Document:

fzmd-ex1043_99.htm

EXHIBIT 10.43

Dated 29/3/18

 

Distributorship agreement

between

Signature Orthopaedics Pty Ltd

And

CPM Medical Consultants LLC

 

 

 

EXHIBIT 10.43

THIS AGREEMENT is dated

Parties

	
(1)
	
Signature Orthopaedics Pty Ltd (ACN 106 702 416) , 7 Sirius Road, Lane Cove, NSW

	
(2)
	
CPM Medical Consultants, LLC of 1565N. Central Expressway, Suite 200, Dallas, TX 75080.

Background

The Supplier wishes to appoint the Distributor as its non-exclusive distributor for the promotion and sale of the Products within the Territory (both as defined below), and the Distributor wishes to promote and sell the Products within the Territory on the terms of this agreement.

Agreed terms

	
1.
	
Definitions and interpretation

	
 
	
1.1
	
The definitions and rules of interpretation in this clause apply in this agreement.

Business Day: a day (other than a Saturday, Sunday or public holiday in Australia) when banks in Sydney are open for business.

Commencement Date: means the date of this agreement.

Control: the ability to direct the affairs of another person, whether by virtue of the ownership of shares, contract or otherwise.

Inactive Territories means a country in which the Distributor has not sold or supplied the Product during the Initial Term.

Initial Term has the meaning given to it in clause 12.1.

Products: As defined in Schedule 1 and includes any other products developed by the Supplier and which the Supplier may permit the Distributor, by express notice in writing, to distribute in the Territory.

Term: the term of this agreement, as determined in accordance with clause 11. Territory: means the territory specified in Schedule 2.

Trade Marks: the trade mark registrations listed in Schedule 3 and any further trade marks that the Supplier may permit, or procure permission for, the Distributor to use in the Territory in respect of the Products by express notice in writing.

GST: goods and services tax chargeable under the Goods and Services Tax Act and any similar replacement or additional tax or such other similar or analogous form of tax under the laws and regulations in the Territory.

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Year: the period of 12 months from the Commencement Date and each consecutive period of 12 months thereafter during the Term.

	
 
	
1.2
	
Clause, schedule and paragraph headings shall not affect the interpretation of this agreement.

	
 
	
1.3
	
A person includes a natural person, corporate or unincorporated body (whether or not having separate legal personality).

	
 
	
1.4
	
The Schedules form part of this agreement and shall have effect as if set out in full in the body of this agreement. Any reference to this agreement includes the Schedules.

	
 
	
1.5
	
A reference to a company shall include any company, corporation or other body corporate, wherever and however incorporated or established.

	
 
	
1.6
	
Words in the singular shall include the plural and vice versa.

	
 
	
1.7
	
A reference to one gender shall include a reference to the other genders.

	
 
	
1.8
	
A reference to any party shall include that party's personal representatives, successors or permitted assigns.

	
 
	
1.9
	
A reference to a statute, statutory provision or any subordinated legislation made under a statute is a reference to such statute, provision or subordinated legislation as amended or re-enacted from time to time, whether before or after the date of this agreement and in the case of a reference to a statute is also to all subordinate legislation made under that statute whether before or after the date of this agreement.

	
 
	
1.10
	
A reference to writing or written includes faxes and e-mail.

	
 
	
1.11
	
Documents in agreed form are documents in the form agreed by the parties and initialled by or on behalf of them for identification.

	
 
	
1.12
	
Any reference to a legal term for any action, remedy, method of judicial proceeding, legal document, legal status, court, official or any legal concept or thing shall, in respect of any jurisdiction other than Australia, be deemed to include a reference to what most nearly approximates to the Australian legal term in that jurisdiction.

	
 
	
1.13
	
A reference to a document is a reference to that document as varied or novated (in each case, other than in breach of the provisions of this agreement) at any time.

	
 
	
1.14
	
References to clauses and schedules are to the clauses and schedules of this agreement.

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1.15
	
Any phrase introduced by the terms including, include, in particular or any similar expression shall be construed as illustrative and shall not limit the sense of the words preceding those terms.

	
2.
	
Appointment

	
 
	
2.1
	
The Supplier appoints the Distributor as its non-exclusive distributor to distribute the Products in the Territory on the terms of this agreement.

	
 
	
2.2
	
Following the expiry of the Initial Term, the Supplier may amend the Territory to remove any Inactive Territories.

	
 
	
2.3
	
Notwithstanding 2.1 and 2.2, the Supplier may sell or supply the Products to end users within USA at anytime.

	
 
	
2.4
	
The Distributor shall not:

	
 
	
(a)
	
represent itself as an agent of the Supplier for any purpose; or

	
 
	
(b)
	
pledge the Supplier's credit; or

	
 
	
(c)
	
give any condition or warranty on the Supplier's behalf except for any warranty or guarantee which cannot be excluded under law; or

	
 
	
(d)
	
make any representation on the Supplier's behalf; or

	
 
	
(e)
	
commit the Supplier to any contracts; or

	
 
	
(f)
	
act as the agent or the buying agent, for any person for any goods which are competitive with the Product; or

	
 
	
(g)
	
retain any monies of the Supplier except on a trustee or fiduciary basis; or

	
 
	
(h)
	
knowingly make any false or misleading statement to any supplier or service provider, or to the Distributor or its business, about the Products or the liability of the Supplier for the cost of any goods or services supplied to the Distributor or its business; or

	
 
	
(i)
	
incur any liability or assume any obligation on behalf of the Supplier; or

	
 
	
2.5
	
The Distributor shall not without the Supplier's prior written consent make any promises or guarantees about the Products beyond those:

	
 
	
(a)
	
agreed between the Distributor and the Supplier; and

	
 
	
(b)
	
contained in any promotional material supplied by the Supplier.

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3.
	
Distributor's undertakings

The Distributor undertakes and agrees with the Supplier that at all times during the Term it will:

	
 
	
(a)
	
use all reasonable endeavours to promote the distribution and sale of the Products;

	
 
	
(b)
	
not use any promotional or advertising material for the Products not approved by the Supplier, such approval not be unreasonably withheld;

	
 
	
(c)
	
provide Yearly non-binding sales forecasts;

	
 
	
(d)
	
establish and maintain documented procedures for identifying the Products with a control number for traceability and copies of those records and procedures must be made available to the Supplier within thirty (30) days of request;

	
 
	
(e)
	
provide regular reports on the sales activities within the Territory;

	
 
	
(f)
	
employ a sufficient number of suitably qualified personnel to ensure the proper fulfilment of the Distributor's obligations under this agreement;

	
 
	
(g)
	
maintain, on its own account, an inventory of the Products at levels which are appropriate and adequate for the Distributor to meet all customer delivery requirements for the Products throughout the Territory;

	
 
	
(h)
	
keep full and proper books of account and records clearly showing all enquiries, quotations, transactions and proceedings relating to the Products;

	
 
	
(i)
	
allow the Supplier, on reasonable notice, access to its accounts and records relating to the sale or distribution of the Products for inspection but not more than once in each year. For clarity, the Supplier will not be permitted access to any accounts or records which do not directly relate to the sale or distribution of the Products;

	
 
	
(j)
	
comply with any reasonable directives or instructions given by the Supplier for any promotional activities, at the suppliers cost, concerning the nature, type, quality, characteristics, fitness for purpose, suitability, use and description of the Products;

	
4.
	
Supply of products

	
 
	
4.1
	
The parties acknowledge that:

	
 
	
(a)
	
the Supplier is the manufacturer of the Products; and

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(b)
	
the Supplier will have no obligation to separately supply the Products, except as otherwise provided for in this Agreement.

	
 
	
4.2
	
Supplier's undertakings

The Supplier undertakes to:

	
 
	
(a)
	
provide information and support that may reasonably be requested by the Distributor to enable it to discharge its duties under this agreement properly and efficiently; and

	
 
	
(b)
	
approve or reject any promotional information or material submitted by the Distributor within 28 days of receipt.

	
5.
	
Prices and payment

	
 
	
5.1
	
The prices to be paid by the Distributor to the Supplier for the Products are to be the Price, as set out in Schedule 4.

	
 
	
5.2
	
Any and all expenses, costs and charges incurred by the Distributor in the performance of its obligations under this agreement will be paid by the Distributor, unless the Supplier has expressly agreed in advance in writing to pay such expenses, costs and charges.

	
 
	
5.3
	
The Distributor must pay the full amount invoiced to it by the Supplier in USD$’s within thirty (45) days of the date of invoice.

	
 
	
5.4
	
Neither party may withhold payment of any amount due to the other because of any set-off, counter-claim, abatement, or other similar deduction.

	
6.
	
GST and taxes (Only Applicable to Australian companies)

	
 
	
6.1
	
All sums payable under this agreement, or otherwise payable by any party to any other party under this agreement are exclusive of any GST chargeable on the supplies for which such sums (or any part of them) are the whole or part of the consideration for GST purposes.

	
 
	
6.2
	
Where, under this agreement, any party makes a supply to any other party (Recipient) for GST purposes and GST is or becomes chargeable on that supply for which the supplying party is required to account to the relevant tax authority, the Recipient shall, subject to the receipt of a valid GST invoice, pay the supplying party (in addition to, and at the same time as, any other consideration for that supply) the amount of such GST.

	
 
	
6.3
	
Where any party is required by this agreement to reimburse or indemnify any other party for any cost or expense, that first party shall reimburse or indemnify the other party for the full amount of the cost or expense, including any GST on that amount, 

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except to the extent that the other party is entitled to credit or repayment for that GST from any relevant tax authority.

