Lazarus 3D Corporation General Terms and Conditions

All Lazarus 3D quotations, sales, and deliveries are subject to these General Terms and Conditions (GTC). Our General Terms and Conditions shall apply exclusively. Any terms and conditions of the Customer, which deviate from these General Terms and Conditions or provide additional terms, are hereby expressly rejected. Neither our failure to object to Customer's terms and conditions nor our delivery of products nor performance of services shall be deemed an acceptance of any Customer's terms and conditions that were not expressly accepted in writing by Lazarus 3D. These General Terms and Conditions shall also apply to all future transactions with the customer.

Section 1 - General

(1.1) This General Terms and Conditions (GTC) constitutes a part of the offer by Lazarus 3D to the Customer and becomes a binding contract under the terms and conditions set forth herein when the offer is accepted by the Customer in writing. The offer shall automatically expire by the expiration date set forth in the offer and may be terminated by Lazarus 3D at any time prior to acceptance by the Customer. Upon acceptance, the Customer's obligations under this offer may not be canceled. If Customer has any objections to any provisions of this Agreement, such objections must be made in writing within ten (10) days after receipt hereof, and failure to make such objections will constitute a waiver of any such objections.

(1.2) These General Terms and Conditions, including without limitation the limited warranty stated in Section 4 and the limitation of liability stated in Section 9, shall also apply to the product that are supplied to the Customer as samples, on loan or for demonstration purposes.

Section 2 - Quotation and Delivery

(2.1) All pricing provided by Lazarus 3D is valid for 60 days from the date of the quote unless otherwise notified by Lazarus 3D.

(2.2) Any product customization questions are subject to written confirmation from Lazarus 3D.

(2.3) All delivery estimates quoted by Lazarus 3D shall begin only upon receipt of payment. If Lazarus 3D has quoted a definitive delivery date, any delay caused by the Customer shall extend the delivery date by an equivalent time.

(2.4) Customer will pay for shipping and any additional coverage required unless Customer provides shipping account numbers to cover for shipping. All orders will be quoted Ex Works. Shipping and packaging costs shall be added to the Invoice at an amount equivalent to the cost incurred by Lazarus 3D.

(2.5) Dependent on the size and quantity of the Customer order, Lazarus 3D reserves the right to ship in partial shipments.

(2.6) All delivery dates are subject to change for any cause which is unforeseen or beyond the control of Lazarus 3D or beyond the control of any Lazarus 3D suppliers or subcontractors, including but not limited to shortages of raw material or energy, mechanical breakdowns or damages to machinery, labor disturbances (strikes, lockouts), Acts of God or other circumstances that significantly hinder or render impossible our performance. The occurrence of any of the foregoing events shall suspend the performance of our obligations during the continuance of such event and shall extend the time or date for delivery to a corresponding time period. If any of the previously described events continue for more than three (3) months. The customer may, after having given us a reasonable extension of time for delivery, cancel the order. In no event shall we be liable for any damages arising out of such cancellation.

(2.5) In the event of the Customer's failure to accept the ordered products, Lazarus 3D shall, in addition to any other remedies available under applicable law, be entitled to sell the products at any price we, in our sole discretion, shall deem acceptable or (i) store the products, at Customer's expense, in a warehouse selected by Lazarus 3D at our sole discretion.

Section 3 - Price, Payment, Order Scheduling, Return

(3.1) Any orders by Customer shall become effective only if confirmed by Lazarus 3D in writing. Written quotations or order confirmations may only be modified or attended in writing and agreed to by both parties.

(3.2) A 1.5% processing fee will be added to all credit card orders. Bank transfer fees are to be paid by the Customer.

(3.2) Payment shall not be deemed to have been received by Lazarus 3D unless and until the respective amounts have been fully credited.

(3.3) Upon the Customer's failure to make payments when they are due, unpaid amounts shall bear interest at the rate of two (2) percentage points over the prevailing prime rate.

