AXIAL3D INSIGHT TERMS OF SERVICE (US)

Except as provided below, these terms of service apply to your use of the Axial3D Insight software, our website, any purchase of content and products through our website/software, as well as your use of any interactive features on the software and/or website.

If you are accessing our website/software in the course of your employment with an organization that has a separate Corporate Purchasing Agreement with us, these terms of service shall not apply to you, and your use is subject to that separate Corporate Purchasing Agreement.

By visiting, accessing, reviewing and/or otherwise using our software/website, its information and content and services, and various interactive features you accept, without limitation or qualification, these terms of service as a binding agreement between you and Axial Medical Printing Inc., a company with offices incorporated and registered in the State of Delaware whose primary address is 2035 Sunset Lake Road, Suite B-2, Newark, Delaware, 19702 (Axial3D).

We may change these terms from time to time. Axial3D’s business is the provision of 3D medical models and services to healthcare providers and medical technology companies and you (Purchaser) wish to obtain and Axial3D wishes to provide 3D medical printing products and/or services on the terms set out in this Agreement. Unless otherwise agreed in writing, Purchaser will use such products and/or services solely for educational, research, and/or demonstration purposes and not for the purposes of patient diagnosis, management, or
treatment.

NOW, THEREFORE, in consideration of the mutual covenants, terms and conditions set forth herein, the Parties
agree as follows:

1. DEFINITIONS

“Agreement” means these terms of service and the Request submitted by the Purchaser.

“Data Protection Laws” means all applicable data protection and privacy laws, regulations, and ordinances in force from time to time that relate to the Products, Related Software, or services provided hereunder, which may include, to the extent applicable: US and UK laws, including but not limited to the Health Insurance Portability and Accountability Act of 1996; the New York Shield Act, the California Consumer Privacy Act; the General Data Protection Regulation ((EU) 2016/679); the Data Protection Act 2018; the Privacy and Electronic
Communications Directive 2002/58/EC (as updated by Directive 2009/136/EC) and the Privacy and Electronic Communications Regulations 2003 (SI 2003/2426) as amended.

“Intellectual Property Rights” means any and all intellectual property rights related to the Products and Relevant Software, including procedures, designs, inventions and rights to invention, discoveries, know-how, show-how and works of authorship, all patents issued or issuable thereon, all copyrights and other rights in works of authorship, collections and arrangements of data, moral rights, business and domain names, rights in get-up and trade dress, mask work rights, trade secrets on a worldwide basis, trademarks, trade names, and
other forms of corporate or product identification, goodwill and the right to sue for passing off or unfair competition, rights in designs, rights in computer software, database rights, rights to use, and protect the confidentiality of, confidential information (including know-how and trade secrets) and all other intellectual property rights.

“Prices” means the prices for the Products and services agreed between Purchaser and Axial3D from time to time.

“Products” means the medical models or other products created within a 3D printed workflow (physical and virtual) to be provided by Axial3D to Purchaser. Except as otherwise explicitly set forth in this Agreement, the term “Products” does not include Axial3D’s Equipment, Relevant Software, or any Intellectual Property Rights. The definition of “Products” includes digital models as well as physical.

“Request” means an order for Products submitted by Purchaser to Axial3D and accepted by Axial3D in accordance with Section 4.

“Request Confirmation” means a request confirmation sent by Axial3D to Purchaser, agreeing to fulfil the request.

“Relevant Software” means axial3Dinsight, which is a web-based platform to manage the transfer of medical images for 3D printed and digital models.

“Specification” means the specification of the Products provided by Purchaser and set out in the Request or any other specification agreed in writing between the Parties from time to time, inclusive of any design, drawing, or input data.

“Term” means the Initial Term and any Renewal Term(s) as set out in Section 2.

“Year” means the period of 12 calendar months from the Commencement Date and each subsequent consecutive period of 12 calendar months during the Term.

2. COMMENCEMENT AND DURATION

2.1 This Agreement commences on the Commencement Date and will apply indefinitely to any Requests submitted by Purchaser unless terminated in accordance with clause 17.

3. SALE OF PRODUCTS

3.1 Axial3D will provide Purchaser with agreed quantities of the Products as have been ordered by Purchaser in a Request, provided that such Request is accepted pursuant to a Request Confirmation.

3.2 Axial3D will use commercially reasonable efforts to supply the Products to Purchaser in accordance with the Specifications and this Agreement in all material respects.

4. REQUEST PROCESS

4.1 When Purchaser wishes to place a Request for Products, it will submit a Specification using the Relevant Software. A Request will be treated as an intention by Purchaser to use services from Axial3D but will not be binding until accepted by Axial3D. Axial3D may, at its sole discretion, accept amendments to a Request after acceptance in accordance with Section 12.

4.2 Axial3D may, at its discretion, accept the Request using a Request Confirmation and this Request Confirmation will be treated as acceptance of Request. Axial3D will arrange delivery of the Products in accordance with Purchaser’s instructions specified in the Request.

4.3 If Purchaser requires a purchase order number or other similar reference in order to settle any invoices to be raised by Axial3D, such reference shall be communicated to Axial3D before Axial3D is required to start production of the Products.

4.4 Once Request has been fulfilled, any edits, variations, or repeat orders must be submitted as a new Request.

5. PRICES PAYMENT AND SECURITY INTEREST

5.1 Purchaser will pay Axial3D for the Products in accordance with any fees agreed between the Parties. Unless otherwise agreed in writing, all fees payable will be invoiced by Axial3D upon delivery of the Products and shall be payable by Purchaser within 30 days of receipt of the invoice.

5.2 Time for payment will be of the essence and no payment will be deemed to have been made until Axial3D has received payment in cleared funds to its nominated bank account (details of which will be provided to Purchaser).