	
 
	
6.4
	
All import taxes, charges, levies, assessments and other fees of any kind imposed on the purchase or import of the Products shall be the responsibility of, and for the account of, the Distributor.

	
7.
	
Advertising and promotion

	
 
	
7.1
	
The Distributor shall:

	
 
	
(a)
	
cooperate with the Supplier in relation to the promotion and advertisement of the Products;

	
 
	
(b)
	
not make any written statement as to the quality or manufacture of the Products without the prior written approval of the Supplier; and

	
 
	
(c)
	
pays its own costs of advertising the Product except where there is any separate advertising campaign which the Supplier and the Distributor have agreed to fund jointly in any agreed proportion.

	
8.
	
Anti-bribery compliance

	
 
	
8.1
	
The Distributor shall:

	
 
	
(a)
	
comply with all applicable laws, statutes and regulations relating to anti-bribery and anti-corruption; and

	
 
	
(b)
	
not engage in any activity, practice or conduct which would constitute an offence.

	
9.
	
Trade marks and intellectual property

	
 
	
9.1
	
The Supplier hereby grants to the Distributor the non-exclusive right, in the Territory, to use the Trade Marks in the promotion, advertisement and sale of the Products, subject to, and for the duration of, this agreement.

	
 
	
9.2
	
The Distributor may sell and/or distribute the Products using the Trade Marks in conjunction with any trade marks owned or licensed by the Distributor.

	
 
	
9.3
	
All representations of the Trade Marks that the Distributor intends to use shall be submitted to the Supplier for approval before use.

	
 
	
9.4
	
Within limiting this clause 12, the Distributor shall be entitled to add a label to the Products it purchases to show that the products purchased are being distributed by the Distributor.

	
 
	
9.5
	
The Supplier represents and warrants that:

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(a)
	
Trade Marks; and

	
 
	
(b)
	
The Products, do not infringe any intellectual property rights of any third parties and the Supplier agrees to indemnify and hold harmless the Distributor against any clauses by a third party for infringement of intellectual property rights in relation to the Products or the Trade marks .

	
 
	
9.6
	
The Distributor shall not sub-license, transfer or otherwise deal with the rights of use of the Trade Marks granted under this agreement.

	
 
	
9.7
	
The Distributor shall not do, or omit to do, anything in its use of the Trade Marks that could adversely affect their validity or the goodwill of the Supplier.

	
 
	
9.8
	
The Distributor shall immediately enter into any document necessary for the recording, registration or safeguarding of the Supplier's Trade Mark rights with the Supplier for the marketing of the Products under the Trade Marks in a form satisfactory to the Supplier, at the suppliers cost.

	
 
	
9.9
	
Each party shall promptly give notice in writing to the other if it becomes aware of:

	
 
	
(a)
	
any infringement or suspected infringement of the Trade Marks or any other intellectual property rights relating to the Products within the Territory; or

	
 
	
(b)
	
any claim that any Product or the manufacture, use, sale or other disposal of any Product within the Territory, whether or not under the Trade Marks, infringes the rights of any third party,

	
 
	
9.10
	
In respect of any matter that falls within clause 9.9(a):

	
 
	
(a)
	
the Supplier shall in its absolute discretion, decide what action to take in respect of the matter (if any);

	
 
	
(b)
	
the Supplier shall conduct and have sole control over any consequent action that it deems necessary; and

	
 
	
(c)
	
the Supplier shall pay all costs in relation to that action and shall be entitled to all damages and other sums that may be paid or awarded as a result of that action.

	
 
	
9.11
	
In respect of any matter that falls within clause 9.9(b):

	
 
	
(a)
	
the Supplier and the Distributor shall agree:

	
 
	
(i)
	
what steps to take to prevent or terminate the infringement; and

	
 
	
(ii)
	
the proportions in which they shall share the cost of those steps and any damages and other sums which may be awarded to or against 

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them, being agreed between the parties that the Supplier shall hold Distributor harmless against any damages connected with any material or workmanship defect of the Products; and

	
 
	
(b)
	
failing agreement between the parties, either party may take any action as it considers necessary or appropriate, at its own expense, to defend the claim and shall be entitled to and responsible for all damages and other sums that may be recovered or awarded against it as a result of that action.

	
 
	
9.12
	
Each party shall, at the request and expense of the other, provide any reasonable assistance to the other (including the use of its name in, or being joined as a party to, proceedings) with any action to be taken by the other party under this clause 9, provided that that party is given such indemnity as it may reasonably require against any losses, costs and expenses it may incur as a result of or in connection with providing such assistance.

	
10.
	
Product liability and insurance

	
 
	
10.1
	
Subject to the Distributor fulfilling all the conditions in this clause 10, the Supplier shall indemnify the Distributor, defend and hold harmless against any liability incurred by the Distributor in respect of damage to property, death or personal injury arising from any fault or defect in the design of the Products and any reasonable costs, claims, demands and expenses, including reasonable attorneys' fees, arising out of or in connection with that liability (Relevant Claim), except to the extent the liability arises as a result of the wilful misconduct of the Distributor. The Supplier shall add the distributor to their current insurance certificate.

	
 
	
10.2
	
The Distributor shall, within five days of a matter which may result in a Relevant Claim:

	
 
	
(a)
	
give the Supplier written notice of the details of the matter;

	
 
	
(b)
	
give the Supplier access to and allow copies to be taken of any materials, records or documents as the Supplier may require to take action under clause 10.2(c);

	
 
	
(c)
	
allow the Supplier the exclusive conduct of any proceedings and take any action that the Supplier requires to defend or resist the matter, including using professional advisers nominated by the Supplier; and

	
 
	
(d)
	
not admit liability or settle the matter without the Supplier's written consent.

	
 
	
10.3
	
During the Term, the Supplier shall maintain product liability insurance with a reputable insurer of no less than AU$10 million for any one occurrence for any and all liability (however arising) for a claim that the Products are faulty or defective. The Supplier shall provide a copy of the insurance policy to the Distributor on request.

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10.4
	
The Distributor undertakes to maintain appropriate, up-to-date and accurate records to enable the immediate recall of any Products or batches of Products from the retail or wholesale markets. These records shall include records of deliveries to customers (including batch numbers, delivery date, name and address of customer, telephone number, fax number and e-mail address).

	
 
	
10.5
	
The Distributor shall, at the Supplier's cost, give any assistance that the Supplier shall reasonably require to recall, as a matter of urgency, Products from the retail or wholesale market.

	
11.
	
Duration and termination

	
 
	
11.1
	
This agreement begins on the Commencement Date and, subject to clause 11.2, shall continue for an initial term of one (1) years (Initial Term) and indefinitely after that until terminated by either party giving at least twelve (12) months' prior written notice to expire on or after the expiry date of the initial term.

	
 
	
11.2
	
Without affecting any other rights that it may be entitled to, either party may give notice in writing to the other terminating this agreement immediately if:

	
 
	
(a)
	
the other party fails to pay any amount due under this agreement on the due date for payment and remains in default not less than 14 days after being notified in writing to make such payment; or

	
 
	
(b)
	
the other party commits a material breach of any material term of this agreement and (if such breach is remediable) fails to remedy that breach within a period of 14 days of being notified in writing to do so; or

	
 
	
(c)
	
the other party repeatedly breaches any of the terms of this agreement in such a manner as to reasonably justify the opinion that its conduct is inconsistent with it having the intention or ability to give effect to the terms of this agreement; or

	
 
	
(d)
	
the other party suspends, or threatens to suspend, payment of its debts or is unable to pay its debts as they fall due or admits inability to pay its debts or (being a company) is deemed unable to pay its debts within the meaning of the Corporations Act 2001 (Cth) OR (being a natural person) is deemed either unable to pay its debts or as having no reasonable prospect of so doing, in either case, within the meaning of the Corporations Act 2001 (Cth) OR (being a partnership) has any partner to whom any of the foregoing apply: or

	
 
	
(e)
	
the other party commences negotiations with all or any class of its creditors with a view to rescheduling any of its debts, or makes a proposal for or enters into any compromise or arrangement with its creditors other than for the sole purpose of a scheme for a solvent amalgamation of that other party with one or more other companies or the solvent reconstruction of that other party; or

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(f)
	
a petition is filed, a notice is given, a resolution is passed, or an order is made, for or in connection with the winding up of that other party other than for the sole purpose of a scheme for a solvent amalgamation of that other party with one or more other companies or the solvent reconstruction of that other party: or

	
 
	
(g)
	
an application is made to court, or an order is made, for the appointment of an administrator or if a notice of intention to appoint an administrator is given or if an administrator is appointed over the other party; or

	
 
	
(h)
	
a person becomes entitled to appoint a receiver over the assets of the other party or a receiver is appointed over the assets of the other party; or

	
 
	
(i)
	
the other party, being an individual, is the subject of a bankruptcy petition or order; or

	
 
	
(j)
	
a creditor or encumbrancer of the other party attaches or takes possession of, or a distress, execution, sequestration or other such process is levied or enforced on or sued against, the whole or any part of its assets and such attachment or process is not discharged within 14 days; or

	
 
	
(k)
	
any event occurs, or proceeding is taken, with respect to the other party in any jurisdiction to which it is subject that has an effect equivalent or similar to any of the events mentioned in clause 11.2(d) to clause 11.2(j) (inclusive); or

	
 
	
(l)
	
the other party suspends or ceases, or threatens to suspend or cease, to carry on all or a substantial part of its business; or

	
 
	
(m)
	
the other party, being an individual, dies or, by reason of illness or incapacity (whether mental or physical), is incapable of managing his or her own affairs or becomes a patient under any mental health legislation.