(3.4) If Lazarus 3D, in its reasonable discretion, has determined that the financial condition of the Customer at any time jeopardizes the Customer's ability to perform any of its obligations, Lazarus 3D may require cash payment, immediate payment of the entire balance, and/or furnishing collateral deemed satisfactory to Lazarus 3D.

(3.5) Customer's failure to pay timely and fully any invoice shall operate to make all our other outstanding invoices to Customer immediately due and payable and, at our sole discretion, shall be grounds for cancellation of any further performance by Lazarus 3D.

(3.6) Our receipt and acceptance of partial payments shall not constitute a waiver of any of our rights set forth herein or available to us under applicable law.

(3.7) Any collection expenses, including reasonable attorney's fees, shall be borne by the Customer.

(3.8) Order scheduling: All orders begin upon receipt of payment. Standard shipping is 7 to 10 calendar days from the date of invoice unless otherwise notified by Lazarus 3D, Inc or requested by the customer. Such change in shipping scheduling must be confirmed in writing and agreed to by Lazarus 3D.

(3.9) Pre-Sure® orders will be shipped only when the Customer has returned Lazarus 3D's BAA agreement.

(3.10) The Customer may request a change to an order by contacting support@laz3d.com no more than two business days after your order.

(3.11) Pre-Sure® products cannot be returned after delivery acceptance. All returns require written authorization from Lazarus 3D. It is within Lazarus 3D's sole discretion to accept the return.

Section 4 - Limited Warranty

(4.1) Lazarus 3D warrants that our products are free from defects in workmanship and materials under NORMAL use and service, excepting ordinary wear and tear, and inappropriate, incorrect or excessive use or application for a period of 12 months.

(4.2) Customer must inspect all products delivered without delay and notify Lazarus 3D in writing of any defects. Lazarus 3D shall not be liable in any way if the Customer fails to inspect the products upon receipt or fails to notify us in writing of any defect within seven (7) calendar days of delivery.

(4.3) In the event that Lazarus 3D and Customer agree that a defect exists, we will, at our sole discretion, correct the same by repairing the defect in the products or by delivering replacement products.

(4.4) This warranty does not cover damages caused to Customer employees, equipment or facilities by or resulting from the use of a Lazarus 3D model in an application for which the model was never intended or designed. The model's intention is specifically explained by the Customer in a written product requirements document accepted by both.

(4.5) Any modifications done to the Lazarus 3D product by customer that result in the poor performance of the product or result in any damages to the Customer's employees, and/or equipment of facility are the SOLE RESPONSIBILITY OF THE CUSTOMER.

(4.6) The warranty shall not apply to a product which has been repaired or altered not in accordance with Lazarus 3D's instructions, nor shall it apply to a product which has been subject to misuse, unauthorized use, negligence, accident, (including fire, water, explosion, smoke, vandalism, etc.) or which has been operated contrary to Lazarus 3D's instructions or any other cause beyond Lazarus 3D's control.

Section 5 - Intellectual Property

(5.1) All manufacturing processes and designs regarding all projects are the exclusive property of Lazarus 3D unless stated in writing and signed by Lazarus 3D including projects that incorporate customer designs.

(5.2) Under no circumstances will Lazarus 3D agree to proprietary distribution of a 3D Print that incorporates standard anatomical data (including pathologies) that are available to the general public.

Section 6 - Confidentiality

Customer will not disclose to third parties, nor use for any purposes other than its performance of this Agreement, any of Lazarus 3D's trade secrets or proprietary information, including Lazarus 3D's specifications, formulas or financial or business information and plans, including (without limitation) the terms of this Agreement. The terms of any separate confidentiality agreement entered into by Lazarus 3D and Customer will remain in full force and effect.

Section 7 - Training & Installation

Lazarus 3D shall provide a training document and/or session and shall provide a comprehensive training on how to use the product, where to install it or how to check for the fitness of the premises, and how to best care for it, unless otherwise specified in the Distribution Agreement. Customer shall indemnify and hold Lazarus 3D harmless against any misuse, loss, damage, or claim arising out of the not following the training recommendation and /or condition of the premises or such utilities.

