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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.
20549
FORM 8-K
CURRENT REPORT
Pursuant to
Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report
(Date of earliest event reported): August 18,
2023
HEALTHTECH SOLUTIONS,
INC./UT
(Exact name of registrant
as specified in its charter)
Utah |
0-51012 |
84-2528660 |
(State or Other Jurisdiction |
(Commission |
(I.R.S. Employer |
of Incorporation) |
File Number) |
Identification No.) |
181 Dante Avenue,
Tuckahoe, New York 10707
(Address of Principal
Executive Office) (Zip Code)
844-926-3399
(Registrant’s
telephone number, including area code)
Check the appropriate box below if
the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities
registered pursuant to Section 12(b) of the Act:
Title of each class |
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Trading
Symbol(s) |
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Name of each exchange
on which registered |
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Indicate by check
mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this
chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth
company ☐
If an emerging
growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any
new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 1.01 Entry into a Material Definitive Agreement.
Binding Term Sheet
On August 18, 2023, Healthtech
Solutions, Inc. (the “Company”), together with its subsidiaries Healthtech Wound Care, Inc. (“HTWC”) and World
Reach Health, LLC (“WR Health”), entered into a binding term sheet (the “Term Sheet”) with HLLT Acquired, LLC
(the “Purchaser”), pursuant to which (i) the Company agreed to grant the Purchaser an option to purchase HLTT’s rights
in and to certain patents (the “Patents”) relating to HLTT’s would care business (the “HLTT Option”), for
a purchase price of $15,500,000, and (ii) HTWC agreed to grant the Purchaser an option to purchase certain assets of HTWC (the “HTWC
Assets”) relating to HTWC’s production of would care products (the “HTWC Option,” and, together with the HLTT
Option, the “Options”), for a purchase price of $2,000,000.
Pursuant to the Term Sheet, the
Options will initially be exercisable by the Purchaser until November 30, 2023 (the “Initial Option Period”), subject to (i)
the parties’ prior execution during the Initial Option Period of asset purchase agreements for the Options that are consistent with
the terms set forth in the Term Sheet, and (ii) the Purchaser’s satisfaction of certain payment obligations described in the Term
Sheet, including payment of a non-refundable option fee of $10,000 for each Option. Provided that the foregoing conditions have been satisfied,
the Purchaser may extend the Initial Option Period by 12 months upon payment, prior to the expiration of the Initial Option Period, of
a non-refundable extension fee of (y) $3,990,000 to HLTT and (z) $190,000 to HTWC.
In addition, the Term Sheet contemplates
that, concurrently with the Purchaser’s satisfaction of its obligations under the asset purchase agreements related to the Options,
the Purchaser will enter into a non-exclusive distribution agreement with WR Health, on mutually agreed upon terms consistent with the
Term Sheet, with respect to any products relating to the HTWC Assets or the Patents that are manufactured by the Purchaser.
The foregoing description of the
terms of the Term Sheet does not purport to be complete and is qualified in its entirety by reference to the full text of the Term Sheet,
a copy of which is attached hereto as Exhibit 10.1 and incorporated herein by reference.
Manufacturing Agreement
On August 18, 2023 (the “Effective
Date”), concurrently with the execution of the Term Sheet, HTWC entered into a Manufacturing Agreement (the “Agreement”)
with the Purchaser, pursuant to which HTWC will, on a non-exclusive basis, manufacture and deliver certain human placental allograft tissue
products (“Products”) to the Purchaser. The initial term of the Agreement commenced on the Effective Date and, unless sooner
terminated in accordance with the terms of the Agreement, will continue for a period of 15 months. Thereafter, the Agreement will renew
automatically for additional 3 month periods unless either party provides written notice of non-renewal to the other party at least 10
business days prior to the expiration of the then-current term.
Pursuant to the terms of the Agreement,
the Purchaser will purchase at least (i) 3,000cm2 of Products within 30 days of the Effective Date and (ii) 5,000cm2
of Products within 60 days of the Effective Date. The Purchaser also agreed, commencing as of the 3rd monthly anniversary of
the Effective Date, to purchase at least 7,500cm2 of Products per month (the “Monthly Minimum”), subject to rollover
provisions for any purchases in excess of the Monthly Minimum in the preceding month. Furthermore, provided that HTWC has not breached
its obligations under the Agreement, the Purchaser will order sufficient quantities of Products over the term of the Agreement such that
the aggregate amount of manufacturing fees due and payable to HTWC over the term equals at least $21,100,000.
Pursuant to the terms of the Agreement,
the Purchaser will provide HTWC with equipment financing in the amount of $500,000 (the “Equipment Financing”). If, on or
prior to November 30, 2023, the Purchaser (i) elects to proceed with the HTWC Option and the HLTT Option, then upon the closing of the
transactions contemplated thereby, 100% of the Equipment Financing payments actually made by the Purchaser shall be applied first to satisfy
any amounts then owed by the Purchaser to HTWC for purchases of Products under the Agreement, with the remaining balance, if any, applied
secondarily towards the purchase price of the HTWC Option, or (ii) elects not to proceed with the HTWC Option and the HLTT Option, then
up to 100% of the Equipment Financing payments actually made by the Purchaser shall either be applied as a credit towards any amounts
due and payable by the Purchaser to HTWC for purchases of Products in the final month of the term of the Agreement, or if no such amounts
are then due and payable under the Agreement, be repaid to the Purchaser within 90 days thereof.
In addition, the Agreement contains
representations and warranties, covenants and indemnification obligations customary for transactions of this type.
The foregoing description of the
terms of the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement,
a copy of which is attached hereto as Exhibit 10.2 and incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
10.1 |
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Binding Term Sheet, dated August 18, 2023 |
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10.2 |
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Manufacturing Agreement, dated August 18, 2023, between Healthtech Wound Care, Inc. and HLLT Acquired, LLC |
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|
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned, hereunto duly authorized.
|
Healthtech Solutions, Inc. |
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|
|
Date: September 6, 2023
|
By: |
/s/ Jelena Olmstead
Jelena
Olmstead, Chief Executive Officer |
AMENDED AND RESTATED BINDING AND CONFIDENTIAL TERM SHEET
This Amended and Restated Binding and Confidential Term Sheet
(this “Term Sheet”) is dated August 18, 2023 (the “Effective Date”) and sets forth the basic terms
of understanding between Healthtech Solutions, Inc. (“HLTT”), a Utah Corporation, with a principal place of
business located at 181 Dante Avenue, Tuckahoe, New York 10707, Healthtech Wound Care, Inc., (“HTWC”), a Delaware
Corporation, with a principal place of business located at 615 Arapeen Drive, Suite 300, Salt Lake City, Utah 84108, and World Reach Health,
LLC (“WRH”), a Delaware limited liability company with a principal place of business located at 3501 W. Algonquin Road,
Suite 135, Rolling Meadows, Illinois 60008 (HLTT, HTWC and WRH will collectively be referred to herein as the “HLTT Parties”)
on the one hand, and HLLT Acquired, LLC (“Purchaser”), a Delaware limited liability company, with a principal
place of business located at 885 Third Avenue, 29th Floor, New York, New York 10022, on the other hand. Each of the HLTT Parties
and Purchaser may sometimes be referred to herein individually as a “Party” and collectively as the “Parties.”
RECITALS
WHEREAS, the Parties previously executed a non-binding
term sheet dated July 3, 2023 (the “Original Term Sheet”); and
WHEREAS, the Parties desire to amend and restate, in
its entirety, the Original Term Sheet, as this Term Sheet; and
WHEREAS, Purchaser desires to purchase from HTWC, and
HTWC desires to sell to Purchaser, the HTWC Assets (defined below), which are owned by HTWC and used by HTWC to produce commercially-viable
quantities of wound care products derived from placental membranes that have received a 361 designation from the Food and Drug Administration
(the “FDA”) in accordance with the terms and conditions contained in this Term Sheet; and
WHEREAS, Purchaser desires to purchase from HLTT, and
HLTT desires to sell to Purchaser the Patent (defined below) in accordance with the terms and conditions contained in this Term Sheet;
and
WHEREAS, until such time as Purchaser concurrently
exercises its option to purchase the HTWC Assets and the Patent, as more fully described herein, Purchaser desires to engage HTWC to manufacture,
and HTWC agrees to be engaged to manufacture, HTWC’s product, pursuant to the Manufacturing Agreement (defined below) in accordance
with the terms and conditions contained in this Term Sheet; and
WHEREAS, Purchaser desires, on or before the satisfaction
of all obligations in accordance with the HTWC Option (defined below) and the HLTT Option (defined below) to enter into a non-exclusive
Distribution Agreement (defined below) with WRH in accordance with the terms and conditions contained in this Term Sheet; and
WHEREAS, this Term Sheet is legally binding and
the Parties agree to be bound by the obligations set forth herein. Upon the complete execution of this Term Sheet, the Parties intend
to draft and execute definitive, legally binding agreements based upon the terms and conditions contained herein and such other terms
and conditions as are agreed.
PURCHASER’S CONTRACT MANUFACTURING ARRANGEMENT WITH HTWC |
Purchaser To Engage HTWC As Contract Manufacturer |
Simultaneously with the execution of, and as a condition precedent to the effectiveness of, this Term Sheet, HTWC and Purchaser shall enter into that certain contract manufacturing agreement (the “Manufacturing Agreement”), which is attached hereto and incorporated herein for reference as Exhibit “A.” |
PURCHASER’S OPTION TO ACQUIRE HTWC’S ASSETS |
Purchaser’s Option to Purchase HTWC’s Assets |
On or before the expiration of the Due Diligence Period, should Purchaser elect to proceed with the transaction, Purchaser and HTWC shall enter into an exclusive option purchase agreement (the “HTWC Option Agreement”), under which Purchaser shall have the option to purchase HTWC’s assets as more fully identified in the HTWC asset list that shall be provided by HTWC to Purchaser during the Due Diligence Period (defined below) (the “HTWC Assets”). |
HTWC Option Term; HTWC Option Fees |
Initial Option Period:
In consideration of the sum of Ten Thousand Dollars ($10,000.00
USD) (the “HTWC Initial Option Fee”), and so long as Purchaser has paid to HLTT the HLTT Initial Option Fee (defined
below) and to HTWC the first installments of the Equipment Financing (as identified in the Manufacturing Agreement), HTWC will grant to
Purchaser, its successors and its assigns, the option, commencing as of the Effective Date of this Term Sheet and continuing through and
including 3:00pm CST on November 30, 2023 (the “HTWC Initial Option Period”), to purchase from HTWC the HTWC Assets,
subject to the Parties’ execution of and upon the terms and conditions set forth in, the HTWC Option Agreement (the “HTWC
Option”). The HTWC Initial Option Fee shall be non-refundable. In the event Purchaser elects to proceed with the transaction,
the HTWC Initial Option Fee shall be fully applicable against the HTWC Asset Purchase Price (defined below). In the event Purchaser does
not proceed with or elects to cancel the transaction, the HTWC Initial Option Fee shall be fully applicable against all amounts Purchaser
owes to HTWC in accordance with the Manufacturing Agreement.
First Extension of the HTWC Option Period:
The period within which the HTWC Option may be exercised may
be automatically extended for an additional period of twelve (12) months through and including 3:00pm CST on Friday, November 29, 2024
(the "HTWC First Extension Period"), upon payment to HTWC of an additional sum of One Hundred Ninety Thousand Dollars
($190,000.00 USD) (the "HTWC First Extension Payment"), which shall be paid on or before the expiration of the Due
Diligence Period. Purchaser shall not be required to provide written notice to HTWC of Purchaser’s election to extend the Initial
Option Period; payment of the HTWC First Extension Payment alone is all that shall be required. The HTWC First Extension Payment shall
be non-refundable and shall be fully applicable against the HTWC Asset Purchase Price.
The period commencing as of the commencement of the HTWC Initial
Option Period and continuing through the last date of the HTWC First Extension Period, if applicable, will be referred to herein as the
“HTWC Option Period.”
The HTWC Option shall be exercisable at any time during the
HTWC Option Period.
If Purchaser exercises the HTWC Option, then, in exchange
for Purchaser’s payment of the HTWC Asset Purchase Price, HTWC will assign to Purchaser all rights, title and interest in and to
the HTWC Assets, excluding the Excluded Assets (defined below), subject to the terms and conditions of the HTWC Option Agreement. |
Due Diligence Period |
Purchaser shall be entitled to a due diligence period commencing
as of the Effective Date of this Term Sheet and continuing through and including 3:00pm CST on Thursday, November 30, 2023 (the “Due
Diligence Period”). During the Due Diligence Period, Purchaser shall have the sole and absolute discretion to conduct any reasonable
and necessary investigations, examinations or analyses regarding the HTWC Assets, HTWC’s operations, and financials, and the Patent
(defined below). The HLTT Parties shall provide all necessary assistance to facilitate the transaction in accordance with all FDA standards
and regulations.
In the event that, within the Due Diligence Period, Purchaser
determines, in Purchaser’s sole discretion, that Purchaser wishes to terminate the HTWC Option, Purchaser shall provide written
notice, via email, to HTWC and with a copy to HTWC’s legal counsel, of its decision to cancel the HTWC Option.
Upon such cancellation of the HTWC Option, each of Purchaser
and HTWC shall have no further obligations or liabilities under the HTWC Option Agreement.
In the event Purchaser elects to terminate the HTWC Option,
the HLTT Option (defined below), shall automatically terminate concurrently with the HTWC Option.
However, unless otherwise later agreed to in writing between
the Parties, the Manufacturing Agreement shall remain in full force and effect. |
Exercise of the HTWC Option |
The HTWC Option shall be exercisable, subject to the Parties’
execution of the HTWC Option Agreement, at any time during the HTWC Option Period but, in any event, no later than 3:00pm CST on the last
day of such period, by written notice via email to HTWC with a copy to HTWC’s legal counsel, is sufficient, of the exercise of the
HTWC Option, provided that Purchaser pays the HTWC Asset Purchase Price less the HTWC Initial Option Fee and the HTWC First Extension
Payment.
In the event Purchaser exercises the HTWC Option, as a condition
precedent thereof, Purchaser shall also be required to simultaneously exercise the HLTT Option and fulfill all obligations in accordance
with the HLTT Option Agreement. |
Purchase Price for the HTWC Assets |
The “HTWC Asset Purchase Price” shall mean Two Million Dollars ($2,000,000.00 USD). |
Bill of Sale for the HTWC Assets |
At Closing, HTWC will assign to Purchaser all of HTWC’s right, title and interest in and to all of HTWC’s Assets, free and clear of all mortgages, liens, pledges, security interests, charges, claims, restrictions and encumbrances of any nature whatsoever, unless otherwise noted herein, pursuant to a bill of sale (the “Bill of Sale”). |
HTWC’s Restrictions During the Option Period |
Other than for the existing and permitted lien(s) between World Reach Med, LLC and HTWC, during the HTWC Option Period, HTWC shall not permit any additional liens, encumbrances or other grant of rights against the HTWC Assets, nor shall HTWC sell or divest the HTWC Assets, except in the ordinary course of business, without the express written consent of Purchaser. No attempt will be made by HTWC or with HTWC’s authorization to encumber, diminish or impair any of the HTWC Assets, and all appropriate protection of the HTWC Assets will continue to be maintained by HTWC. |
HTWC’s Excluded Assets |
The following assets of HTWC will not be acquired by Purchaser
hereunder and shall be excluded from the definition of the HTWC Assets for all purposes under this Term Sheet (collectively, the “Excluded
Assets”):
·
the assets to be listed on the excluded asset list that shall be provided by HTWC to Purchaser during the Due Diligence Period;
·
all cash on hand or in banks, all cash equivalents, and all rights to any refunds of cash or cash equivalents;
·
HTWC’s right to and claims for federal or state income or franchise tax refunds and refunds of other taxes paid upon or measured
by the income of HTWC prior to the Closing;
·
all accounts receivable and notes receivable and all accounts payable and notes payable related to periods prior to the Effective
Date;
·
the corporate seals, organizational documents, minute books, stock books, tax returns, book of account or other records having
to do with the corporate organization of HTWC. HTWC will make all the aforementioned data and documents available for Purchaser to be
able to complete financial statements that may be audited in accordance with PCAOB policies. This undertaking includes HTWC, HTWC’s
staff and outside contracted entities working with Purchaser to obtain and/or provide necessary information on a timely basis;
·
all employee liabilities, benefit plans of HTWC, if any, and all accrued compensation, paid time off, vacation or other benefits
accrued to employees as of the Closing Date;
·
the HLTT Parties’ security deposit under the Arapeen Lease (defined below);
·
any insurance policies and rights thereunder; and
·
the rights that accrue or will accrue to HTWC under this Term Sheet or any definitive long-form agreements contemplated hereunder. |
Assignment of HTWC Contracts |
Effective as of the date Purchaser exercises the HTWC Option
and pays the entire HTWC Asset Purchase Price to HTWC (the “HTWC Closing Date”), HTWC shall assign to Purchaser, and
Purchaser shall assume, all of HTWC’s obligations under the contracts to later be listed on the Assigned Contracts list that shall
be provided by HTWC to Purchaser during the Due Diligence Period (the “Assigned Contracts”).
Commencing as of the HTWC Closing Date, Purchaser shall assume
HTWC’s respective obligations under such Assigned Contracts. HTWC shall use its best effort to obtain such consents for assignment
(if needed) prior to the HTWC Closing Date; provided, however, that as to any HTWC Assigned Contracts, the assignment of which by its
terms requires the prior written consent of any third-party thereto, in the event such consent is not obtained prior to the HTWC Closing
Date, Purchaser shall pay to HTWC, or pursuant to a direction to pay, to the applicable third-party, all amounts due on or before the
applicable due date.
HTWC represents and warrants that each of the applicable HTWC
Assigned Contracts are in full force and effect as of the Effective Date of this Term Sheet. |
Purchaser May Engage HTWC’s Executive(s) as Consultant |
Commencing as of the HTWC Closing Date and continuing for
a period of such duration as Purchaser and HTWC may agree, Purchaser may elect to pay HTWC a consulting fee (the “Consulting
Fee”), for the non-exclusive consulting services of Jelena Olmstead (“Olmstead”) and/or other HTWC executives,
in Purchaser’s sole discretion.
Olmstead may oversee all transitional endeavors relevant to
the transactions contemplated hereunder. |
Purchaser May Acquire and Employ HTWC’s Employees |
Commencing as of the HTWC Closing Date, all of HTWC’s
then-employed personnel (the “HTWC Personnel”) that Purchaser desires to engage, shall be permitted by HTWC to resign
from HTWC and shall immediately become employed by Purchaser or its designee. If Purchaser declines to offer employment to one (1) or
more of the HTWC Personnel, HTWC shall be permitted to either (a) retain said person or (b) terminate said person, at HTWC’s sole
discretion.
During the Due Diligence Period, HTWC shall provide Purchaser
with an HTWC Personnel list (the “Personnel List”).
Purchaser agrees that, should Purchaser elect to employ any
of the HTWC Personnel, Purchaser shall do so on the same terms and conditions as between HTWC and the HTWC Personnel, as in effect as
of the HTWC Closing Date, particularly pertaining to base salary, seniority, vacation time, sick days, health insurance, 401k benefits,
etc. |
No Assumed Liabilities for HTWC |
Except for liabilities arising out of the Assigned Contracts on or after the HTWC Closing Date, Purchaser shall not assume and shall not be responsible to pay, perform or discharge any liabilities or obligations of HTWC of any kind or nature whatsoever, all of which shall remain the sole liabilities and obligations of HTWC and all of which HTWC shall pay and satisfy in due course. |
Deliverables at Closing |
As of the HTWC Closing Date, HTWC and Purchaser shall deliver
or cause to be delivered to the other the following:
·
the Bill of Sale
·
instruments sufficient to assign to Purchaser all of HTWC’s rights under the Assigned Contracts, with all necessary consents
of counterparties (if applicable);
·
such other documents and instruments reasonably necessary or appropriate to vest in Purchaser good and marketable title to the
HTWC Assets, free and clear of all liens, claims and encumbrances whatsoever, and all certificates of title covering the HTWC Assets with
warranties of title, all in such form reasonably acceptable to Purchaser;
·
actual possession of the HTWC Assets to Purchaser; and/or
·
such other certificates or other instruments as HTWC and Purchaser may mutually approve. |
Automatic Termination of the HTWC Option Agreement |
In the event Purchaser fails to make all payments when due
in accordance with the Manufacturing Agreement and/or all payments when due in accordance with the HTWC Option Agreement and the HLTT
Option Agreement, all of Purchaser’s rights pursuant to the HTWC Option Agreement will immediately and automatically terminate,
with all rights reverting to HTWC, unless otherwise later agreed to in writing between HTWC and Purchaser.
Notwithstanding the foregoing, Purchaser shall have thirty
(30) calendar days to cure any non-disputed payments then due. HTWC and Purchaser shall agree to an expeditious dispute resolution method
for all disputed payments. During the resolution period, the HTWC Option Agreement shall remain in full force and effect. |
PURCHASER’S OPTION TO PURCHASE
HLTT’S PATENTS APPLICABLE TO THE Q-CODE PRODUCT |
Purchaser’s Option to Purchase HLTT’s Patents Applicable to the Q-Code |
On or before the expiration of the Due Diligence Period, should
Purchaser elect to proceed with the transaction, Purchaser and HLTT shall enter into an exclusive patent option purchase agreement (the
“HLTT Option Agreement”), under which Purchaser shall have the option to purchase HLTT’s Patents applicable to
the FDA-approved allograft tissue, in accordance with Q-Code No. 4225 (the “Q-Code”), and all inventions and discoveries
related to HLTT’s business of wound care, and all derivative creations emanating therefrom, including, but not limited to any other
products produced in connection with or use of placentas to develop skin graft and wound care products, which include, without limitation,
the following:
·
Patent Ref. No. 207469-702102/PRO, filed on 6/30/22, Application No. 63/357,125
·
Patent Ref. No. 207469-702201/US, filed on 12/16/22, Application No. 18/083,019
(collectively, the “Patent”).