	
 
	
(n)
	
Without affecting any other rights that it may be entitled to, the Supplier may give notice in writing to the Distributor terminating this agreement immediately if the Distributor purports to assign its rights or obligations under this agreement to an entity that is not (1) affiliated with, (2) related to, or (3) sharing common ownership with the Distributor (a Permitted Assignee).

	
12.
	
Effectsof termination

	
 
	
12.1
	
Termination of this agreement for any reason shall not affect any rights or liabilities accrued at the date of termination.

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12.2
	
At the Supplier's option, on termination of this agreement:

	
 
	
(a)
	
the Supplier may buy from the Distributor all or any stocks of Products for the current market value for those Products. The Distributor must deliver such Products to the Supplier within 14 days of receiving the Supplier's notice, and the Supplier must pay for the Products in full within 30 days of their delivery. The Supplier shall be responsible for the costs of packaging, insurance and carriage of the Products; or

	
 
	
(b)
	
the Distributor may dispose of the balance of the Products in its possession and account to the Supplier for the Price for those Products; and

	
 
	
(c)
	
subject to clause 12.2(b), the Distributor must cease using any intellectual property of the Supplier or of another person that relates to the distributorship and the Distributor must sign any instrument and do any other act that is necessary to achieve this purpose;

	
 
	
12.3
	
For the purposes of clause 12.2(a) the current market value in respect of Products shall be the price that the Products are ordinarily supplied as at the date of termination of this agreement.

	
 
	
12.4
	
Subject to clause 12.2, all other rights and licences of the Distributor under this agreement shall terminate on the termination date.

	
13.
	
Confidentiality

	
 
	
13.1
	
Each party undertakes that it shall not at any time, disclose to any person any confidential information concerning the business, affairs, customers, clients or suppliers of the other party or of any member of the group of companies to which the other party belongs, except as provided by clause 13.2.

	
 
	
13.2
	
Each party may disclose the other party's confidential information:

	
 
	
(a)
	
to those of its employees, officers, representatives or advisers who need to know such information for the purpose of carrying out the party's obligations under this agreement. Each party shall ensure that its employees, officers, representatives or advisers to whom it discloses the other party's confidential information comply with this clause 13; and

	
 
	
(b)
	
as may be required by law, court order or any governmental or regulatory authority; provided, however, that the other party reserves the right to challenge such disclosure under applicable law. If such party elects to challenge the disclosure, no confidential information shall be disclosed during the pendency of such challenge.

	
 
	
13.3
	
No party shall use any other party's confidential information for any purpose other than to perform its obligations under this agreement.

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14.
	
Entire agreement

	
 
	
14.1
	
This agreement (and any document referred to in it) constitutes the whole agreement between the parties and supersedes all previous agreements between the parties relating to its subject matter.

	
 
	
14.2
	
Each party acknowledges that, in entering into this agreement (and any document referred to in it), it has not relied on, and shall have no right or remedy in respect of, any statement, representation, assurance or warranty (whether made negligently or innocently) other than as expressly set out in this agreement. Each party agrees that its only liability in respect of those representations and warranties that are set out in this agreement (whether made innocently or negligently) shall be for breach of contract.

	
 
	
14.3
	
Nothing in this clause shall limit or exclude any liability for fraud.

	
15.
	
Variation

No amendment or variation of this agreement shall be effective unless it is in writing and signed by the parties (or their authorised representatives).

	
16.
	
Assignment and other dealings prohibited

	
 
	
16.1
	
The Distributor shall not assign, transfer, mortgage, charge, declare a trust of or deal in any other manner with this agreement or any of its rights and obligations under or arising out of this agreement, or purport to do any of the same; provided, however, the Distributor may assign or transfer this agreement to a Permitted Assignee without the consent of Supplier. The Distributor shall not sub-contract or delegate in any manner any or all of its obligations under this agreement to any third party or agent.

	
 
	
16.2
	
If the Distributor seeks the Supplier's consent to any proposed dealing under clause 16.1, the Distributor must: -

	
 
	
(a)
	
disclose fully in writing all material facts relating to the dealing

	
 
	
(b)
	
comply fully with any conditions or requirements set down by the Supplier which attach to any Suppliers consent that is given.

	
 
	
16.3
	
Each party that has rights under this agreement is acting on its own behalf and not for the benefit of another person.

	
17.
	
Freedom to contract

The parties declare that they each have the right, power and authority and have taken all action necessary to execute and deliver and to exercise their rights and perform their obligations under this agreement.

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18.
	
Waiver

No failure or delay by a party to exercise any right or remedy provided under this agreement or by law shall constitute a waiver of that or any other right or remedy, nor shall it preclude or restrict the further exercise of that or any other right or remedy. No single or partial exercise of such right or remedy shall preclude or restrict the further exercise of that or any other right or remedy.

	
19.
	
Severance

	
 
	
19.1
	
If any provision of this agreement (or part of any provision) is found by any court or other authority of competent jurisdiction to be invalid, illegal or unenforceable, that provision or part-provision shall, to the extent required, be deemed not to form part of this agreement, and the validity and enforceability of the other provisions of this agreement shall not be affected.

	
 
	
19.2
	
If a provision of this agreement (or part of any provision) is found illegal, invalid or unenforceable, the provision shall apply with the minimum modification necessary to make it legal, valid and enforceable.

	
20.
	
Notices

	
 
	
20.1
	
Any notice required to be given under this agreement, shall be in writing and shall be delivered personally, by email, or sent by pre-paid first class post or recorded delivery or by commercial courier, to each party required to receive the notice at its address as set out at the beginning of this agreement or as otherwise specified by the relevant party by notice in writing to each other party.

	
 
	
20.2
	
Any notice shall be deemed to have been duly received:

	
 
	
(a)
	
if delivered personally, when left at the address and for the contact referred to in this clause; or

	
 
	
(b)
	
if sent by pre-paid first class post or recorded delivery, at 9.00 am on the second Business Day after posting; or

	
 
	
(c)
	
if delivered by commercial courier, on the date and at the time that the courier's delivery receipt is signed; or

	
 
	
(d)
	
if delivered by email, on the date and at the time such email is received by the recipient whether such message is opened at that time.

Any notice given or received by a lawyer for a party to this agreement is deemed to be given or received with the actual or ostensible authority of the lawyer.

The Supplier may at times by notice nominate an address for service of legal proceeding, whether in Australia or in any other place. A nomination binds the 

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parties but nothing prevents the Supplier from making further nomination in place of any earlier nomination.

	
 
	
20.3
	
A notice given under this agreement shall not be validly given if sent by e-mail.

	
21.
	
Third party rights

	
 
	
21.1
	
A person who is not a party to this agreement shall not have any rights under or in connection with it by virtue of the Contracts

	
 
	
21.2
	
The rights of the parties to terminate, rescind or agree any variation, waiver or settlement under this agreement are not subject to the consent of any person that is not a party to this agreement.

	
22.
	
No partnership or agency

Except as expressly provided, nothing in this agreement is intended to, or shall be deemed to, establish any partnership or joint venture between the parties, constitute either party the agent of the other, nor authorise a party to make or enter into any commitments for or on behalf of the other party.

	
23.
	
Counterparts

This agreement may be executed in any number of counterparts, each of which when executed and delivered shall constitute an original of this agreement, but all the counterparts shall together constitute the same agreement.

	
24.
	
Governing law and jurisdiction

	
 
	
24.1
	
This agreement and any dispute or claim arising out of or in connection with it or its subject matter or formation (including non-contractual disputes or claims) shall be governed by and construed in accordance with Ohio law.

	
 
	
24.2
	
The parties irrevocably agree that the courts of Ohio shall have non-exclusive jurisdiction to settle any dispute or claim that arises out of or in connection with this agreement or its subject matter or formation (including non-contractual disputes or claims).

This agreement has been entered into on the date stated at the beginning of it.

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Schedule 1

AriaTM Hip Stem System

RemedyTM Hip Stem system

LogicalTM Hip Cup system

Signature BiPolar Head

Genius Total knee system

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Schedule 2Territory

USA.

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Schedule 3The Trade Marks

OriginTM, LogicalTM, AriaTM, RemedyTM, GeniusTM

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Schedule 4Prices

Aria Stem $610

Origin Stem $610

Remedy Stem $610

Logical Cup $450

Logical Liner $210

Metal Head $240

Ceramic Head $340

BiPolar Head $250

PS / CR Femoral Component $550

Insert $340

Tibia Tray $440

Patella $70

18

 

 

			
			
	
SIGNED by

Signature Orthopaedics Pty Ltd

(ACN 106 702 416)

In accordance with section 127 of the Corporations Act:
	
)

)

)

)

)
	
 

	
 

Director/Secretary

 

Name (please print)
	
 
	
 

Director

 

Name (please print)

	
SIGNED by

CPM Medical LLC
	
)

)

)

)

)
	
 

	
 

Director/Secretary

 

Name (please print)
	
 
	
 

Director

 

Name (please print)

 

19fzmd-ex1044_100.htm

EXHIBIT 10.44

MASTER IMPLANT PURCHASE AGREEMENT 
BY AND BETWEEN 
METHODIST HEALTH SYSTEM 
AND 
CPM Medical Consultants, LLC

WHEREAS, this Master Implant Purchase Agreement is made effective as of the 1 day of February, 2018 (the “Effective Date”) by and between Methodist Hospitals of Dallas d/b/a Methodist Health System (“MHS” or “Customer”), a Texas nonprofit corporation whose address is 1441 N. Beckley Avenue, Dallas, Texas 75203 and CPM Medical Consultants, LLC “Contractor”) located at 1565 N. Central Expy, Suite 200 Richardson, Texas 75080.  MHS and Contractor are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.

