Terms and Conditions

InSimili General Terms and Conditions of Sale (GTCS)

1. Scope and Acceptance

1.1 Scope: These General Terms and Conditions of Sale ("GTCS") apply exclusively to all Agreements governing the sale of Products by InSimili S.r.l. (referred to herein as "InSimili," "Seller," or "We") and the Customer (as defined below, and together as the "Parties").

1.2 Target Customer: Our offers are directed exclusively at professional Buyers (legal entities and entrepreneurs). Sales to consumers are excluded.

1.3 Acceptance: By placing an order, the Customer accepts these GTCS. The Buyer's terms and conditions are expressly excluded and do not apply, even if InSimili does not explicitly object to them.

2. Definitions

2.1 Agreement: Any offer, quotation, study proposal, or purchase order established and confirmed by InSimili and the Customer for the supply of Products.

2.2 Customer: A legal entity or entrepreneur who engages InSimili to purchase Products subject to an Agreement.

2.3 InSimili Technology: Any and all intellectual property, proprietary protocols, methods, formulas, data, and know-how related to the InSimili OxygenControl Plate, its underlying technology, and its function in regulating oxygen in vitro.

2.4 Products: The InSimili OxygenControl Plates, any InSimili custom device based on the OxygenControl technology, and any related materials provided by InSimili.

2.5 Specifications: The qualitative, quantitative, and functional characteristics of the Product, as defined exclusively by the product specifications provided in the website.

3. Offer and Agreement Formation

3.1 Offer Validity: An offer or quotation is valid for fourteen (14) days from the date of issuance.

3.2 Acceptance: The Customer must accept the offer via email or digital confirmation within the validity period. The Agreement is concluded only upon InSimili's written confirmation of the Customer's acceptance.

3.3 No Guarantee of Results: Information regarding expected results or performance is indicative. The Customer accepts that InSimili does not guarantee a particular result will be achieved due to the research nature of the Products.

4. Prices and Payment Terms

4.1 Pricing and Adjustments: Product prices are provided in InSimili's offer or quotation. The price applicable is that confirmed in the Agreement. Prices quoted are net prices (excluding VAT, duties, and taxes) unless explicitly stated otherwise. InSimili reserves the right to adjust product prices for future orders at any time.

4.2 Costs: Costs for packaging and shipping will be communicated by InSimili in the quotation.

4.3 Payment Terms: Unless otherwise specified by InSimili, Customer orders are payable by invoice within thirty (30) days of the invoice date. Alternatively, InSimili is entitled to require prepayment, which will be indicated in InSimili's offer.

4.4 Creditworthiness: If, between the date of InSimili's offer and delivery, circumstances arise that cast reasonable doubt on the Customer's creditworthiness, InSimili is entitled to convert payment by invoice to prepayment or require the granting of other security.

5. Product Characteristics and Warranties

5.1 Product Characteristics: The characteristics of the Products are defined exclusively by the Specifications. InSimili makes no promises regarding any properties or uses beyond these Specifications.

5.2 Disclaimers: Statements regarding quality or durability are NOT guarantees unless expressly agreed upon and designated as such in writing. InSimili disclaims all implied warranties of merchantability and fitness for a particular purpose.

5.3 REACH Compliance: The "identified uses" relevant to the Products under the European Chemicals Regulation (REACH Regulation) do not constitute an agreement on a corresponding contractual quality.

5.4 Advice: To the extent InSimili provides advice, it is to the best of our knowledge. Information and advice do not relieve the Buyer of their own responsibility to conduct tests and trials to determine the suitability and safety of the Products.

6. Delivery, Risk, and Retention of Title (RoT)

6.1 Delivery Terms: Delivery is subject to the terms FCA seller’s premises (FCA, Bologna, Incoterms® 2020). Delivery and service deadlines and dates provided by InSimili are always approximate and non-binding.

6.2 Partial Delivery: InSimili is entitled to make and invoice partial deliveries, provided the partial delivery is usable by the Customer within the contractual purpose and the Customer does not incur any significant uncompensated additional effort.

6.3 Risk Transfer: The risk of loss or damage to the Products passes to the Customer upon their departure from InSimili's works and handover to the shipping carrier.

6.4 Transport Damage: The Customer must report any complaints regarding transport damage directly to the transport company, with a copy to InSimili, within the specified time limits of the carrier.

6.5 Compliance with Legal Regulations: The Customer is solely responsible for obtaining and maintaining all necessary approvals, permits, and licenses for its intended use of the Products, and for ensuring their use and handling is in strict compliance with all applicable laws, rules, and regulations, including those governing import, transport, storage, and disposal.

6.6 Retention of Title (RoT) (Italian Law):

• (a) RoT until Payment: InSimili retains ownership of the delivered Products in all cases until the full purchase price and any ancillary costs related to the delivery are paid in full (as per Article 1523 of the Italian Civil Code). Until full payment, the Customer may not encumber, pledge, or otherwise transfer possession of the Products to any third party.
• (b) Cooperation: The Customer must assist InSimili in taking any measures necessary to protect the RoT in the relevant country of destination.