During the Due Diligence Period, HTWC will provide Purchaser
with a form of the HLTT Option Agreement, along with the complete intellectual property information pertaining to same, including, but
not limited the Patent information, filings, attorney opinions, and related agreements. |
HLTT Option Term; HLTT Option Fees |
Initial Option Period:
In consideration of the sum of Ten Thousand Dollars ($10,000.00
USD) (the “HLTT Initial Option Fee”), and so long as Purchaser has paid to HTWC the HTWC Initial Option Fee and
the first installments of the Manufacturing Fee and the Equipment Financing, HLTT will grant to Purchaser, its successors and its assigns,
the option, commencing as of the Effective Date of this Term Sheet and continuing through and including 3:00pm CST on November 30, 2023
(the “HLTT Initial Option Period”), to purchase from HLTT the Patent, subject to the parties’ execution of and
upon the terms and conditions set forth in, the HLTT Option Agreement (the “HLTT Option”). The HLTT Initial Option
Fee shall be non-refundable. In the event Purchaser elects to proceed with the transaction, the HLTT Initial Option Fee shall be fully
applicable against the HLTT Purchase Price (defined below). In the event Purchaser does not proceed with or elects to cancel the transaction,
the HLTT Initial Option Fee shall be fully applicable against all amounts Purchaser owes to HTWC in accordance with the Manufacturing
Agreement.
First Extension of the HLTT Option Period:
The period within which the HLTT Option may be exercised may
be automatically extended for an additional period of twelve (12) months through and including 3:00pm CST on Friday, November 29, 2024
(the "HLTT First Extension Period"), upon payment to Seller of an additional sum of Three Million Nine Hundred Ninety
Thousand Dollars ($3,990,000.00 USD) (the "HLTT First Extension Payment"), which shall be paid on or before the expiration
of the Due Diligence Period. Purchaser shall not be required to provide written notice to HLTT of Purchaser’s election to extend
the HLTT Initial Option Period; payment of the HLTT First Extension Payment alone is all that shall be required. The HLTT First Extension
Payment shall be non-refundable and shall be fully applicable against the HLTT Purchase Price.
The period commencing as of the commencement of the HLTT Initial
Option Period and continuing through the last date of the HLTT First Extension Period, if applicable, will be referred to herein as the
“HLTT Option Period.”
The HLTT Option shall be exercisable, subject to the parties’
execution of the HLTT Option Agreement, at any time during the HLTT Initial Option Period and, if applicable, the, HLTT First Extension
Period, by written notice, via email, to HLTT’s legal counsel, of the exercise of the HLTT Option.
In the event Purchaser exercises the HLTT Option, as a condition
precedent thereof, Purchaser shall also be required to simultaneously exercise and fulfill all obligations in accordance with the HTWC
Option Agreement.
If Purchaser exercises the HLTT Option and pays the HLTT Purchase
Price, then HLTT hereby irrevocably grants and assigns to Purchaser, and Purchaser’s successors and assigns, in perpetuity, all
rights of every kind and nature in and to the Patent. |
Termination of the HLTT Option |
Upon the expiration or earlier termination by Purchaser of the HLTT Option, the HTWC Option shall immediately and automatically terminate concurrently therewith and shall no longer be exercisable. |
Purchase Price for the Patent |
The “HLTT Purchase Price” shall mean Fifteen
Million Five Hundred Thousand Dollars ($15,500,000.00 USD).
The HLTT Purchase Price, less the HLTT Initial Option Fee,
the HLTT First Extension Payment (if paid), and the Manufacturing Fee Adjustment (as defined below), shall be paid to HLTT, via bank wire
transfer, to coordinates to be separately provided by HLTT, in twelve (12) monthly installments in accordance with the “HLTT
Payment Schedule,” the form of which (prior to the expiration of the Due Diligence Period) will be mutually approved between
HLTT and Purchaser, and will later be attached to the HLTT Option Agreement. For the avoidance of doubt, the HLTT Purchase Price shall
be subject to the HLTT Option Agreement.
In the event that the HTWC First Extension Payment and the
HLTT First Extension Payment are paid prior to the expiration of the Due Diligence Period, and so long as Purchaser has paid HTWC for
all amounts due to HTWC that accrued during the Due Diligence Period in accordance with the Manufacturing Agreement, Eighty-Five Percent
(85%) of the Manufacturing Fee actually paid by Purchaser to HTWC from the Effective Date of the Manufacturing Agreement through the expiration
of the Due Diligence Period shall be applied against the HLTT First Extension Payment (defined below), and, if applicable, against the
HLTT Purchase Price (the “Manufacturing Fee Adjustment”). For the avoidance of doubt, the Manufacturing Fee Adjustment
shall be equal to the (i) difference between (A) the Contract Manufacturing Price (as defined in Manufacturing Agreement) and (B) Manufacturing
Cost ($30 per square centimeter), multiplied by (ii) the number of Square Centimeters produced and supplied by HTWC to Purchaser. |
HLTT’s Restrictions During the HLTT Option Period |
Other than for the existing and permitted lien(s) between
World Reach Med, LLC and HLTT, during the HLTT Option Period, HLTT shall not permit any additional liens, encumbrances or other grant
of rights against the Patent, nor shall HLTT sell or divest the Patent, without the express written consent of Purchaser. No attempt will
be made by HLTT or with HLTT’s authorization to encumber, diminish or impair the Patent, and all appropriate protection of the Patent
will continue to be maintained by HLTT.
HLTT shall maintain the Patent in full force and effect and
shall pay to the US Patent and Trademark Office (the “USPTO”) all maintenance fees, renewal fees and similar charges
when due.
HLTT shall not file any amendments, modifications, continuations
in part (“CIP”), abandonments, or make any other changes to the Patent or any other filings with the USPTO without
the written consent of Purchaser in each instance. |
HLTT’s Post-Closing Covenants |
The assignment and transfer of title of the Patent from HLTT to Purchaser shall be free and clear of all licenses, contracts, liens, claims and encumbrances. From and after such assignment and transfer, HLTT shall be excluded from practicing under the Patent without the express written consent of Purchaser. Further, HLTT shall not attack the title of Purchaser in and to the Patent and HLTT shall not take any adverse action to Purchaser’s ownership or use of the Patent or challenging the validity of the Patent. HLTT shall provide further assurances to cooperate and perform all necessary actions to effectuate the assignments of the exclusive rights contemplated hereunder. |
Assignment of Lease of 615 Arapeen Dr., Salt Lake City, UT 84108 |
As of the Effective Date of this Term Sheet, HLTT is currently
a party to a real property lease for the property commonly known as 615 Arapeen Dr., Suites 300 and 302, Salt Lake City, Utah 84108 (the
“Arapeen Lease”). The current term of the Arapeen Lease ends on December 31, 2023. As of the Effective Date of this
Term Sheet, Purchaser acknowledges having received a copy of the Arapeen Lease. HLTT shall provide a copy of the Arapeen Lease promptly
upon the execution of this Term Sheet.
Purchaser acknowledges and agrees that HLTT, along with HTWC,
have been occupying suite 304 as part of HTWC’s operations; however, HLTT and the landlord have not yet consummated a lease for
suite 304; however, Purchaser shall be required to include suite 304 in any lease assignment(s) contemplated hereunder.
It shall be a condition subsequent to this Term Sheet and
any definitive long form agreements contemplated hereunder, that either (i) Purchaser, at the time Purchaser pays the entire HTWC Asset
Purchase Price and the HLTT Purchase Price, shall have entered into an assignment agreement between the landlord, HLTT and Purchaser,
or (ii) in the event Purchaser is not able to consummate an assignment of the Arapeen Lease with the landlord on or before the Closing
Date, Purchaser shall pay an amount equal to the base rent for suites 300, 302 and 304 in accordance with the Arapeen Lease to HLTT, or,
pursuant to a direction to pay, to the landlord on a month-to-month basis for the duration of any then-applicable lease term. |
Deliverables at Closing |
Effective as of the date Purchaser exercises the HLTT Option
and pays the entire HLTT Purchase Price to HLTT (the “HTWC Closing Date”), HLTT and Purchaser shall deliver or cause
to be delivered to the other the following:
·
instruments sufficient to assign to Purchaser all of HLTT’s rights under the Patent, with all necessary filings and consents
of counterparties (if applicable);
·
such other certificates or other instruments as HLTT and Purchaser may mutually approve. |
Automatic Termination of the HLTT Option Agreement |
In the event Purchaser fails to make all payments when due
in accordance with the Manufacturing Agreement and/or all payments when due in accordance with the HLTT Option Agreement and/or the HTWC
Option Agreement, all of Purchaser’s rights pursuant to the HLTT Option Agreement will immediately and automatically terminate,
with all rights reverting to HLTT, unless otherwise later agreed to in writing between HTWC and Purchaser.
Notwithstanding the foregoing, Purchaser shall have thirty
(30) calendar days to cure any non-disputed payments then due in accordance with the HLTT Option Agreement. HLTT and Purchaser shall agree
to an expeditious dispute resolution method for all disputed payments. During the resolution period, the HLTT Option Agreement shall remain
in full force and effect. |
PURCHASER TO ENTER INTO A DISTRIBUTION AGREEMENT
FOR PURCHASER’S PRODUCTS WITH WORLD REACH HEALTH,
LLC |
World Reach Health to Distribute Products Manufactured by Purchaser |
WRH currently serves as the exclusive distributor for all
of HTWC’s products.
Concurrently with Purchaser’s satisfaction of all obligations
in accordance with the HTWC Option Agreement and the HLTT Option Agreement, Purchaser shall enter into a non-exclusive distribution agreement
(the “Distribution Agreement”) between Purchaser and WRH relevant to any products manufactured by Purchaser, or its
designee(s) and/or assign(s) relevant to Purchaser’s purchase of the HTWC Assets and the HLTT Patent. |
Term of the Distribution Agreement |
Three (3) Years from the effective date of the Distribution Agreement. |
Fee Split Between WRH and Purchaser |
WRH shall be granted the Q-Code product on consignment and
shall sell the product to third parties in accordance with all then-applicable insurance reimbursement rates. When WRH is paid for the
products that WRH sold, WRH shall retain sixty-five percent (65%) of the gross revenues of the sales price. WRH, within fifteen (15) business
days of the end of each calendar month, shall provide Purchaser with a statement of all collected sales and shall pay Purchaser, via bank
wire transfer, thirty-five percent (35%) of the gross revenues for the applicable sales transactions.
Any product distributed and sold by Purchaser via other channels
shall not be subject to a split of the gross revenues and Purchaser shall be entitled to retain all revenues derived therefrom. |
Restrictive Covenants for the Distribution Agreement |
During the term of the Distribution Agreement, Purchaser will
not, directly or indirectly, attempt to circumvent WRH to sell the products directly to WRH’s customers and/or sub-distributors.
During the term of the Distribution Agreement, and for a period
of twelve (12) months following the effective date of termination of the Distribution Agreement (the “Restrictive Period”),
unless otherwise later agreed to in writing between Purchaser and WRH.
Additionally, during the Restrictive Period, Purchaser and
WRH shall covenant and agree that neither will, directly or indirectly, alone or in combination with any other Person (as defined in the
Distribution Agreement), engage in any of the following:
·
solicit, in any capacity (whether as an employee, consultant, owner, member, independent contractor or otherwise any Covered Employee
(as defined in the Distribution Agreement);
·
interfere with, alter or attempt to interfere with or alter, any relationship between Purchaser and WRH and any Person referred
to in the paragraph above.
Further, during the Restrictive Period, Purchaser shall not
be permitted to sell products directly to, nor shall Purchaser be permitted to enter into sales representative agreements and/or distribution
agreements with any of WRH’s restricted parties, as more fully identified in the “Restricted Party List,” a copy
of which is attached to and incorporated in the Distribution Agreement for reference. |
MISCELLANEOUS |
Pre-Closing Covenants |
The Parties shall use their reasonable best efforts to obtain
all necessary third-party and government consents (including all certificates, permits and approvals required in connection with Purchaser’s
acquisition the HTWC Assets and the Patent.
The HLTT Parties, and its owners, officers, directors and
employees shall continue to operate HTWC consistent with past practice, and, during the period between the Effective Date of this Term
Sheet and the closing date, ensure there is no material adverse change in the business, financial condition or prospects.
During the term of the Manufacturing Agreement, and for a
period of two (2) years following the completion of the transactions contemplated herein, the HLTT Parties, its subsidiaries, affiliates,
successors, assigns, and all related personnel (collectively referred to as the “Restricted Parties”) shall be subject
to the following restrictive covenant:
Non-Competition Obligation: The Restricted Parties
shall not directly or indirectly engage in, or have any interest, ownership, or participation in any business or activity that involves
the development or manufacturing of any skin graft wound care product or any derivative or ancillary works stemming from the HLTT Patent
(collectively referred to as “Prohibited Business”). |
Non-Solicitation |
Commencing as of the Effective Date of this Term Sheet, and
for a period of twenty-four (24) months thereafter (the “Non-Solicitation Period”), neither Party hereto, nor any of
their parents, subsidiaries and/or affiliated entities shall solicit, in any capacity, whether as an employee, consultant, owner, shareholder,
member, manager and/or independent contractor or otherwise, any Covered Employee (defined below).
For purposes of this Term Sheet, “Covered Employee”
means any individual who is or was, within the twelve (12) month period prior to such solicitation, employment or engagement, was employed
or otherwise engaged by the other Party hereto.
The Non-Solicitation Period shall no longer be applicable
to HTWC’s Personnel if Purchaser exercises the HTWC Option. |
Mutual Non-Disparagement |
Commencing as of the Effective Date of this Term Sheet, and at all times thereafter, no Party hereto, or their members, managers, officers, directors or shareholders or employees shall make any oral or written statement, or other communication, that disparages or places any Party hereto, or any of the Party’s members, manager designees, subsidiaries, affiliates, principals, officers, directors, employees, partners, investors, products or services in a false or negative light; provided, however, that nothing herein shall preclude any of the Parties from testifying as required by lawful subpoena or other legal process, making good faith reports to governing regulatory bodies or authorities, or communicating inside either Party consistent with legitimate business needs. |
Representations and Warranties |
The transaction documents will contain representations, warranties and other terms and conditions customary to transactions of their size and nature. |
Risk Factors |
The transactions contemplated herein are speculative and may involve a high degree of risk. |
Exclusive Dealing |
So long as Purchaser pays the initial amounts owed to HTWC in accordance with the Manufacturing Agreement, the HTWC Initial Option Fee and the HLTT Initial Option Fee, during the period from the Effective Date of this Term Sheet until the earlier of the expiration of the Due Diligence Period in accordance with its terms, the HLTT Parties shall not enter into any agreement, discussion, or negotiation with, or provide information to, or solicit, encourage, entertain or consider any inquiries or proposals from any other individuals or entities with respect to (i) the possible disposition of a material portion of the HTWC Assets, (ii) any business combination involving HTWC, whether by way of merger, consolidation, share exchange or other transaction, and/or (iii) the license or sale of the HLTT Patent (excluding any existing licensure of the Patent between HLTT and HTWC). |
Conditions Precedent |
Without limiting the foregoing, the following are conditions
precedent to each Parties’ obligations hereunder:
·
the execution of this Term Sheet by all Parties; and
·
HLTT’s Board of Directors’ approval of this Term Sheet. |
Counterparts |
This Term Sheet may be executed in counterparts, each of which, when so executed and delivered, will be deemed originals for all purposes, all of which taken together shall constitute one and the same instrument, respectively. Delivery of any executed counterpart of this Term Sheet by facsimile or transmitted electronically in either a Tagged Image Format File (“TIFF”) or Portable Document Format (“PDF”) shall be equally effective as delivery of a manually executed counterpart of this Term Sheet. |
Legal & Professional Expenses |
Each Party will bear its own legal, accounting and/or professional costs regarding the negotiation and drafting this Term Sheet, any and all due diligence to be conducted and the definitive agreements contemplated herein, unless otherwise later agreed to in writing between the Parties. |
Law & Jurisdiction |
This Term Sheet will be construed under the laws of the State of Utah and the Parties hereby submit to the exclusive jurisdiction of the Utah federal and state courts with general jurisdiction over Salt Lake County, Utah, for the resolution of any dispute with respect to this Term Sheet. |
Legal Representation; Waiver of Jury Trial |
THE PARTIES HEREBY REPRESENT AND WARRANT THAT EACH PARTY
HERETO HAS HAD AN OPPORTUNITY TO CONSULT INDEPENDENT LEGAL COUNSEL AND/OR HAVE BEEN REPRESENTED BY COUNSEL OF THEIR OWN CHOOSING IN THE
PREPARATION AND ANALYSIS OF THIS TERM SHEET. THE PARTIES HERETO EACH HAVE READ THIS TERM SHEET WITH CARE AND BELIEVES THAT EACH OF THE
PARTIES HERETO ARE FULLY AWARE OF AND UNDERSTAND THE CONTENTS OF THIS TERM SHEET AND ITS LEGAL EFFECT.
AS A MATERIAL INDUCEMENT FOR THIS AGREEMENT, EACH PARTY
HEREBY KNOWINGLY, VOLUNTARILY, INTENTIONALLY AND IRREVOCABLY WAIVES ALL RIGHTS TO A TRIAL BY JURY OF ANY ISSUES SO TRIABLE. |
Integration |
Until such a time as definitive, legally binding agreements are executed between the Parties, this Term Sheet constitutes the entire understanding between the Parties and will not be modified, altered or otherwise amended except in writing signed by all Parties. |
Confidentiality of this Term Sheet |
The terms of this Term Sheet are strictly confidential and each Party agrees not to disclose or permit the disclosure of the terms and conditions contained herein to any third party without the prior written consent of the other Party(ies), except that each Party may disclose such terms to its respective attorneys, tax advisors, other advisors, governmental entities or parties required by law. |
No Assignment of this Term Sheet |
None of the Parties hereto may assign this Term Sheet, in whole or in part, to any person, firm or corporation, without all Parties’ prior written consent. |
Authority |
Each Party hereby represents and warrants for itself that it is and will remain free to enter into and fully perform under this Term Sheet in all respects, and that its execution and delivery of the Term Sheet have been fully authorized by its governing authority. |
No Public Announcements |
Except as otherwise required by applicable securities laws,
neither Party shall make any announcement of the transactions contemplated by this Term Sheet or any definitive agreements contemplated
hereunder without the written approval of the other Party(ies).
The foregoing shall not restrict, in any capacity, any Party’s
ability to communicate information concerning this Term Sheet and the transactions contemplated hereby to the Parties’ respective
affiliates, officers, directors, employees and professional advisors, and, to the extent relevant, to third parties whose consent is required
in connection with the transactions contemplated by this Term Sheet. |
No Strict Construction |
The language used in this Term Sheet will be deemed to be the language chosen by the Parties to express their mutual intent, and no rule of strict construction will be applied against any Party hereto. |
Modification and Waiver of Breach |
No waiver or modification of this Term Sheet shall be binding unless it is in writing and signed by the Parties hereto. No waiver of a breach hereof shall be deemed to constitute a waiver of a further breach, whether of a similar or dissimilar nature. The failure of any Party hereto to enforce, at any time, any provision of this Term Sheet shall not be construed to be a waiver of such provision, nor in any way to affect the validity of this Agreement or any part hereof or the right of any Party thereafter to enforce each and every such provision. |
Captions and Headings |
The captions and section headings used in this Term Sheet are for convenience of reference only, and shall not affect the construction or interpretation of this Term Sheet or any of the provisions hereof. |
Approval of Term Sheet |
The Parties desire to approve of this Term Sheet on or before August 10, 2023. |
Closing Date |
The Parties desire to hold a closing relevant to the execution of definitive documents between the Parties on or before the expiration of the Due Diligence Period, unless otherwise extended pursuant to the mutual written consent of the Parties. |
Expiration of Term Sheet |
This Term Sheet shall automatically expire upon the earlier of (i) the execution of definitive documents between the Parties, or (ii) the expiration of the Due Diligence Period, unless mutually accepted by the Parties, or as otherwise extended pursuant to the mutual written consent of the Parties. |
Termination of this Term Sheet |
Upon the Parties’ consummation of definitive, long form agreements, the applicable provisions of this Term Sheet shall be deemed terminated and shall have no further force or effect. |
SIGNATURE PAGE FOLLOWS
THE REMAINDER OF THIS PAGE IS INTENTIONALLY LEFT BLANK
SIGNATURE PAGE TO THE
TERM SHEET DATED AUGUST 18, 2023
BETWEEN
HEALTHTECH SOLUTIONS, INC., HEALTHECH WOUND CARE, INC.,
WORLD REACH HEALTH, LLC
AND
HLLT ACQUIRED, LLC
If the above terms, conditions and understandings are acceptable,
please indicate your acceptance and intentions by signing below and returning the fully executed Term Sheet to representatives of each
of the Parties as follows:
Accepted and Agreed to by:
Healthtech Solutions, Inc. |
|
Healthtech Wound Care, Inc. |
_/s/Jelena Olmstead____________
By: Jelena Olmstead
Its: Authorized Signatory |
|
_/s/Jelena Olmstead____________
By: Jelena Olmstead
Its: Authorized Signatory |
|
|
|
World Reach Health, LLC
/s/ Jim Pesoli______________________
By: Jim Pesoli
Its: Authorized Signatory
|
|
|
|
|
|
PURCHASER:
HLLT Acquired, LLC
_/s/ Zalman Schapiro_________________
By: Zalman Schapiro
Its: Authorized Signatory |
|
|
EXHIBIT A
MANUFACTURING AGREEMENT
*See Attached
MANUFACTURING AGREEMENT
This Manufacturing Agreement (this “Agreement”)
is entered into as of August 18, 2023 (the “Effective Date”), by and between Healthtech Wound Care, Inc. (“HTWC”),
a Delaware corporation, with a principal place of business located at 615 Arapeen Dr., Suite 300, Salt Lake City, Utah 84108, and HLLT
Acquired, LLC (“Customer”), a Delaware limited liability company, with a principal place of business located at
885 Third Avenue, 29th Floor, New York, New York 10022. HTWC and Customer may sometimes be referred to herein individually
as a “Party” and collectively as the “Parties.”