5.3 If Purchaser fails to make any payment due to Axial3D under this Agreement by the due date for payment, then, without limiting Axial3D’s remedies under this Agreement or otherwise, Purchaser will pay interest on the overdue amount at the rate of 4% per annum above the effective federal funds rate reported by the Federal Reserve Bank of New York but at 4% a year for any period when that base rate is below 0%. Such interest will accrue on a daily basis from the due date until actual payment of the overdue amount, whether before or after judgment. Purchaser will pay the interest together with the overdue amount. Notwithstanding the foregoing, to the extent that the interest rate identified herein exceeds the maximum rate of interest permitted by applicable law, then such interest rate will be reduced to the maximum legally permissible rate. Additionally, Axial3D may refuse additional Requests, in its sole discretion, until full payment has been made.

5.4 All amounts due under this Agreement will be paid by Purchaser to Axial3D in full without any set-off, counterclaim, deduction or withholding (other than any deduction or withholding of tax as required by law).

5.5 Purchaser agrees that Axial3D will have a first priority security interest in the Products, which will serve as collateral for payment of the purchase. Such security interest will be extinguished upon payment in full for all Products ordered by Purchaser.

6. SPECIFICATION OF THE PRODUCTS

6.1 The Products will be produced by Axial3D for Purchaser according to the Specification. Axial3D will use its reasonable endeavours to produce the Products so that they reflect that Specification as accurately as possible, however Purchaser acknowledges that the nature of the Products is such that it is impossible to produce a model which is one hundred percent accurate and there will be discrepancies from time to time. Purchaser further acknowledges that the Products’ compliance with the Specification is dependent upon the quality and resolution of the medical imaging files that Purchaser makes available to Axial3D.

7. DELIVERY OF THE PRODUCTS

7.1 If Axial3D requires Purchaser to return any packaging materials to them, that fact shall be stated on the delivery note. Purchaser will make any such packaging materials available for collection at such times as Axial3D will reasonably request. Returns of packaging materials will be at Axial3D’s expense.

7.2 Axial3D will not be liable for any delay in delivery or non-delivery of the Products that is caused by a Force Majeure Event (or any event outside of Axial3D’s control) or Purchaser’s failure to provide Axial3D with adequate delivery instructions or any other instructions that are relevant to the supply of the Products.

8. PURCHASER’S OBLIGATIONS

8.1 Purchaser shall provide to Axial3D in a timely manner all documents, information, items and materials in any form (whether owned by Purchaser, or another third party) required under a Request or otherwise reasonably required by Axial3D in connection with the Products and ensure that they are accurate and complete in all material respects; and shall obtain and maintain all necessary licenses, permits, and consents and comply with all relevant laws as required to enable Axial3D to provide the Products.

8.2 If Axial3D’s performance of its obligations under this Agreement is prevented or delayed by any act or omission of Purchaser then, without prejudice to any other right or remedy it may have, Axial3D will be allowed an extension of time to perform its obligations equal to the delay caused by such act or omission.

8.3 If Purchaser fails to provide any information requested by Axial3D within a reasonable period of time for any given Request, Axial3D shall have the right at its sole discretion to cancel that Request and invoice Purchaser for the costs incurred up to the point of cancellation at its then-applicable rates. Purchaser shall settle such invoice in accordance with clause 5.

9. AXIAL3D’S WARRANTIES & DISCLAIMERS

9.1 Axial3D warrants to Purchaser that on delivery the Products will:

9.1.1 conform in all material respects with the Specification; and

9.1.2 be free from material defects in material and workmanship.

9.2 AXIAL3D PROVIDES NO WARRANTIES OR GUARANTEES EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT. ALL PRODUCTS ARE PROVIDED AS-IS. EXCEPT AS SET FORTH HEREIN, AXIAL3D DISCLAIMS ALL WARRANTIES AND REPRESENTATIONS AND CONDITIONS OF ANY KIND OR NATURE, EXPRESS OR IMPLIED (EITHER IN FACT OR BY OPERATION OF LAW), STATUTORY OR OTHERWISE, ALL TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, INCLUDING BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, QUALITY OR FITNESS FOR A PARTICULAR PURPOSE AND ANY WARRANTY IMPLIED BY CUSTOM OF TRADE OR COURSE OF DEALING, ANY WARRANTY AGAINST HIDDEN DEFECTS, AND/OR ANY WARRANTY REGARDING TITLE, AND ANY WARRANTY ARISING FROM CONDUCT, COURSE OF DEALING, LAW, CUSTOM, OR USAGE IN TRADE. AXIAL3D DISCLAIMS ANY WARRANTY AGAINST INFRINGEMENT EXCEPT AS SPECIFICALLY SET FORTH IN SECTION 14.2 AND SUBJECT TO THE REMEDIES SET FORTH THEREIN.

9.3 AXIAL3D FURTHER DISCLAIMS ANY AND ALL WARRANTIES AS TO ANY THIRD PARTIES. THE PARTIES FURTHER AGREE THAT THERE ARE NO THIRD PARTY BENEFICIARIES THAT MAY RELY ON OR HAVE ANY EXPECTATION OF ANY BENEFIT AS THE RESULT OF AXIAL3D’S PERFORMANCE UNDER THIS AGREEMENT.