Section 8 - Limitation of Liability

EXCEPT AS EXPRESSLY AGREED UPON, UNDER NO CIRCUMSTANCES SHALL LAZARUS 3D HAVE ANY LIABILITY WHETHER DIRECTLY OR BY WAY OF INDEMNITY OR OTHERWISE, INDIRECT, CONSEQUENTIAL, PUNITIVE, EXEMPLARY OR OTHER DAMAGES, INCLUDING BUT NOT LIMITED TO DAMAGES FOR INJURIES TO PERSONS OR TO PROPERTY OR LOSS OF FUTURE BUSINESS OR REPUTATION, WHETHER BASED ON BREACH OF CONTRACT, WARRANTY, TORT, STRICT OR PRODUCTS LIABILITY, INFRINGEMENT OF PATENTS. TRADE SECRETS TRADEMARKS, COPYRIGHTS OR OTHER PROPRIETARY RIGHTS OR ANY OTHER LEGAL THEORY IN CONNECTION WITH THE PURCHASE, INSTALLATION OR USE OF THE PRODUCTS OR IN CONNECTION WITH OUR PERFORMANCE UNDER OUR ORDER CONFIRMATION. THESE GENERAL TERMS AND CONDITIONS, OR ANY BREACH BY RESPECTIVELY THE CUSTOMER, LAZARUS 3D OR THEIR EMPLOYEE OF ITS DATA PROTECTION OBLIGATIONS UNDER THESE GENERAL TERMS AND CONDITIONS.

Section 9 - Applicable Law Venue, Severability

(9.1) The business relationship between Lazarus 3D and the Customer shall be governed by, and construed in accordance with, the laws of the State of Oregon without giving effect to its content.

(9.2) The invalidity or unenforceability of any one or more provisions of these General Terms and Conditions shall not affect the validity or enforceability of the remaining provisions hereafter.

Section 10 - Indemnification

Customer will indemnify and save and hold Lazarus 3D harmless from and against any and all damages, losses, claims, liabilities, or demands resulting from Customer's: (a) breach of this Agreement; (b) negligence, gross negligence, or intentional misconduct; or (c) misuse of the Products.

Section 11 - Waiver

The waiver of any term, condition or provision of this Agreement will not be construed to be a waiver of any other such term, condition or provision, nor will such waiver be deemed a waiver of a subsequent breach of the same term, condition or provision.

Section 12 - No Assignment

The Customer may not, without the prior written consent of Lazarus 3D, in whole or in part, assign this Agreement, or any rights or obligations granted in this Agreement. Lazarus 3D may, in whole or in part, assign this Agreement or any rights and undertakings hereunder.

Section 13 - Reselling and Exporting

Without the written permission of Lazarus 3D, the Product may not be moved to another country than specified in the Agreement even if ownership has not changed. Notwithstanding the above, the Customer will provide Lazarus 3D with updated contact information in any case should the models be moved to a new location.

Section 14: Lazarus 3D's Financial Conflict of Interest Policy

14.1 Objective

This Financial Conflict of Interest Policy (this “Policy”) describes certain legal obligations applicable to Investigators’ disclosure of potential Financial Conflicts of Interest (“FCOI”). The purpose of this Policy is to comply with applicable law and to ensure the objectivity of the research conducted by Lazarus 3D, Inc. and its subsidiaries (the “Company”), and their respective employees, contractors, and consultants.

This Policy requires that each Investigator, subrecipient, subgrantee and collaborator affiliated with the Company on a Funding Agency project be in compliance with 42 CFR Part 50, Subpart F for grants and cooperative agreements (and 45 CFR Part 94 for contracts). In addition, these regulations describe NIH’s commitment to preserving the public’s trust that the research supported by the NIH is conducted without bias and with the highest scientific and ethical standards. The Company intends to comply with these regulations for all other Federal Agency grant and contract efforts, as tailored or amended accordingly.