WHEREAS, HTWC is the manufacturer
of that certain product line of Food and Drug Administration (“FDA”) approved human placental allograft tissue commonly
known as “DermaBind-TL,” (a/k/a “AmnioBind”) Q-Code 4225 (the "Q-Code") (individually
a/the “Product” and collectively, the “Products”), as more particularly described in the product
schedule (the “Product Schedule”), a copy of which is attached hereto and incorporated herein for reference as Exhibit
“A”;
WHEREAS, Customer anticipates
entering into a conditional asset option-purchase agreement (the “HTWC Option Agreement”) with HTWC, whereby Customer
shall have the exclusive option (the “HTWC Option”) to purchase HTWC’s assets (the “HTWC Assets”),
as more fully identified in the HTWC Option Agreement, on the terms and conditions contained in the HTWC Option Agreement;
WHEREAS, Customer anticipates
entering into an intellectual property option purchase agreement (the “HLTT Option Agreement”) with HTWC’s parent
company, Healthtech Solutions, Inc. (“HLTT”), whereby Customer shall have the exclusive option (the “HLTT
Option”) to purchase HLTT’s intellectual property solely associated with the Product (the “HLTT IP”),
as more fully identified in the HLTT Option Agreement, on the terms and conditions contained in the HLTT Option Agreement; and
WHEREAS, until the later of such
time as Customer consummates the acquisition of the HTWC Assets in accordance with the HTWC Option Agreement, and Customer consummates
the acquisition of the HLTT IP in accordance with the HLTT Option Agreement, or until the termination of this Agreement, Customer desires
for HTWC to manufacture certain quantities of the Product during the Term (defined below) hereof, and HTWC wishes to manufacture certain
quantities of the Product for Customer on the terms and conditions contained herein. Moreover, the Parties acknowledge that HTWC may decide
to manufacture other products in its lab or facilities that are not limited to the Product specified in this Agreement, and the Parties
desire to expand collaboration and amend this Agreement as necessary to include additional products.
NOW, THEREFORE, in consideration
of the mutual covenants, terms, and conditions set forth herein, and for other good and valuable consideration, the receipt and sufficiency
of which are hereby acknowledged, the Parties agree as follows:
| 1. | Incorporation by reference. The
Recitals and introductory paragraph above, and the definitions set forth therein, are incorporated by this reference. |
| 2. | Conditions Precedent. Each Party’s
obligations hereunder shall be contingent upon the occurrence of all of the following events (the “Conditions Precedent”): |
| a. | each Party fully executes and delivers to the other Party this Agreement. |
| a. | Initial Term. The term of this Agreement commences on the Effective Date and continues through
the fifteenth (15th) month anniversary of the Effective Date (the “Initial Term”), unless it is earlier
terminated pursuant to the terms of this Agreement or applicable law. |
| b. | Renewal Term. Upon expiration of the Initial Term, the term of this Agreement will automatically
renew for additional successive three (3) month terms unless either Party provides written notice (email is sufficient) of non-renewal
at least ten (10) business days prior to the end of the then-current term (each a “Renewal Term” and together with
the Initial Term, the “Term”), unless any Renewal Term is earlier terminated pursuant to the terms of this Agreement,
the mutual written consent of the Parties or applicable law. If the Initial Term or any Renewal Term is renewed for any additional Renewal
Term(s) pursuant to this section, the terms and conditions of this Agreement during each such Renewal Term will be the same as the terms
in effect immediately prior to such renewal, unless otherwise later agreed to in writing between the Parties. In the event either Party
provides timely notice of its intent not to renew this Agreement, then, unless earlier terminated in accordance with its terms, this Agreement
terminates on the expiration of the Initial Term or then-current Renewal Term, as applicable. |
| c. | Termination In Accordance with the HTWC Option Agreement and the HLTT Option Agreement. In the
event the Parties consummate the HTWC Option Agreement and the HLTT Option Agreement and Customer exercises its options thereunder and
pays all amounts due HTWC and HLTT in accordance therewith, this Agreement shall automatically terminate effective the last calendar day
of the then-current month that the final balances due to HTWC in accordance with the HTWC Option Agreement and the final balances due
to HLTT in accordance with the HLTT Option Agreement were paid. |
| d. | Termination for Cause. Either Party may terminate this Agreement for cause with immediate effect
upon written notice (email is sufficient) to the other Party: |
| i. | if such other Party fails to perform any material obligation under this Agreement or otherwise materially
breaches this Agreement, through |
no fault of the Party initiating such termination,
that remains uncured for fifteen (15) business days, or such other period of time as the Parties may mutually approve of in writing,
following written notice (email is sufficient) to such Party of such failure or breach;
| ii. | if the other Party becomes insolvent, is generally unable to pay, or fails to pay, its debts as they become
due, files a petition for bankruptcy or commences or has commenced against it proceedings relating to bankruptcy, receivership, reorganization,
or assignment for the benefit of creditors. |
| e. | Termination Without Cause. During the Initial Term, Customer may terminate this Agreement for convenience
upon three (3) months’ advance written notice of termination, provided such termination shall not be effective before January 31,
2024. |
| f. | Effect of Expiration or Termination. |
| i. | Immediately, upon the effectiveness of a notice of termination, except for termination in accordance with
Section 3(c), HTWC shall, unless otherwise directed by Customer, and subject to HTWC’s obligation to provide resourcing cooperation:
(A) promptly terminate all performance under this Agreement; and (B) transfer title and deliver to Customer all finished Products completed
prior to effectiveness of the notice of termination. HTWC agrees, if requested by Customer, to finish any work in progress that remains
after it receives a termination notice from Customer, subject to Customer’s full payment for such services. |
| ii. | The termination or expiration of this Agreement for any reason shall not release any Party hereto of any
liability, which at the time of termination or expiration had already accrued to the other Party in respect to any act or omission prior
thereto. |
| iii. | Upon the expiration or earlier termination of this Agreement, each Party shall return to the other Party
or destroy all documents and tangible materials (and any copies) containing, reflecting, incorporating, or based on the other Party’s
Confidential Information (defined below). In addition, and if applicable, each Party, upon the other Party’s written request (email
is sufficient), will certify in writing to such other Party that it has complied with the requirements of this section. |
| 4. | HTWC to Manufacture the Product. |
| a. | Manufacture. Subject to the terms and conditions of this Agreement, HTWC shall manufacture the
Product in accordance with all FDA and/or Tissue Reference Group (“TRG”) specifications and/or requirements applicable
to the Q-Code, including ordering and management of required components to make the Product. Additionally, during the Term hereof, HTWC
shall maintain its manufacturing facility to be compliant with all ISO-13485 standards. |
| i. | Initial 60-Day Product Quantities. Commencing as of the Effective Date of this Agreement, HTWC
shall manufacture and/or deliver, and Customer shall pay for, not less than Three Thousand centimeters squared (3,000cm2) within thirty
(30) days of the Effective Date of this Agreement, and not less than Five Thousand centimeters squared (5,000cm2) within sixty (60) days
of the Effective Date of this Agreement. |
| ii. | Monthly Minimum; Desired Product Quantities. Unless Customer notifies HTWC in writing (email is
sufficient) to request quantities in excess of those noted in Section 4(a)(i) sooner in time, commencing as of the third (3rd)
monthly anniversary of the Effective Date of this Agreement, Customer ultimately desires for HTWC to manufacture and deliver to Customer
approximately Ten Thousand square centimeters (10,000cm2) of the Product on average per calendar month during the Term. However, Customer
understands and acknowledges that a ramp up period to achieve such quantities may be applicable for up to one hundred eighty (180) days
from the Effective Date of this Agreement, as HTWC will require additional equipment and raw materials, and lead times apply. Commencing
as of the third (3rd) monthly anniversary of the Effective Date of this Agreement, HTWC shall commit to manufacturing and delivering
to Customer, and Customer shall pay for, a variety of Product sizes collectively amounting to not less than Seven Thousand Five Hundred
centimeters squared (7,500cm2) per month (the “Monthly Minimum”). Further, unless otherwise later agreed to in writing
between the Parties, commencing as of the third (3rd) monthly anniversary of the Effective Date of this Agreement, Customer
commits to purchasing not less than Seven Thousand Five Hundred centimeters squared (7,500cm2) per month for the duration of the Term.
Any variations of manufacturing capacities and/or delivery schedules regarding the Product and/or the Monthly Minimum will be mutually
approved by the Parties. Any additional, contrary, or different terms contained in any subsequent purchase order, acknowledgement, confirmation,
invoice or communication, and any other attempt to modify, supersede, supplement, or otherwise alter this Agreement, are deemed rejected
by the other Party and will not modify this Agreement or be binding on the Parties unless such terms have been fully approved in a signed
writing by authorized representatives of both Parties. |
| iii. | Over-Runs/Under-Runs. Over-runs and under-runs per Product type ordered may vary plus or minus
5% of the Monthly Minimum. Delivered quantity within the above listed range shall be deemed to constitute fulfillment of the Monthly Minimum. |
| b. | Forecasts and Inventory Planning. On a monthly basis, Customer will provide HTWC with a non-binding
rolling forecast for the following month. Forecasts beyond the Monthly Minimum production requirements contained herein are for informational
purposes only and do not create any binding obligations on behalf of either Party, unless otherwise agreed to in writing between the Parties.
HTWC will be responsible for material planning to meet the rolling forecast and mutually agreed upon service levels for the Product. HTWC
will promptly notify Customer if HTWC becomes aware that HTWC cannot meet the rolling forecast; provided, however, that a failure to provide
such notice shall not constitute a breach under this Agreement. |
| 5. | Shipment, Delivery, Acceptance, and Inspection. |
| a. | Shipment and Delivery Requirements. HTWC shall manufacture, assemble, pack, mark, and ship the
Product in accordance with all applicable FDA, TRG and/or Q-Code specifications, strictly in the quantities and by the methods, to the
delivery locations and by the delivery dates, specified in this Agreement or as instructed on a case-by-case basis by Customer. Each
shipment will constitute a separate sale, and Customer will pay for the Products shipped whether the shipment is in whole or partial fulfillment
of the Monthly Minimum. The quantity of any installment of the Products, as recorded by HTWC on the
dispatch from HTWC’s place of business, is evidence of the quantity received by Customer upon delivery, unless Customer provides
evidence to the contrary. HTWC will not be liable for any non-delivery of the Products to a Customer-designated delivery location, unless
Customer gives written notice to HTWC of the non-delivery within fifteen (15) calendar days following the date that Customer would, in
the ordinary course of business, have received the Products. HTWC’s liability for any non-delivery of the Products will be limited
to replacing the Products within a reasonable time or adjusting the invoice for the Products to reflect the actual quantity delivered. |
| i. | Method of Shipping. All Products shipped by HTWC shall be shipped via FedEx Ground. Customer, or
Customer’s designated third party(ies) may request expedited shipping services; however, Customer, or Customer’s designated
third party(ies) shall be subject to additional charges for such expedited services. |
| 1. | Customer-Provided Shipping Labels. If Customer elects to utilize Customer’s, or any Customer-designated
third party’s FedEx or other freight carrier account, it shall be Customer’s |
responsibility to provide HTWC, via email, with the
applicable shipping labels.
| ii. | Costs of Shipping. The Manufacturing Fee (defined below) does not include the cost
of shipping to Customer’s designated location, unless otherwise later agreed to in writing between the Parties. HTWC shall separately
invoice Customer on a monthly basis for any and all shipping costs incurred by HTWC. All such shipping invoices shall be payable to HTWC
upon Customer’s receipt of said invoices. |
| iii. | Delays in Shipment of Products to Customer. HTWC will use commercially reasonable efforts to ship
the Products to arrive by any requested delivery date quoted or acknowledged. However, none of the Parties hereto will be liable for any
delay in shipment or delay in performance under this Agreement, due to unforeseen circumstances, or due to causes beyond their control,
including, but not limited to an event of Force Majeure (defined below). Subject to Section 16(s), in the event a substantial amount of
the Product ordered by Customer herein is substantially delayed, and such delay exceeds ninety (90) consecutive days, Customer may elect
to terminate this Agreement upon written notice to HTWC (email shall be sufficient), upon which HTWC shall, within ninety (90) days of
the date of such termination, be required to refund the purchase price actually paid by Customer for any undelivered Products to Customer
and repay the the Equipment Financing (defined below) payment actually made by Customer to Customer. |
| b. | Transfer of Title and Risk of Loss. Title to Products and risk of loss to the Product shipped passes
to Customer, or to such other third party or parties as may have been designated by Customer, upon receipt and acceptance by the shipping
carrier, freight forwarder, Customer and/or any third-party(ies) designated by Customer, whichever occurs first. HTWC will bear the risk
of loss or damage to the Product in transit to the carrier or freight forwarder. |
| c. | Packaging and Labeling. HTWC shall properly pack, mark, and ship the Product as instructed by Customer
and otherwise in accordance with applicable law and industry standards and shall provide Customer with shipment documentation showing
HTWC’s identification number for the subject Product, the quantity of pieces in shipment, shipment tracking number and/or bill of
lading number, and such other information as Customer reasonably requests. |
| d. | Inspection. Customer shall have fifteen (15) business days following delivery of any Products under
this Agreement (the “Inspection Period”), to inspect all such Products received and to notify HTWC, in writing (email
containing photographic proof of the nonconforming Product is sufficient), of Customer’s |
rejection of any such Products it believes to be Nonconforming
Products (as defined below). For purposes of this Agreement, “Nonconforming Products” means any Product received by
Customer from HTWC that: (i) does not conform to the applicable FDA, TRG and/or Q-Code specifications; (ii) Customer, upon visual inspection,
reasonably and in good faith determines is defective or damaged; or (iii) exceeds the quantity of the Products ordered by Customer. For
any Nonconforming Products, Customer may elect to (y) require HTWC, at HTWC’s sole cost, to timely replace the rejected Products
at the location specified by Customer (which may include HTWC’s location, Customer’s location or the location of a third party),
or (z) retain the rejected Product; in each case, without limiting the exercise by Customer of any other rights available to Customer
under this Agreement or pursuant to applicable law; provided, however, that to the extent any Products are deemed to be Nonconforming
Products because they exceed the quantity of Product ordered by Customer, Customer may return such Nonconforming Products to HTWC. All
returns of Nonconforming Products to HTWC are at HTWC’s sole risk and expense, so long as the return shipping is coordinated by
HTWC, which HTWC shall timely coordinate. Product that is not rejected within the Inspection Period will be deemed to have been accepted
by Customer; provided, however, that Customer’s acceptance of any Product will not be deemed to be a waiver or limitation of HTWC’s
obligations pursuant to this Agreement (or any breach thereof).
| e. | No Refunds / Exchanges. Except for instances involving Nonconforming Products, Products covered
by the Product Warranty, or Product returns governed under a separate agreement on a case-by-case basis between the Parties, all
sales are final. There shall be no refunds, returns or exchanges of the Product, unless (i) HTWC fails to deliver the Product
to Customer within thirty (30) days of the date the Customer paid HTWC for the Products (or such later date as agreed or noted in writing
between the Parties on a case-by-case basis), (ii) as otherwise later agreed to in writing between the Parties, or (iii) for the avoidance
of doubt, any Products that are subject to the Product Warranty may be eligible for return or exchange in accordance with the terms and
conditions of the Product Warranty. If a return is authorized by HTWC for reasons not involving Nonconforming Products or the Product
Warranty, Customer shall bear all risk of loss or damage during shipment, as well as all shipping expenses, of any returned Product, and
Customer shall be subject to and responsible for the payment of a restocking fee in an amount equal to thirty-five percent (35%) of the
Base Rate (as defined below). |
| f. | Non-Returnable Products. Return of Products that would have been subject to return under separate
agreement or for Nonconforming Products, shall not be permitted to be returned for the following circumstances (each “Non-Returnable
Products”). Non-Returnable Products will not be eligible for authorized return and Customer will neither receive credit nor
be released from payment obligations in the event of an unauthorized return that is |
outside of the eligible return criteria set forth
under separate agreement. For the avoidance of doubt, the following Products shall not be eligible for credit or replacement under the
above, regardless of whether the Products otherwise satisfies the requirements in any of the sections previously specified:
| i. | Products that are not in their original packaging or container and/or not bearing its original label due
to causes reasonably beyond HTWC’s control; or lot numbers or expiration dates are missing; unless (a) a certification of return
circumstances that would not require the return of physical Products (e.g., loss, damage, etc.) and proper disposal, if applicable, has
been submitted and HTWC has approved and processed such certification or (b) Products are physically returned, but are damaged (at time
of shipment by HTWC) making fulfillment of this requirement impossible; |
| ii. | Products involved in a fire, flood, natural disaster, due to causes reasonably beyond HTWC’s control; |
| iii. | Products that are in a deteriorated condition from improper storage due to causes reasonably beyond HTWC’s
control; |
| iv. | Products that have been repackaged due to causes reasonably beyond HTWC’s control; |
| v. | Products purchased for research or clinical trials or shipped as a no cost item (e.g., physician sample,
Products replaced through separate HTWC-approved Product replacement program, etc.); and/or |
| vi. | Products damaged or rendered unusable due to mishandling or error due to causes reasonably beyond HTWC’s
control. |
| g. | Collection Costs. Customer hereby agrees to pay HTWC for all collection costs HTWC incurs to collect
from Customer any amount past due. |
| h. | Delivery Withholdings. Without waiving any other rights or remedies available to HTWC under applicable
law or otherwise, HTWC may, at its option: (i) defer shipment and/or deliveries of Products until all past-due accounts of Customer owed
to HTWC have been satisfied in full, or (ii) require Customer to pay for Products prior to shipment, or ship Products on a “cash
on delivery” basis if HTWC determines, in its reasonable discretion, not to extend credit to Customer. |
| 6. | Manufacturing Fees to HTWC. |
| i. | Customer shall provide HTWC with equipment financing in the amount of Five Hundred Thousand Dollars ($500,000.00
USD) (the “Equipment Financing”). The payment for the Equipment Financing shall be made by Customer as follows: |
| 1. | Within five (5) business days of the the execution of this Agreement, Customer shall pay Fourteen Thousand
Five Hundred Ninety-Five Dollars ($14,595.00 USD) directly to HTWC’s vendor, Van Der Stahl, for an integrated peel tester; |
| 2. | Within five (5) business days of the, Customer shall pay One Hundred Thirty-Eight Thousand Three Hundred
Thirty-One Dollars and 33/100ths ($138,331.33 USD) directly to HTWC’s vendor, SP VirTis, for a freeze dryer; |
| 3. | Within five (5) business days of the, Customer shall pay Two Hundred Fifty Four Thousand Eight Hundred
Fifty-Two Dollars and 77/100ths ($254,852.77 USD) to HTWC; and |
| 4. | in accordance with the invoice terms for the final installment for the purchase of the freeze dryer, Ninety-Two
Thousand Two Hundred Twenty and 90/100ths ($92,220.90) to HTWC’s vendor, SP VirTis. |
| ii. | Advancement or Cancellation of the HTWC Option and the HLTT Option. |
| 1. | If, during the period commencing as of the Effective Date of this Agreement and ending at 3:00pm CST on
Thursday, November 30, 2023 (the “Due Diligence Period”), Customer elects to proceed with the HTWC Option Agreement
and the HLTT Option Agreement, then upon the closing of the transactions contemplated thereby, an amount equal to one hundred percent
(100%) of the Equipment Financing payments actually made by Customer shall be applied first to satisfy any amounts then owed by Customer
to HTWC for purchases of the Product under this Agreement, with the remaining balance, if any, applied secondarily towards the HTWC Option
Purchase Price (as defined in the HTWC Option Agreement). |
| 2. | If, during the Due Diligence Period, Customer elects not to proceed with the HTWC Option Agreement and
the HLTT Option Agreement (either by way of Customer’s failure to enter into the HTWC Option Agreement and/or the HLTT Option Agreement,
or through the cancellation, termination or expiration of such |
agreements or the HTWC Option and/or HLTT Option granted
therein, or otherwise), then an amount equal to up to one hundred percent (100%) of the Equipment Financing payments actually made by
Customer shall be applied as a credit towards the amount payable by Customer to HTWC for purchases of the Product under this Agreement
in the final month of the Term. Notwithstanding the foregoing, if the Term of the Agreement is terminated prior to the initially anticipated
final month of the Term, then one hundred percent (100%) of the Equipment Financing payments actually made by Customer shall be applied
as a credit towards the amount payable by Customer to HTWC for purchases of the Product under this Agreement then due and owing. Moreover,
if for whatever reason there are no amounts due and payable to HTWC then HTWC shall be required, within ninety (90) days’ to repay
to Customer one hundred percent (100%) of the Equipment Financing payments actually made by Customer.
| i. | Invoicing and Payment Schedule; Minimum Manufacturing Fee. |
| 1. | Invoices. HTWC shall provide Customer with invoices for the Products ordered by and shipped to
Customer, detailing the quantity, unit price, and total amount due. Invoices shall be submitted within three (3) days from the date of
Product shipment to Customer. Customer shall pay each invoice (less the amount of any corresponding Deposit (as defined below)) within
thirty (30) days from the date of such invoice (“Net 30”), or Net 30 from the last day of the then applicable month
of the Term (if Customer did not provide shipping instructions for a particular quantity of the Monthly Minimum of Product prior to the
month end), whichever is sooner. |
| 2. | Deposit Payments. Commencing as of the second (2nd) month of the Term hereof, on or
before the first (1st) day of each month of the Term, Customer shall pay to HTWC a deposit equal to ten percent (10%) of the
Manufacturing Fee (defined below) (the “Deposit”) applicable for each month in accordance with and as set forth the
table in Section 6(b)(i)(3)(a). The Deposit shall be pro-rated on a per square centimeter basis applicable to the Monthly Minimum, and,
as each Product is shipped, the ninety percent (90%) per square centimeter balance shall be paid in accordance with Section 6(b)(i)(1). |
| 3. | Manufacturing Fee. Provided that HTWC has not breached its obligations under this Agreement, Customer
shall order sufficient quantities of Product over the course of the Term such that the manufacturing fee due and owing HTWC over the Term
equals the aggregate amount of Twenty-One Million One Hundred Thousand Dollars ($21,100,000.00 USD) (the “Manufacturing Fee”),
unless this Agreement is earlier terminated in accordance with Section 3 hereof. The Manufacturing Fee shall be fully applicable against
all amounts Customer shall owe to HTWC relevant to the Monthly Minimum (e.g., 7,500cm2). |
| a. | Minimum Monthly Payments of the Manufacturing Fee. The Customer agrees to order quantities of the
Products that would equal the Manufacturing Fee for each month of the Term as set forth on the table below (each a “Monthly Installment”)
as follows: |
Month |
Deposit |
Balance of Manufacturing Fee |
Total Monthly Installment |
1 |
$0 |
$600,000 |
$600,000 |
2 |
$100,000 |
$900,000 |
$1,000,000 |
3-15 |
$150,000 |
$1,350,000 |
$1,500,000 |
| c. | Adjustments for Product Orders. The amounts specified for the Monthly Installments are based on
the projected order of Products. In the event that the Customer’s Product orders for any given month are less than the amount associated
with the Monthly Installment, the Customer shall pay the remainder of the applicable month’s Monthly Installment at the end of the
month in accordance with the invoice. HTWC shall ship out Products equaling the amount to be invoiced prior to such invoice being issued.