WITNESSETH:

Whereas, Contractor provides medical devices_and MHS has a need for such items and/or services; and

Whereas, the Parties to this agreement entered into a _________________ Service Agreement that terminates on _________________ [THIS WILL MOST LIKELY NOT BE NEEDED IN MOST CASES]; and

Whereas, MHS desires and Contractor is willing to enter into this agreement that spells out the Terms and Conditions of the Parties for Contractor to provide the pricing, items and/or scope of services as described in Exhibit A and described in future exhibits to this Agreement which are signed by MHS and Contractor as amendments to this Agreement; and

Whereas, as of the Effective Date of this agreement (“Agreement”), the Parties agree that any existing or prior agreement between the parties covering the same subject matter as Agreement is hereby superseded and replaced by this Agreement; and

Now, therefore, as of the Effective Date, in consideration of the mutual promises herein contained, MHS and Contractor agree that any prior agreement is hereby terminated and this Agreement is entered into upon the terms and conditions as hereinafter set forth:

1.ACCESS TO RECORDS:  If and to the extent required by Section 1395x(v)(1)(I) of Title 42 of the United States Code, until the expiration of four (4) years after the termination of this Agreement, Contractor shall make available, upon written request by the Secretary of the Department of Health and Human Services, or upon request by the Comptroller General of the United States General Accounting Office, or any of their duly authorized representatives, a copy of this Agreement and such books, documents and records as are necessary to certify the nature and extent of the costs of the services provided by Contractor under this Agreement.  Contractor further agrees that in the event it carries out any of its duties under this Agreement through a subcontract with a related organization with a value or cost of Ten Thousand Dollars ($10,000.00) or more over a twelve (12) month period, such subcontract shall contain a provision requiring the related organization to make available until the expiration of four (4) years after the furnishing of 

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EXHIBIT 10.44

such services pursuant to such subcontract upon written request to the Secretary of the United States Department of Health and Human Services, or upon request to the Comptroller General of the United States General Accounting Office, or any of their duly authorized representatives, a copy of such subcontract and such books, documents and records of such organization as are necessary to verify the nature and extent of such costs.

2.EXCLUDED PROVIDER:  In conjunction with its provision of services under this Agreement, Manager shall not employ or otherwise engage an “Ineligible Person,” as defined herein.  An “Ineligible Person” shall be any person (individual or entity) that (i) is currently excluded, debarred, or otherwise ineligible to participate in federal procurement and/or non-procurement programs, or any federal or state health care programs, or (ii) has been convicted of a criminal offense relating to or arising out of the provision of health care services or items, whether or not such person has yet been excluded, debarred, or otherwise declared ineligible, or (iii) is currently listed on the Specially Designated Nationals List maintained by the Office of Foreign Assets Control of the United States Treasury Department and with which U.S. persons are prohibited from dealing.  Manager hereby certifies that it is not an Ineligible Person, and that neither it nor its employees or contractors used to provide any services under this Agreement are listed on the General Services Administration’s List of Parties Excluded from Federal Programs or the List of Excluded Individuals/Entities maintained by the Office of Inspector General of the Department of Health and Human Services, or the list of Specially Designated Nationals List maintained by the Office of Foreign Assets Control of the United States Treasury Department.

3.TERM OF AGREEMENT:  The term of this Agreement shall be for period of Three (3) years, and shall commence on the 1 day of February, 2018 (“Effective Date”) and will terminate on the 31 day of January, 2021 (“Initial Term”).  This Agreement will then automatically renew for successive one (1) year periods thereafter (“Renewal Terms”), unless terminated earlier as stated herein.  The Initial Term and any Renewal Terms are referred to herein as the (“Term”).

4.TERMINATION:  (a)Either party shall have the right to terminate this Agreement at any time without cause upon not less than thirty (30) days’ prior written notice to the other party, without any additional payment and or penalty.

(b)Customer may terminate this Agreement under the following conditions:

	
 
	
i.
	
If the Contractor or any of its affiliates divests itself of any Product, then the Contractor may assign to the person or entity acquiring that Product any of the Contractor’s rights under this agreement relating to that Product, on the condition that the assignee will also assume the Contractor’s obligations under this agreement relating to that Product.  Any purported assignment in violation of this section will be void.

	
 
	
ii.
	
In the event the service levels or product quality falls below Customer expectations, the Customer will notify the Contractor in writing.  Upon receipt of this notice, the Contractor will have thirty (30) days to remedy the situation to the approval of the Customer.  If not remedied within thirty (30) days, the Customer will have the authority to terminate this contract.

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EXHIBIT 10.44

	
 
	
iii.
	
Customer reserves the right to renegotiate or cancel the contract if the awarded Contractor offers better pricing or other cost saving incentives to other Group Purchasing Organizations or Regional Competitors.  Customer reserves the right to renegotiate in good faith with the awarded Contractor if competitive pressures, business strategies or new technology alters Customer’s ability to effectively compete in the regional marketplace.  Failure of the Contractor to respond in good faith or the inability to reach an agreement within the time frame required by Customer will result in termination of this Agreement upon issuance of notice by Customer.

(c)Customer may, in its sole discretion, terminate this Agreement, effective immediately, upon notice to Contractor, in the event of:

	
 
	
i.
	
Charging or conviction of Contractor of any crime involving fraud, moral turpitude or immoral conduct.

	
 
	
ii.
	
Contractor’s suspension or exclusion from any health care program funded in whole or part with federal or state funds.

	
 
	
iii.
	
Contractor’s inability to perform, for any reason, the required services as outlined herein.

	
 
	
iv.
	
Failure to maintain the required insurance as outlined herein.

Termination of this Agreement for any reason shall not affect or negate any obligations of either party to the other arising prior to the date of the termination.  Further, any termination of this Agreement shall not affect any right or remedy to which the terminating party may be entitled either at law, or in equity, or under this Agreement.

5.INSURANCE:  Contractor shall maintain, in full force and effect during the Term of this Agreement, commercial general liability insurance (including products and completed operations liability), and professional liability insurance, issued by an insurer acceptable to Customer, covering Contractor and any person or entity fulfilling any of Contractor’s responsibilities under this Agreement against all claims arising out of the services to be performed by Contractor under this Agreement (“Liability Insurance”).  Liability Insurance shall be in amounts of coverage no less than the minimum required by Customer of $1 million per occurrence and $3 million aggregate as well as Workers Compensation at statutory limits.  The insurance policy shall require the carrier to provide Customer with written notice of any cancellation or reduction of insurance coverage at least twenty (20) days in advance of such cancellation or reduction.  If the Liability Insurance coverage is on a claims made basis and Contractor ceases to maintain such liability coverage or changes insurance carriers, Contractor shall obtain from an insurance carrier acceptable to Customer an unlimited reporting endorsement or extended coverage policy (“tail”) in the amounts set forth above covering all acts or occurrences during the original term or any renewal term of this Agreement as to which claims may still be asserted.  On or before the Effective Date and thereafter upon request, Contractor shall promptly deliver to Customer certificates of insurance evidencing such coverage.

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EXHIBIT 10.44

6.NOTICE:  (a)Any notices, demands, or requests required or authorized by this Agreement, or any other instrument or document required or authorized to be tendered or delivered by either party, must be in writing and personally delivered or sent by certified mail, return receipt requested (except that billing statements and payments may be by regular mail), postage prepaid, to:

If to Contractor:

1565 N. Central Expy, Suite 200
Richardson, Texas 75080__________
Attention:  Kiyoko McDonald__________
____________________________________
PH:  972.331.5872 

If to Customer:

Methodist Health System 
P.O. Box 655999
Dallas, Texas 75265-5999 
Attention:  ____________________

(b)The person to receive notices or the address for such notices may be changed by written notice from one party to the other party under this Section.  Any written notice, demand, or request given under this Section is deemed to be given upon the earlier of (i) actual receipt, or (ii) deposit in the U.S. mail, properly addressed, and with adequate postage.  If a party is required to take some action within a certain time, which period is begun by a notice given by mail, then the time is extended by three Business Days.

7.RELATIONSHIP OF THE PARTIES:  Contractor acknowledges that it is at all times acting as an independent contractor under this Agreement and is not an agent, employee, partner or joint venturer of Customer.  Neither party has any right, power, or authority to enter any agreement or undertaking for, or act on behalf of, or to act as or be an agent or representative of, or to otherwise bind, the other party.  Contractor agrees to be solely responsible for all matters relating to compensation of its employees, including, but not limited to, compliance with laws governing workers’ compensation, Social Security, withholding and payment of any and all federal, state and local personal income taxes, disability insurance, unemployment, and any other taxes for such persons, including any related employer assessment or contributions required by law, and all other regulations governing such matters, and the payment of all salary, vacation and other employee benefits (“Employment Obligations”).

8.INDEMNIFICATION:  Contractor shall be fully responsible for its own representatives and agrees to reimburse, indemnify, defend (at Customer’s election), and hold harmless Customer for, from, and against any and all claims, damages, losses, deficiencies, liabilities, penalties, charges, costs, and expenses (including reasonable attorneys’ fees) (collectively “Losses”) resulting from, relating to, or arising out of, the acts or omissions of Contractor or Contractor’s employees in connection with Contractor’s performance of Contractor’s duties under this Agreement.  Contractor further agrees they will be totally and completely responsible for any 

4

 

EXHIBIT 10.44

damage that occurs in the performance of their duties as outlined hereunder.  If such damage occurs, Contractor may be asked to repair said damage at their sole expense, or Customer at Customer’s sole discretion, may elect to repair the damage themselves or through another Contractor.  Any expense incurred by Customer in the repair of any damage that was caused by Contractor will be deducted from any amounts owed by Customer to Contractor.