9.4 Subject to Section 9.5, Purchaser’s sole and exclusive remedies for breach of the warranties set forth in Section 9.1 must be pursued as and are limited as follows:

(i) The Parties agree that, based on the nature of the Products, a reasonable inspection period will be the greater of ten (10) days or the minimum inspection period required by applicable law;

(ii) If Purchaser discovers a breach of Section 10.1 within ten (10) days after any specific Product is delivered, then Purchaser must notify Axial3D in writing immediately thereafter, or within the minimum reasonable time required by law;

(iii) Thereafter, unless otherwise agreed, the Purchaser must promptly return such Products breaching Section 9.1 to Axial3D’s place of business at Purchaser’s expense;

(iv) Axial3D will be given a reasonable opportunity to examine any allegedly defective Products for a period of ten (10) days after delivery of the Products to its place of business; and

(v) Axial3D will, at its sole option, and as Purchaser’s sole and exclusive remedy, either (a) repair or replace any defective Products, or (b) refund the price of the defective Products in full.

9.5 Axial3D will not be liable for Products’ failure to comply with the warranty set out in Section 9.1 in any of the following events:

(vi) Purchaser, or any other person makes any unintended use of, or alterations to, the Product; or

(vii) the defect arises as a result of Axial3D following any drawing, input data, design, or Specification supplied by Purchaser.

9.6 This Section 9 will apply to any repaired or replacement Products supplied by Axial3D.

10. PURCHASER’S WARRANTIES & INDEMNIFICATION

10.1 PURCHASER REPRESENTS AND WARRANTS THAT THE PRODUCTS ARE BEING ORDERED, AND WILL BE USED, FOR EDUCATIONAL OR DEMONSTRATION PURPOSES ONLY. THE PARTIES ACKNOWLEDGE AND AGREE THAT AXIAL3D DOES NOT PROVIDE MEDICAL OR HEALTH CARE OR LEGAL SERVICES AND IS NOT RESPONSIBLE IN ANY MANNER FOR OVERALL PATIENT CARE OR OUTCOMES OR CLIENT OUTCOMES OR PRODUCT LEGAL ADMISSIBILITY. AXIAL3D MAKES NO REPRESENTATIONS AS TO THE QUALITY OR ADEQUACY OF MEDICAL SERVICES OR COURSE OF TREATMENT, ACCURACY OF DIAGNOSES, OR THE APPROPRIATENESS OF MEDICAL EVALUATIONS OR OPINIONS RENDERED.

10.2 UNLESS DUE TO FAILURE TO COMPLY WITH ANY WARRANTY, AXIAL3D’S PRODUCTS ARE NOT REIMBURSABLE. AXIAL3D MAKES NO REPRESENTATION TO PURCHASER REGARDING PURCHASER’S ABILITY TO CHARGE, BILL, OR SEEK REIMBURSEMENT FROM ANY CLIENT, PATIENT, INSURER, HEALTH PLAN, GOVERNMENT HEALTHCARE PROGRAM, PAYOR, OR OTHER THIRD-PARTY IN RELATION TO THE PRODUCTS. PURCHASER AGREES THAT IT IS SOLELY LIABLE FOR THE SAME AND REPRESENTS TO AXIAL3D THAT IT WILL EXERCISE ALL REASONABLE EFFORTS TO COMPLY WITH ALL APPLICABLE LAWS AND REGULATIONS PERTAINING TO CODING, BILLING, REIMBURSEMENT, AND THE COLLECTION FOR SUCH PRODUCTS.

10.3 PURCHASER AGREES TO INDEMNIFY, DEFEND, AND HOLD HARMLESS AXIAL3D AND ITS OFFICERS, DIRECTORS, MANAGERS, SHAREHOLDERS, PRINCIPALS, AGENTS, EMPLOYEES, CONTRACTORS, PARENTS, SUBSIDIARIES, HEIRS, SUCCESSORS, AND ASSIGNS FROM AND AGAINST ALL LIABILITIES, COSTS, EXPENSES, DAMAGES, CLAIMS, LAWSUITS, ADMINISTRATIVE ACTIONS, CIVIL ACTION, AND LOSSES (INCLUDING BUT NOT LIMITED TO ANY DIRECT, INDIRECT OR CONSEQUENTIAL LOSSES, LOSS OF PROFIT, LOSS OF REPUTATION AND ALL INTEREST, PENALTIES AND LEGAL COSTS (CALCULATED ON A FULL INDEMNITY BASIS) AND ALL OTHER REASONABLE PROFESSIONAL COSTS AND EXPENSES) THAT ARISE OUT OF OR ARE RELATED TO ANY BREACH OF THIS AGREEMENT.

11. TITLE AND RISK

11.1 Risk in the Products will pass to Purchaser on completion of delivery, and all risk of loss or damage to Products in transit is upon Axial3D.

11.2 If Purchaser fails to give Axial3D written notice of a defect in the Products within the time period for inspection set forth in Section 9.4(i), the Products will be deemed to have been delivered complete, undamaged, without a defect, conforming to Purchaser’s Request and accepted by Purchaser, and Purchaser waives rejection or revocation of acceptance of such Products. Purchaser’s sole remedies for any defects are those identified in Section 9.4.(v).

11.3 Title to the Products will not pass to Purchaser until Axial3D receives payment in full (in cash or cleared funds) for the Products and any other Products that Axial3D have supplied to Purchaser in respect of which payment has become due, in which case title to the Products will pass at the time of payment of all such sums.

12. CHANGES TO REQUESTS

12.1 If Purchaser wishes to request a change to a Request it will notify Axial3D and provide as much detail as Axial3D reasonably requires of the proposed changes, including:

(i) the timing of the proposed changes;

(ii) the possible effect of the proposed changes on Axial 3D’s pricing;

(iii) the effect of the proposed changes on the timetable for provision of the Products; and

(iv) the effect of the proposed changes on the terms of this Agreement.

12.2 Axial3D will, at its absolute discretion and as soon as reasonably practicable after receiving the required information at 12.1 provide Purchaser with a decision as to whether the proposed changes are accepted and, if applicable, whether any additional fees are payable as a result of the proposed changes.