14.2 Scope

This Policy applies to Investigators applying for and working on Public Health Services (“PHS”), National Institutes of Health (“NIH”), or National Science Foundation (“NSF”) funded research. Investigators must disclose significant financial interests that are related to the Investigator’s institutional responsibilities. Investigators are all persons, regardless of title or position, who are responsible for the design, conduct, or reporting of research proposed for funding by the PHS, NIH, or NSF (the foregoing agencies, together with any other organizations providing funding through grant or contract to which the regulations contemplated herein apply, collectively, the “Funding Agencies”), including collaborators or consultants. This Policy provides the framework to identify, evaluate and correct or remove real, apparent and potential conflicts of interest.

14.3 Responsibilities

14.3.1 Investigator – responsible for reporting SFI Disclosures as per Section 6.2.1 and training on this Policy as per Section 6.

14.3.2 Policy Coordinator – responsible for reviewing each SFI Disclosure and evaluating whether any such SFI Disclosure has given rise to an FCOI as per Section 6.2.2.

14.3.3 Lazarus 3D is responsible for reporting FCOIs as per Section 6.2.2.

14.4 Terms and Definitions

14.4.1. Financial Conflict of Interest (FCOI) - exists when the Company reasonably determines that a significant financial interest could directly and significantly affect the design, conduct or reporting of Funded Research.
14.4.2. Funded Research - any research funded by a Funding Agency but excludes applications for Phase I support under the SBIR and STTR programs.
 14.4.3. Investigator - means any person (including subrecipients, subgrantees, and collaborators) who is responsible for the design, conduct, or reporting of Funded Research.
 14.4.4. Management (of an FCOI) - taking action to address an FCOI, which can include reducing or eliminating the FCOI, to ensure, to the extent possible, that the design, conduct, and reporting of Funded Research will be free from bias.
 14.4.5. Policy Coordinator - the Company’s FCOI Policy Coordinator.
 14.4.6. Significant Financial Interest (SFI) - a financial interest of the Investigator consisting of one or more of the interests described below (including those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities.
 14.4.7. SFI Disclosure - a report that each Investigator shall submit to the Policy Coordinator: (a) at the time of application for Funded Research and prior to the expenditure of any Funding Agency funds therefor; (b) annually thereafter; (b) in the event of certain sponsored travel, as set forth below; and (c) within thirty (30) days of the discovery or acquisition by an Investigator of any SFI.

14.5. Policy

14.5.1. Determination of a Significant Financial Interest (SFI)

14.5.1.1. What is an SFI?

14.5.1.1.1. With regard to any publicly traded entity, an SFI exists if the value of any remuneration received by the Investigator (or the Investigator’s spouse or dependent children) from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity, subject to the Exemptions defined below, as of the date of disclosure, when aggregated, exceeds $5,000.

14.5.1.1.2. With regard to any privately held company, a SFI exists if the value of any remuneration received by the Investigator (or the Investigator’s spouse or dependent children) from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest in the entity (e.g., stock, stock options, or other ownership interest).

14.5.1.1.3. For purposes of the definition of an SFI, remuneration includes, subject to the Exemptions defined below, salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); and equity interest includes stock, stock options, or other ownership interest, as valued through reference to the public trading price or other reasonable measures of fair market value.

14.5.1.1.4. An SFI exists, subject to the Exemptions defined below, with respect to intellectual property rights and interests (e.g., patents, trademarks, copyrights) upon receipt of (or right to receive) any income or other value related to such intellectual property rights and interests.

14.5.1.1.5. With respect to a Significant Financial Interest, Investigators also must disclose (and such disclosure shall constitute an SFI Disclosure) any reimbursed or sponsored travel (i.e., travel which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, an institution of higher education as defined at 20 USC 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. This disclosure will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. Upon receipt of this disclosure, the Policy Coordinator will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes a FCOI.