9.GOVERNING LAW:  This Agreement shall be governed by the laws of the State of Texas and is performable and shall be enforceable in Dallas County, Texas.  The federal and state courts of Dallas County, Texas, shall be the exclusive courts of jurisdiction and venue for any litigation, special proceeding or other proceeding as between the parties that may be brought, or arise out of, in connection with or by reason of this Agreement.

10.CONTINUING OBLIGATION; SURVIVAL OF PROVISIONS:  Except as otherwise specifically provided herein, termination of this Agreement shall not relieve any party hereto from any obligation under this Agreement that accrued or arose from facts and circumstances in existence prior thereto.  In addition, the provisions of this Agreement that by their nature contemplate continuing obligations shall survive expiration or termination of this Agreement.

11.PERSONNEL:  Contractor represents, warrants and ensures that all personnel provided will, at all times while providing services under this Agreement, (i) have and maintain any required state license/registration; (ii) be properly trained to provide the Services; (iii) have successfully completed a screening process which includes a health clearance, a professional reference check, a drug screening, and a criminal background check; and (iv) be in appropriate attire and properly identified while in Customer’s facility.

12.RIGHT TO DISMISS:  While on Customer’s premises, Contractor’s personnel or those performing services on behalf of Contractor shall comply with all policies, rules and regulations of Customer regarding personal and professional conduct (including, but not limited to, wearing an identification badge and adhering to regulations and general safety practices or procedures) and otherwise conduct themselves in a businesslike and professional manner.  In the event that Customer determines that any of Contractor’s personnel are not behaving accordingly, Customer may immediately remove or have removed such individual from Customer’s or have Contractor remove such individual, and Customer may thereafter require Contractor to replace that individual.

13.PRICE PROTECTION:  Prices for products and services outlined herein will remain firm for the duration of the Agreement.

14.TAXES:  Customer is a non-profit organization with a tax-exempt status.  Customer will provide Contractor with a tax-exempt certificate upon request.  Taxes will not be a line item on the invoice.

15.MINIMUM ORDER REQUIREMENTS:  The parties hereby agree there are no minimum order requirements for any order placed with Contractor by Customer or its employees, nor will Methodist Health System or its employees be required to meet any annual volume requirements to obtain maximum discounts.

16.VENDOR BACKGROUND:  If Contractor and Customer agree that Contractor or its employees will have access to patient care areas or records, Contractor will cooperate with 

5

 

EXHIBIT 10.44

Customer’s verification process before such access is allowed.  This may include criminal background checks, governmental program eligibility verification, verification of current immunizations, and cooperation with any credentialing verification service that Customer may use for such purposes.

17.COMPLIANCE WITH ALL LAWS, REGULATIONS AND STANDARDS:  Contractor warrants that all Services to be provided hereunder, whether by it directly or by approved sub-contractors of Contractor, shall fully comply with all applicable federal, state and local statutes, rules and regulations and applicable accreditation standards or requirements including:  The Joint Commission and The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), and updates to incorporate any changes to such laws, rules, regulations, requirements and standards as well as the Business Associate Agreement attached hereto as Exhibit B, and that it shall be deemed a material breach of this Agreement by Contractor if it shall fail to observe this requirement.  If such a breach occurs Customer may terminate this Agreement without penalty and without limiting any other rights and remedies set forth in this Agreement.

18.DEFAULT:  In the event either party shall give written notice to the other that such other party has substantially defaulted in the performance of any material duty or material obligation (which obligation must be for the benefit of the party giving notice) imposed upon it by this Agreement, and such default shall not have been cured within thirty (30) days following the giving of such written notice, the party giving such written notice shall have the right to immediately terminate this Agreement unless the Non Defaulting Party believes that the defaulting party, within said thirty (30) day period, made a good faith effort to initiate corrective action, and the non-defaulting party believes such corrective action will be completed within the following thirty (30) day period.

19.TERMINATION BECAUSE OF LEGAL JEOPARDY:  The parties acknowledge and agree that this Agreement is intended to comply with all state and federal laws and regulations regarding Medicare and Medicaid fraud and abuse, all corporate practice of medicine and fee splitting laws, Methodist’s status as a recipient of governmental or private funds for the provision of health care services, Methodist’s status as tax-exempt organization, and Methodist’s (and its affiliates) ability to issue tax-exempt bonds and to maintain the tax-exempt status of any existing bonds.  Either party shall have the right to terminate this Agreement without liability, if on the reasonable written advice of its legal counsel, it determines, in its reasonable judgment, that the terms of this Agreement (including but not limited to the fair market value of the compensation paid by one party to the other party) either more likely than not would be interpreted to violate any laws or regulations applicable to it or if, in the opinion of such counsel, under the circumstances the terms of the Agreement present an unacceptable legal risk of or a material violation, which, if violated, would jeopardize its status as a recipient of governmental or private funds for the provision of health care services or its status as a tax-exempt organization, or its ability to issue tax-exempt bonds or to maintain the tax-exempt status of any existing bonds.  Notwithstanding a party’s right to terminate, the party shall first use good faith efforts to amend this Agreement either only to the extent necessary to conform the potentially non-conforming terms to the applicable law or regulation, and will only terminate this Agreement pursuant to this Section if it determines, in its good faith judgment, that an amendment cannot be obtained or will not result in compliance.  Any amendment of this Agreement will require mutual agreement of the parties.  The parties will act in good faith to attempt to reach such mutual agreement.  If a party in good faith withholds its 

6

 

EXHIBIT 10.44

consent to an amendment proposed pursuant to this Section, then this Agreement shall terminate upon thirty days notice.  The parties agree that a party’s withholding of consent shall be deemed valid if the proposed amendment would result in a change to this Agreement that would be materially adverse to that party.

20.EQUIPMENT, PRICE AND FACILITIES:  The specific equipment and pricing as well as the specific facilities of Customer that fall under this Agreement are outlined on the Exhibits attached hereto and incorporated by reference herein.  Invoices for services provided herein should be mailed to Customer.  Payment should be made within thirty (30) days after receiving Invoice.  Invoices that are not received by Customer within ninety (90) days of service will not be paid.  In the event there is a conflict between the terms and conditions of this Master Services Agreement and any or all of the Exhibits, the Master Services Agreement shall take precedence

21.BILL ONLY PURCHASE ORDERS:  All purchases involving Bill Only purchase orders must be approved by the respective Operating Room Director or designee prior to an item being used by Customer.  All product orders will require a valid Customer purchase order (“PO”) number to be considered for payment.  Packing slip and Invoice must be in PO line item order.  Invoices must include the following data in order to receive payment:

(a)Only one invoice should be filled out per patient.  Products can be shipped together, but only one patient’s data should appear on an invoice.

(b)Products, product numbers, component definitions, quantity, and component prices should be listed on the invoice.

(c)Patient’s ID #, surgeon’s name, and date of surgery should also be listed.

(d)Pricing must be pre negotiated before implantation.

(e)Items opened but not used will not be considered for payment.  Opened but not implanted items appearing on a Bill Only form must clearly indicate the item was unused and not subject to invoicing.

22.INVENTORY:  Contractor shall be responsible for any and all inventory brought into Customer’s Facility until such time as it is implanted into a Patient of Customer.  Contractor shall be totally responsible for any and all losses and or damages that may occur with any inventory brought into and/or stored on Customer’s premises.

23.OPENED UNUSED PRODUCTS:  Products opened that have been verified by both a Customer and a Contractor representative present during a procedure that are not used and do not come into contact with the patient will be paid at a rate of 50% off agreed upon List price.

24.IMPLANTED/EXPLANTED PRODUCTS:  Products implanted and then explanted on a patient (e.g., due to incorrect fit) will be paid at a rate of 50% off Current List Price and not to exceed Customer’s contract price.  Customer and Contractor shall periodically evaluate any charges for these related implanted/explanted products to ensure that appropriate decision making processes are being implemented to minimize these instances in future cases.

7

 

EXHIBIT 10.44

25.DEFECTIVE/UNUSABLE PRODUCTS:  Contractor will issue full credit for any implant component or supply determined by the physician to be unusable (defective, incorrect product/incorrect packaging, etc.) during a procedure.

26.EXPIRED PRODUCTS:  Each Contractor is responsible for monitoring and replacing any and all products that reach expiration.  These replacements will take place at no expense to Customer.

27.NEW TECHNOLOGY:  If, during the term of this Contract, the Customer determines that new technology for a product becomes available from the Contractor, the new technology product may be added to this agreement subject to mutually agreed upon pricing via an amendment.  The Contractor will make reasonable efforts to notify Customer of a new technology product following national launch of the product.  New products must be approved by the Customer’s Materials Analysis Committee (MAC) or Department Director before introduction into any Customer facility.

28.MARKETING:  Contractor agrees not to make any written use of or reference to Customer or MHS’ name, logo, or trademarks for any marketing, public relation, advertising, display or other business purpose or make any use of Customer’s facilities for any activity unrelated to the express business purposes and interests of Customer under this Agreement, without the prior written consent of Customer, which consent may be withheld or granted in Customer’s sole and absolute discretion.

29.MEDICAL EXCISE TAX:  Contractor may not directly or indirectly pass through to Customer any taxes that are imposed on Vendor, or otherwise adjust the pricing terms of this Agreement in connection with any such taxes, including without limitation the medical device excise tax set forth in Section 4191 of the Internal Revenue Code.