Notwithstanding the foregoing, Customer, in its sole and absolute discretion may elect for HTWC to store the then invoiced Products on
behalf of Customer, or to ship said Products to a third-party designated by Customer. |
| d. | Rollover Quantities Applied to Monthly Minimum. If the quantity of Products ordered by Customer
in any month of the Term exceeds the amount associated with such month’s Monthly Minimum, then the amount such excess quantity of
Products shall be credited towards the following month’s Monthly Minimum. |
| e. | Method of Payment. The Equipment Financing and the Manufacturing Fee shall be paid to HTWC, or
the applicable designee noted herein, by bank wire transfer, to coordinates to be separately provided by HTWC. |
| f. | Base Unit Rate. HTWC shall invoice Customer on a per centimeter squared base unit rate equal to
Two Hundred Dollars ($200.00 USD) per centimeter squared (the “Base Rate”), regardless of the size of the Product.
The applicable aggregate unit rate for the following products shall be as follows: |
Product Size |
Total cm2 |
Unit Rate |
1cm2 x 1cm2 |
1cm2 |
$200/ea |
2cm2 x 2mc2 |
4cm2 |
$800/ea |
3cm2 x 3cm2 |
9cm2 |
$1,800/ea |
4cm2 x 4cm2 |
16cm2 |
$3,200/ea |
6.5cm2 x 6.5cm2 |
43cm2 |
$8,600/ea |
| g. | Overage Payments. In the event that Customer orders Product in excess of the Monthly Minimum to
Customer, Customer shall pay HTWC the Base Rate per unit of Product. All such amounts shall be invoiced at the time of shipment and due
within thirty (30) days of delivery of the Product. |
| h. | Additional Products. In the event Customer desires to purchase alternate products from HTWC, which
are subject to alternate Q-codes, the Parties agree to negotiate in good faith the terms and conditions of any such purchase/sale and/or
manufacturing arrangements. |
| i. | Setoff; Contingent or Disputed Claims. Customer agrees to pay all undisputed charges under this
Agreement without counterclaim, set-off or deduction. In the event that Customer legitimately and reasonably disputes an invoiced amount,
Customer will provide HTWC with written notice of the amount in dispute and the basis for the dispute. HTWC agrees that it will work with
Customer to resolve the dispute reasonably and expeditiously within a thirty (30) day period. |
| j. | Fair and Reasonable Pricing. Customer hereby acknowledges and agrees that the Unit Price per Product
and/or the Purchase Price, as stated in each Sales Confirmation, is fair and reasonable, that the Customer believes, based upon Customer’s
independent analysis, that the Unit Price and/or the Purchase Price is competitive within the marketplace, and that the Customer does
not believe the Unit Price and/or the Purchase Price is unconscionably excessive. |
| k. | Sales Tax. All stated prices are exclusive of any taxes, fees, duties,
and levies, however designated or imposed, including, but not limited to value-added and withholding taxes that are levied or based upon
the amounts paid under the terms contained herein (collectively, “Taxes”). Any Taxes related to the Products purchased
pursuant to the terms contained herein are the responsibility of Customer (excluding taxes based on HTWC’s net income) |
unless Customer presents an exemption certificate
acceptable to HTWC and the applicable taxing authorities. If possible, HTWC will bill Taxes as a separate item on the invoice presented
to Customer. If any exemption certificate presented by Customer is held to be invalid, then Customer will pay HTWC the amount of the Taxes
and any penalties and interest related thereto within fifteen (15) business days of the date Customer is notified by HTWC. Each of the
Parties shall indemnify and hold the other Party harmless from and against any loss, expense and increase in costs incurred by the other
Party as a consequence of default on the part of the Party discharging its obligations for payment of any taxes, customs duties, levies
and other charges for which it is responsible under these the terms contained herein and under law.
| 7. | Customer’s Authorization to Resell the Product; Customer’s Sales Reporting; Insurance Billing. |
| a. | Limited Authorization to Resell the Product. Customer acknowledges and agrees that World Reach
Health, LLC (“WRH”) is currently the exclusive master distributor of the Product. However, during the Term hereof,
HTWC and WRH have agreed that Customer will be permitted, to resell the Products to third parties, in accordance with the following terms
and conditions(notwithstanding the foregoing, if during the Due Diligence Period Customer elects not to proceed with the HTWC Option Agreement
and the HLTT Option Agreement (either by way of Customer’s failure to enter into the HTWC Option Agreement and/or the HLTT Option
Agreement, or through the cancellation, termination or expiration of such agreements or the HTWC Option and/or HLTT Option granted therein,
or otherwise), then the Parties shall negotiate in good faith to terminate this Agreement and simultaneously enter into a distribution
agreement with WRH); in the event such distribution agreement is not entered into, this Agreement shall remain in full force and effect
for the duration of the Term): |
| i. | Customer does not sell the Product to any current Customer of WRH (Customer shall coordinate with WRH
to ensure no conflicts result on a case-by-case basis), and, conversely, WRH shall not attempt to sell directly to any customer of Customer; |
| ii. | Customer conforms with and adheres to WRH’s code of conduct; |
| iii. | Customer, at its discretion, may have HTWC drop-ship the Product to each end-user so that the Parties
can ensure all requisite packaging enclosures are included (e.g., IFU, Packing Slip, etc.); |
| iv. | Customer shall not sell the Product to any end user for a rate, which would be less than Seven Hundred
Twenty-Five Dollars ($725.00 USD) per centimeter squared, or such other averages sales price (“ASP”) attributable to
the Product, as notified to Customer by HTWC from time |
to time, without the express written consent of
HTWC on a case-by-case basis;
| 1. | Customer shall inform all end-users who submit the Product for insurance reimbursement to bill the Product
at the then-applicable reimbursement rate or ASP; |
| v. | Customer shall not attempt to white label the Product or alter the Product labeling or packaging in any
capacity; |
| vi. | Customer shall only use marketing and promotional materials, which have been pre-approved by HTWC's regulatory
and compliance personnel; |
| 1. | shall enforce Customer’s own terms and conditions of sale with each applicable end-user; |
| 2. | shall resell the Products in compliance with all applicable federal and state laws and regulations, as
well as all compliance guidance published by federal or state agencies, including, without limitation, the Medicare and Medicaid anti-kickback
law, the Stark self-referral prohibition, and compliance guidance published by the Office of the Inspector General of the Department of
Health and Human Service. Customer acknowledges that Customer understands these requirements and shall remain educated and informed regarding
the applicable federal and state laws and regulations, as well as all compliance guidance published by federal or state agencies, that
pertain to Customer’s resale of the Product. In the event Customer knows that any activities of any agent or affiliate of Customer
implicates any such requirements or guidance, Customer shall immediately inform HTWC; |
| 3. | shall not provide any entertainment, gifts, or other benefits for end-user outside of the written guidelines
established by HTWC which shall be provided to Customer by HTWC and/or in violation of applicable law and/or regulation, without the prior
written consent of HTWC; |
| 4. | shall not fund continuing education, grants or other benefits for any end-users, including, without limitation,
payment of any end-user’s rent and/or payment to any relative of an end-user, without the prior written consent of the Company; |
| 5. | represents and warrants that no personnel member of Customer who will be associated with the resale of
the Product has been convicted of any criminal offense related to healthcare, or been debarred, sanctioned, excluded or otherwise made
ineligible for participation in a federal or state health care program by any federal or state agency. In the event any such personnel
or affiliated parties have been convicted of a criminal offense, or debarred, sanctioned, excluded or otherwise made ineligible for participation,
or are threatened with any of the foregoing sanctions, Customer shall immediately notify HTWC; and |
| 6. | Customer will not provide any coding or billing advice to any end-user as part of Customer’s resale
of the Product, except for any coding or billing information provided by HTWC. |
| viii. | Customer shall not sell the Products outside of the United States, Canada or Mexico. |
| ix. | Customer will not, without HTWC’s prior written consent, use any trademark
or trade name of HTWC, HLTT and/or WRH in connection with any of the Products, other than with respect to the resale of the Products pre-marked
or packaged by or on behalf of HTWC. |
| b. | FDA/AATB-Required Record Keeping. Customer will keep or cause to be kept in accordance with FDA
and/or The American Association of Tissue Banks (the “AATB”), and shall share such records with HTWC, regulatory requirements
books and records regarding the purchases and sales of FDA-approved Products pursuant to this Agreement. All tissue utilization records
will be returned to HTWC. Further, to the extent, and only to the extent required by law, until the expiration of four (4) years after
the furnishing of the Products and services provided pursuant to this Agreement, Customer will make available to HTWC, and, if applicable,
Customer will make available to the Secretary of the U.S. Department of Health and Human Services, the U.S. Comptroller General, and their
representatives, the terms contained herein and all books, documents and records necessary to certify the nature and extent of the costs
of any Products or services provided hereunder. |
| 8. | Certain Obligations of HTWC. |
| i. | HTWC shall meet or exceed all FDA-requirements for the Product. |
| ii. | HTWC shall provide commercially reasonable support as requested by Customer to address and correct quality
concerns. |
| iii. | HTWC shall meet or exceed any FDA, TRG and/or Q-Code and other relevant quality system standards applicable
to the manufacturing of the Product. |
| b. | Maintenance of Equipment. Unless otherwise agreed to by Customer in writing, HTWC, at its sole
expense, shall furnish, keep in good condition, and replace when necessary, all equipment and other items necessary for the production
of the Product. |
| c. | Prohibited Acts. HTWC shall not: |
| i. | take any action that interferes with or challenges Customer’s intellectual property rights, including
Customer’s ownership or exercise thereof; or |
| ii. | alter, obscure, or remove any of Customer’s trademark or copyright notices or any other proprietary
rights notices placed on the Product purchased under this Agreement (including Products), marketing materials or other materials. |
| a. | Compliance. HTWC shall at all times comply with all applicable laws related HTWC’s performance
of its obligations hereunder. Without limiting the foregoing, HTWC shall ensure the Products and any related packaging conform fully to
any applicable law. HTWC shall manufacture the Product in accordance with all applicable FDA, TRG and/or Q-Code specifications and shall
also maintain effective quality systems that minimize the potential for product quality, regulatory and compliance issues. |
| b. | Permits, Licenses, and Authorizations. HTWC shall obtain and maintain all permits necessary for
the exercise of its rights and performance of HTWC’s obligations under this Agreement, including any permits required for the import
of Products or any raw materials and other manufacturing parts used in the production and manufacture of the Product, and the shipment
of hazardous materials, as applicable. |
| 10. | Representations and Warranties; Product Warranty. |
| a. | HTWC’s Representations and Warranties. HTWC represents and warrants to Customer that, as
of the date hereof: |
| i. | it is a corporation, duly organized, validly existing and in good standing under the laws of Delaware; |
| ii. | it is duly qualified to do business and is in good standing in every jurisdiction in which such qualification
is required for purposes of this Agreement, including, without limitation, the State of Utah; |
| iii. | it has the full right, power, and authority to enter into this Agreement and to perform its obligations
hereunder; |
| iv. | the execution of this Agreement by its representative whose signature is set forth at the end of this
Agreement and the delivery of this Agreement by HTWC, have been duly authorized by all necessary action on the part of HTWC; |
| v. | HTWC hasall applicable permits and/or licenses to manufacture the Product; |
| vi. | that HTWC’s manufacture of the Product does not knowingly violate and/or infringe upon any patent,
copyright or trademark laws and/or rights of any third parties[1]; |
| vii. | the Product Q-Code is billable in accordance with Medicare Part B, as well as certain private insurances,
and reimbursable at the price of the then published Medicare Part B Rate Schedule; and |
| viii. | that HTWC’s execution and delivery of this Agreement does not and will not knowingly conflict with
or result in a breach by HTWC of any of the terms or provisions of, or constitute a default under (x) the certificate of formation or
by-laws of HTWC, each as currently in effect, (y) any other material agreement to which HTWC is a party, or (z) to HTWC’s knowledge,
any existing applicable law, rule or regulation or any applicable decree, judgment or order of any court, United States federal or state
regulatory body, administrative agency, or other governmental body having jurisdiction over HTWC, except for such conflict, breach or
default, which would not have or result in a material adverse effect to HTWC. |
| b. | Customer’s Representations and Warranties. Customer represents and warrants to HTWC that: |
[1]
Customer acknowledges and agrees that HTWC has made agreements with a third party who is the trademark owner of a similarly
competitive product brand named “AmnioBand” to cease utilizing the name “AmnioBind.” Said third party is aware
that HTWC has applied to the FDA/TRG for a name change to “DermaBind,” which is pending. HTWC has the right to continue using
the name "AmnioBind" during this interim change period without issue per agreement of the parties. HTWC anticipates the name
change to DermaBind to be approved by the applicable regulatory parties in or around October 2023.
| i. | it is a limited liability company, duly organized, validly existing and in good standing under the laws
of Delaware; |
| ii. | it is duly qualified to do business and is in good standing in every jurisdiction in which such qualification
is required for purposes of this Agreement; |
| iii. | it has the full right, power, and authority to enter into this Agreement and to perform its obligations
hereunder; |
| iv. | the execution of this Agreement by its representative whose signature is set forth at the end of this
Agreement and the delivery of this Agreement by Customer, have been duly authorized by all necessary action on the part of Customer; |
| v. | it has received a copy of the instructions for use (“IFU”) applicable to the Product,
and shall not use the Product, except in accordance with the IFU; |
| vi. | it has sufficient financing and/or available cash on hand to timely pay HTWC the Equipment Financing and
the Manufacturing Fee and all other amounts that may become due under this Agreement. Further, HTWC, during the Term of this Agreement,
may require Customer to provide adequate assurances (“Adequate Assurances”) of Customer’s available financing.
In the event that Customer defaults on any amounts owed to HTWC hereunder, and HTWC requests Adequate Assurances from Customer, and Customer
fails to provide HTWC with such Adequate Assurances within ten (10) business days, HTWC may (a) withhold or suspend its obligations, including
the obligations to deliver the Product and/or continue manufacturing the Product in accordance with this Agreement (b) if applicable,
proceed against Customer for damages occasioned by Customer’s failure to perform, and/or (c) exercise its termination rights in
accordance with this Agreement. |
| c. | Product Warranty. HTWC warrants to Customer (the “Product Warranty”) that: |
| i. | Limited Warranty for Tissue Products. The Products shall be manufactured in accordance with all
applicable FDA, TRG and/or Q-Code specifications, and shall be subject to a one (1) year warranty after shipment (prior to application
on any patient) that each amnion-based Products have been collected, processed and stored in compliance with all applicable laws and standards,
FDA, TRG and/or Q-Code specifications, including the AATB Standards and Title 21, Code of Federal Regulations 1271, Human Cells, Tissues
and Cellular and |
Tissue-Based Products, and has a shelf-life of at
least three (3) years from the date the Product was manufactured (the “Shelf-Life”). Commencing as of the third (3rd)
monthly anniversary of the Effective Date of this Agreement, all Products provided to Customer hereunder shall have not less than at least
twenty-four (24) months remaining of the Shelf-Life (Products provided during the first sixty (60) days of this Agreement may have a Shelf-Life
less than twenty-four (24) months, but will be at least twelve (12) months);
1.
the Product will conform, in all material respects, to the applicable FDA, TRG and/or Q-Code specifications, standards, quality
and performance requirements and be free from defects in material and workmanship;
2.
HTWC’s manufacturing of the Product, including its processes and/or technical data, and the Product’s packaging, does
not knowingly violate or infringe upon any patent, copyright or trademark laws and/or rights of any third parties;
3.
each Product will be new and conveyed by HTWC to Customer with good title, free and clear of all encumbrances;
4.
HTWC hereby warrants to Customer, for period of twelve (12) months after the date of delivery of the specific Product, that the
Product shall (x) comply with and perform in accordance with HTWC’s written specifications for the Product and (y) be produced,
labeled and packaged in compliance with all applicable United States laws and regulations in effect at the date of delivery of the Product
to Customer. Customer’s exclusive remedy and HTWC’s sole liability under this warranty shall be to replace any Non-Conforming
Product, or, at HTWC’s sole discretion, to refund the purchase price paid therefor(including any shipping charges incurred);
| 5. | the above warranties do not apply to any Product which has, due to reasons beyond HTWC’s reasonable
control (a) been subjected to abuse, misuse, accident, or mishandling, (b) been modified or altered other than in the ordinary course
of its intended use, (c) been used for or subjected to applications, environments, or stress or conditions other than as intended and
recommended by HTWC, (d) been improperly stored, transported, installed, or used, (e) been used for any use not approved by the Food and
Drug Administration and not specified on the Product's label or otherwise permitted under applicable law, or (f) had its serial number
or other identification markings altered or removed; |
| 6. | THE WARRANTIES SET FORTH IN THIS SECTION 10(c) ARE THE ONLY WARRANTIES GIVEN BY HTWC WITH RESPECT TO
THE PRODUCTS AND ARE GIVEN IN LIEU OF ANY AND ALL OTHER WARRANTIES, WHETHER EXPRESS, IMPLIED, STATUTORY, OR ARISING BY CUSTOM, TRADE USAGE,
OR COURSE OF DEALING OR OTHERWISE, AND HTWC HEREBY DISCLAIMS ANY AND ALL OTHER WARRANTIES TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE
LAW. |
| d. | Withdrawal or Recall of Products. If HTWC or any governmental authority determines that any Product
sold to Customer is materially defective and a recall campaign is necessary, HTWC will have the right to implement such recall campaign
and will coordinate the return of defective Product by Customer to HTWC or order Customer to destroy such recalled Product, as determined
by HTWC in its reasonable discretion, at HTWC’s sole cost and risk. |
| i. | In the event that (A) the FDA and/or TRG issues a request, directive or order that any Products be recalled,
(B) a court of competent jurisdiction orders such a recall, or (C) HTWC reasonably determines, after consultation with Customer, that
any Products should be recalled, Customer shall cooperate with HTWC in effecting such recall as HTWC may reasonably request. HTWC shall
have administrative responsibility for effecting any such recall. |
| ii. | HTWC will be liable for all of Customer’s costs associated with any recall campaign, including without
limitation, if Customer does not elect to have the Product be exchanged, the price paid for the Product, if such recall campaign is based
upon a reasonable determination that the Product materially failed to conform to the warranties set forth in this Agreement. |
| e. | DISCLAIMER OF OTHER REPRESENTATIONS AND WARRANTIES; NON-RELIANCE. EXCEPT FOR THE PRODUCT WARRANTY
SET FORTH IN SECTION 10(c): (i) NEITHER HTWC NOR ANY PERSON ON HTWC’S BEHALF HAS MADE OR MAKES ANY EXPRESS OR IMPLIED REPRESENTATION
OR WARRANTY WHATSOEVER, EITHER ORAL OR WRITTEN, INCLUDING ANY WARRANTIES OF MERCHANTABILITY, WHETHER ARISING BY LAW, COURSE OF DEALING,
COURSE OF PERFORMANCE, USAGE OF TRADE OR OTHERWISE, ALL OF WHICH ARE EXPRESSLY DISCLAIMED, AND (ii) CUSTOMER ACKNOWLEDGES THAT IT HAS
NOT RELIED UPON ANY REPRESENTATION OR WARRANTY MADE BY HTWC, OR ANY OTHER PERSON ON HTWC’S BEHALF, EXCEPT AS SPECIFICALLY PROVIDED
IN SECTIONS 9(a) and 9(c) OF THIS AGREEMENT. |
| a. | Indemnification by HTWC. HTWC shall indemnify, defend and hold harmless Customer, its affiliates
and their respective representatives, and its permitted successors and assigns (the “Customer Indemnitees”), against
any and all costs, losses, damages, liabilities and expenses (including reasonable attorneys’ fees) (collectively, “Losses”)
in connection with any and all actions, suits, claims and demands (collectively, “Claims”) of third parties arising
out of or related to (i) HTWC’s gross negligence or intentionally wrongful acts or material omissions associated with HTWC’s
manufacture and supply of the Product; (ii) any material, uncured breach by HTWC of any of its representations, warranties or obligations
under this Agreement; or (iii) any alleged patent infringement, regardless of direct, contributory or inducement, by Customer, its affiliates
or their respective representatives, as a result of the performance of Customer’s obligations under this Agreement, except, in each
case, to the extent such Claims arise out of any material breach by Customer of any of its obligations under this Agreement, or are as
a result of any gross negligence or intentionally wrongful act or omission on the part of any Customer Indemnitees. |
| b. | Indemnification by Customer. Customer shall indemnify, defend and hold harmless HTWC, its
affiliates and their respective representatives, and its permitted successors and assigns (the “Manufacturer Indemnitees”),
against any and all Losses in connection with any Claims of third parties arising out of or related to (i) any breach by Customer of any
of its representations, warranties, or obligations under this Agreement or (ii) any gross negligence and/or intentionally wrongful acts
or material omissions of Customer; except, in each case, to the extent such Claims arise out of any material breach by HTWC of any of
its obligations under this Agreement, or are as a result of any gross negligence or intentionally wrongful act or omission on the part
of any Manufacturer Indemnitees. |
| i. | A Party believing that it is entitled to indemnification under Sections 11(a)-(b) (an “Indemnified
Party”) shall give prompt written notification to the other Party (the “Indemnifying Party”) of the commencement
of any Claim by a Third Party for which indemnification may be sought or, if earlier, upon the assertion of any such Claim by a third
party (it being understood and agreed, however, that the failure by an Indemnified Party to give notice of a third party Claim as provided
in this Section 11(c)(i) shall not relieve the Indemnifying Party of its indemnification obligation under this Agreement except and only
to the extent that such Indemnifying Party is actually materially prejudiced as a result of such failure to give notice). Within thirty
(30) days after delivery of such notification, the Indemnifying Party may, upon written notice thereof to the |
Indemnified Party, assume control of the defense
of such Claim with counsel reasonably satisfactory to the Indemnified Party. If a Party believes that a Claim presented to it for indemnification
is one as to which the Party seeking indemnification is not entitled to indemnification under Sections 11(a)-(b), it shall so notify the
Party seeking indemnification.
| ii. | If the Indemnifying Party elects to assume the defense of such Claim, the Indemnified Party may participate
in such defense at its own expense; provided that if the Indemnified Party reasonably concludes, based on advice from counsel,
that the Indemnifying Party and the Indemnified Party have conflicting interests with respect to such Claim, the Indemnifying Party shall
be responsible for the reasonable fees and expenses of counsel to the Indemnified Party solely in connection therewith |
| iii. | The Indemnifying Party shall keep the Indemnified Party advised of the status of such Claim and the defense
thereof and shall consider recommendations made by the Indemnified Party with respect thereto. |
| iv. | The Indemnified Party shall not agree to any settlement of such Claim without the prior written consent
of the Indemnifying Party, which shall not be unreasonably withheld, conditioned or delayed. The Indemnifying Party shall not agree to
any settlement of such Claim or consent to any judgment in respect thereof that does not include a complete and unconditional release
of the Indemnified Party from all liability with respect thereto or that imposes any liability or obligation on the Indemnified Party
or adversely affects the Indemnified Party without the prior written consent of the Indemnified Party, which shall not be unreasonably
withheld, conditioned or delayed. |
| d. | Insurance Requirements. Each Party agrees to obtain and maintain, during the Term and for two (2)
years after the Term, commercial general liability insurance, including products liability insurance, with minimum “A-” AM
Best rated insurance carriers, in each case with limits of not less than one million dollars ($1,000,000) per occurrence and in the aggregate.
