Document:

Document

Exhibit 10.4

CERTAIN CONFIDENTIAL INFORMATION IDENTIFIED IN THIS DOCUMENT, MARKED BY [**], HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

[**]

Re: Memorandum of Understanding for the Supply of [**] Pens [**]

Dear Ms. [**],

Pursuant to the terms of this letter, US WorldMeds, LLC (“USWM”), Britannia Pharmaceuticals Ltd. (“BPL”) (collectively the “Purchasers”), and [**], acting through its [**] business unit (“[**]”) (each, a “Party” and collectively, the “Parties”) hereby agree and acknowledge the intent by the Parties to move forward in good faith toward [**] providing the Purchasers certain services (the “Services”) related to (i) the recommissioning of [**] pen line for the supply of [**] pens (“[**] Pens”), (ii) the supply of USWM’s requirements of [**] in the quantities and at the prices set forth herein, and (iii) the [**] and [**] of [**] for [**] with [**].

In regard to the development and supply of [**], the following terms shall apply:

•[**].  Within [**] days of the date of last signing below, the Parties shall resolve a [**] and associated agreement which shall contain the essential elements of the [**] of the [**], including details concerning the [**], [**], [**] and [**], [**] and [**] obligations and other requirements (as set forth in the attached [**] to [**] (the [**])) (the [**]).  At the time of signing, it is believed by [**] that [**] represents an [**] for the [**] with a number of [**] other [**] and a [**] and [**].  While it is the intention of all the Parties to proceed to seeking [**] for [**], [**] will additionally have the right, but not the obligation, to pursue [**] projects with the [**].  
•Terms of [**].  The [**] shall include key terms of [**] for the [**].  Furthermore, promptly following the completion of the [**] of the [**], the Parties shall negotiate and agree in good faith on a [**], which shall include the key terms of [**] from the [**], amended as necessary to comply with laws then applicable and any changing conditions and to reflect such other customary terms and provisions as the parties may agree.
•Payment Terms.  [**] will issue periodic invoices to [**] for all amounts due to [**] hereunder, setting forth in reasonable detail the amounts payable by [**] under this letter.  [**] invoices will be payable within [**] days of [**] receipt of the respective invoice.
•Deposit.  In order to commence work on an expeditious basis and ensure that all timelines are met, the [**] agree to paying $[**] of the [**] (total $[**]) for the [**] of [**] within [**] business days of the last signing of this agreement.
•Non-Assurance.  The Parties acknowledge that [**] of the [**] by the [**] is not assured.  As long as a Party uses its commercially reasonable efforts to perform its obligations under this letter and the [**], that Party shall not be in default for any failure to achieve any particular result or [**].  For purposes of clarity, the [**] shall 
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not be financially accountable for [**] of [**] or additional [**] beyond this letter and/or the [**] (but shall remain accountable, for the avoidance of doubt, for payments through [**] totaling $[**] in the [**]), in the event the [**] are not [**] by the [**]. 
•Termination.  The Parties will use their commercially reasonable best efforts to seek [**] and [**] of [**] in the [**].  [**] obligation to deliver [**] will remain in place until [**].

In regard to [**] to be supplied to USWM by [**], the following terms shall apply:

•RLP Recommissioning.  Promptly following the date of last signing below, [**] will recommission its manufacturing of [**] as set forth in the attached “Proposal for recommissioning of [**] ([**]) to deliver Apomorphine hydrochloride” (the “Recommissioning Proposal”).
•Payment Terms.  [**] will issue periodic invoices to USWM for all amounts due to [**] hereunder, setting forth in reasonable detail the amounts payable by USWM under this letter.  [**] invoices will be payable within [**] days of USWM’s receipt of the respective invoice.
•Deposit.  In order to commence work on an expeditious basis and ensure that all timelines are met, the Purchasers agree to paying [**]% of the cost for the recommissioning of the [**] line [**] within [**] business days of the last signing of this agreement.
•The total price for the recommissioning of the [**] line under the Recommissioning Proposal shall be $[**]; the amount of the deposit is therefore $[**].
•Price and Quantity.  The purchase price of [**] will be $[**] and quantities of [**] to be produced will be mutually agreed by the Parties based on the outcome of the [**] and [**] of the [**], with a reasonable amount of [**] produced to account for the [**] for [**] in [**] of the [**].
•Delivery Date.  [**] will target the first delivery of [**] to occur on [**].  [**] agrees that first delivery of [**] shall occur no later than [**] (“Delivery Date”), though [**] shall endeavor to accelerate such delivery if reasonably possible.  Notwithstanding the foregoing, the Purchasers hereby agree to pay [**] an additional [**] and [**] ($[**]) as an incentive bonus to [**] if the [**] are delivered prior to [**] in sufficient quantity to avoid an out of stock situation. 

For further clarity, neither BPL nor USWM assume any liability to [**] in respect of the obligations of the other Purchaser beyond the [**] this MOU and any joint liability of the Purchasers hereunder shall be extinguished upon the [**] of the [**] of the [**] to which such liability relates and the [**] of a [**] (if applicable) with respect to the events, obligations or milestones to which such liability relates. Except as expressly set forth in this letter, the sale and purchase of [**] and [**] shall be governed by [**] Terms and Conditions of Sale in effect from time to time or such other contractual terms as the Parties may have agreed or in the future agree in writing.
[Signature Page Follows]

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37153181.1 08/14/2020

Acknowledged and agreed upon by:

						
	

/s/ [**]________________
[**]
on behalf of
[**]
Date: February 25, 2019

	

/s/ [**]_________________
[**]
on behalf of
US WorldMeds, LLC
Date: February 22, 2019

	

/s/ [**]_________________
[**]
on behalf of
Britannia Pharmaceuticals Ltd.
Date: February 20, 2019

	

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37153181.1 08/14/2020

[**] MEDICAL - PHARMACEUTICAL SYSTEMS,
SELF-ADMINISTRATION INJECTION SYSTEMS

Proposal for recommissioning of [**]
to deliver
Apomorphine hydrochloride
Feb 14th 2019

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Proposal for recommissioning of [**] pens

1.Impacted Products:
									
	Catalog No.:	Description	Customer

	[**]	[**]	US WorldMeds

2.Project Description

The [**] is designed to provide a convenient means for multiple injections for the delivery of apomorhine drug.  By easy [**] adjustments, the [**] can be [**] from injection to injection.

The system consists of the following separately supplied components:
•[**]
•Drug Cartridge
•Needle

[**] has been discontinued via project [**], but US WorldMeds has informed [**] that they would like to restore the [**] to produce additional inventory to avoid an [**] until the [**] to [**].

Work estimations included in this statement of work:
						
	Development Work:	
	SAP Material Updates	Material Updates:
		ACR(s)
	Design Control Deliverables	•Process Validations
•Risk Management (Design FMEA & Risk Management Report)
•Design & Development Plan
•Design Output Documentation
•Design Verification ([**]), Accelerated Age Testing ([**]), Real-Time Age Testing & Ship Testing (Vibration, etc.)
•Design Verification Design Review
•Design Transfer Design Review
•ECO release(s)
•ECO104:  SAP Data & Document Updates

	Customer Deliverables	•Biocompatibility ISO 10993 Compliance Statement
•Material Certifications

		Risk Management Summary Report (RMSR)
		•Customer External R&D Documents
•Material Statement Quality Statement for Customers

						
	Manufacturing Work:	
	Customer Deliverables	Customer External Process Validation Document (VESR)

External Deliverables:
•External R&D Document (ERD) for DV Summary
•Process Validations Molding & Assembly
•External Operations Document (VESR) for Process Validation
•Biocompatibility ISO 10993 Compliance Statement

3.Project costs

The proposal below includes [**] release, and [**] closure for [**]
						
	Project Costs for [**] Production	Total: $[**]
$[**] Plus $[**] incentive bonus for delivering up to [**] pens by [**].  Final quantity to be determined.