30.FOB DESTINATION:  Orders under this Agreement are classified either as Delivered orders or Regular orders.  Delivered orders represent products that are hand delivered to the Customer by the sales representative of Contractor for use during surgery, and the Customer is invoiced for the items used during surgery.  Terms for Delivered orders shall be FOB Destination, net 30 days.  Regular orders represent those shipped from a Contractor’s warehouse directly to the Customer.  Terms for Regular orders shall be FOB Origin, except that Contractor will cover all shipping costs except for those related to special delivery and/or emergency air shipments, in which case the Customer shall bear the costs to ship.

31.SHIPPING FEES:  Customer will not pay any additional freight, instrument fees, consignment costs, delivery, handling and loaner/rental fees above the discounted product prices (per the pricing attached hereto).

32.INTELLECTUAL PROPERTY INDEMNIFICATION:  Contractor warrants and represents that it has the right to sell and/or license any codes, products, programs, firmware, software, know-how, methods, and/or concepts associated with any products that are the subject of this Agreement.  Accordingly, Contractor agrees to indemnify and hold harmless Customer from all damages, costs and expenses, including reasonable attorneys’ fees arising out of any infringement or claim of infringement of patents, trademarks, or copyrights arising out of the use 

8

 

EXHIBIT 10.44

of any products that are the subject of this Agreement.  Contractor’s obligations shall (a) be contingent upon Contractor being granted control of the defense, compromise or settlement of such claim, and (b) not extend to any claim of infringement based upon Contractor’s combination of equipment not manufactured by Contractor or Customer’s modifications to equipment Customer shall assist Contractor to the extent reasonably required for such defense.

33.CONTRACTOR WARRANTIES:  Contractor warrants that any and all work performed under this Agreement will be performed in accordance with manufacturers’ specifications.  Contractor warrants that any parts provided by Contractor will have clear title and be free from defects in material and workmanship at the time of sale.

34.PHYSICIAN OWNERSHIP:  Contractor represents and warrants that any and all products that are the subject matter of this Agreement are not being manufactured, sold and or distributed by a physician-owned entity or by an entity that has physician investors.  If the products that are the subject matter of this Agreement are manufactured, sold and or distributed by a physician-owned entity or by an entity that has physician investors, or becomes physician-owned or physicians invest in the entity, Contractor agrees to fully disclose this information to Customer within ten (10) days.  Failure to do so will be considered a material breach of this Agreement.  Should such a Breach occur, Customer may immediately terminate this Agreement without any additional payment and or penalty.  Contractor shall indemnify and hold harmless Customer against all actions, claims, demands and liabilities, and against all loss, damage, costs and expenses, including reasonable attorneys’ fees, arising directly or indirectly, out of any violation of this Section by Contractor.

35.DOCUMENTS REQUIRED:  Contractor shall provide the following documents to Customer, if applicable, prior to providing any Service and/or product to Customer.

	
 
	
a)
	
All Representative Contact Information

	
 
	
b)
	
510K information and documents

	
 
	
c)
	
Certificate of Insurance in amounts as shown in Paragraph 3 above.

	
 
	
d)
	
FDA information and documents

	
 
	
e)
	
AATB Certification for tissue and graphs

Failure to provide the above required documents and/or information will be considered a material breach of this Agreement.  If such a Breach occurs, Customer may immediately terminate this Agreement without any additional payment and or penalty.

36.WAIVER:  No waiver by Contractor or Customer of any breach of any term, provision or condition contained in this Agreement, or the failure to insist upon strict performance thereof shall be deemed to be a waiver of such term, provision or condition as to any subsequent breach thereof or a waiver of any other term, provision or condition contained in this Agreement.  The exercise of any right or remedy hereunder shall not be deemed to preclude or effect the exercise of any other right or remedy provided herein.

37.ENTIRE AGREEMENT:  This Agreement contains the entire agreement of the parties hereto, supersedes all prior agreements, and understandings, whether oral or in writing, if any, 

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EXHIBIT 10.44

relating to the subject matter hereof, and may be amended only by written agreement of the parties hereto.

38.ASSIGNMENT:  Neither party may assign or transfer this Agreement, or any portion thereof, without the prior written consent of the other party.  Any assignment or transfer of this Agreement or any portion thereof without such written consent will void this Agreement.  However Customer shall have the power and right to assign its interest in the Agreement to any successor-in-interest or to any subsidiary, parent corporation, sponsor, wholly owned or controlled affiliate of Customer.

39.SEVERABILITY:  If any provision of this Agreement or the application thereof to any Party or circumstance shall to any extent be ruled invalid or unenforceable in any jurisdiction, that provision shall be severed from this Agreement as to such jurisdiction (but, to the extent permit by law, not elsewhere), and shall not affect the remainder hereof.

[Signature Page Follows]

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EXHIBIT 10.44

IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their duly authorized representatives, effective as of the Effective Date.

		
	
CONTRACTOR:
	
CPM Medical Consultants, LLC

	
 
	
Signature:

	
 
	
Print:  Bill McLaughlin

	
 
	
Title:  Chief Financial Officer

	
 
	
Date:

	
 
	
 

	
CUSTOMER
	
METHODIST HEALTH SYSTEM

	
 
	
Signature:

	
 
	
Print:

	
 
	
Title:

	
 
	
Date:

 

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EXHIBIT 10.44

EXHIBIT B

HIPAA BUSINESS ASSOCIATE AGREEMENT

This Business Associate Agreement (“Agreement”), effective the 1 day of February, 2018 (“Effective Date”), is entered into by and between CPM Medical Consultants, LLC (referred to herein as the “Business Associate”) and Methodist Health System (the “Covered Entity”) (each a “Party” and collectively the “Parties”).

CITATIONS TO THE CODE OF FEDERAL REGULATIONS REFER TO THE PRIVACY REGULATION AND SECURITY REGULATION PUBLISHED ON DECEMBER 28, 2000 AND SHALL BE READ TO INCLUDE AND REQUIRE ALL SUBSEQUENT, UPDATED, AMENDED OR REVISED PROVISIONS RELATING TO HIPAA’S PRIVACY REGULATION.

Business Associate is a limited liability corporation with principle office located in Richardson, Texas, and the Covered Entity is a Texas non-profit corporation.  The Parties are entering into a contractual relationship (“Contractual Relationship”) under which the Covered Entity discloses and/or the Business Associate may come into contact with Protected Health Information in Business Associate’s performance of the Services described below.  Both Parties are committed to complying with the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Regulation”) and the Security Standards for the Protection of Electronic Protected Health Information (the “Security Regulation”) under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”),as each may be amended, from time to time.  This Agreement sets forth the terms and conditions pursuant to which Protected Health Information that is provided to, used by, or received by, the Business Associate from, or on behalf of, the Covered Entity, will be handled between the Business Associate and the Covered Entity and with third parties during the term of the Parties Contractual Relationship and after its termination.  The Parties agree as follows:

	
1.
	
PERMITTED USES AND DISCLOSURES OF PROTECTED HEALTH INFORMATION

	
1.1
	
Services.  Pursuant to the parties Contractual Relationship, Business Associate provides services (“Services”) for the Covered Entity that involve the use and disclosure of Protected Health Information.  Specifically, Business Associate provides the following Services to the Covered Entity that may require the Business Associate’s use and/or disclosure of the Protected Health Information:

 

The Business Associate agrees to not use or disclose Protected Health Information other than as permitted or required by this Agreement or as required by law.  All other uses not authorized by this Agreement are prohibited.  Moreover, Business Associate may disclose Protected Health Information for the purposes authorized by this Agreement only:  (i) to its employees, subcontractors, and agents, in accordance with Section 2.1(g); (ii) as 

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EXHIBIT 10.44

directed by the Covered Entity; or (iii) as otherwise permitted by the terms of this Agreement including, but not limited to, Section 1.2(b) below.

	
1.2
	
Business Activities of the Business Associate.  Unless otherwise limited herein, the Business Associate may:

	
 
	
a.
	
use the Protected Health Information in its possession for its proper management and administration and to fulfill any present or future legal responsibilities of the Business Associate provided that such uses are permitted under state and federal confidentiality laws.

	
 
	
b.
	
disclose the Protected Health Information in its possession to third parties for the purpose of its proper management and administration or to fulfill any present or future legal responsibilities of the Business Associate, provided that the Business Associate represents to the Covered Entity, in writing, that (i) the disclosures are required by law, or (ii) the Business Associate has received from the third party written assurances regarding its confidential handling of such Protected Health Information and the person agrees to notify Business Associate of any instances that it becomes aware in which the confidentiality of the Protected Health Information has been breached.  Business Associate may not use or disclose Protected Health Information in a manner that would result in a HIPAA violation if done by Covered Entity.

	
2.
	
RESPONSIBILITIES OF THE PARTIES WITH RESPECT TO PROTECTED HEALTH INFORMATION 

	
2.1
	
Responsibilities of the Business Associate.  With regard to its use and/or disclosure of Protected Health Information, the Business Associate hereby agrees to do the following:

	
 
	
a.
	
use and/or disclose the Protected Health Information only as permitted or required by this Agreement or as otherwise required by law.

	
 
	
b.
	
use appropriate safeguards, and comply with 45 CFR Part 164 Subpart C with respect to electronic Protected Health Information, to prevent use or disclosure of Protected Health Information other than as provided for by the Agreement.