All deductibles/retentions will be the responsibility of the named insured. To the extent of its culpability, all coverages of HTWC will
be primary and non-contributing with any similar insurance carried by Customer. Notwithstanding any provision of this Section 11(d) to
the contrary, Customer may meet its obligations under this Section 11(d) through self-insurance. Neither Party’s insurance will
be construed to create a limit of liability with respect to its indemnification obligations under Sections 11(a)-(b). |
| e. | Exceptions and Limitations on Indemnification/Liability. EXCEPT (i) FOR CLAIMS FOR WHICH A PARTY
HAS AN INDEMNIFICATION OBLIGATION |
UNDER SECTION 11(a) or (b), (ii) FOR A BREACH OF A
PARTY’S OBLIGATIONS IN SECTION 12 HEREIN, (iii) IN THE CASE OF A PARTY’S FRAUD OR WILLFUL MISCONDUCT OR GROSS NEGLIGENCE,
AND (iv) CUSTOMER’S PAYMENT OBLIGATIONS UNDER THIS AGREEMENT, NEITHER PARTY, NOR ANY OF ITS AFFILIATES, SHALL BE LIABLE TO THE OTHER
PARTY, OR ANY OF ITS AFFILIATES, FOR ANY SPECIAL, PUNITIVE, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING LOST PROFITS, LOST
REVENUES OR PENALTIES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES.
| 12. | Confidentiality; Publicity. |
| a. | Confidentiality. Except to the extent expressly authorized by this Agreement or otherwise agreed
in writing, the Parties agree that, for the term of this Agreement and for three (3) years thereafter, each Party (the “Receiving
Party”), receiving any Confidential Information of the other Party (the “Disclosing Party”) hereunder shall
keep such Confidential Information confidential and shall not publish or otherwise disclose or use such Confidential Information for any
purpose other than as provided for in this Agreement. “Confidential Information means any technical, scientific, regulatory,
commercial, business or other information provided by or on behalf of the Disclosing Party to the Receiving Party pursuant to this Agreement
or otherwise relating to or disclosed during any transaction contemplated hereby (including information disclosed prior to the Effective
Date under a confidentiality agreement in contemplation of this Agreement), including information relating to the terms of this Agreement
or the Product, and the scientific, regulatory or business affairs or other activities of either Party; provided that,
Confidential Information shall not include any information that the Receiving Party can establish: |
| i. | was already known to the Receiving Party (other than under an obligation of confidentiality), at the time
of disclosure by the Disclosing Party and such Receiving Party has documentary evidence to that effect; |
| ii. | was generally available to the public or otherwise part of the public domain at the time of its disclosure
to the Receiving Party; |
| iii. | became generally available to the public or otherwise part of the public domain after its disclosure or
development, as the case may be, and other than through any act or omission of a Party in breach of this confidentiality obligation; |
| iv. | was disclosed to that Party, other than under an obligation of confidentiality, by a Third Party who had
no obligation, directly or |
indirectly, to the Disclosing Party, not to disclose
such information to others; or
| v. | was independently discovered or developed by or on behalf of the Receiving Party without the use of the
Confidential Information belonging to the other Party and the Receiving Party has documentary evidence to that effect. |
| b. | Authorized Use and Disclosure. |
| i. | Disclosure. Notwithstanding the foregoing Section 12(a), each Party may disclose to Third
Parties Confidential Information belonging to the other Party to the extent such disclosure is reasonably necessary to: |
| 1. | Prosecute or defend litigation; |
| 2. | exercise or enforce rights hereunder; provided that such disclosure is covered by terms
of confidentiality no less stringent than those set forth herein, and |
| 3. | comply with inquires by a Governmental Authority or subpoena issued by a Governmental Authority or a court
of competent jurisdiction. |
In the event a Party shall deem it necessary to
disclose pursuant to this Section 11(b) Confidential Information belonging to the other Party, the Disclosing Party shall to the extent
possible give reasonable advance notice of such disclosure to the other Party and take reasonable measures to ensure confidential treatment
of such information.
| ii. | Use. Notwithstanding the foregoing Section 11(a), during the Term, each Party shall have the right
to use the other Party’s Confidential Information in carrying out its respective responsibilities under this Agreement. |
| c. | Certain Regulatory Filings. Either Party may disclose the terms of this Agreement to the extent
required, in the reasonable opinion of such Party’s legal counsel, to comply with applicable laws, including the rules and regulations
promulgated by the United States Securities and Exchange Commission or by any stock exchange or regulatory body to which the Party is
subject. Before disclosing this Agreement or any of the terms hereof pursuant to this Section 11(c), the Parties will consult with one
another regarding the terms in this Agreement to be redacted in making any such disclosure. If a Party discloses this Agreement or any
of the terms hereof in accordance with this Section 11(c), such Party agrees, at its own expense, to |
seek confidential treatment of portions of this
Agreement or such terms, as may be reasonably requested by the other Party.
| d. | Public Announcements. Neither Party shall issue any news release or other public announcement relating
to this Agreement, including any of its terms, or to the performance of either Party hereunder, without the prior written approval of
the other Party; provided that nothing in this Agreement shall prohibit HTWC from making required disclosures or filings
required by applicable law or by the rules and regulations of any securities exchange. Once the text or substance of any announcement
has been so approved, it may be repeated without further approval. |
| e. | Use of Names. Except as described in this Agreement and as may be required by applicable law, neither
Party shall distribute or have distributed any publicity or information which bears the name of the other without the prior written approval
of the other. |
| i. | Restriction on Name Usage. At all times during the Term of this Agreement, and in perpetuity thereafter,
Customer shall be prohibited from using any of the following trade names, or any combination(s) thereof, in any capacity, without the
express written consent of HTWC (provided, however, that Customer shall not be restricted from the following trade names with
respect to the resale of the Products pre-marked or packaged by or on behalf of HTWC): |
| 1. | “Healthtech Wound Care”; |
| 6. | “World Reach Health”; and/or |
| 13. | Tooling, Equipment and Materials. Subject to the mutual written
consent of te Parties, if applicable, HTWC will be reimbursed, at cost, for any specially-required equipment and/or fixtures (collectively,
“Tooling”) and improvements to equipment and Tooling purchased by HTWC needed for or used in the production of the
Product (“Product Tooling”) and/or to perform HTWC’s obligations to Customer. HTWC will be responsible for normal
maintenance of Customer’s Tooling and equipment in its possession. Equipment and Tooling paid for by Customer remains the property
of |
HTWC. Expenditures greater that Five Thousand Dollars
($5,000 USD) (hereinafter “Substantive Expenditures”) within any ninety (90) day period for Tooling or equipment will
be made only with the prior written authorization of Customer. Any Tooling or equipment requiring Substantive Expenditures for third party
calibration or refurbishment will require Customer’s pre-approval and will be the financial responsibility of Customer if approved.
In the event HTWC is required to make a prepayment on Tooling or equipment, Customer will reimburse HTWC at the time the prepayment is
made.
| 14. | HTWC’s Ownership. Unless and until the HTWC Option
Agreement and the HLTT Option Agreement are fully exercised and all amounts due to HTWC and/or HLTT thereunder are satisfied, HTWC, HLTT
and/or their affiliated entities, shall exclusively own all right, title and interest in and to and all patents, copyrights, trademarks,
mask works, manufacturing data and/or processes, trade secrets and other intellectual property rights (the “Intellectual Property
Rights”) related to: |
| b. | all manufacturing processes, know-how and other information and materials provided by HTWC to Customer
before and after the Effective Date of this Agreement (the “Information”), including Information to design, manufacture
or test of the Products; |
| c. | any Product Tooling purchased by HTWC; |
| d. | any inventions, ideas, discoveries, modifications, enhancements,
improvements or derivative works conceived, made, created, developed or reduced to practice by HTWC, solely or jointly, or in whole or
in part, during the Term of this Agreement that relate to the Product, Information or Product Tooling, or to any services provided under
this Agreement (“Assigned Inventions”). |
| e. | HTWC shall exclusively own all right, title and interest in and
to, and all Intellectual Property Rights related to: |
| i. | all know-how, technology, processes, procedures, ideas and concepts
developed by HTWC for manufacturing products (“Manufacturer Processes”); |
| ii. | any modifications, enhancements, and improvements to the Manufacturer Processes created by HTWC during
the Term of this Agreement; and |
| iii. | any non-Product specific Tooling created by HTWC during the Term of this Agreement ((i), (ii), and (iii) collectively,
“Manufacturer Rights”). |
| 15. | Restrictive Covenants. |
| a. | Customer and HTWC Restrictions. During the Term, and for a period of twelve (12) months following
the last date of the Term hereof (the “Restricted Period”), Customer, nor its directors, officers, members, managers,
shareholders, parents, subsidiaries and/or affiliated entities shall own, operate and/or enter into a contract manufacturing arrangement
with any other third-party for similarly competitive products without the express written consent of HTWC, which shall not be unreasonably
withheld or delayed, nor shall Customer, or any of Customer’s members/shareholders owning ten percent (10%) or more of Customer,
own or operate a similarly competitive company to that of HTWC. Conversely, in the event Customer exercises Customer’s rights pursuant
to the HTWC Option Agreement and the HLTT Option Agreement and pays all amounts due to HTWC and
HLTT thereunder, the Restricted Period shall no longer be of force or effect for the Customer; however, for a period of twelve
(12) months following the final payment of the HTWC Asset Purchase Price and the HLTT Purchase Price (the “Seller Restricted
Period”), HTWC, HLTT, and WRH, nor its directors, officers, members, managers, shareholders, parents, subsidiaries and/or affiliated
entities shall own, operate and/or enter into a contract manufacturing arrangement with any other third-party for similarly competitive
products without the express written consent of Customer, which shall not be unreasonably conditioned, withheld or delayed, nor shall
HTWC, HLTT, and WRH, or any of HTWC, HLTT, and WRH’s members/shareholders owning ten percent (10%) or more of HTWC, HLTT, or WRH,
own or operate a similarly competitive company. |
| b. | Non-Solicitation of Personnel; Non-Interference. During the Term hereof, and for a period of twelve
(12) months following the effective date of termination (the “Non-Solicitation Period”), unless otherwise later agreed
to in writing between the Parties, neither Party shall, either directly or indirectly, alone or in combination with any other Person (defined
below): |
| i. | solicit in any capacity (whether as an employee, consultant, owner, member, independent contractor or
otherwise any employee, who was employed within twelve (12) months of the effective date of termination of this Agreement, of either Party;
and/or |
| ii. | interfere with, alter or attempt to interfere with or alter, any relationship between the other Party
and any person referred to in Section 15(b)(i). |
| a. | No Right to Contract. The Parties hereby acknowledge and agree that neither Party shall have any
consent or authorization of the other Party to contract for the purchase or rental of any article or material, or, make any commitment
and/or agreements whereby the other Party will be required to pay money or other consideration, or which will otherwise obligate the other
Party, unless otherwise later agreed to in writing between the Parties. |
| b. | Further Assurances. Upon a Party’s reasonable request, the other Party shall, at its sole
cost and expense, execute and deliver all such further documents and instruments, and take all such further acts, necessary to give full
effect to this Agreement. |
| c. | Relationship of the Parties. The relationship between HTWC and Customer is solely that of vendor
and vendee and they are independent contracting parties. Nothing in this Agreement creates any agency, joint venture, partnership or other
form of joint enterprise, employment, or fiduciary relationship between the Parties. Neither Party has any express or implied right or
authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract,
agreement or undertaking with any third party. |
| d. | Confidentiality of this Agreement. The terms of this Agreement may not be revealed by the Parties
to any third party (except to each of the Parties’ agent(s), attorney(s), accountant(s) and manager(s), each of whom will observe
confidentiality, or if legally required to do so by statute, regulation, judicial or governmental order or by deposition, interrogatory,
request for documents, subpoena, civil investigative demand or similar process in a judicial or governmental proceeding or in connection
with legal action or arbitration to enforce this Agreement). |
| e. | Entire Agreement. This Agreement, including and together with any related exhibits, schedules,
and the applicable terms of any purchase orders and/or shipping instructions, constitutes the sole and entire understanding and agreement
of the Parties with respect to the subject matter contained herein and therein, and supersedes all prior and contemporaneous understandings,
agreements, proposals, discussions, representations, and warranties, both written and oral, with respect to such subject matter. If there
is a conflict between the terms of this Agreement and of any exhibit, schedules or purchase orders, the terms of this Agreement shall
govern. |
| f. | Notices. All notices, requests, consents, claims, demands, waivers, and other communications under
this Agreement (each, a “Notice”) must be in writing and addressed to the other Party at its address set forth below
(or to such other address that the receiving Party may designate from time to time in accordance with this section). All Notices must
be delivered by personal delivery, nationally recognized overnight courier or certified or registered |
mail (in each case, return receipt requested, postage
prepaid) or email (with confirmation of transmission). Except as otherwise provided in this Agreement, a Notice is effective only (a)
on receipt by the receiving Party, and (b) if the Party giving the Notice has complied with the requirements of this Section.
| g. | Interpretation. The Parties drafted this Agreement without regard to any presumption or rule requiring
construction or interpretation against the Party drafting an instrument or causing any instrument to be drafted. The exhibits, schedules,
and attachments referred to herein are an integral part of this Agreement to the same extent as if they were set forth verbatim herein. |
| h. | Headings. The headings in this Agreement are for reference only and do not affect the interpretation
of this Agreement. |
| i. | Severability. If any term or provision of this Agreement is held void, voidable, invalid, illegal,
or unenforceable in any jurisdiction, no other provision of this Agreement shall be affected as a result thereof, and the remaining provisions
of this Agreement shall be valid and remain in full force and effect as if such void, voidable, invalid, illegal, or unenforceable provision
had been omitted. |
| j. | Amendment and Modification. No amendment, change, modification, alteration, addition to, rescission,
termination or discharge of this Agreement is effective unless it is in writing and signed by authorized representatives of both Parties. |
| k. | Waiver. None of the terms of this Agreement may be waived, in whole or in part, unless such
waiver is in writing and signed by an authorized representative of both Parties. Any waiver authorized on one occasion is effective only
in that instance and only for the purpose stated and does not operate as a waiver on any future occasion or any other provision of the
Agreement. Any course of dealing between the Parties or failure or delay in exercising any right, remedy, power, or privilege or in enforcing
any condition under this Agreement shall not constitute a waiver or estoppel of any right, remedy, power, privilege, or condition arising
from this Agreement. |
| l. | Assignment. This Agreement may not be assigned or otherwise transferred, nor may any right or obligation
hereunder be assigned or transferred, by either Party without the prior written consent of the other Party. Notwithstanding the foregoing,
either Party may, without consent of the other Party, assign this Agreement and its rights and obligations hereunder in whole or in part
to an Affiliate of such Party, or in whole to its successor in interest in connection with the sale of all or substantially all of its
stock or its assets to which this Agreement relates, or in connection with a merger, acquisition or similar transaction. Any attempted
assignment not in accordance with the foregoing shall be null and void and of no legal effect. Any permitted assignee |
shall assume all assigned obligations of its assignor
under this Agreement. The terms and conditions of this Agreement shall be binding upon, and shall inure to the benefit of, the Parties
and their respected successors and permitted assigns.
| m. | Successors and Assigns. This Agreement is binding on and inures to the benefit of the Parties and
their respective permitted successors and permitted assigns. |
| n. | No Third-Party Beneficiaries. Unless otherwise expressly provided for in writing, nothing in this
Agreement is intended or will be construed to give any person or entity, other than each Party hereto, and their successors or assigns,
any legal or equitable right, remedy, or claim under or with respect to this Agreement or any provisions contained herein. |
| o. | Survivability. Terms and conditions that require performance after the termination or expiration
of this Agreement, including without limitation, use restrictions, limitations of liability, indemnification, and confidentiality provisions,
will survive any termination or expiration of this Agreement. |
| p. | Governing Law, Venue and Remedies. All questions concerning the construction, validity, enforcement,
and interpretation of this Agreement shall be governed by and construed and enforced in accordance with the internal laws of the State
of Utah, without regard to the principles of conflicts of law thereof. If any dispute should arise between the Parties that cannot be
resolved informally, it shall be settled by arbitration in a mutually approved office of the American Arbitration Association before an
arbitrator designated by the American Arbitration Association in accordance with the Rules of the American Arbitration Association then
effective in Utah. However, in the event the Parties are unable to mutually approve a location for the arbitration, is shall take place
by default in Salt Lake City, Utah. Subject to the arbitrator’s award, the cost of any arbitration proceedings and the prevailing
Party’s reasonable, outside attorneys’ fees shall be borne by the Party against whom an award is made. The decision of the
arbitrators shall be binding and conclusive upon the Parties. If the American Arbitration Association shall not then be in existence,
arbitration shall be settled by such other organization, if any, as shall then have become the successor of said Association. |
| q. | Waiver of Jury Trial. EACH PARTY ACKNOWLEDGES AND AGREES THAT ANY CONTROVERSY THAT MAY ARISE OUT
OF OR RELATE TO THIS AGREEMENT IS LIKELY TO INVOLVE COMPLICATED AND DIFFICULT ISSUES AND, THEREFORE, EACH SUCH PARTY IRREVOCABLY AND UNCONDITIONALLY
WAIVES ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN RESPECT OF ANY LEGAL ACTION ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE TRANSACTIONS
CONTEMPLATED HEREBY. Each Party certifies and acknowledges that (a) no representative of the other Party has |
represented, expressly or otherwise, that such other
Party would not seek to enforce the foregoing waiver in the event of a legal action, (b) such Party has considered the implications of
this waiver, (c) such Party made this waiver voluntarily, and (d) such Party has been induced to enter into this Agreement by, among other
things, the mutual waivers and certifications in this Section.
| r. | Attorneys’ Fees. In the event that either Party employs attorneys to enforce any right arising
out of or relating to this Agreement, the prevailing Party shall be entitled to recover its reasonable attorneys’ fees and costs. |
| s. | Force Majeure. No Party shall be liable or responsible to the other Party, nor be deemed to have
defaulted under or breached this Agreement, for any failure or delay in fulfilling or performing any term of this Agreement, when and
to the extent such party’s (the “Impacted Party”) failure or delay is caused by or results from the following
force majeure events (“Force Majeure Event(s)”): acts of God, flood, fire, earthquake, hurricane, tornado, epidemic,
pandemic, explosion, war, terrorism, riot, government order or action. The Impacted Party shall give notice to the other Party as soon
as practicable, stating the period of time the occurrence is expected to continue. The Impacted Party shall use diligent efforts to end
the failure or delay and ensure the effects of such Force Majeure Event are minimized. The Impacted Party shall resume the performance
of its obligations as soon as reasonably practicable after the removal of the cause. Notwithstanding the forgoing, the other Party may
terminate this Agreement upon written notice if the Impacted Party’s nonperformance continues for a period of ninety (90) consecutive
days. |
| t. | Counterparts. This Agreement may be executed in counterparts, each of which is deemed an original,
but all of which together is deemed to be one and the same agreement. A signed copy of this Agreement delivered by facsimile, e-mail or
other means of electronic transmission is deemed to have the same legal effect as delivery of an original signed copy of this Agreement. |
SIGNATURE PAGE FOLLOWS
THE REMAINDER OF THIS PAGE IS INTENTIONALLY LEFT BLANK
SIGNATURE PAGE TO THE
MANUFACTURING AGREEMENT DATED AUGUST 18, 2023
BETWEEN
HEALTHTECH WOUND CARE, INC.
AND
HLLT ACQUIRED, LLC
IN WITNESS WHEREOF,
the Parties hereto have executed this Agreement as of the Effective Date.
HTWC:
Healthtech Wound Care, Inc.
Date
_________________________________
By:
Its:
Date
________________________________
By:
Its:
CUSTOMER:
HLLT Acquired, LLC
Date
_________________________________
By:
Its:
EXHIBIT A
PRODUCT SCHEDULE
*See Attached
MANUFACTURING AGREEMENT
This Manufacturing Agreement (this “Agreement”)
is entered into as of August 18, 2023 (the “Effective Date”), by and between Healthtech Wound Care, Inc. (“HTWC”),
a Delaware corporation, with a principal place of business located at 615 Arapeen Dr., Suite 300, Salt Lake City, Utah 84108, and HLLT
Acquired, LLC (“Customer”), a Delaware limited liability company, with a principal place of business located at
885 Third Avenue, 29th Floor, New York, New York 10022. HTWC and Customer may sometimes be referred to herein individually
as a “Party” and collectively as the “Parties.”