13. INTELLECTUAL PROPERTY RIGHTS

13.1 Purchaser agrees that all aspects of the Intellectual Property Rights, Relevant Software, and associated documentation, including, without limitation, the source and object code, and the design and structure of individual programs/services/solutions, the business model, patents (including patents pending), copyrights, trademarks, trade secrets and other aspects of the Products constitute Intellectual Property of Axial3D or its lessors/licensors. Purchaser will not in any manner use, disclose, provide, or otherwise make available, such Intellectual Property Rights, in any form to any third party, without the prior written consent of Axial3D.

13.2 During the Term of this Agreement, and solely during the Term of this Agreement, Axial3D grants Purchaser, or will procure the direct or indirect grant to Purchaser of, a limited, fully paid, non exclusive, non-transferable, non-sublicensable, revocable right and license to use only worldwide the Relevant Software for the sole purpose of receiving and ordering the Products in its business on the relevant terms and conditions of the Relevant Software applicable when registering to use it.

13.3 Purchaser will not:

(i) use or disclose the Relevant Software or any portion of its underlying source code to any third parties;

(ii) sell, lease, give, license, sub-license, assign or otherwise transfer the rights granted in Section 13.2.

13.4 Axial3D warrants to Purchaser (and not to any other persons) that the receipt and use of the Products and Relevant Software by Purchaser will not infringe the rights, including any Intellectual Property Rights, of any third party; provided, however, that such warranty will not apply to the extent the infringement arises from:

(i) the use of the Specification in the development of, or the inclusion of the Specification in any Product;

(ii) any modification of the Products, other than modifications made by Axial3D; and

(iii) compliance with Purchaser’s Specifications or instructions or data input.

13.5 Subject to Section 13.4, if a claim is made that all or any portion of any Product infringes on the proprietary rights of a third party, Axial3D will, at its sole cost and expense and as the Purchaser’s sole and exclusive remedy, either procure for Purchaser the right to continue to use the Product or replace or modify the Product so that it becomes non-infringing, or, at Axial3D’s discretion, refund to Purchaser the cost of the Products up to the limits set forth in this Agreement.

13.6 Purchaser warrants that the receipt and use of the Specification(s) and the data provided by Purchaser (including medical imaging data) to Axial3D in the performance of this Agreement by Axial3D, its agents, subcontractors or consultants will not infringe the rights of any third party, including any privacy rights or Intellectual Property Rights.

13.7 Purchaser hereby grants Axial3D a perpetual irrevocable fully paid-up transferrable and sublicensable licence to use any materials and data provided by the Purchaser pursuant to this Agreement to use such materials and data on an anonymised basis to train, develop and improve the Relevant Software and the underlying technology used to produce the Products.

14. CONFIDENTIALITY

14.1 Each Party agrees that it may not at any time during or after the Term of this Agreement use or disclose to any person any confidential information, including information concerning the other Party’s business, affairs, customers, clients, or suppliers, except as permitted by Section 15.2.

14.2 A Party may use or disclose the other Party’s confidential information only:

(i) As set forth in this Agreement, and to exercise its rights and perform its obligations under or in connection with this Agreement;

(ii) to its employees, officers, representatives, or advisers who need to know such information for the purposes of exercising a Party’s rights or carrying out its obligations under or in connection with this Agreement. Each Party will ensure that its employees, officers, representatives or advisers to whom it discloses the other Party’s confidential information comply with this Section 14; and

(iii) As may be required by law, a court of competent jurisdiction or any governmental or regulatory authority.

14.3 Notwithstanding anything to the contrary, Purchaser agrees that Axial3D’s intellectual property, business plans, source code, protocols, methods of operation, know-how, marketing materials, and the identities of its customers, licensors, vendors, and suppliers as they each may exist occasionally, are valuable, special and unique assets of Axial3D and are deemed to be its “Trade Secrets.” Purchaser represents and warrants that it will protect and maintain in strict confidence any and all of Axial3D’s Trade Secrets and will never disclose such Trade Secrets without the express written consent of Axial3D (including upon expiry or termination of this Agreement).

15. DATA PROTECTION AND HIPAA

15.1 The Parties warrant that they will comply with all of their respective obligations under the Data Protection Laws.

15.2 It is the intent of the Parties that in performing its duties hereunder, Axial3D will not have access to, and Purchaser will not deliver to or share with Axial3D any personal data or special category data, and Purchaser shall ensure that any Request or other communication submitted to Axial 3D does not contain such data. In the event that any personal data or special category data is shared, the Parties agree to enter into a separate Data Sharing Agreement.

15.3 Furthermore, Purchaser will endeavor to deliver to Axial3D the minimum amount necessary of any protected health information and will anonymise or de-identify any data that is provided to Axial3D. To the extent that Axial3D is deemed to be the business associate of Purchaser, the Parties agree that the Business Associate Addendum, which is attached as SCHEDULE 1 will apply. Axial3D may access/use patient data provided (if any) to respond to service or technical problems or at Purchaser’s request, as may be necessary to provide the Products/Axial3D’s services, and as otherwise set forth in the HIPAA Business Associate Addendum.

16. LIMITATION OF LIABILITY

16.1 To the maximum extent permitted by law, neither Party will under any circumstances whatever be liable to the other Party, whether in contract, tort (including negligence), breach of statutory duty, or otherwise, for indirect, exemplary, punitive, special, incidental, or consequential damages or losses; lost profits or interest or anticipated savings or revenue or goodwill or data or images or business opportunities or business interruption; loss of use; the cost of procurement of substitute items or services; cost of capital; or claims of third parties (including, but not limited to, claims related to legal or medical malpractice, medical diagnosis, or other liabilities from the use (intended or non-intended of the Products).