	
 
	
c.
	
report to the designated Privacy Officer of the Covered Entity, in writing, without unreasonable delay, but no later than five (5) days following Business Associate’s discovery of any use or disclosure of Protected Health Information not provided for by the Agreement of which it becomes aware, including breaches of unsecured Protected Health Information as required at 45 CFR 164.410, and any security incident of which it becomes aware.  Business Associate’s report shall include:

	
 
	
(i)
	
the identification of each individual whose Protected Health Information has been, or is reasonably believed by the Business Associate to have been, accessed, acquired, used, or disclosed during the Breach;

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EXHIBIT 10.44

	
 
	
(ii)
	
a brief description of what happened, including the date of the Breach and the date of the discovery of the Breach, if known;

	
 
	
(iii)
	
a description of the types of unsecured Protected Health Information that were involved in the Breach (i.e., full name, social security number, date of birth, home address, account number, diagnosis, disability code, or other types of information that were involved);

	
 
	
(iv)
	
any steps that the individual(s) impacted by the Breach should take to protect itself, himself, or herself from potential harm resulting from the Breach;

	
 
	
(v)
	
a brief description of what the Business Associate involved is doing to investigate the Breach, to mitigate harm to the individual, and to protect against further Breaches; and

	
 
	
(vi)
	
Contact procedures for Covered Entity to ask Business Associate questions or learn additional information from Business Associate, which shall include a telephone number, an e-mail address, and postal address.

Business Associate shall be responsible for any and all costs related to the notification to Covered Entity, individuals, or their representatives or next of kin of any Breach that should be reported by Business Associate to Covered Entity.  Business Associate shall also be responsible for all costs and expenses incurred by Covered Entity to comply with the notification requirements under the HITECH Act (defined below) as a result of Business Associate’s or its subcontractors’ Breach.

	
 
	
d.
	
use and disclose Protected Health Information consistent with Covered Entity’s minimum necessary policies and procedures.

	
 
	
e.
	
establish procedures for mitigating, to the greatest extent possible, any deleterious effects from any improper use and/or disclosure of Protected Health Information in violation of the requirements of this Agreement.

	
 
	
f.
	
have in place administrative, physical, and technical safeguards in compliance with the Security Regulation that reasonably and appropriately protect the confidentiality, integrity, and availability of Protected Health Information that it creates, receives, maintains or transmits on behalf of Covered Entity pursuant to this Agreement and to prevent the use or disclosure of Covered Entity’s Protected Health Information other than as provided for in this Agreement, or as required by law.

	
 
	
g.
	
require all of its subcontractors and agents that receive, use, or have access to Protected Health Information under this Agreement to agree, in writing, to adhere to the same restrictions and conditions on the use and/or disclosure of Protected Health Information that apply to the Business Associate pursuant to this Agreement.

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EXHIBIT 10.44

	
 
	
h.
	
make available all internal practices, records, books, agreements, policies, and procedures relating to the use and/or disclosure of Protected Health Information to the Secretary of the Department of Health and Human Services (“DHHS”) for purposes of determining the Covered Entity’s compliance with HIPAA, subject to attorney-client and other applicable legal privileges.  Business Associate must cooperate with DHHS, if it undertakes an investigation or compliance review of the policies, procedures, or practices of the Business Associate to determine whether it is complying with the applicable HIPAA requirements.

	
 
	
i.
	
upon prior written request, make available during normal business hours at Business Associate’s offices all records, books, agreements, policies, and procedures relating to the use and/or disclosure of Protected Health Information to the Covered Entity within five (5) days of such request for purposes of enabling the Covered Entity to determine the Business Associate’s compliance with the terms of this Agreement.

	
 
	
j.
	
maintain and report the requisite account information to the Covered Entity as is requested by the Covered Entity to permit it to respond to a request by an individual for an accounting of the disclosures of the individual’s Protected Health Information in accordance with:

	
 
	
(i)
	
The HIPAA Regulations accounting requirements as provided in 45 C.F.R. 164.528; and

	
 
	
(ii)
	
The accounting requirements as provided in the Health Information Technology for Economic and Clinical Health Act (the “HITECH” Act), as may be amended from time to time, in the event Covered Entity uses or maintains an electronic health record at any time during this term of this Agreement.

Business Associate agrees to provide to Covered Entity, in writing and within five (5) days of a written request, information collected in accordance of this section to permit Covered Entity to respond to a request by an individual for an accounting of disclosures of Protected Health Information.

	
 
	
k.
	
provide access, upon written request by Covered Entity, to Protected Health Information in a designated record set to Covered Entity in order to meet the requirements of 45 C.F.R. § 164.524.  If an individual contacts Business Associate to request access to his or her Protected Health Information that Business Associate received from Covered Entity, or was created or received by Business Associate on behalf of Covered Entity, Business Associate shall notify Covered Entity of the request within five (5) business days.  It shall be Covered Entity’s responsibility to respond to the individual’s request.

	
 
	
l.
	
make Protected Health Information available to Covered Entity for amendment at the written request of Covered Entity, in order for Covered Entity to meet the 

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EXHIBIT 10.44

	
 
		
requirements of 45 C.F.R. § 164.526, to the extent Business Associate has Protected Health Information contained in a designated record set.

	
 
	
m.
	
incorporate amendments presented by Covered Entity, upon Covered Entity’s written request, to the extent Business Associate has Protected Health Information contained in a designated record set.  If an individual contacts Business Associate to request amendment to his or her Protected Health Information that Business Associate received from Covered Entity, or was created or received by Business Associate on behalf of Covered Entity, Business Associate shall notify Covered Entity of the request within five (5) business days.  It shall be Covered Entity’s responsibility to respond to the individual’s request.

	
 
	
n.
	
subject to Section 4.4 below, return to the Covered Entity or destroy, within five (5) days of the termination of this Agreement, the Protected Health Information in its possession and retain no copies (which for purposes of this Agreement shall mean destroying all backup tapes).

	
2.2
	
Responsibilities of the Covered Entity.  With regard to the use and/or disclosure of Protected Health Information by the Business Associate, the Covered Entity hereby agrees:

	
 
	
a.
	
to inform the Business Associate, by way of keeping Covered Entity’s current Notice of Privacy Practices posted on Covered Entity’s website, of any changes in the form of the Notice of Privacy Practices (hereinafter the “Notice”) that the Covered Entity provides to individuals pursuant to 45 C.F.R. §164.520.  A copy of Covered Entity’s most recent Notice is currently available for Business Associate’s review and information on Covered Entity’s website.

	
 
	
b.
	
to inform the Business Associate of any changes in, or withdrawal of, the consent or authorization provided to the Covered Entity by individuals pursuant to 45 C.F.R. §164.506 or §164.508.

	
 
	
c.
	
to notify the Business Associate, in writing and in a timely manner, of any arrangements permitted by or required of the Covered Entity under 45 C.F.R. Parts 160 and 164 that may impact in any manner the use and/or disclosure of Protected Health Information by the Business Associate under this Agreement, including, but not limited to, any restrictions on the use and/or disclosure of Protected Health Information as provided for in 45 C.F.R. § 164.522 as agreed to by the Covered Entity.

	
 
	
d.
	
that Business Associate may make any use and/or disclosure of Protected Health Information permitted under 45 C.F.R. § 164.512, except that uses or disclosures for research are not permitted without Covered Entity’s prior approval

	
 
	
e.
	
that Covered Entity shall not request Business Associate to use or disclose Protected Health Information in any manner that would not be permissible under 45 C.F.R. Part 164 Subpart E if done by Covered Entity.

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EXHIBIT 10.44

	
3.
	
REPRESENTATIONS AND WARRANTIES

	
3.1
	
Mutual Representations and Warranties of the Parties.  Each Party represents and warrants to the other Party:

	
 
	
a.
	
that it is duly organized, validly existing, and in good standing under the laws of the jurisdiction in which it is organized or licensed; that it has the full power to enter into this Agreement and to perform its obligations hereunder; and that the performance by it of its obligations under this Agreement have been duly authorized by all necessary corporate or other actions and will not violate any provision of any applicable license, corporate charter, or bylaws.

	
 
	
b.
	
that neither the execution of this Agreement, nor its performance hereunder, will directly or indirectly violate or interfere with the terms of another agreement to which it is a party, or give any governmental entity the right to suspend, terminate, or modify any of its governmental authorizations or assets required for its performance hereunder.

	
 
	
c.
	
that it will not enter into any agreement the execution and/or performance of which would violate or interfere with this Agreement.

	
 
	
d.
	
that it is not currently the subject of a voluntary or involuntary petition in bankruptcy, does not currently contemplate filing any such voluntary petition, and is not aware of any claim for the filing of an involuntary petition.

	
 
	
e.
	
that all of its employees, agents, representatives, and members of its workforce, whose services may be used to fulfill obligations under this Agreement are or shall be appropriately informed of the terms of this Agreement and are under legal obligation to each Party, respectively, by contract or otherwise, sufficient to enable each Party to fully comply with all provisions of this Agreement including, without limitation, the requirement that modifications or limitations that the Covered Entity has agreed to adhere to with regards to the use and disclosure of Protected Health Information of any individual that materially affect and/or limit the uses and disclosures otherwise permitted under 45 C.F.R. § 164.512 will be communicated to the Business Associate, in writing, and in a timely fashion.

	
 
	
f.
	
that it will reasonably cooperate with the other Party in the performance of the mutual obligations under this Agreement.