14.5.1.2. Exemptions:  What is not an SFI?

14.5.1.2.1. An SFI does not include the following types of financial interests:

14.5.1.2.1.1. Salaries, royalties, or other remuneration paid by the Company to the Investigator if the Investigator is currently employed or otherwise appointed by the Company, including with respect to intellectual property rights assigned to the Company and agreements to share in royalties related to such rights;

14.5.1.2.1.2. Any ownership interest in the Company held by the Investigator;

14.5.1.2.1.3. Income from investment vehicles, such as mutual funds and retirements accounts, as long as the Investigator does not directly control the investment decisions made by these vehicles;

14.5.1.2.1.4. Income from seminars, lectures, or teaching engagements sponsored by a federal, state or local government agency, an institution of higher education as defined at 20 USC 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education; or

14.5.1.2.1.5. Income from service on advisory committees or review panels for a federal, state or local government agency, an institution of higher education as defined at 20 USC001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.

14.5.2. SFI Disclosures and Reporting Process

14.5.2.1. Each Investigator shall submit SFI Disclosures to the Policy Coordinator as follows:

14.5.2.1.1. At the time of hire or engagement of such Investigator with respect to any Funded Research on which such Investigator shall be working;

14.5.2.1.2. At the time of application for Funded Research on which such Investigator shall be working and prior to the expenditure of any Funding Agency funds therefor;

14.5.2.1.3. Annually on or before the anniversary date of such Investigator’s initial SFI Disclosure;

14.5.2.1.4. Promptly in the event of certain sponsored travel, as set forth above; and

14.5.2.1.5. Within thirty (30) days of the discovery or acquisition of any SFI by such Investigator.

14.5.2.2. The Policy Coordinator will review each SFI Disclosure and evaluate whether any such SFI Disclosure has given rise to an FCOI. If it is determined that there is no FCOI, the SFI Disclosure will be filed with the Policy Coordinator’s SFI Disclosure records. If a FCOI is identified, it will be included in the Company’s FCOI report submitted via the online eRA Commons FCOI module (or, where the Company is a sub-grantee or sub-awardee, then the Company will report the FCOI as required under the applicable subgrant or subaward agreement) prior to the expenditure of any Funding Agency funds therefor. The Company will then report any newly identified FCOIs to the applicable Funding Agency within 60 days of the Company’s determination thereof and implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such financial conflict of interest. If an Investigator with an FCOI conducts any Funded Research, the Company shall disclose the FCOI in each public presentation related to the results of the Funded Research. The Company will also provide, on an annual basis, an annual progress report providing the status of an FCOI and any changes to the management plan.

14.5.3. Training

14.5.3.1. All Investigators are required to complete training related to this Policy and applicable law as follows:

14.5.3.1.1. Upon joining the Company;

14.5.3.1.2. Prior to engaging in Funded Research;

14.5.3.1.3. At least once every four years;

14.5.3.1.4. In the event of any modifications to this Policy that affects an Investigator’s obligations hereunder; and

14.5.3.1.5. In the event the Company determines that an Investigator is not in compliance with this Policy or any FCOI management plan. 

14.5.3.1.6. NIH web-based training can be accessed through the NIH website at https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html, and participants are required to provide the Company with proof of completion.

14.5.4. Public Disclosure and Records Management

14.5.4.1. This policy will be publicly available on the Company’s website at www.Lazarus3D.com, and certain information regarding FCOIs will be available within 10 days of a qualified written request therefor.  The Company will maintain records of all SFI disclosures, and records of resulting company management or other action with respect to the respective FCOI, for at least three years from the date of submission of the final expenditures report for the applicable Funded Research.

14.5.5. Compliance and Penalties for Non-Performance

14.5.5.1. Within 120 days of any determination by the Company that an Investigator has failed to comply with this Policy, the Company shall complete a retrospective review of such Investigator’s activities to determine the possibility of any bias in such Investigator’s research activities. If the Company determines that there has been any such bias, the Company shall submit a mitigation report to the applicable Funding Agency, in accordance with 42 CFR 50.605(b)(3), that shall address the impact of the bias on the Funded Research and the actions the Company has taken to mitigate the bias and manage the FCOI.  The Company will work with the Investigator to establish an FCOI management plan, and the Investigator shall disclose the FCOI in each public presentation related to the results of the applicable Funded Research if not previously disclosed. In certain instances, the Investigator may be prohibited from continuing to work on the project or receiving any NIH funding in the future.