16.2 Except under any indemnity, each Party’s total liability to the other Party in respect of all other loss or damage arising under or in connection with this Agreement, whether in contract, tort (including negligence), breach of statutory duty, or otherwise, will in no circumstances exceed one hundred and twenty percent (120%) of the Prices paid for the Product in question.

16.3 Nothing in this Agreement shall limit or exclude the liability of either party for: death or personal injury resulting from negligence; fraud or fraudulent misrepresentation; breach of the terms implied by clause 12 of the Sale of Goods Act 1979; or breach of clause 2 of the Consumer Protection Act 1987.

17. TERMINATION AND CONSEQUENCES OF TERMINATION

17.1 Without affecting any other rights or remedies to which it may be entitled, either Party may give notice in writing to the other terminating this Agreement immediately if:

(i) the other Party commits a material breach of any obligation under this Agreement, and in the case of a breach which is capable of remedy fails to remedy it within fourteen (14) days of receipt of notice from the first Party of such breach and of its intention to exercise its rights under this Section;

(ii) the other Party will: (a) become insolvent or file or have filed against it a petition in bankruptcy (which is not dismissed within thirty (30) days after it is filed); (b) make an assignment for the benefit of creditors; or (c) dissolve or cease to do business in the ordinary course or as a going business;

(iii) the other Party has a receiver or administrative receiver or administrator or similar official appointed over all or any of its assets and not discharged within a period of thirty (30) days;

(iv) the other Party is declared insolvent or makes any general composition with its creditors; or

(v) if the other Party ceases or threatens to cease to carry on the whole or any material part of its business.

17.2 Any provision of this Agreement that expressly or by implication is intended to come into or continue in force on or after termination or expiry of this Agreement will remain in full force and effect, including but not limited to any provisions establishing a right to indemnification and any/all continuing warranties made by Purchaser.

17.3 Termination or expiration of this Agreement will not affect any rights, remedies, obligations or liabilities of the Parties that have accrued up to the date of termination or expiration, including the right to claim damages in respect of any breach of this Agreement which existed at or before the date of termination or expiry.

18. FORCE MAJEURE

18.1 Force Majeure Event means any circumstance not within a Party’s reasonable control including, without limitation:

(i) acts of God, flood, storm, drought, earthquake, or other natural disaster;

(ii) epidemic or pandemic;

(iii) terrorist attack, civil war, civil commotion or riots, war, threat of or preparation for war, armed conflict, imposition of sanctions, embargo, or breaking off of diplomatic relations;

(iv) nuclear, chemical or biological contamination or sonic boom;

(v) any law or any action taken by a government or public authority, including without limitation, laws imposing an export or import restriction, quota or prohibition;

(vi) collapse of buildings, breakdown of plant or machinery, fire, explosion or accident; and

(vii) interruption or failure of utility service.

18.2 If a Party is prevented, hindered or delayed in or from performing any of its obligations under this Agreement by a Force Majeure Event (“Affected Party”), the Affected Party will not be in breach of this Agreement or otherwise liable for any such failure or delay in the performance of such obligations. The time for performance of such obligations will be extended accordingly. For the avoidance of doubt, the timely payment obligations of a Party will not be excused as the result of a Force Majeure Event.

18.3 The Affected Party will:

(i) as soon as reasonably practicable after the start of the Force Majeure Event but no later than thirty (30) days from its start, notify the other Party in writing of the Force Majeure Event, the date on which it started, its likely or potential duration, and the effect of the Force Majeure Event on its ability to perform any of its obligations under this Agreement;

(ii) use all reasonable endeavours to mitigate the effect of the Force Majeure Event on the performance of its obligations; and

(iii) as soon as reasonably possible after the end of the Force Majeure Event, notify the other Party that the Force Majeure Event has ended and resume performance of its obligations under this Agreement.

18.4 If the Force Majeure Event prevents, hinders or delays the Affected Party’s performance of its obligations for a continuous period of more than six (6) weeks, the Party not affected by the Force Majeure Event may terminate this Agreement by giving written notice to the Affected Party.

19. COMPLIANCE AND CORPORATE CITIZENSHIP.

19.1 Each Party will comply with applicable law. Each Party is responsible for its own compliance with the same, and neither Party is relying upon the other’s representations, warranties, or assertions with respect to the legality or propriety of the other Party’s operations.

20. OTHER PROVISIONS

20.1 This Agreement constitutes the complete and exclusive statement of agreement and understanding between the Parties, which supersedes and excludes all prior or contemporaneous proposals, understandings, agreements, or representations, whether oral or written, with respect to the subject matter hereof.

20.2 No amendment or variation of this Agreement will be effective unless it is in writing and signed by the Parties (or their authorized representatives).

20.3 This Agreement is personal to the Parties and neither Party will assign, transfer, mortgage, charge, subcontract, declare a trust over or deal in any other manner with any of its rights and obligations under this Agreement without the prior written consent of the other Party (which will not be unreasonably withheld, delayed or conditioned).

20.4 Notwithstanding the foregoing, Axial3D may assign this Agreement as part of a corporate reorganization, consolidation, merger, acquisition, change of control with respect to its outstanding stock, or sale of substantially all of its assets, and provided further that Axial3D will remain liable for any unperformed obligations under this Agreement arising prior to the effective date of any such transaction.

20.5 No failure or delay by a Party to exercise any right or remedy provided under this Agreement or by law will constitute a waiver of that or any other right or remedy, nor will 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 will preclude or restrict the further exercise of that or any other right or remedy.