	
 
	
g.
	
that neither the Party, nor its shareholders, members, directors, officers, agents, employees, or members of its workforce have been excluded or served a notice of exclusion, or have been served with a notice of proposed exclusion, or have committed any acts which are cause for exclusion, from participation in, or had any sanctions or civil or criminal penalties imposed under, any federal or state healthcare program, including but not limited to Medicare or Medicaid, or have been convicted, under federal or state law (including, without limitation, a plea of nolo contendere or participation in a first offender deterred adjudication or other arrangement whereby a judgment of conviction has been withheld), of a criminal 

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EXHIBIT 10.44

	
 
		
offense related to (a) the neglect or abuse of a patient, (b) the delivery of an item or service, including the performance of management or administrative services related to the delivery of an item or service, under a federal or state healthcare program, (c) fraud, theft, embezzlement, breach of fiduciary responsibility, or other financial misconduct in connection with the delivery of a healthcare item or service or with respect to any act or omission in any program operated by or financed in whole or in part by any federal, state or local government agency, (d) the unlawful, manufacture, distribution, prescription or dispensing of a controlled substance, or (e) interference with or obstruction of any investigation into any criminal offense described in (a) through (d) above.

Each Party further agrees to notify the other Party immediately after the Party becomes aware that any of the foregoing representations or warranties may be inaccurate or may become incorrect.

	
4.
	
TERMS AND TERMINATION

	
4.1
	
Term.  This Agreement shall become effective on the Effective Date and shall continue in effect until all obligations of the Parties have been met, unless terminated as provided in this Section 4.  In addition, certain provisions and requirements of this Agreement shall survive its expiration or other termination in accordance with Section 7.3 herein.

	
4.2
	
Termination by the Covered Entity.  As provided for under 45 C.F.R. § 164.504(e)(2)(iii), the Covered Entity may immediately terminate this Agreement and any related agreements if the Covered Entity makes the determination that the Business Associate has breached a material term of this Agreement.

	
4.3
	
Automatic Termination.  This Agreement will automatically terminate without any further action of the Parties upon the termination or expiration of the Contractual Relationship between the Parties.

	
4.4
	
Effect of Termination.  Upon the event of termination pursuant to this Section 4, Business Associate agrees to return or destroy all Protected Health Information pursuant to 45 C.F.R. § 164.504(e)(2)(1), if it is feasible to do so.  Prior to doing so, the Business Associate further agrees to recover any Protected Health Information in the possession of its subcontractors or agents.  If it is not feasible for the Business Associate to return or destroy said Protected Health Information, the Business Associate will notify the Covered Entity in writing.  Said notification shall include:  (i) a statement that the Business Associate has determined that it is infeasible to return or destroy the Protected Health Information in its possession, and (ii) the specific reasons for such determination, which reasons the Covered Entity must agree are valid reasons not to return or destroy the Protected Health Information.  Business Associate further agrees to extend any and all protections, limitations, and restrictions contained in this Agreement to the Business Associate’s use and/or disclosure of any Protected Health Information retained after the termination of this Agreement, and to limit any further uses and/or disclosures to the purposes that make the return or destruction of the Protected Health Information infeasible.  If it is infeasible for the Business Associate to obtain, from a subcontractor or agent any Protected Health 

18

 

EXHIBIT 10.44

		
Information in the possession of the subcontractor or agent, the Business Associate must provide a written explanation to the Covered Entity and require the subcontractors and agents to agree to extend any and all protections, limitations and restrictions contained in this Agreement to the subcontractors’ and/or agents’ use and/or disclosure of any Protected Health Information retained after the termination of this Agreement, and to limit any further uses and/or disclosures to the purposes that make the return or destruction of the Protected Health Information infeasible.

	
5.
	
CONFIDENTIALITY

In the course of performing under this Agreement, Business Associate may receive, be exposed to or acquire the Confidential Information including but not limited to, all information, data, reports, records, summaries, tables and studies, whether written or oral, fixed in hard copy or contained in any computer data base or computer readable form, as well as any information identified as confidential (“Confidential Information”) of the Covered Entity.  For purposes of this Agreement, “Confidential Information” shall not include Protected Health Information, the security of which is the subject of this Agreement and is provided for elsewhere.  The Business Associate including its employees, agents or representatives (i) shall not disclose to any third party the Confidential Information of the Covered Entity except as otherwise permitted by this Agreement, (ii) only permit use of such Confidential Information by employees, agents and representatives having a need to know in connection with performance under this Agreement, and (iii) advise its employees, agents, and representatives of their obligations to keep such Confidential Information confidential.  Notwithstanding anything to the contrary herein, each Party shall be free to use, for its own business purposes, any ideas, suggestions, concepts, know-how or techniques contained in information received from each other that directly relates to the performance under this Agreement.  This provision shall not apply to Confidential Information:  (a) after it becomes publicly available through no fault of either Party; (b) which is later publicly released by either Party in writing; (c) which is lawfully obtained from third parties without restriction; or (d) which can be shown to be previously known or developed by either Party independently of the other Party.

	
6.
	
INDEMNIFICATION

Subject to the Limitations of Liability under Section 7.8, the Parties agree to indemnify, defend and hold harmless each other and each other’s respective employees, directors, officers, subcontractors, agents or other members of its workforce, each of the foregoing hereinafter referred to as “indemnified party,” against all actual and direct losses suffered by the indemnified party and all liability to third parties arising from or in connection with any breach of this Agreement or of any warranty hereunder or from any negligence or wrongful acts or omissions, including failure to perform its obligations under the Privacy or Security Regulation, by the indemnifying party or its employees, directors, officers, subcontractors, agents or other members of its workforce.  Accordingly, on demand, the indemnifying party shall reimburse any indemnified party for any and all actual and direct losses, liabilities, lost profits, fines, penalties, costs or expenses (including reasonable attorneys’ fees) which may for any reason be imposed upon any indemnified party by reason of any suit, claim, action, proceeding or demand by any third party which results 

19

 

EXHIBIT 10.44

from the indemnifying party’s breach hereunder.  The Parties’ obligation to indemnify any indemnified party shall survive the expiration or termination of this Agreement for any reason.

	
7.
	
MISCELLANEOUS

	
7.1
	
Business Associate.  For purposes of this Agreement, Business Associate shall generally have the same meaning as the term “business associate” at 45 C.F.R. § 160.103, and in reference to the party to this agreement, shall mean Digital Innovation, Inc.

	
7.2
	
Survival.  The respective rights and obligations of Business Associate and Covered Entity under the provisions of Sections 4.4, 6, 7.2, 7.5, 7.8, and Section 2.1 solely with respect to Protected Health Information Business Associate retains in accordance with Section 4.4 because it is not feasible to return or destroy such Protected Health Information, shall survive termination of this Agreement indefinitely.

	
7.3
	
Amendments; Waiver.  This Agreement may not be modified, nor shall any provision hereof be waived or amended, except in a writing duly signed by authorized representatives of the Parties.  A waiver with respect to one event shall not be construed as continuing, or as a bar to or waiver of any right or remedy as to subsequent events.

	
7.4
	
No Third Party Beneficiaries.  Nothing express or implied in this Agreement is intended to confer, nor shall anything herein confer, upon any person other than the Parties and the respective successors or assigns of the Parties, any rights, remedies, obligations, or liabilities whatsoever.

	
7.5
	
Notices.  Any notices to be given hereunder to a Party shall be made via U.S. Mail or express courier to such Party’s address given below, and/or (other than for the delivery of fees) via facsimile to the facsimile telephone numbers listed below.

If to Business Associate, to:

CPM Medical Consultants, LLC __________
1565 N. Central Expy Suite 200__________
Richardson, Texas 75080______________
Attn:  Kiyoko McDonald_______________
PH:972.331.5872

If to Covered Entity, to:

Methodist Health System 
1401 N. Beckley Ave. 
Dallas, TX 75203
Attention:  Privacy Officer

with a copy (which shall not constitute notice) to:

Methodist Health System

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EXHIBIT 10.44

P.O. Box 655999
Dallas, TX 75265-5999
Attn:  Ex. Vice President — Legal Affairs

Each Party named above may change its address and that of its representative for notice by the giving of notice thereof in the manner hereinabove provided.

	
7.6
	
Counterparts; Facsimiles.  This Agreement may be executed in any number of counterparts, each of which shall be deemed an original.  Facsimile copies hereof shall be deemed to be originals.

	
7.7
	
Disputes.  If any controversy, dispute or claim arises between the Parties with respect to this Agreement, the Parties shall make good faith efforts to resolve such matters informally.

	
7.8
	
LIMITATION OF LIABILITY.  NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR ANY INCIDENTAL, CONSEQUENTIAL, SPECIAL, OR PUNITIVE DAMAGES OF ANY KIND OR NATURE, WHETHER SUCH LIABILITY IS ASSERTED ON THE BASIS OF CONTRACT, TORT (INCLUDING NEGLIGENCE OR STRICT LIABILITY), OR OTHERWISE, EVEN IF THE OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSS OR DAMAGES.

	
7.9
	
Relationship of the Parties.  Covered Entity and Business Associate agree that Business Associate’s Services hereunder are being carried out as an independent contractor and not as an employee or agent of the Covered Entity.

	
7.10
	
Modifications to HIPAA.  If HIPAA or its implementing regulations, including, but not limited to the Privacy Regulation and the Security Regulation, are modified in any way impacting this Agreement, Covered Entity and Business Associate shall, prior to the compliance date for such modifications, amend this Agreement, as appropriate, to ensure compliance with such modifications.

	
8.
	
CERTAIN DEFINITIONS

	
8.1
	
Protected Health Information.  “Protected Health Information” shall have the meaning as set out in its definition at 45 C.F.R. § 164.501, as such provision is currently drafted and as it is subsequently updated, amended or revised.

	
8.2
	
Breach.  “Breach” means the unauthorized acquisition, access, use, or disclosure of Protected Health Information, which comprises the security or privacy of such information.

 

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