WHEREAS, HTWC is the manufacturer
of that certain product line of Food and Drug Administration (“FDA”) approved human placental allograft tissue commonly
known as “DermaBind-TL,” (a/k/a “AmnioBind”) Q-Code 4225 (the "Q-Code") (individually
a/the “Product” and collectively, the “Products”), as more particularly described in the product
schedule (the “Product Schedule”), a copy of which is attached hereto and incorporated herein for reference as Exhibit
“A”;
WHEREAS, Customer anticipates
entering into a conditional asset option-purchase agreement (the “HTWC Option Agreement”) with HTWC, whereby Customer
shall have the exclusive option (the “HTWC Option”) to purchase HTWC’s assets (the “HTWC Assets”),
as more fully identified in the HTWC Option Agreement, on the terms and conditions contained in the HTWC Option Agreement;
WHEREAS, Customer anticipates
entering into an intellectual property option purchase agreement (the “HLTT Option Agreement”) with HTWC’s parent
company, Healthtech Solutions, Inc. (“HLTT”), whereby Customer shall have the exclusive option (the “HLTT
Option”) to purchase HLTT’s intellectual property solely associated with the Product (the “HLTT IP”),
as more fully identified in the HLTT Option Agreement, on the terms and conditions contained in the HLTT Option Agreement; and
WHEREAS, until the later of such
time as Customer consummates the acquisition of the HTWC Assets in accordance with the HTWC Option Agreement, and Customer consummates
the acquisition of the HLTT IP in accordance with the HLTT Option Agreement, or until the termination of this Agreement, Customer desires
for HTWC to manufacture certain quantities of the Product during the Term (defined below) hereof, and HTWC wishes to manufacture certain
quantities of the Product for Customer on the terms and conditions contained herein. Moreover, the Parties acknowledge that HTWC may decide
to manufacture other products in its lab or facilities that are not limited to the Product specified in this Agreement, and the Parties
desire to expand collaboration and amend this Agreement as necessary to include additional products.
NOW, THEREFORE, in consideration
of the mutual covenants, terms, and conditions set forth herein, and for other good and valuable consideration, the receipt and sufficiency
of which are hereby acknowledged, the Parties agree as follows:
| 1. | Incorporation by reference. The
Recitals and introductory paragraph above, and the definitions set forth therein, are incorporated by this reference. |
| 2. | Conditions Precedent. Each Party’s
obligations hereunder shall be contingent upon the occurrence of all of the following events (the “Conditions Precedent”): |
| a. | each Party fully executes and delivers to the other Party this Agreement. |
| a. | Initial Term. The term of this Agreement commences
on the Effective Date and continues through the fifteenth (15th) month anniversary of the Effective Date (the “Initial
Term”), unless it is earlier terminated pursuant to the terms of this Agreement or applicable law. |
| b. | Renewal Term. Upon expiration of the Initial Term,
the term of this Agreement will automatically renew for additional successive three (3) month terms unless either Party provides written
notice (email is sufficient) of non-renewal at least ten (10) business days prior to the end of the then-current term (each a “Renewal
Term” and together with the Initial Term, the “Term”), unless any Renewal Term is earlier terminated pursuant
to the terms of this Agreement, the mutual written consent of the Parties or applicable law. If the Initial Term or any Renewal Term is
renewed for any additional Renewal Term(s) pursuant to this section, the terms and conditions of this Agreement during each such Renewal
Term will be the same as the terms in effect immediately prior to such renewal, unless otherwise later agreed to in writing between the
Parties. In the event either Party provides timely notice of its intent not to renew this Agreement, then, unless earlier terminated in
accordance with its terms, this Agreement terminates on the expiration of the Initial Term or then-current Renewal Term, as applicable.
|
| c. | Termination In Accordance with the HTWC Option Agreement
and the HLTT Option Agreement. In the event the Parties consummate the HTWC Option Agreement and the HLTT Option Agreement and Customer
exercises its options thereunder and pays all amounts due HTWC and HLTT in accordance therewith, this Agreement shall automatically terminate
effective the last calendar day of the then-current month that the final balances due to HTWC in accordance with the HTWC Option Agreement
and the final balances due to HLTT in accordance with the HLTT Option Agreement were paid. |
| d. | Termination for Cause. Either Party may terminate
this Agreement for cause with immediate effect upon written notice (email is sufficient) to the other Party: |
| i. | if such other Party fails to perform any material obligation
under this Agreement or otherwise materially breaches this Agreement, through |
no fault of the Party initiating such termination,
that remains uncured for fifteen (15) business days, or such other period of time as the Parties may mutually approve of in writing,
following written notice (email is sufficient) to such Party of such failure or breach;
| ii. | if the other Party becomes insolvent, is generally unable
to pay, or fails to pay, its debts as they become due, files a petition for bankruptcy or commences or has commenced against it proceedings
relating to bankruptcy, receivership, reorganization, or assignment for the benefit of creditors. |
| e. | Termination Without Cause. During the Initial
Term, Customer may terminate this Agreement for convenience upon three (3) months’ advance written notice of termination, provided
such termination shall not be effective before January 31, 2024. |
| f. | Effect of Expiration or Termination. |
| i. | Immediately, upon the effectiveness of a notice of termination,
except for termination in accordance with Section 3(c), HTWC shall, unless otherwise directed by Customer, and subject to HTWC’s
obligation to provide resourcing cooperation: (A) promptly terminate all performance under this Agreement; and (B) transfer title and
deliver to Customer all finished Products completed prior to effectiveness of the notice of termination. HTWC agrees, if requested by
Customer, to finish any work in progress that remains after it receives a termination notice from Customer, subject to Customer’s
full payment for such services. |
| ii. | The termination or expiration of this Agreement for any
reason shall not release any Party hereto of any liability, which at the time of termination or expiration had already accrued to the
other Party in respect to any act or omission prior thereto. |
| iii. | Upon the expiration or earlier termination of this Agreement,
each Party shall return to the other Party or destroy all documents and tangible materials (and any copies) containing, reflecting, incorporating,
or based on the other Party’s Confidential Information (defined below). In addition, and if applicable, each Party, upon the other
Party’s written request (email is sufficient), will certify in writing to such other Party that it has complied with the requirements
of this section. |
| 4. | HTWC to Manufacture the Product. |
| a. | Manufacture. Subject to the terms and conditions
of this Agreement, HTWC shall manufacture the Product in accordance with all FDA and/or Tissue |
Reference Group (“TRG”)
specifications and/or requirements applicable to the Q-Code, including ordering and management of required components to make the Product.
Additionally, during the Term hereof, HTWC shall maintain its manufacturing facility to be compliant with all ISO-13485 standards.
| i. | Initial 60-Day Product Quantities. Commencing
as of the Effective Date of this Agreement, HTWC shall manufacture and/or deliver, and Customer shall pay for, not less than Three Thousand
centimeters squared (3,000cm2) within thirty (30) days of the Effective Date of this Agreement, and not less than Five Thousand centimeters
squared (5,000cm2) within sixty (60) days of the Effective Date of this Agreement. |
| ii. | Monthly Minimum; Desired Product Quantities. Unless
Customer notifies HTWC in writing (email is sufficient) to request quantities in excess of those noted in Section 4(a)(i) sooner in time,
commencing as of the third (3rd) monthly anniversary of the Effective Date of this Agreement, Customer ultimately desires for
HTWC to manufacture and deliver to Customer approximately Ten Thousand square centimeters (10,000cm2) of the Product on average per calendar
month during the Term. However, Customer understands and acknowledges that a ramp up period to achieve such quantities may be applicable
for up to one hundred eighty (180) days from the Effective Date of this Agreement, as HTWC will require additional equipment and raw materials,
and lead times apply. Commencing as of the third (3rd) monthly anniversary of the Effective Date of this Agreement, HTWC shall
commit to manufacturing and delivering to Customer, and Customer shall pay for, a variety of Product sizes collectively amounting to not
less than Seven Thousand Five Hundred centimeters squared (7,500cm2) per month (the “Monthly Minimum”). Further, unless
otherwise later agreed to in writing between the Parties, commencing as of the third (3rd) monthly anniversary of the Effective
Date of this Agreement, Customer commits to purchasing not less than Seven Thousand Five Hundred centimeters squared (7,500cm2) per month
for the duration of the Term. Any variations of manufacturing capacities and/or delivery schedules regarding the Product and/or the Monthly
Minimum will be mutually approved by the Parties. Any additional, contrary, or different terms contained in any subsequent purchase order,
acknowledgement, confirmation, invoice or communication, and any other attempt to modify, supersede, supplement, or otherwise alter this
Agreement, are deemed rejected by the other Party and will not modify this Agreement or be binding on the Parties unless such terms have
been fully approved in a signed writing by authorized representatives of both Parties. |
| iii. | Over-Runs/Under-Runs. Over-runs and under-runs
per Product type ordered may vary plus or minus 5% of the Monthly Minimum. |
Delivered quantity within the above listed
range shall be deemed to constitute fulfillment of the Monthly Minimum.
| b. | Forecasts and Inventory Planning. On a monthly
basis, Customer will provide HTWC with a non-binding rolling forecast for the following month. Forecasts beyond the Monthly Minimum production
requirements contained herein are for informational purposes only and do not create any binding obligations on behalf of either Party,
unless otherwise agreed to in writing between the Parties. HTWC will be responsible for material planning to meet the rolling forecast
and mutually agreed upon service levels for the Product. HTWC will promptly notify Customer if HTWC becomes aware that HTWC cannot meet
the rolling forecast; provided, however, that a failure to provide such notice shall not constitute a breach under this Agreement. |
| 5. | Shipment, Delivery, Acceptance, and Inspection. |
| a. | Shipment and Delivery Requirements. HTWC shall
manufacture, assemble, pack, mark, and ship the Product in accordance with all applicable FDA, TRG and/or Q-Code specifications, strictly
in the quantities and by the methods, to the delivery locations and by the delivery dates, specified in this Agreement or as instructed
on a case-by-case basis by Customer. Each shipment will constitute a separate sale, and Customer will pay
for the Products shipped whether the shipment is in whole or partial fulfillment of the Monthly Minimum. The quantity
of any installment of the Products, as recorded by HTWC on the dispatch from HTWC’s place of business, is evidence of the quantity
received by Customer upon delivery, unless Customer provides evidence to the contrary. HTWC will not be liable for any non-delivery of
the Products to a Customer-designated delivery location, unless Customer gives written notice to HTWC of the non-delivery within fifteen
(15) calendar days following the date that Customer would, in the ordinary course of business, have received the Products. HTWC’s
liability for any non-delivery of the Products will be limited to replacing the Products within a reasonable time or adjusting the invoice
for the Products to reflect the actual quantity delivered. |
| i. | Method of Shipping. All Products shipped by HTWC
shall be shipped via FedEx Ground. Customer, or Customer’s designated third party(ies) may request expedited shipping services;
however, Customer, or Customer’s designated third party(ies) shall be subject to additional charges for such expedited services. |
| 1. | Customer-Provided Shipping Labels. If Customer
elects to utilize Customer’s, or any Customer-designated third party’s FedEx or other freight carrier account, it shall be
Customer’s responsibility to provide HTWC, via email, with the applicable shipping labels. |
| ii. | Costs of Shipping. The Manufacturing Fee (defined
below) does not include the cost of shipping to Customer’s designated location, unless otherwise later agreed to in
writing between the Parties. HTWC shall separately invoice Customer on a monthly basis for any and all shipping costs incurred by HTWC.
All such shipping invoices shall be payable to HTWC upon Customer’s receipt of said invoices. |
| iii. | Delays in Shipment of Products to Customer. HTWC
will use commercially reasonable efforts to ship the Products to arrive by any requested delivery date quoted or acknowledged. However,
none of the Parties hereto will be liable for any delay in shipment or delay in performance under this Agreement, due to unforeseen circumstances,
or due to causes beyond their control, including, but not limited to an event of Force Majeure (defined below). Subject to Section 16(s),
in the event a substantial amount of the Product ordered by Customer herein is substantially delayed, and such delay exceeds ninety (90)
consecutive days, Customer may elect to terminate this Agreement upon written notice to HTWC (email shall be sufficient), upon which HTWC
shall, within ninety (90) days of the date of such termination, be required to refund the purchase price actually paid by Customer for
any undelivered Products to Customer and repay the the Equipment Financing (defined below) payment actually made by Customer to Customer. |
| b. | Transfer of Title and Risk of Loss. Title to Products
and risk of loss to the Product shipped passes to Customer, or to such other third party or parties as may have been designated by Customer,
upon receipt and acceptance by the shipping carrier, freight forwarder, Customer and/or any third-party(ies) designated by Customer, whichever
occurs first. HTWC will bear the risk of loss or damage to the Product in transit to the carrier or freight forwarder. |
| c. | Packaging and Labeling. HTWC shall properly pack,
mark, and ship the Product as instructed by Customer and otherwise in accordance with applicable law and industry standards and shall
provide Customer with shipment documentation showing HTWC’s identification number for the subject Product, the quantity of pieces
in shipment, shipment tracking number and/or bill of lading number, and such other information as Customer reasonably requests. |
| d. | Inspection. Customer shall have fifteen (15) business
days following delivery of any Products under this Agreement (the “Inspection Period”), to inspect all such Products
received and to notify HTWC, in writing (email containing photographic proof of the nonconforming Product is sufficient), of Customer’s
rejection of any such Products it believes to be Nonconforming Products (as defined below). For purposes of this Agreement, “Nonconforming
Products” means any Product received by Customer from HTWC that: (i) does not |
conform to the applicable FDA, TRG and/or
Q-Code specifications; (ii) Customer, upon visual inspection, reasonably and in good faith determines is defective or damaged; or (iii)
exceeds the quantity of the Products ordered by Customer. For any Nonconforming Products, Customer may elect to (y) require HTWC, at HTWC’s
sole cost, to timely replace the rejected Products at the location specified by Customer (which may include HTWC’s location, Customer’s
location or the location of a third party), or (z) retain the rejected Product; in each case, without limiting the exercise by Customer
of any other rights available to Customer under this Agreement or pursuant to applicable law; provided, however, that to the extent any
Products are deemed to be Nonconforming Products because they exceed the quantity of
Product ordered by Customer, Customer may return such Nonconforming Products to HTWC. All returns of Nonconforming Products to HTWC are
at HTWC’s sole risk and expense, so long as the return shipping is coordinated by HTWC, which HTWC shall timely coordinate. Product
that is not rejected within the Inspection Period will be deemed to have been accepted by Customer; provided, however, that Customer’s
acceptance of any Product will not be deemed to be a waiver or limitation of HTWC’s obligations pursuant to this Agreement (or any
breach thereof).
| e. | No Refunds / Exchanges. Except for instances involving
Nonconforming Products, Products covered by the Product Warranty, or Product returns governed under a separate agreement on a case-by-case
basis between the Parties, all sales are final. There shall be no refunds, returns or exchanges of the Product, unless (i)
HTWC fails to deliver the Product to Customer within thirty (30) days of the date the Customer paid HTWC for the Products (or such later
date as agreed or noted in writing between the Parties on a case-by-case basis), (ii) as otherwise later agreed to in writing between
the Parties, or (iii) for the avoidance of doubt, any Products that are subject to the Product Warranty may be eligible for return or
exchange in accordance with the terms and conditions of the Product Warranty. If a return is authorized by HTWC for reasons not involving
Nonconforming Products or the Product Warranty, Customer shall bear all risk of loss or damage during shipment, as well as all shipping
expenses, of any returned Product, and Customer shall be subject to and responsible for the payment of a restocking fee in an amount equal
to thirty-five percent (35%) of the Base Rate (as defined below). |
| f. | Non-Returnable Products. Return of Products that
would have been subject to return under separate agreement or for Nonconforming Products, shall not be permitted to be returned for the
following circumstances (each “Non-Returnable Products”). Non-Returnable Products will not be eligible for authorized
return and Customer will neither receive credit nor be released from payment obligations in the event of an unauthorized return that is
outside of the eligible return criteria set forth under separate agreement. For the avoidance of doubt, the following Products shall not
be eligible for credit |
or replacement under the above, regardless
of whether the Products otherwise satisfies the requirements in any of the sections previously specified:
| i. | Products that are not in their original packaging or
container and/or not bearing its original label due to causes reasonably beyond HTWC’s control; or lot numbers or expiration dates
are missing; unless (a) a certification of return circumstances that would not require the return of physical Products (e.g., loss, damage,
etc.) and proper disposal, if applicable, has been submitted and HTWC has approved and processed such certification or (b) Products are
physically returned, but are damaged (at time of shipment by HTWC) making fulfillment of this requirement impossible; |
| ii. | Products involved in a fire, flood, natural disaster,
due to causes reasonably beyond HTWC’s control; |
| iii. | Products that are in a deteriorated condition from improper
storage due to causes reasonably beyond HTWC’s control; |
| iv. | Products that have been repackaged due to causes reasonably
beyond HTWC’s control; |
| v. | Products purchased for research or clinical trials or
shipped as a no cost item (e.g., physician sample, Products replaced through separate HTWC-approved Product replacement program, etc.);
and/or |
| vi. | Products damaged or rendered unusable due to mishandling
or error due to causes reasonably beyond HTWC’s control. |
| g. | Collection Costs. Customer hereby agrees to pay
HTWC for all collection costs HTWC incurs to collect from Customer any amount past due. |
| h. | Delivery Withholdings. Without waiving any other
rights or remedies available to HTWC under applicable law or otherwise, HTWC may, at its option: (i) defer shipment and/or deliveries
of Products until all past-due accounts of Customer owed to HTWC have been satisfied in full, or (ii) require Customer to pay for Products
prior to shipment, or ship Products on a “cash on delivery” basis if HTWC determines, in its reasonable discretion, not to
extend credit to Customer. |
| 6. | Manufacturing Fees to HTWC. |
| i. | Customer shall provide HTWC with equipment financing
in the amount of Five Hundred Thousand Dollars ($500,000.00 USD) (the |
“Equipment Financing”).
The payment for the Equipment Financing shall be made by Customer as follows:
| 1. | Within five (5) business days of the the execution of
this Agreement, Customer shall pay Fourteen Thousand Five Hundred Ninety-Five Dollars ($14,595.00 USD) directly to HTWC’s vendor,
Van Der Stahl, for an integrated peel tester; |
| 2. | Within five (5) business days of the, Customer shall
pay One Hundred Thirty-Eight Thousand Three Hundred Thirty-One Dollars and 33/100ths ($138,331.33 USD) directly to HTWC’s vendor,
SP VirTis, for a freeze dryer; |
| 3. | Within five (5) business days of the, Customer shall
pay Two Hundred Fifty Four Thousand Eight Hundred Fifty-Two Dollars and 77/100ths ($254,852.77 USD) to HTWC; and |
| 4. | in accordance with the invoice terms for the final installment
for the purchase of the freeze dryer, Ninety-Two Thousand Two Hundred Twenty and 90/100ths ($92,220.90) to HTWC’s vendor, SP VirTis. |
| ii. | Advancement or Cancellation of the HTWC Option and
the HLTT Option. |
| 1. | If, during the period commencing as of the Effective
Date of this Agreement and ending at 3:00pm CST on Thursday, November 30, 2023 (the “Due Diligence Period”), Customer
elects to proceed with the HTWC Option Agreement and the HLTT Option Agreement, then upon the closing of the transactions contemplated
thereby, an amount equal to one hundred percent (100%) of the Equipment Financing payments actually made by Customer shall be applied
first to satisfy any amounts then owed by Customer to HTWC for purchases of the Product under this Agreement, with the remaining balance,
if any, applied secondarily towards the HTWC Option Purchase Price (as defined in the HTWC Option Agreement). |
| 2. | If, during the Due Diligence Period, Customer elects
not to proceed with the HTWC Option Agreement and the HLTT Option Agreement (either by way of Customer’s failure to enter into the
HTWC Option Agreement and/or the HLTT Option Agreement, or through the cancellation, termination or expiration of such agreements or the
HTWC Option and/or HLTT Option granted therein, or otherwise), then an amount equal to up to one hundred percent (100%) of the Equipment
Financing payments |
actually made by Customer shall be applied
as a credit towards the amount payable by Customer to HTWC for purchases of the Product under this Agreement in the final month of the
Term. Notwithstanding the foregoing, if the Term of the Agreement is terminated prior to the initially anticipated final month of the
Term, then one hundred percent (100%) of the Equipment Financing payments actually made by Customer shall be applied as a credit towards
the amount payable by Customer to HTWC for purchases of the Product under this Agreement then due and owing. Moreover, if for whatever
reason there are no amounts due and payable to HTWC then HTWC shall be required, within ninety (90) days’ to repay to Customer one
hundred percent (100%) of the Equipment Financing payments actually made by Customer.
| i. | Invoicing and Payment Schedule; Minimum Manufacturing
Fee. |
| 1. | Invoices. HTWC shall provide Customer with invoices
for the Products ordered by and shipped to Customer, detailing the quantity, unit price, and total amount due. Invoices shall be submitted
within three (3) days from the date of Product shipment to Customer. Customer shall pay each invoice (less the amount of any corresponding
Deposit (as defined below)) within thirty (30) days from the date of such invoice (“Net 30”), or Net 30 from the last
day of the then applicable month of the Term (if Customer did not provide shipping instructions for a particular quantity of the Monthly
Minimum of Product prior to the month end), whichever is sooner. |
| 2. | Deposit Payments. Commencing as of the second
(2nd) month of the Term hereof, on or before the first (1st) day of each month of the Term, Customer shall pay to
HTWC a deposit equal to ten percent (10%) of the Manufacturing Fee (defined below) (the “Deposit”) applicable for each
month in accordance with and as set forth the table in Section 6(b)(i)(3)(a). The Deposit shall be pro-rated on a per square centimeter
basis applicable to the Monthly Minimum, and, as each Product is shipped, the ninety percent (90%) per square centimeter balance shall
be paid in accordance with Section 6(b)(i)(1). |
| 3. | Manufacturing Fee. Provided that HTWC has not
breached its obligations under this Agreement, Customer shall order sufficient quantities of Product over the course of the Term such
that the manufacturing fee due and owing HTWC over the Term |
equals the aggregate amount of Twenty-One
Million One Hundred Thousand Dollars ($21,100,000.00 USD) (the “Manufacturing Fee”), unless this Agreement is earlier
terminated in accordance with Section 3 hereof. The Manufacturing Fee shall be fully applicable against all amounts Customer shall owe
to HTWC relevant to the Monthly Minimum (e.g., 7,500cm2).
| a. | Minimum Monthly Payments of the Manufacturing Fee.