20.6 If any provision or part-provision of this Agreement is or becomes invalid, illegal or unenforceable, it will be deemed modified to the minimum extent necessary to make it valid, legal and enforceable. If such modification is not possible, the relevant provision or part-provision will be deemed deleted. Any modification to or deletion of a provision or part-provision under this Section will not affect the validity and enforceability of the rest of this Agreement.

20.7 Except as explicitly identified herein, there are no third-party beneficiaries of this Agreement and a person who is not a party to this Agreement will not have any rights to enforce any term of this Agreement.

20.8 Nothing in this Agreement is intended to, or will be deemed to, establish any partnership or joint venture between any of the Parties, or authorize any Party to make or enter into any commitments for or on behalf of any other Party.

20.9 This Agreement may be executed in any number of counterparts, each of which when executed and delivered will constitute a duplicate original, but all the counterparts will together constitute the one agreement. Signatures to this Agreement or to any such counterpart, may be delivered by electronic means and will be treated in all manner and respects as an original executed counterpart and will be considered to have the same binding legal effect as if it were the original signed version delivered in person.

20.10 Purchaser hereby grants Axial3D the right to use/disclose Purchaser’s name and corporate branding on customer lists and in any communication to the general public or to current or potential customers. This use/disclosure will not affect the confidentiality of the remainder of the Agreement or any other confidential information.

20.11 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) will be governed by and construed in accordance with the law of Delaware, without regard to its conflicts of laws or choice of law rules, and further to the exclusion of the United Nations Convention on Contracts for the International Sale of Goods. Each party and its counsel have participated fully in the review and revision of this Agreement. Any rule of construction to the effect that ambiguities are to be resolved against the drafting party will not apply in interpreting this Agreement. The language in this Agreement will be interpreted as to its fair meaning and not strictly for or against any party.

20.12 Each Party irrevocably agrees that the courts of Delaware will apply its laws (excluding choice of law provisions) and its jurisdiction to settle any dispute or claim arising out of or in connection with this Agreement or its subject matter or formation (including non-contractual disputes or claims) and each Party waives any objection to venue therein.


SCHEDULE 1

HIPAA Business Associate Addendum

(Only Applicable if Axial3D is Deemed a Business Associate)

THIS HIPAA BUSINESS ASSOCIATE ADDENDUM (the “Addendum”) is entered into by and between Axial3D (“Business Associate”), and Purchaser, on behalf of itself and its and affiliates, if any (individually and collectively, the “Covered Entity”), and adds to any current or future agreement(s) for services entered into between Business Associate and Covered Entity which involve the creation, use, receipt, or disclosure of PHI (the “Agreement”).

Pursuant to the Agreement, Business Associate may perform functions or activities on behalf of Covered Entity involving the use and/or disclosure of protected health information received from, or created or received by, Business Associate from/on behalf of Covered Entity (“PHI”). Therefore, if Business Associate is functioning as a business associate to Covered Entity, Business Associate agrees to the following terms and conditions set forth in this Addendum.

1. Definitions and Regulatory References.

For purposes of this Addendum, the terms used herein, whether or not capitalized, unless otherwise specifically defined, will have the same meanings as used in the Health Insurance Portability and Accountability Act of 1996, and any amendments or implementing regulations and the Health Information Technology for Economic and Clinical Health Act (Title XIII of the American Recovery and Reinvestment Act of 2009), and any amendments or implementing regulations (collectively, “HIPAA”, inclusive of the Privacy, Security, Breach Notification, and Enforcement Rules at 45 C.F.R. Part 160 and 164). A reference in this Addendum to any provision of a law or regulation means the provision as then in effect, amended, or implemented via regulation.

2. Compliance with Applicable Law.

The parties acknowledge and agree that Business Associate will comply with its obligations under this Addendum and with all obligations of a business associate under HIPAA. All other provisions of HIPAA that are applicable to Business Associate, and its relationship with Covered Entity under this Addendum and the Agreement, will be and by this reference hereby are incorporated into this Addendum.

3. General Limitation on Uses and Disclosures of PHI.

Business Associate will not, and will ensure that its directors, officers, employees, subcontractors and agents do not, use or disclose PHI in any manner that is not permitted or required by the Agreement, this Addendum, or by law. Business Associate may also not use or disclose PHI in a manner that would violate Subpart E of 45 C.F.R. Part 164 of HIPAA if done by Covered Entity, except, Business Associate may use or disclose PHI for Business Associate’s own management and administration and legal responsibilities or for data aggregation services.

4. Permissible Use and Disclosure of PHI.

Business Associate may only use and disclose PHI as is specifically and minimally necessary to carry out its duties to Covered Entity pursuant to the terms of the Agreement and as otherwise allowed by this Addendum.

5. Uses and Disclosures for Management and Administration.

Business Associate may also use and disclose PHI: (i) for its own proper management and administration; and/or (ii) to carry out its legal responsibilities. If Business Associate discloses PHI to a third party for either above reason, unless such disclosure is required by law, prior to making any such disclosure, Business Associate must obtain: (a) reasonable written assurances from the receiving party that such PHI will be held and remain confidential and be used and further disclosed only as required by law or for the purposes for which it was disclosed to such receiving party; and (b) an agreement from such receiving party to immediately notify Business Associate of any instances of which it is aware in which the confidentiality of the PHI has been compromised. Without limiting the foregoing, Business Associate may permit access to the system by Business Associate’s contracted system developers under appropriate confidentiality agreements.

