			Section B.iv.b. Section B.iv.b of the Agreement, is hereby amended and restated in its entirety as follows:

			

 

“b.     Milestone Payments will be due and payable as follows:

 

1.   A Milestone Payment will be due and payable on the earlier of enrollment of the first patient in the next AEROSURF clinical study as evidenced by use of the Next Generation System in the clinic or April 15, 2020; and

 

2.   A Milestone Payment will be due and payable on the earlier of the date on which Windtree completes the device technology transfer to the selected manufacturer and assembler for the Next Generation System, as evidenced by contract manufacturers’ production of at least one disposable and durable unit or September 1, 2020.”

 

The following sentence that immediately follows Section B.iv.b.2., is hereby removed in its entirety.

 

“Notwithstanding the foregoing, if any Milestone Payments remain unpaid on December 31, 2019 for any reason whatsoever, including, but not limited to Windtree’s failure to complete a Follow- on Financing, enroll a first patient in a clinical study or complete Device Technology Transfer, then all unpaid Milestone Payments shall be accelerated and become due and payable on or before January 7, 2020.”

 

	 	
			3.

				
			No Other Modifications. Except as expressly set forth in this Amendment, the Agreement and all provisions thereof in effect as of the Amendment Effective Date shall continue in full force and effect without any modification or amendment.

			

 

1

 

 

	 	
			4.

				
			Counterparts. This Amendment may be executed in one or more counterparts, each of which shall be an original and all of which shall constitute together the same document.

			

 

	 	
			5.

				
			Signatures. Electronic signatures sent via electronic mail or similar means shall be deemed to be original signatures for purposes of this Amendment.

			

 

[signature page follows]

 

 

 

 

In Witness Whereof, the Parties have duly executed this Amendment as of the Amendment Effective Date.

 

	WINDTREE THERAPEUTICS, INC. 	BATTELLE MEMORIAL INSTITUTE
	 	Corporate Operations
	 	 
	 	 
	By: /s/ John Tattory                                   	By: /s/ Amanda K. Botti                               
	Name: John Tattory	Name: Amanda K. Botti
	Title: SVP and Chief Financial Officer  	Title: Contracts Manager
	Date: March 30, 2020	Date: March 30, 2020

 

3ex_182491.htm

Exhibit 10.49

 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***] HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED.

 

BINDING TERM SHEET

 

THIS BINDING TERM SHEET (this “Term Sheet”) is entered into on March 18, 2020 (the “Effective Date”), by and between LEE’S PHARMACEUTICAL (HK) LTD. (“LP”), and WINDTREE THERAPEUTICS, INC., a Delaware corporation (“WINT”), as follows:

 

Purpose of Term Sheet

 

	 	
			●

				
			The parties intend for this Term Sheet to provide (1) guidance to the parties in the preparation of definitive written agreement(s) for the transactions described in this Term Sheet (collectively, the “Definitive Agreement”) and (2) certain obligations legally binding on the parties.

			

 

Terms

 

	 	
			●

				
			LP shall pay to WINT the following amounts (the “Project Expenses”), which payment will be used by WINT in connection with the development of AEROSURF® from April 1, 2020 through September 30, 2020, with the main focus being the carrying out of the “Device Bridging Study” as briefly described in Exhibit A: (a) USD$1,000,000 no later an April 1, 2020; (b) USD$1,400,000 no later than July 1, 2020; and (c) USD$1,500,000 or USD$ 400,000 (as the case may be), subject to the provisions set forth below, no later than September 1, 2020. The payments above are non-refundable. In any case, the parties expressly agree that, on or prior to August 31, 2020, if WINT both (1) receives proceeds, net of transaction costs including legal fees, accounting fees and underwriter discounts, commissions and fees, from the sale of its equity securities equal to USD$4,500,000 or more and (2) WINT’s common stock becomes listed on the NASDAQ National Market or NASDAQ Global Market, then the Project Expenses will be adjusted such that WINT will absorb USD$ 1,100,000 of the budgeted KL4 platform fixed costs (as set forth in Exhibit A). In such case, the third payment under (c) above will be lowered from US$1,500,000 to USD$ 400,000.