	Unit Cost per [**]	$[**] (per [**] units)

***Execution of the [**] project is contingent upon [**] commitment

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37153181.1 08/14/2020

Exhibit 1: Project Payment Milestones (Draft To be finalized at Kick-off meeting)

									
	Milestone	Timelines*	Invoice Amount:

	#1:  MoU execution for Recommission [**] project
•US WorldMeds to issue a PO for $[**]

	[**]	$[**] ([**]% of [**])
	#2:  Kick-off Meeting to align on project plan and deliverables for [**] activities

	[**]	$[**]
	#3:  Process Validation – Body, Vial Retainer, Cap

	[**]	$[**]
	#4:  Assembly Validation

	[**]	[**]
	#5:  Design Verification Testing – Accelerated Aging

	[**]	[**]
	#6:  Design Review, Customer Notification of Change

	[**]	[**]
	#7:  Completion of project and release of [**] code for sale

	[**]	$[**]
	TOTAL FEE		$[**] Plus [**] of [**] for [**] + $[**] incentive bonus for [**] delivery of [**]

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37153181.1 08/14/2020Document

Exhibit 10.5

CERTAIN CONFIDENTIAL INFORMATION IDENTIFIED IN THIS DOCUMENT, MARKED BY [**], HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

September 20, 2019

[**]

Re: Exclusive Supply of [**] Pens for Apomorphine

Dear [**],

Reference is made to that certain Memorandum of Understanding for the Supply of [**] Pens and [**] of [**] for [**] (the “MOU”) executed February 25, 2019 by and among US WorldMeds, LLC (“USWM”), Britannia Pharmaceuticals Ltd. (“BPL”), and [**] (“[**]”) (USWM, BPL, and [**] each a “Party” and collectively, the “Parties”).  Capitalized terms used but not otherwise defined herein have the respective meanings assigned to the same in the MOU.

In regard to the supply of [**] pens for the administration of apomorphine to treat symptoms of Parkinson’s disease (hereinafter, “RLPs”), the Parties, intending to be legally bound, hereby agree as follows:

[**] shall not, and shall not authorize or permit any of its affiliates, representatives, or agents to, directly or indirectly, (i) enter into or participate in any discussions or negotiations with any person or group of persons other than USWM, BPL or either of their respective affiliates regarding a Restricted Transaction, (ii) furnish any non-public information relating to USWM, BPL or either of their respective affiliates or businesses, in all cases for the purpose or with the effect of assisting with or facilitating a Restricted Transaction, or (iii) enter into a Restricted Transaction or any agreement, arrangement or understanding, including without limitation, any legally binding agreement, letter of intent, term sheet or similar document relating to a Restricted Transaction.  Immediately upon execution of this letter agreement, [**] shall, and shall cause its affiliates, representatives, and agents to, terminate any and all existing discussions or negotiations with any person or group of persons other than USWM, BPL or either of their respective affiliates regarding a Restricted Transaction.

As used herein, a “Restricted Transaction” means the [**], [**], [**], [**], [**] or [**] of RLPs in the United States market during the Exclusivity Period (as defined below).