6. Data Aggregation Services; De-Identified Data; Limited Data Sets; Other Data Uses.

Business Associate may use and further disclose PHI to provide data aggregation services as permitted by 45 C.F.R. § 164.504(e)(2)(i)(B). Business Associate may use PHI to prepare activity or quality reports and analyses or other reports that may from time to time be necessary or integral or related to either the services provided under the Agreement or for Business Associate’s own management and administration. Such reports and analyses will not make any disclosure of PHI that is not permitted by applicable laws, rules and/or regulations, or under the Agreement or this Addendum. Business Associate may also use PHI to de-identify the PHI in accordance with 45 C.F.R. §§ 164.502(d) and 164.514(a)-(c). Business Associate may create Limited Data Sets (“LDS”) from PHI. Business Associate may disclose the LDS for any purpose allowable by applicable law, rule and/or regulation. Business Associate will require the recipient of the LDS to enter into a Data Use Agreement specifying that the permitted uses and disclosures of the LDS are limited to the purpose of research, public health, or health care operations, and restrictions and/or guidelines on use of the LDS. Business Associate may use PHI to identify patients of Covered Entity who may be eligible for certain programs, including, but not necessarily limited to including savings programs, coupons, sampling, educational, safety, adherence or treatment support materials which you may choose to share with your patients, and to provide notification of same. Said notifications of potential eligibility are not a substitute for Covered Entity’s professional medical judgment regarding the appropriateness of said programs for a patient. Business Associate may receive remuneration in connection with presenting Covered Entity with patients’ eligibility for said programs. Business Associate may incorporate information received from Covered Entity’s authorized service providers, Business Associates third party associates, or other covered entities (including their business associates) who are providing or paying for services for one or more of Covered Entity’s patients, into the services provided by Business Associate. Covered Entity hereby authorizes Business Associate to request and receive such information on Covered Entity’s behalf and to incorporate same as described herein. Finally, Covered Entity acknowledges and agrees that Business Associate may engage in further data use/disclosure activities (to the extent permitted by law), and that such activities may not be explicitly described herein. Covered Entity agrees to the same, so long as Business Associate conducts its activities in accordance with law.

It is further acknowledged and agreed that without the rights conferred in this Section 6 Business Associate would not have agreed to or entered into the Agreement or this Addendum. All rights, title and interest to any De-Identified Data, aggregated data, LDS data, or other data created by Business Associate is the exclusive property of Business Associate, who may use, disclose, market, license and sell such data for any allowable purpose, and without restriction, without further consideration. In many instances, such data is no longer PHI and is no longer subject to HIPAA. Further, it is explicitly acknowledged that Business Associate may receive any allowable remuneration in connection with the same.

Minimum Necessary. All uses and disclosures of, and requests by, Business Associate for PHI are subject to the minimum necessary rule of the HIPAA Privacy Rules. Business Associate will comply with the same.

7. Required Safeguards To Protect PHI.

Business Associate agrees that it will implement appropriate safeguards in accordance with the HIPAA Privacy and Security Rules to prevent the use or disclosure of PHI other than pursuant to the terms and conditions of this Addendum. In doing so, without limitation, Business Associate will comply with Subpart C of 45 C.F.R. Part 164 with respect to electronic PHI.

8. Reporting of Improper Uses and Disclosures of PHI, Security Incidents, and Breaches.

Business Associate will promptly report to Covered Entity any security incident, or any use or disclosure of PHI which is not provided for in this Addendum or is otherwise violative of HIPAA, of which it becomes aware. This provision applies regardless of whether such unauthorized use or disclosure was by Business Associate, its officers, directors, employees, agents, subcontractors, or by any third party. Business Associate will promptly report to Covered Entity a Breach of Unsecured PHI, in accordance with 45 C.F.R. §§ 164.400-414.

9. Mitigation of Harmful Effects.

Business Associate agrees to mitigate, to the extent practicable, any harmful effect of an unauthorized use or disclosure of PHI by Business Associate in violation of the requirements of this Addendum or HIPAA.

10. Business Associate Agreements Required With Third Parties.

Business Associate will enter into a written agreement with any agent or subcontractor of Business Associate that will have access to PHI, or who will create, receive, maintain, or transmit PHI on behalf of Business Associate. Pursuant to such written agreement and 45 C.F.R. §§ 164.502(e)(1)(ii) and 164.308(b)(2), the agent or subcontractor will agree to be bound by the same restrictions, terms, conditions, and requirements that apply to Business Associate under this Addendum with respect to such PHI.

11. Access to Information.

Promptly upon a request by Covered Entity, Business Associate will make available PHI maintained by Business Associate in a Designated Record Set, to Covered Entity, as necessary to satisfy Covered Entity’s obligations under 45 C.F.R. § 164.524. In the event any individual delivers directly to Business Associate a request for access to PHI, Business Associate will promptly forward such request to Covered Entity. Unless otherwise required by law, the term “Designated Record Set,” for the purposes of this Addendum, will not include any information in the possession of Business Associate that is the same as information in the possession of Covered Entity (information will be considered the same information even if the information is held in a different format, medium or presentation or it has been standardized). Business Associate may charge Covered Entity a reasonable fee for such access.

12. Availability of PHI for Amendment.

Promptly upon the receipt of a request from Covered Entity, Business Associate will make any amendment(s) to PHI maintained by Business Associate in a Designated Record Set as directed or agreed to by Covered Entity pursuant to 45 C.F.R. § 164.526, or take other measures as necessary to satisfy Covered Entity’s obligations under 45 C.F.R. § 164.526. In the event any individual delivers directly to Business Associate a request for amendment to PHI, Business Associate will promptly forward such request to Covered Entity.

13. Access and Amendment Responsibility.

Pursuant to HIPAA, in the event that Business Associate maintains PHI in a Designated Record Set, the parties agree that Covered Entity will have the responsibility to handle, track and maintain records of all requests by individuals to access or amend such PHI. Business Associate, as a business associate of Covered Entity, will not have any responsibility to handle, track and maintain records of any such requests except as set forth above or in the Agreement.