			

 

	 	
			●

				
			During the period from April 1, 2020 through September 30, 2020, the parties will negotiate in good faith for a definitive agreement concerning LP provision of additional semi-annual non-refundable payments to cover the continued development of AEROSURF after September 30, 2020. Such payments would also be considered Project Expenses. The parties expect such payments to be equal and subject to an agreed budget for such continued development, which budget will be agreed no later than one month prior to the start of each subsequent 6-month period/s. Additionally, WINT and LP will agree no later than one month prior to the end of any 6-month period, on the ongoing global strategy and operating plan to include review of development progress and plan of global development under WINT’s active management (versus localizing programs and costs and support (i.e., analytics) into China only).

			

 

	 	
			●

				
			“Commercialization Net Revenue” means (a) any and all revenue amounts and payments received by WINT and its affiliate/s in consideration for any sale, divesture, license or other development and/or commercialization of the KL4/AEROSURF portfolio (i.e., Surfaxin, Surfaxin LS; AEROSURF as well as any KL4-containing product as a mono-substance and in combination with other active ingredients) including, without limitation, upfront and milestone payments, distributions of net profit, license maintenance fees, royalties and sublicense income but excluding (i) payments made by another licensee for bona fide research and development conducted by WINT; (ii) reimbursement paid to WINT by another licensee of patent expenses for the KL4/AEROSURF patent portfolio and (iii) all amounts received by WINT under the License, Development and Commercialization Agreement between LP and WINT dated as of June 12, 2017 (as amended, the “License Agreement”); minus (b) any payments, such as royalties and milestone payments, owed and paid by WINT in respect of third party intellectual property not previously funded by LP.

			

 

 

 

 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***] HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED.

 

	 	
			●

				
			Until WINT has paid LP a total amount of Commercialization Net Revenue equal to one hundred twenty five percent (125%) of Project Expenses, WINT will pay LP fifty percent (50%) of Commercialization Net Revenue.

			

 

	 	
			●

				
			Additionally, LP and WINT will amend Section 7.4(a)(i) (Royalty Rates for the Surfaxin Product and/or Surfaxin LS) of the License Agreement to decrease (i) royalty rates from [***]% to [***]% in the less than or equal to annual [***] tier, (ii) from [***]% to [***]% in the greater than annual [***] but less than or equal to annual [***] tier, (iii) from [***]% to [***]% in the greater than annual [***] but less than or equal to annual [***] tier and iv) from [***]% to [***]% in the greater than annual [***] tier.

			

 

	 	
			●

				
			Except as required by law, neither party shall publicly announce that the parties have entered into this Term Sheet or the terms and conditions of this Term Sheet except with the prior written consent of the other party.

			

 

	 	
			●

				
			The parties agree that: (1) this Term Sheet shall be governed by, construed and enforced in accordance with the laws of England and Wales; (2) all disputes arising out of or in connection with the Term Sheet and the Definitive Agreement shall be finally settled by arbitration before a single arbitrator under the auspices of JAMS, Inc., pursuant to its Comprehensive Arbitration Rules and Procedures then in effect (the “JAMS Rules”); (3) the arbitration will be conducted in London (United Kingdom), the language of the arbitration will be English and judgment on the award may be entered in any court having jurisdiction; (4) each party has participated fully in the review and revision of this Term Sheet and, therefore, any rule of construction to the effect that ambiguities are to be resolved against the drafting party shall not be applied in interpreting this Term Sheet; (5) the parties shall bear their own attorneys’ fees, costs, and expenses incurred in connection with the negotiation, preparation, execution and delivery of this Term Sheet and the Definitive Agreement; (6) this Term Sheet may be executed in counterparts, each of which shall be deemed to be an original, but all of which together shall constitute one agreement; (7) this Term Sheet constitutes the final, complete, and exclusive statement of the terms of the agreement between the parties pertaining to the subject matter of this Term Sheet and supersedes all other prior or contemporaneous, oral or written understandings and agreements of the parties; and (8) this Term Sheet may be supplemented, amended, or modified only by a writing signed by both parties.

			

 

[Signature Page to Follow]

 

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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***] HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED.

 

IN WITNESS WHEREOF, the parties have executed this Term Sheet as of the Effective Date.

 

 

	
			WINDTREE THERAPEUTICS, INC.

			 

			 

			By:    /s/ Craig Fraser                                       

			 

			Name:     Craig Fraser                                       

			 

			Title:     CEO                                                    

				
			LEE’S PHARMACEUTICAL (HK) LTD. 

			 

			 

			By:    /s/ Benjamin Li                                   

			 

			Name:    Benjamin Li                                   

			 

			Title:      CEO                                                

			

 

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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***] HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED.

 

 

EXHIBIT A

 

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