The Customer agrees to order quantities of the Products that would equal the Manufacturing Fee for each month of the Term as set forth
on the table below (each a “Monthly Installment”) as follows: |
Month |
Deposit |
Balance of Manufacturing Fee |
Total Monthly Installment |
1 |
$0 |
$600,000 |
$600,000 |
2 |
$100,000 |
$900,000 |
$1,000,000 |
3-15 |
$150,000 |
$1,350,000 |
$1,500,000 |
| c. | Adjustments for Product Orders. The amounts specified
for the Monthly Installments are based on the projected order of Products. In the event that the Customer’s Product orders for any
given month are less than the amount associated with the Monthly Installment, the Customer shall pay the remainder of the applicable month’s
Monthly Installment at the end of the month in accordance with the invoice. HTWC shall ship out Products equaling the amount to be invoiced
prior to such invoice being issued. Notwithstanding the foregoing, Customer, in its sole and absolute discretion may elect for HTWC to
store the then invoiced Products on behalf of Customer, or to ship said Products to a third-party designated by Customer. |
| d. | Rollover Quantities Applied to Monthly Minimum. If
the quantity of Products ordered by Customer in any month of the Term exceeds the amount associated with such month’s Monthly Minimum,
then the amount such excess quantity of Products shall be credited towards the following month’s Monthly Minimum. |
| e. | Method of Payment. The Equipment Financing and
the Manufacturing Fee shall be paid to HTWC, or the applicable designee noted herein, by bank wire transfer, to coordinates to be separately
provided by HTWC. |
| f. | Base Unit Rate. HTWC shall invoice Customer on
a per centimeter squared base unit rate equal to Two Hundred Dollars ($200.00 USD) per centimeter |
squared (the “Base Rate”),
regardless of the size of the Product. The applicable aggregate unit rate for the following products shall be as follows:
Product Size |
Total cm2 |
Unit Rate |
1cm2 x 1cm2 |
1cm2 |
$200/ea |
2cm2 x 2mc2 |
4cm2 |
$800/ea |
3cm2 x 3cm2 |
9cm2 |
$1,800/ea |
4cm2 x 4cm2 |
16cm2 |
$3,200/ea |
6.5cm2 x 6.5cm2 |
43cm2 |
$8,600/ea |
| g. | Overage Payments. In the event that Customer orders
Product in excess of the Monthly Minimum to Customer, Customer shall pay HTWC the Base Rate per unit of Product. All such amounts shall
be invoiced at the time of shipment and due within thirty (30) days of delivery of the Product. |
| h. | Additional Products. In the event Customer desires
to purchase alternate products from HTWC, which are subject to alternate Q-codes, the Parties agree to negotiate in good faith the terms
and conditions of any such purchase/sale and/or manufacturing arrangements. |
| i. | Setoff; Contingent or Disputed Claims. Customer
agrees to pay all undisputed charges under this Agreement without counterclaim, set-off or deduction. In the event that Customer legitimately
and reasonably disputes an invoiced amount, Customer will provide HTWC with written notice of the amount in dispute and the basis for
the dispute. HTWC agrees that it will work with Customer to resolve the dispute reasonably and expeditiously within a thirty (30) day
period. |
| j. | Fair and Reasonable Pricing. Customer hereby acknowledges
and agrees that the Unit Price per Product and/or the Purchase Price, as stated in each Sales Confirmation, is fair and reasonable, that
the Customer believes, based upon Customer’s independent analysis, that the Unit Price and/or the Purchase Price is competitive
within the marketplace, and that the Customer does not believe the Unit Price and/or the Purchase Price is unconscionably excessive. |
| k. | Sales Tax. All stated prices are
exclusive of any taxes, fees, duties, and levies, however designated or imposed, including, but not limited to value-added and withholding
taxes that are levied or based upon the amounts paid under the terms contained herein (collectively, “Taxes”). Any
Taxes related to the Products purchased pursuant to the terms contained herein are the responsibility of Customer (excluding taxes based
on HTWC’s net income) unless Customer presents an exemption certificate acceptable to HTWC and the applicable taxing authorities.
If possible, HTWC will bill Taxes as a separate item on the invoice presented to Customer. If any exemption certificate |
presented by Customer is held to be invalid,
then Customer will pay HTWC the amount of the Taxes and any penalties and interest related thereto within fifteen (15) business days of
the date Customer is notified by HTWC. Each of the Parties shall indemnify and hold the other Party harmless from and against any loss,
expense and increase in costs incurred by the other Party as a consequence of default on the part of the Party discharging its obligations
for payment of any taxes, customs duties, levies and other charges for which it is responsible under these the terms contained herein
and under law.
| 7. | Customer’s Authorization to Resell the Product;
Customer’s Sales Reporting; Insurance Billing. |
| a. | Limited Authorization to Resell the Product. Customer
acknowledges and agrees that World Reach Health, LLC (“WRH”) is currently the exclusive master distributor of the Product.
However, during the Term hereof, HTWC and WRH have agreed that Customer will be permitted, to resell the Products to third parties, in
accordance with the following terms and conditions(notwithstanding the foregoing, if during the Due Diligence Period Customer elects not
to proceed with the HTWC Option Agreement and the HLTT Option Agreement (either by way of Customer’s failure to enter into the HTWC
Option Agreement and/or the HLTT Option Agreement, or through the cancellation, termination or expiration of such agreements or the HTWC
Option and/or HLTT Option granted therein, or otherwise), then the Parties shall negotiate in good faith to terminate this Agreement and
simultaneously enter into a distribution agreement with WRH); in the event such distribution agreement is not entered into, this Agreement
shall remain in full force and effect for the duration of the Term): |
| i. | Customer does not sell the Product to any current Customer
of WRH (Customer shall coordinate with WRH to ensure no conflicts result on a case-by-case basis), and, conversely, WRH shall not attempt
to sell directly to any customer of Customer; |
| ii. | Customer conforms with and adheres to WRH’s code
of conduct; |
| iii. | Customer, at its discretion, may have HTWC drop-ship
the Product to each end-user so that the Parties can ensure all requisite packaging enclosures are included (e.g., IFU, Packing Slip,
etc.); |
| iv. | Customer shall not sell the Product to any end user for
a rate, which would be less than Seven Hundred Twenty-Five Dollars ($725.00 USD) per centimeter squared, or such other averages sales
price (“ASP”) attributable to the Product, as notified to Customer by HTWC from time to time, without the express written
consent of HTWC on a case-by-case basis; |
| 1. | Customer shall inform all end-users who submit the Product
for insurance reimbursement to bill the Product at the then-applicable reimbursement rate or ASP; |
| v. | Customer shall not attempt to white label the Product
or alter the Product labeling or packaging in any capacity; |
| vi. | Customer shall only use marketing and promotional materials,
which have been pre-approved by HTWC's regulatory and compliance personnel; |
| 1. | shall enforce Customer’s own terms and conditions
of sale with each applicable end-user; |
| 2. | shall resell the Products in compliance with all applicable
federal and state laws and regulations, as well as all compliance guidance published by federal or state agencies, including, without
limitation, the Medicare and Medicaid anti-kickback law, the Stark self-referral prohibition, and compliance guidance published by the
Office of the Inspector General of the Department of Health and Human Service. Customer acknowledges that Customer understands these requirements
and shall remain educated and informed regarding the applicable federal and state laws and regulations, as well as all compliance guidance
published by federal or state agencies, that pertain to Customer’s resale of the Product. In the event Customer knows that any activities
of any agent or affiliate of Customer implicates any such requirements or guidance, Customer shall immediately inform HTWC; |
| 3. | shall not provide any entertainment, gifts, or other
benefits for end-user outside of the written guidelines established by HTWC which shall be provided to Customer by HTWC and/or in violation
of applicable law and/or regulation, without the prior written consent of HTWC; |
| 4. | shall not fund continuing education, grants or other
benefits for any end-users, including, without limitation, payment of any end-user’s rent and/or payment to any relative of an end-user,
without the prior written consent of the Company; |
| 5. | represents and warrants that no personnel member of Customer
who will be associated with the resale of the Product has been convicted of any criminal offense related to healthcare, |
or been debarred, sanctioned, excluded or
otherwise made ineligible for participation in a federal or state health care program by any federal or state agency. In the event any
such personnel or affiliated parties have been convicted of a criminal offense, or debarred, sanctioned, excluded or otherwise made ineligible
for participation, or are threatened with any of the foregoing sanctions, Customer shall immediately notify HTWC; and
| 6. | Customer will not provide any coding or billing advice
to any end-user as part of Customer’s resale of the Product, except for any coding or billing information provided by HTWC. |
| viii. | Customer shall not sell the Products outside of the United
States, Canada or Mexico. |
| ix. | Customer will not, without HTWC’s
prior written consent, use any trademark or trade name of HTWC, HLTT and/or WRH in connection with any of the Products, other than with
respect to the resale of the Products pre-marked or packaged by or on behalf of HTWC. |
| b. | FDA/AATB-Required Record Keeping. Customer will
keep or cause to be kept in accordance with FDA and/or The American Association of Tissue Banks (the “AATB”), and shall
share such records with HTWC, regulatory requirements books and records regarding the purchases and sales of FDA-approved Products pursuant
to this Agreement. All tissue utilization records will be returned to HTWC. Further, to the extent, and only to the extent required by
law, until the expiration of four (4) years after the furnishing of the Products and services provided pursuant to this Agreement, Customer
will make available to HTWC, and, if applicable, Customer will make available to the Secretary of the U.S. Department of Health and Human
Services, the U.S. Comptroller General, and their representatives, the terms contained herein and all books, documents and records necessary
to certify the nature and extent of the costs of any Products or services provided hereunder. |
| 8. | Certain Obligations of HTWC. |
| i. | HTWC shall meet or exceed all FDA-requirements for the
Product. |
| ii. | HTWC shall provide commercially reasonable support as
requested by Customer to address and correct quality concerns. |
| iii. | HTWC shall meet or exceed any FDA, TRG and/or Q-Code
and other relevant quality system standards applicable to the manufacturing of the Product. |
| b. | Maintenance of Equipment. Unless otherwise agreed
to by Customer in writing, HTWC, at its sole expense, shall furnish, keep in good condition, and replace when necessary, all equipment
and other items necessary for the production of the Product. |
| c. | Prohibited Acts. HTWC shall not: |
| i. | take any action that interferes with or challenges Customer’s
intellectual property rights, including Customer’s ownership or exercise thereof; or |
| ii. | alter, obscure, or remove any of Customer’s trademark
or copyright notices or any other proprietary rights notices placed on the Product purchased under this Agreement (including Products),
marketing materials or other materials. |
| a. | Compliance. HTWC shall at all times comply with
all applicable laws related HTWC’s performance of its obligations hereunder. Without limiting the foregoing, HTWC shall ensure the
Products and any related packaging conform fully to any applicable law. HTWC shall manufacture the Product in accordance with all applicable
FDA, TRG and/or Q-Code specifications and shall also maintain effective quality systems that minimize the potential for product quality,
regulatory and compliance issues. |
| b. | Permits, Licenses, and Authorizations. HTWC shall
obtain and maintain all permits necessary for the exercise of its rights and performance of HTWC’s obligations under this Agreement,
including any permits required for the import of Products or any raw materials and other manufacturing parts used in the production and
manufacture of the Product, and the shipment of hazardous materials, as applicable. |
| 10. | Representations and Warranties; Product Warranty. |
| a. | HTWC’s Representations and Warranties. HTWC
represents and warrants to Customer that, as of the date hereof: |
| i. | it is a corporation, duly organized, validly existing
and in good standing under the laws of Delaware; |
| ii. | it is duly qualified to do business and is in good standing
in every jurisdiction in which such qualification is required for purposes of this Agreement, including, without limitation, the State
of Utah; |
| iii. | it has the full right, power, and authority to enter
into this Agreement and to perform its obligations hereunder; |
| iv. | the execution of this Agreement by its representative
whose signature is set forth at the end of this Agreement and the delivery of this Agreement by HTWC, have been duly authorized by all
necessary action on the part of HTWC; |
| v. | HTWC hasall applicable permits and/or licenses to manufacture
the Product; |
| vi. | that HTWC’s manufacture of the Product does not
knowingly violate and/or infringe upon any patent, copyright or trademark laws and/or rights of any third parties[1]; |
| vii. | the Product Q-Code is billable in accordance with Medicare
Part B, as well as certain private insurances, and reimbursable at the price of the then published Medicare Part B Rate Schedule; and |
| viii. | that HTWC’s execution and delivery of this Agreement
does not and will not knowingly conflict with or result in a breach by HTWC of any of the terms or provisions of, or constitute a default
under (x) the certificate of formation or by-laws of HTWC, each as currently in effect, (y) any other material agreement to which HTWC
is a party, or (z) to HTWC’s knowledge, any existing applicable law, rule or regulation or any applicable decree, judgment or order
of any court, United States federal or state regulatory body, administrative agency, or other governmental body having jurisdiction over
HTWC, except for such conflict, breach or default, which would not have or result in a material adverse effect to HTWC. |
| b. | Customer’s Representations and Warranties.
Customer represents and warrants to HTWC that: |
| i. | it is a limited liability company, duly organized, validly
existing and in good standing under the laws of Delaware; |
[1]
Customer acknowledges and agrees that HTWC has made agreements with a third party who
is the trademark owner of a similarly competitive product brand named “AmnioBand” to cease utilizing the name “AmnioBind.”
Said third party is aware that HTWC has applied to the FDA/TRG for a name change to “DermaBind,” which is pending. HTWC has
the right to continue using the name "AmnioBind" during this interim change period without issue per agreement of the parties.
HTWC anticipates the name change to DermaBind to be approved by the applicable regulatory parties in or around October 2023.
| ii. | it is duly qualified to do business and is in good standing
in every jurisdiction in which such qualification is required for purposes of this Agreement; |
| iii. | it has the full right, power, and authority to enter
into this Agreement and to perform its obligations hereunder; |
| iv. | the execution of this Agreement by its representative
whose signature is set forth at the end of this Agreement and the delivery of this Agreement by Customer, have been duly authorized by
all necessary action on the part of Customer; |
| v. | it has received a copy of the instructions for use (“IFU”)
applicable to the Product, and shall not use the Product, except in accordance with the IFU; |
| vi. | it has sufficient financing and/or available cash on
hand to timely pay HTWC the Equipment Financing and the Manufacturing Fee and all other amounts that may become due under this Agreement.
Further, HTWC, during the Term of this Agreement, may require Customer to provide adequate assurances (“Adequate Assurances”)
of Customer’s available financing. In the event that Customer defaults on any amounts owed to HTWC hereunder, and HTWC requests
Adequate Assurances from Customer, and Customer fails to provide HTWC with such Adequate Assurances within ten (10) business days, HTWC
may (a) withhold or suspend its obligations, including the obligations to deliver the Product and/or continue manufacturing the Product
in accordance with this Agreement (b) if applicable, proceed against Customer for damages occasioned by Customer’s failure to perform,
and/or (c) exercise its termination rights in accordance with this Agreement. |
| c. | Product Warranty. HTWC warrants to Customer (the
“Product Warranty”) that: |
| i. | Limited Warranty for Tissue Products. The Products
shall be manufactured in accordance with all applicable FDA, TRG and/or Q-Code specifications, and shall be subject to a one (1) year
warranty after shipment (prior to application on any patient) that each amnion-based Products have been collected, processed and stored
in compliance with all applicable laws and standards, FDA, TRG and/or Q-Code specifications, including the AATB Standards and Title 21,
Code of Federal Regulations 1271, Human Cells, Tissues and Cellular and Tissue-Based Products, and has a shelf-life of at least three
(3) years from the date the Product was manufactured (the “Shelf-Life”). Commencing as of the third (3rd)
monthly anniversary of the Effective |
Date of this Agreement, all Products provided
to Customer hereunder shall have not less than at least twenty-four (24) months remaining of the Shelf-Life (Products provided during
the first sixty (60) days of this Agreement may have a Shelf-Life less than twenty-four (24) months, but will be at least twelve (12)
months);
| 1. | the Product will conform, in all material respects, to
the applicable FDA, TRG and/or Q-Code specifications, standards, quality and performance requirements and be free from defects in material
and workmanship; |
| 2. | HTWC’s manufacturing of the Product, including
its processes and/or technical data, and the Product’s packaging, does not knowingly violate or infringe upon any patent, copyright
or trademark laws and/or rights of any third parties; |
| 3. | each Product will be new and conveyed by HTWC to Customer
with good title, free and clear of all encumbrances; |
| 4. | HTWC hereby warrants to Customer, for period of twelve
(12) months after the date of delivery of the specific Product, that the Product shall (x) comply with and perform in accordance with
HTWC’s written specifications for the Product and (y) be produced, labeled and packaged in compliance with all applicable United
States laws and regulations in effect at the date of delivery of the Product to Customer. Customer’s exclusive remedy and HTWC’s
sole liability under this warranty shall be to replace any Non-Conforming Product, or, at HTWC’s sole discretion, to refund the
purchase price paid therefor(including any shipping charges incurred); |
| 5. | the above warranties do not apply to any Product which
has, due to reasons beyond HTWC’s reasonable control (a) been subjected to abuse, misuse, accident, or mishandling, (b) been modified
or altered other than in the ordinary course of its intended use, (c) been used for or subjected to applications, environments, or stress
or conditions other than as intended and recommended by HTWC, (d) been improperly stored, transported, installed, or used, (e) been used
for any use not approved by the Food and Drug Administration and not specified on the Product's label or otherwise permitted under applicable
law, or (f) had its serial number or other identification markings altered or removed; |
| 6. | THE WARRANTIES SET FORTH IN THIS SECTION 10(c) ARE
THE ONLY WARRANTIES GIVEN BY HTWC WITH RESPECT |
TO THE PRODUCTS AND ARE GIVEN IN LIEU OF
ANY AND ALL OTHER WARRANTIES, WHETHER EXPRESS, IMPLIED, STATUTORY, OR ARISING BY CUSTOM, TRADE USAGE, OR COURSE OF DEALING OR OTHERWISE,
AND HTWC HEREBY DISCLAIMS ANY AND ALL OTHER WARRANTIES TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW.
| d. | Withdrawal or Recall of Products. If HTWC or any
governmental authority determines that any Product sold to Customer is materially defective and a recall campaign is necessary, HTWC will
have the right to implement such recall campaign and will coordinate the return of defective Product by Customer to HTWC or order Customer
to destroy such recalled Product, as determined by HTWC in its reasonable discretion, at HTWC’s sole cost and risk. |
| i. | In the event that (A) the FDA and/or TRG issues a request,
directive or order that any Products be recalled, (B) a court of competent jurisdiction orders such a recall, or (C) HTWC reasonably determines,
after consultation with Customer, that any Products should be recalled, Customer shall cooperate with HTWC in effecting such recall as
HTWC may reasonably request. HTWC shall have administrative responsibility for effecting any such recall. |
| ii. | HTWC will be liable for all of Customer’s costs
associated with any recall campaign, including without limitation, if Customer does not elect to have the Product be exchanged, the price
paid for the Product, if such recall campaign is based upon a reasonable determination that the Product materially failed to conform to
the warranties set forth in this Agreement. |
| e. | DISCLAIMER OF OTHER REPRESENTATIONS AND WARRANTIES;
NON-RELIANCE. EXCEPT FOR THE PRODUCT WARRANTY SET FORTH IN SECTION 10(c): (i) NEITHER HTWC NOR ANY PERSON ON HTWC’S BEHALF HAS
MADE OR MAKES ANY EXPRESS OR IMPLIED REPRESENTATION OR WARRANTY WHATSOEVER, EITHER ORAL OR WRITTEN, INCLUDING ANY WARRANTIES OF MERCHANTABILITY,
WHETHER ARISING BY LAW, COURSE OF DEALING, COURSE OF PERFORMANCE, USAGE OF TRADE OR OTHERWISE, ALL OF WHICH ARE EXPRESSLY DISCLAIMED,
AND (ii) CUSTOMER ACKNOWLEDGES THAT IT HAS NOT RELIED UPON ANY REPRESENTATION OR WARRANTY MADE BY HTWC, OR ANY OTHER PERSON ON HTWC’S
BEHALF, EXCEPT AS SPECIFICALLY PROVIDED IN SECTIONS 9(a) and 9(c) OF THIS AGREEMENT. |
| a. | Indemnification by HTWC. HTWC shall indemnify,
defend and hold harmless Customer, its affiliates and their respective representatives, and its permitted successors and assigns (the
“Customer Indemnitees”), against any and all |
costs, losses, damages, liabilities and expenses
(including reasonable attorneys’ fees) (collectively, “Losses”) in connection with any and all actions, suits,
claims and demands (collectively, “Claims”) of third parties arising out of or related to (i) HTWC’s gross negligence
or intentionally wrongful acts or material omissions associated with HTWC’s manufacture and supply of the Product; (ii) any material,
uncured breach by HTWC of any of its representations, warranties or obligations under this Agreement; or (iii) any alleged patent infringement,
regardless of direct, contributory or inducement, by Customer, its affiliates or their respective representatives, as a result of the
performance of Customer’s obligations under this Agreement, except, in each case, to the extent such Claims arise out of any material
breach by Customer of any of its obligations under this Agreement, or are as a result of any gross negligence or intentionally wrongful
act or omission on the part of any Customer Indemnitees.
| b. | Indemnification by Customer. Customer shall
indemnify, defend and hold harmless HTWC, its affiliates and their respective representatives, and its permitted successors and assigns
(the “Manufacturer Indemnitees”), against any and all Losses in connection with any Claims of third parties arising
out of or related to (i) any breach by Customer of any of its representations, warranties, or obligations under this Agreement or (ii)
any gross negligence and/or intentionally wrongful acts or material omissions of Customer; except, in each case, to the extent such Claims
arise out of any material breach by HTWC of any of its obligations under this Agreement, or are as a result of any gross negligence or
intentionally wrongful act or omission on the part of any Manufacturer Indemnitees. |
| i. | A Party believing that it is entitled to indemnification
under Sections 11(a)-(b) (an “Indemnified Party”) shall give prompt written notification to the other Party (the “Indemnifying
Party”) of the commencement of any Claim by a Third Party for which indemnification may be sought or, if earlier, upon the assertion
of any such Claim by a third party (it being understood and agreed, however, that the failure by an Indemnified Party to give notice of
a third party Claim as provided in this Section 11(c)(i) shall not relieve the Indemnifying Party of its indemnification obligation under
this Agreement except and only to the extent that such Indemnifying Party is actually materially prejudiced as a result of such failure
to give notice). Within thirty (30) days after delivery of such notification, the Indemnifying Party may, upon written notice thereof
to the Indemnified Party, assume control of the defense of such Claim with counsel reasonably satisfactory to the Indemnified Party. If
a Party believes that a Claim presented to it for indemnification is one as to which the Party |
seeking indemnification is not entitled
to indemnification under Sections 11(a)-(b), it shall so notify the Party seeking indemnification.
| ii. | If the Indemnifying Party elects to assume the defense
of such Claim, the Indemnified Party may participate in such defense at its own expense; provided that if the Indemnified
Party reasonably concludes, based on advice from counsel, that the Indemnifying Party and the Indemnified Party have conflicting interests
with respect to such Claim, the Indemnifying Party shall be responsible for the reasonable fees and expenses of counsel to the Indemnified
Party solely in connection therewith |
| iii. | The Indemnifying Party shall keep the Indemnified Party
advised of the status of such Claim and the defense thereof and shall consider recommendations made by the Indemnified Party with respect
thereto. |
| iv. | The Indemnified Party shall not agree to any settlement
of such Claim without the prior written consent of the Indemnifying Party, which shall not be unreasonably withheld, conditioned or delayed.