14. Documentation and Accounting of Disclosures.

Business Associate will maintain, and make available promptly upon a request by Covered Entity, the information required to provide an accounting of disclosures, to Covered Entity, as necessary to satisfy Covered Entity’s obligations under 45 C.F.R. § 164.528. In the event the request for an accounting is delivered directly to Business Associate, Business Associate will promptly forward such request to Covered Entity. Unless otherwise required by changed HIPAA regulations or the Agreement, in response to a request from an individual for an accounting of disclosures from an electronic health record maintained or hosted by Business Associate, Covered Entity will provide the individual with an accounting of disclosures in accordance with HIPAA. Unless otherwise required by changed HIPAA regulations or the Agreement, with respect to Business Associate, Covered Entity may not elect to provide an individual with Business Associate’s name and contact information.

15. Business Associate Performing Covered Entity’s Obligations (If Applicable).

To the extent that Business Associate is required by this Addendum or the Agreement to carry out one or more of Covered Entity’s obligation(s) under Subpart E of 45 C.F.R. Part 164, Business Associate must comply with the requirements of Subpart E that apply to Covered Entity in the performance of such obligation(s).

16. Availability of Books and Records.

Business Associate hereby agrees to make its internal practices, books, and records relating to the use and disclosure of PHI available to the Secretary of the Department of Health and Human Services for purposes of determining compliance with HIPAA.

17. Term and Termination.

The Term of this Addendum will be effective as of the effective date of the underlying Agreement(s), and will terminate on the termination or expiration of the last of the underlying Agreement(s), or on the date Covered Entity terminates this Addendum as authorized below, whichever is sooner. Covered Entity may: (i) terminate this Addendum if Covered Entity reasonably determines that Business Associate has violated a material term of HIPAA or this Addendum; or (ii) at Covered Entity’s option, Covered Entity may permit Business Associate to cure or end any such violation within the reasonable period of time specified by Covered Entity.

18. Effect of Termination of Addendum.

Upon the termination or expiration of this Addendum for any reason, Business Associate, with respect to PHI received from Covered Entity, or created, maintained, or received by Business Associate on behalf of Covered Entity, will do the following:

  • Retain only that PHI which is necessary for Business Associate to continue its proper management and administration or to carry out its legal responsibilities or for which it is not feasible for Business Associate to return or destroy;
  • Return to Covered Entity, or, if agreed to by Covered Entity, destroy, other remaining PHI that the Business Associate still maintains in any form, recorded on any medium, or stored in any storage system;
  • Continue to use appropriate safeguards and comply with Subpart C of 45 C.F.R. Part 164 with respect to electronic PHI to prevent use or disclosure of the PHI, other than as provided for in this Section, for as long as Business Associate retains the PHI;
  • Not use or disclose the PHI retained by Business Associate other than for the purposes for which such PHI was retained and subject to the same conditions set forth in this Addendum which applied prior to termination; and
  • Return to Covered Entity, or, if agreed to by Covered Entity, destroy, the PHI retained by Business Associate when it is feasible to do so and the PHI is no longer needed by Business Associate for its proper management and administration or to carry out its legal responsibilities.

Notwithstanding the foregoing, the parties agree that it is infeasible for Business Associate to destroy PHI, and that Business Associate needs to retain PHI for its proper management and administration and to carry out its legal responsibilities. Business Associate will remain bound by the provisions of this Addendum, which will survive even after termination or expiration of the Agreement or Addendum.

19. Covered Entity Obligations.

Covered Entity will notify Business Associate of any limitation(s) in the notice of privacy practices of Covered Entity under 45 C.F.R. § 164.520, to the extent that such limitation may affect Business Associate’s use or disclosure of PHI. Covered Entity will notify Business Associate of any changes in, or revocation of, the permission by an individual to use or disclose his or her PHI, to the extent that such changes may affect Business Associate’s use or disclosure of PHI. Covered Entity will notify Business Associate of any restriction on the use or disclosure of PHI that Covered Entity has agreed to or is required to abide by under 45 C.F.R. § 164.522, to the extent that such restriction may affect Business
Associate’s use or disclosure of PHI. Covered Entity will not request for Business Associate to use or disclose PHI in any manner that would not be permissible under Subpart E of 45 C.F.R. Part 164 if done by Covered Entity, except that Business Associate may use or disclose PHI for data aggregation or management and administration and legal responsibilities of Business Associate.

20. Third Party Rights.

The terms of this Addendum do not grant any rights to any parties other than Business Associate and Covered Entity.

21. Independent Contractor Status.

For the purpose of this Addendum, Business Associate is an independent contractor of Covered Entity, and will not be considered an agent of Covered Entity.

22. Changes in the Law.

The parties agree that, with no further action required by the parties, this Addendum will be deemed automatically amended to include and incorporate amendments or revisions to HIPAA, so that the parties remain in compliance with such amendments or revisions. All references to regulations or provisions of HIPAA herein will be deemed to also refer to any amendment or revision thereto and/or to any successor regulation.

If, as a result of any amendments or revisions to HIPAA, both parties determine that modifications to the terms of this Addendum: (i) may not be deemed to be automatically incorporated into this Addendum; and (ii) are strictly required by HIPAA to be reduced to writing; the parties agree to take such action as is necessary to enter into a mutually acceptable amendment to this Addendum that addresses solely the legal changes that are required to be reduced to writing. The parties agree that this Addendum may only be modified by mutual written amendment, signed by both parties, effective on the date set forth in the amendment. Neither party has the right to unilaterally amend or alter the provisions of this Addendum.

23. Interpretation and Conflicts.

Any ambiguity in this Addendum will be interpreted to permit compliance with HIPAA. If there is any direct conflict between the Agreement and this Addendum, the terms and conditions of this Addendum will control.