As used herein, “Exclusivity Period” means, together with any Extended Exclusivity Periods, the period of time commencing on the date of last signing below and continuing for [**] thereafter; provided, however, that USWM shall be entitled to extend the Exclusivity Period for up to [**] successive [**] periods (each an “Extended Exclusivity Period”) upon USWM and/
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or BPL (x) providing [**] written notice of their intent to extend the Exclusivity Period (or an Extended Exclusivity Period, if applicable) at least [**] days prior to the end of the then-current Exclusivity Period and (y) paying [**] $[**] within [**] days prior to the end of the then-current Exclusivity Period (or an Extended Exclusivity Period, if applicable).  For purposes of clarity, (i) if the Exclusivity Period is extended pursuant to this paragraph, the terms and conditions of this letter agreement during each such Extended Exclusivity Period shall be the same as the terms and conditions in effect immediately prior to such extension and (ii) the aggregate Exclusivity Period including all Extended Exclusivity Periods shall not exceed [**] from the date of last signing below.  In addition, [**] agrees to support USWM by maintaining sufficient manufacturing capabilities to ensure commercial supply to USWM of additional RLPs until the [**] of (i) [**] (under terms to be negotiated in good faith), or (ii) for so long as the [**] of [**] (as defined in the MOU) is delayed beyond [**] due to [**] related to [**], but no [**] than [**].

As sole consideration for [**] obligations hereunder, USWM shall make the following [**], [**] payments to [**] (which [**] hereby acknowledges constitutes good and valuable consideration) within [**] business [**] of the occurrence of the following Milestone Events:
									
	Payment	Amount	Milestone Event

	1	$[**]	Prior to [**]

	2	$[**]	[**] months elapse from the date Payment 1 above is made

	3	$[**]	[**] months elapse from the date Payment 2 above is made

	4, 5 and 6, each only if there is a corresponding [**]

	$[**]	[**] days before expiration of the [**] or then-current [**]

Miscellaneous

The Parties hereto acknowledge that a breach of this letter agreement would cause irreparable harm for which monetary damages would be an inadequate remedy.  Accordingly, the Parties hereby agree that USWM may seek equitable relief in the event of any breach or threatened breach of this letter agreement, including injunctive relief against any breach thereof and specific performance of any provision thereof, in addition to any other remedy to which USWM may be entitled.

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37154234.1 08/14/2020

This letter agreement shall be governed by and construed in accordance with the internal laws of the state of Delaware, United States of America, without giving effect to any choice or conflict of law provision or rule (whether of the state of Delaware or any other jurisdiction) that would cause the application of laws of any jurisdiction other than those of the state of Delaware.  The prevailing party in any dispute arising under this letter agreement and/or the subject matter set forth herein shall be entitled to recover all reasonable attorney’s fees and costs incurred by the prevailing party due to any such dispute.

No Party hereto may assign any of its rights or delegate any of its obligations hereunder without the prior written consent of the other Parties, which consent shall not be unreasonably withheld, conditioned or delayed; provided, however, that any Party hereto may assign its rights or delegate its obligations, in whole or in part, without such consent, to an entity that acquires all or substantially all of the business or assets of such Party to which this letter agreement pertains, whether by merger, reorganization, acquisition, sale, or otherwise.  Any purported assignment or delegation in violation hereof shall be null and void.  This letter agreement shall be binding upon and inure to the benefit of any permitted assignee or delegate.

Nothing herein is intended or shall be construed to confer upon any person or entity other than the Parties and their successors or assigns, any rights or remedies under or by reason of this MOU.

This letter agreement may be executed in counterparts (and by different parties hereto in different counterparts), each of which shall constitute an original, but all taken together shall constitute a single contract.  This letter agreement, together with the MOU, constitute the entire contract among the Parties with respect to the subject matter hereof and supersede all previous agreements and understandings, oral or written, with respect thereto.  Delivery of an executed counterpart of a signature page to this letter agreement by facsimile or in electronic (“pdf” or “tif”) format shall be effective as delivery of a manually executed counterpart of this letter agreement.

[Signature Page Follows]

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Acknowledged and agreed upon by:

						
	

/s/ [**]
[**]
on behalf of
[**]
Date: September 23, 2019

	

/s/ [**]
[**]
on behalf of
US WorldMeds, LLC
Date: September 20, 2019

	

/s/ [**]
[**]
on behalf of
Britannia Pharmaceuticals Ltd.
Date: September 23, 2019

	

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37154234.1 08/14/2020

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