The Indemnifying Party shall not agree to any settlement of such Claim or consent to any judgment in respect thereof that does not include
a complete and unconditional release of the Indemnified Party from all liability with respect thereto or that imposes any liability or
obligation on the Indemnified Party or adversely affects the Indemnified Party without the prior written consent of the Indemnified Party,
which shall not be unreasonably withheld, conditioned or delayed. |
| d. | Insurance Requirements. Each Party agrees to obtain
and maintain, during the Term and for two (2) years after the Term, commercial general liability insurance, including products liability
insurance, with minimum “A-” AM Best rated insurance carriers, in each case with limits of not less than one million dollars
($1,000,000) per occurrence and in the aggregate. All deductibles/retentions will be the responsibility of the named insured. To the extent
of its culpability, all coverages of HTWC will be primary and non-contributing with any similar insurance carried by Customer. Notwithstanding
any provision of this Section 11(d) to the contrary, Customer may meet its obligations under this Section 11(d) through self-insurance.
Neither Party’s insurance will be construed to create a limit of liability with respect to its indemnification obligations under
Sections 11(a)-(b). |
| e. | Exceptions and Limitations on Indemnification/Liability.
EXCEPT (i) FOR CLAIMS FOR WHICH A PARTY HAS AN INDEMNIFICATION OBLIGATION UNDER SECTION 11(a) or (b), (ii) FOR A BREACH OF A PARTY’S
OBLIGATIONS IN SECTION 12 HEREIN, (iii) IN THE CASE OF A PARTY’S FRAUD OR WILLFUL MISCONDUCT OR GROSS NEGLIGENCE, AND (iv) CUSTOMER’S
PAYMENT OBLIGATIONS UNDER THIS AGREEMENT, NEITHER PARTY, NOR ANY OF ITS |
AFFILIATES, SHALL BE LIABLE TO THE OTHER
PARTY, OR ANY OF ITS AFFILIATES, FOR ANY SPECIAL, PUNITIVE, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING LOST PROFITS, LOST
REVENUES OR PENALTIES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES.
| 12. | Confidentiality; Publicity. |
| a. | Confidentiality. Except to the extent expressly
authorized by this Agreement or otherwise agreed in writing, the Parties agree that, for the term of this Agreement and for three (3)
years thereafter, each Party (the “Receiving Party”), receiving any Confidential Information of the other Party (the
“Disclosing Party”) hereunder shall keep such Confidential Information confidential and shall not publish or otherwise
disclose or use such Confidential Information for any purpose other than as provided for in this Agreement. “Confidential Information
means any technical, scientific, regulatory, commercial, business or other information provided by or on behalf of the Disclosing Party
to the Receiving Party pursuant to this Agreement or otherwise relating to or disclosed during any transaction contemplated hereby (including
information disclosed prior to the Effective Date under a confidentiality agreement in contemplation of this Agreement), including information
relating to the terms of this Agreement or the Product, and the scientific, regulatory or business affairs or other activities of either
Party; provided that, Confidential Information shall not include any information that the Receiving Party can establish: |
| i. | was already known to the Receiving Party (other than
under an obligation of confidentiality), at the time of disclosure by the Disclosing Party and such Receiving Party has documentary evidence
to that effect; |
| ii. | was generally available to the public or otherwise part
of the public domain at the time of its disclosure to the Receiving Party; |
| iii. | became generally available to the public or otherwise
part of the public domain after its disclosure or development, as the case may be, and other than through any act or omission of a Party
in breach of this confidentiality obligation; |
| iv. | was disclosed to that Party, other than under an obligation
of confidentiality, by a Third Party who had no obligation, directly or indirectly, to the Disclosing Party, not to disclose such information
to others; or |
| v. | was independently discovered or developed by or on behalf
of the Receiving Party without the use of the Confidential Information belonging to the other Party and the Receiving Party has documentary
evidence to that effect. |
| b. | Authorized Use and Disclosure. |
| i. | Disclosure. Notwithstanding the foregoing
Section 12(a), each Party may disclose to Third Parties Confidential Information belonging to the other Party to the extent such disclosure
is reasonably necessary to: |
| 1. | Prosecute or defend litigation; |
| 2. | exercise or enforce rights hereunder; provided that
such disclosure is covered by terms of confidentiality no less stringent than those set forth herein, and |
| 3. | comply with inquires by a Governmental Authority or subpoena
issued by a Governmental Authority or a court of competent jurisdiction. |
In the event a Party shall deem it necessary to
disclose pursuant to this Section 11(b) Confidential Information belonging to the other Party, the Disclosing Party shall to the extent
possible give reasonable advance notice of such disclosure to the other Party and take reasonable measures to ensure confidential treatment
of such information.
| ii. | Use. Notwithstanding the foregoing Section 11(a),
during the Term, each Party shall have the right to use the other Party’s Confidential Information in carrying out its respective
responsibilities under this Agreement. |
| c. | Certain Regulatory Filings. Either Party may disclose
the terms of this Agreement to the extent required, in the reasonable opinion of such Party’s legal counsel, to comply with applicable
laws, including the rules and regulations promulgated by the United States Securities and Exchange Commission or by any stock exchange
or regulatory body to which the Party is subject. Before disclosing this Agreement or any of the terms hereof pursuant to this Section
11(c), the Parties will consult with one another regarding the terms in this Agreement to be redacted in making any such disclosure. If
a Party discloses this Agreement or any of the terms hereof in accordance with this Section 11(c), such Party agrees, at its own expense,
to seek confidential treatment of portions of this Agreement or such terms, as may be reasonably requested by the other Party. |
| d. | Public Announcements. Neither Party shall issue
any news release or other public announcement relating to this Agreement, including any of its terms, or to the performance of either
Party hereunder, without the prior written approval of the other Party; provided that nothing in this Agreement shall
prohibit HTWC from making required disclosures or filings required by applicable law or by the rules and regulations of any securities
exchange. Once the text or substance of any announcement has been so approved, it may be repeated without further approval. |
| e. | Use of Names. Except as described in this Agreement
and as may be required by applicable law, neither Party shall distribute or have distributed any publicity or information which bears
the name of the other without the prior written approval of the other. |
| i. | Restriction on Name Usage. At all times during
the Term of this Agreement, and in perpetuity thereafter, Customer shall be prohibited from using any of the following trade names, or
any combination(s) thereof, in any capacity, without the express written consent of HTWC (provided, however, that Customer shall not be
restricted from the following trade names with respect to the resale of the Products pre-marked or packaged
by or on behalf of HTWC): |
| 1. | “Healthtech Wound Care”; |
| 6. | “World Reach Health”; and/or |
| 13. | Tooling, Equipment and Materials. Subject to the mutual written
consent of te Parties, if applicable, HTWC will be reimbursed, at cost, for any specially-required equipment and/or fixtures (collectively,
“Tooling”) and improvements to equipment and Tooling purchased by HTWC needed for or used in the production of the
Product (“Product Tooling”) and/or to perform HTWC’s obligations to Customer. HTWC will be responsible for normal
maintenance of Customer’s Tooling and equipment in its possession. Equipment and Tooling paid for by Customer remains the property
of HTWC. Expenditures greater that Five Thousand Dollars ($5,000 USD) (hereinafter “Substantive Expenditures”) within
any ninety (90) day period for Tooling or equipment will be made only with the prior written authorization of Customer. Any |
Tooling or equipment requiring Substantive
Expenditures for third party calibration or refurbishment will require Customer’s pre-approval and will be the financial responsibility
of Customer if approved. In the event HTWC is required to make a prepayment on Tooling or equipment, Customer will reimburse HTWC at the
time the prepayment is made.
| 14. | HTWC’s Ownership. Unless and until the HTWC Option
Agreement and the HLTT Option Agreement are fully exercised and all amounts due to HTWC and/or HLTT thereunder are satisfied, HTWC, HLTT
and/or their affiliated entities, shall exclusively own all right, title and interest in and to and all patents, copyrights, trademarks,
mask works, manufacturing data and/or processes, trade secrets and other intellectual property rights (the “Intellectual Property
Rights”) related to: |
| b. | all manufacturing processes, know-how and other information
and materials provided by HTWC to Customer before and after the Effective Date of this Agreement (the “Information”),
including Information to design, manufacture or test of the Products; |
| c. | any Product Tooling purchased by HTWC; |
| d. | any inventions, ideas, discoveries,
modifications, enhancements, improvements or derivative works conceived, made, created, developed or reduced to practice by HTWC, solely
or jointly, or in whole or in part, during the Term of this Agreement that relate to the Product, Information or Product Tooling, or to
any services provided under this Agreement (“Assigned Inventions”). |
| e. | HTWC shall exclusively own all
right, title and interest in and to, and all Intellectual Property Rights related to: |
| i. | all know-how, technology, processes,
procedures, ideas and concepts developed by HTWC for manufacturing products (“Manufacturer Processes”); |
| ii. | any modifications, enhancements, and improvements to
the Manufacturer Processes created by HTWC during the Term of this Agreement; and |
| iii. | any non-Product specific Tooling created by HTWC during
the Term of this Agreement ((i), (ii), and (iii) collectively, “Manufacturer Rights”). |
| 15. | Restrictive Covenants. |
| a. | Customer and HTWC Restrictions. During the Term,
and for a period of twelve (12) months following the last date of the Term hereof (the “Restricted Period”), Customer,
nor its directors, officers, members, managers, shareholders, parents, subsidiaries and/or affiliated entities shall own, operate and/or
enter into a contract manufacturing arrangement with any other third-party for similarly competitive products without the express written
consent of HTWC, which shall not be unreasonably withheld or delayed, nor shall Customer, or any of Customer’s members/shareholders
owning ten percent (10%) or more of Customer, own or operate a similarly competitive company to that of HTWC. Conversely, in the event
Customer exercises Customer’s rights pursuant to the HTWC Option Agreement and the HLTT Option
Agreement and pays all amounts due to HTWC and HLTT thereunder, the Restricted Period shall no longer be of force or effect for
the Customer; however, for a period of twelve (12) months following the final payment of the HTWC Asset Purchase Price and the HLTT Purchase
Price (the “Seller Restricted Period”), HTWC, HLTT, and WRH, nor its directors, officers, members, managers, shareholders,
parents, subsidiaries and/or affiliated entities shall own, operate and/or enter into a contract manufacturing arrangement with any other
third-party for similarly competitive products without the express written consent of Customer, which shall not be unreasonably conditioned,
withheld or delayed, nor shall HTWC, HLTT, and WRH, or any of HTWC, HLTT, and WRH’s members/shareholders owning ten percent (10%)
or more of HTWC, HLTT, or WRH, own or operate a similarly competitive company. |
| b. | Non-Solicitation of Personnel; Non-Interference.
During the Term hereof, and for a period of twelve (12) months following the effective date of termination (the “Non-Solicitation
Period”), unless otherwise later agreed to in writing between the Parties, neither Party shall, either directly or indirectly,
alone or in combination with any other Person (defined below): |
| i. | solicit in any capacity (whether as an employee, consultant,
owner, member, independent contractor or otherwise any employee, who was employed within twelve (12) months of the effective date of termination
of this Agreement, of either Party; and/or |
| ii. | interfere with, alter or attempt to interfere with or
alter, any relationship between the other Party and any person referred to in Section 15(b)(i). |
| a. | No Right to Contract. The Parties hereby acknowledge
and agree that neither Party shall have any consent or authorization of the other Party to contract for the purchase or rental of any
article or material, or, make any commitment |
and/or agreements whereby the other Party
will be required to pay money or other consideration, or which will otherwise obligate the other Party, unless otherwise later agreed
to in writing between the Parties.
| b. | Further Assurances. Upon a Party’s reasonable
request, the other Party shall, at its sole cost and expense, execute and deliver all such further documents and instruments, and take
all such further acts, necessary to give full effect to this Agreement. |
| c. | Relationship of the Parties. The relationship
between HTWC and Customer is solely that of vendor and vendee and they are independent contracting parties. Nothing in this Agreement
creates any agency, joint venture, partnership or other form of joint enterprise, employment, or fiduciary relationship between the Parties.
Neither Party has any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other
Party or to bind the other Party to any contract, agreement or undertaking with any third party. |
| d. | Confidentiality of this Agreement. The terms of
this Agreement may not be revealed by the Parties to any third party (except to each of the Parties’ agent(s), attorney(s), accountant(s)
and manager(s), each of whom will observe confidentiality, or if legally required to do so by statute, regulation, judicial or governmental
order or by deposition, interrogatory, request for documents, subpoena, civil investigative demand or similar process in a judicial or
governmental proceeding or in connection with legal action or arbitration to enforce this Agreement). |
| e. | Entire Agreement. This Agreement, including and
together with any related exhibits, schedules, and the applicable terms of any purchase orders and/or shipping instructions, constitutes
the sole and entire understanding and agreement of the Parties with respect to the subject matter contained herein and therein, and supersedes
all prior and contemporaneous understandings, agreements, proposals, discussions, representations, and warranties, both written and oral,
with respect to such subject matter. If there is a conflict between the terms of this Agreement and of any exhibit, schedules or purchase
orders, the terms of this Agreement shall govern. |
| f. | Notices. All notices, requests, consents, claims,
demands, waivers, and other communications under this Agreement (each, a “Notice”) must be in writing and addressed
to the other Party at its address set forth below (or to such other address that the receiving Party may designate from time to time in
accordance with this section). All Notices must be delivered by personal delivery, nationally recognized overnight courier or certified
or registered mail (in each case, return receipt requested, postage prepaid) or email (with confirmation of transmission). Except as otherwise
provided in this Agreement, a Notice is effective only (a) on receipt by the receiving Party, and |
(b) if the Party giving the Notice has complied
with the requirements of this Section.
| g. | Interpretation. The Parties drafted this Agreement
without regard to any presumption or rule requiring construction or interpretation against the Party drafting an instrument or causing
any instrument to be drafted. The exhibits, schedules, and attachments referred to herein are an integral part of this Agreement to the
same extent as if they were set forth verbatim herein. |
| h. | Headings. The headings in this Agreement are for
reference only and do not affect the interpretation of this Agreement. |
| i. | Severability. If any term or provision of this
Agreement is held void, voidable, invalid, illegal, or unenforceable in any jurisdiction, no other provision of this Agreement shall be
affected as a result thereof, and the remaining provisions of this Agreement shall be valid and remain in full force and effect as if
such void, voidable, invalid, illegal, or unenforceable provision had been omitted. |
| j. | Amendment and Modification. No amendment, change,
modification, alteration, addition to, rescission, termination or discharge of this Agreement is effective unless it is in writing and
signed by authorized representatives of both Parties. |
| k. | Waiver. None of the terms of this Agreement
may be waived, in whole or in part, unless such waiver is in writing and signed by an authorized representative of both Parties. Any waiver
authorized on one occasion is effective only in that instance and only for the purpose stated and does not operate as a waiver on any
future occasion or any other provision of the Agreement. Any course of dealing between the Parties or failure or delay in exercising any
right, remedy, power, or privilege or in enforcing any condition under this Agreement shall not constitute a waiver or estoppel of any
right, remedy, power, privilege, or condition arising from this Agreement. |
| l. | Assignment. This Agreement may not be assigned
or otherwise transferred, nor may any right or obligation hereunder be assigned or transferred, by either Party without the prior written
consent of the other Party. Notwithstanding the foregoing, either Party may, without consent of the other Party, assign this Agreement
and its rights and obligations hereunder in whole or in part to an Affiliate of such Party, or in whole to its successor in interest in
connection with the sale of all or substantially all of its stock or its assets to which this Agreement relates, or in connection with
a merger, acquisition or similar transaction. Any attempted assignment not in accordance with the foregoing shall be null and void and
of no legal effect. Any permitted assignee shall assume all assigned obligations of its assignor under this Agreement. The terms
and conditions of this Agreement shall be binding upon, and shall inure |
to the benefit of, the Parties and their
respected successors and permitted assigns.
| m. | Successors and Assigns. This Agreement is binding
on and inures to the benefit of the Parties and their respective permitted successors and permitted assigns. |
| n. | No Third-Party Beneficiaries. Unless otherwise
expressly provided for in writing, nothing in this Agreement is intended or will be construed to give any person or entity, other than
each Party hereto, and their successors or assigns, any legal or equitable right, remedy, or claim under or with respect to this Agreement
or any provisions contained herein. |
| o. | Survivability. Terms and conditions that require
performance after the termination or expiration of this Agreement, including without limitation, use restrictions, limitations of liability,
indemnification, and confidentiality provisions, will survive any termination or expiration of this Agreement. |
| p. | Governing Law, Venue and Remedies. All questions
concerning the construction, validity, enforcement, and interpretation of this Agreement shall be governed by and construed and enforced
in accordance with the internal laws of the State of Utah, without regard to the principles of conflicts of law thereof. If any dispute
should arise between the Parties that cannot be resolved informally, it shall be settled by arbitration in a mutually approved office
of the American Arbitration Association before an arbitrator designated by the American Arbitration Association in accordance with the
Rules of the American Arbitration Association then effective in Utah. However, in the event the Parties are unable to mutually approve
a location for the arbitration, is shall take place by default in Salt Lake City, Utah. Subject to the arbitrator’s award, the cost
of any arbitration proceedings and the prevailing Party’s reasonable, outside attorneys’ fees shall be borne by the Party
against whom an award is made. The decision of the arbitrators shall be binding and conclusive upon the Parties. If the American Arbitration
Association shall not then be in existence, arbitration shall be settled by such other organization, if any, as shall then have become
the successor of said Association. |
| q. | Waiver of Jury Trial. EACH PARTY ACKNOWLEDGES
AND AGREES THAT ANY CONTROVERSY THAT MAY ARISE OUT OF OR RELATE TO THIS AGREEMENT IS LIKELY TO INVOLVE COMPLICATED AND DIFFICULT ISSUES
AND, THEREFORE, EACH SUCH PARTY IRREVOCABLY AND UNCONDITIONALLY WAIVES ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN RESPECT OF ANY LEGAL
ACTION ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY. Each Party certifies and acknowledges that
(a) no representative of the other Party has represented, expressly or otherwise, that such other Party would not seek to enforce the
foregoing waiver in the event of a legal action, (b) such Party has considered |
the implications of this waiver, (c) such
Party made this waiver voluntarily, and (d) such Party has been induced to enter into this Agreement by, among other things, the mutual
waivers and certifications in this Section.
| r. | Attorneys’ Fees. In the event that either
Party employs attorneys to enforce any right arising out of or relating to this Agreement, the prevailing Party shall be entitled to recover
its reasonable attorneys’ fees and costs. |
| s. | Force Majeure. No Party shall be liable or responsible
to the other Party, nor be deemed to have defaulted under or breached this Agreement, for any failure or delay in fulfilling or performing
any term of this Agreement, when and to the extent such party’s (the “Impacted Party”) failure or delay is caused
by or results from the following force majeure events (“Force Majeure Event(s)”): acts of God, flood, fire, earthquake,
hurricane, tornado, epidemic, pandemic, explosion, war, terrorism, riot, government order or action. The Impacted Party shall give notice
to the other Party as soon as practicable, stating the period of time the occurrence is expected to continue. The Impacted Party shall
use diligent efforts to end the failure or delay and ensure the effects of such Force Majeure Event are minimized. The Impacted Party
shall resume the performance of its obligations as soon as reasonably practicable after the removal of the cause. Notwithstanding the
forgoing, the other Party may terminate this Agreement upon written notice if the Impacted Party’s nonperformance continues for
a period of ninety (90) consecutive days. |
| t. | Counterparts. This Agreement may be executed in
counterparts, each of which is deemed an original, but all of which together is deemed to be one and the same agreement. A signed copy
of this Agreement delivered by facsimile, e-mail or other means of electronic transmission is deemed to have the same legal effect as
delivery of an original signed copy of this Agreement. |
SIGNATURE PAGE FOLLOWS
THE REMAINDER OF THIS PAGE IS INTENTIONALLY LEFT BLANK
SIGNATURE PAGE TO THE
MANUFACTURING AGREEMENT DATED AUGUST 18, 2023
BETWEEN
HEALTHTECH WOUND CARE, INC.
AND
HLLT ACQUIRED, LLC
IN WITNESS WHEREOF,
the Parties hereto have executed this Agreement as of the Effective Date.
HTWC:
Healthtech Wound Care, Inc.
/s/ Jelena Olmstead |
|
By: Jelena Olmstead
Its: Authorized Signatory |
8/18/2023
Date |
|
|
/s/ Jim Pesoli
By: Jim Pesoli
Its: Authorized Signatory
|
8/18/2023
Date |
|
|
CUSTOMER:
|
|
HLLT Acquired, LLC
/s/ Zalman Schapiro
By: Zalman Schapiro
Its: Authorized Signatory
|
8/18/2023
Date |
EXHIBIT A
PRODUCT SCHEDULE
*See Attached
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HealthTech Solutions (CE) (USOTC:HLTT)
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