7. Payment Default and Security

7.1 Late Payment: Failure to pay the purchase price when due (30 days after the invoice date) constitutes a material breach of contractual obligations, and the Customer will be in default without the need for a separate reminder.

7.2 Default Interest: In the event of late payment, InSimili is entitled to charge default interest at a rate of 8 percentage points above the reference rate of the European Central Bank (pursuant to Italian Legislative Decree 231/2002), without prejudice to InSimili's right to claim further damages.

7.3 Set-off and Rights of Retention: The Customer is only entitled to set-off or to assert rights of retention insofar as their counterclaims are undisputed or have been legally established by a court of law.

8. Claims, Defects, and Remedies

8.1 Acceptance Period: The Buyer must inspect the Products immediately upon receipt. Claims for non-conformity with the Specifications must be reported to InSimili in writing within ten (10) business days from receipt of the delivery.

8.2 Exclusions: InSimili is not responsible for defects or non-compliance caused after the risk has transferred, including due to improper handling, storage, or use contrary to the provided instructions.

8.3 Sole Remedy: If a legitimate and timely defect claim is established, InSimili will, in its sole discretion, provide a one-time re-shipment of the correct Products or a partial/full refund of the purchase price. This single action constitutes the Customer’s sole and exclusive remedy for any defect.

9. Intellectual Property (IP) Protection

9.1 InSimili Technology Ownership: All Intellectual Property Rights, including all patents, copyrights, trademarks, trade secrets, know-how, and technology related to the InSimili OxygenControl Plate and its function, technology, formulation, and manufacturing process (InSimili Technology), shall remain the exclusive property of InSimili.

9.2 License Limitation: The Customer is granted only a non-exclusive, non-transferable, and limited license to use the Products solely for internal, non-commercial research and development purposes in accordance with the Specifications.

9.3 Prohibited Use (Commercial Purpose Defined): The Customer shall not use the Products for any Commercial Purpose. A "Commercial Purpose" includes, but is not limited to: (i) use in a fee-for-service capacity (e.g., as a CRO or Core Facility); (ii) use in manufacturing; (iii) use in clinical trials or diagnostics; or (iv) the production of goods for sale or creating a competing product. Furthermore, the Customer shall not attempt to reverse engineer, analyze, disassemble, modify, reproduce, or otherwise derive the underlying InSimili Technology for any reason.

9.4 Customer Improvements and Disclosure:

• (a) Disclosure: The Customer must promptly disclose to InSimili in writing any invention, discovery, improvement, modification, or derivative (collectively, "Improvements") made, conceived, or reduced to practice by the Customer (whether solely or jointly with others) that relates to the Products, the InSimili Technology, or the use thereof.
• (b) Ownership: All rights, title, and interest in and to any such Improvements, regardless of whether patentable or not, shall belong exclusively to InSimili. The Customer hereby assigns, and agrees to assign, all such Improvements to InSimili and shall execute all necessary documents and take all necessary actions, at InSimili's expense, to perfect InSimili’s ownership and to allow InSimili to file and prosecute patent applications in any country.

9.5 Request for Commercial License: Any use of the Products for a Commercial Purpose requires the Customer to first obtain a separate, written Commercial Use License Agreement from InSimili.

10. Publication / Publicity

10.1 Mutual Consent for Mentioning: Each Party may mention the other Party as a cooperation partner in relevant (i) scientific publications, presentations, or speeches and (ii) marketing documents, such as brochures and websites, only upon prior written consent of the other Party.

10.2 Customer Restrictions: The Customer shall not, without InSimili’s written consent, issue any press release or make any public statement, including any opinion or technical review, about InSimili, the Products, or the Agreement. The Customer shall likewise not publicly disclose any images of Products without the prior written consent of InSimili.

11. Confidentiality

11.1 Obligation: Each Party agrees to respect and keep strictly confidential all Confidential Information belonging to the other Party, and undertakes to respect confidentiality regarding the negotiations and execution of the Agreement.

11.2 Definition and Use: "Confidential Information" includes, but is not limited to, technical, financial, and business information. The Parties shall not use such Confidential Information for any purpose other than the performance of the Agreement and shall only disclose this information to their Representatives on a strict need-to-know basis.

11.3 Exceptions: The confidentiality obligations shall not apply to Confidential Information which: (i) is or becomes part of the public domain without fault on the part of the receiving Party; (ii) was already known by the receiving Party without breach of any legal obligation; or (iii) becomes known to the receiving Party on a non-confidential basis through disclosure by sources other than the disclosing Party who have the legal right to disclose such information.

11.4 Required Disclosure: If the receiving Party is legally required to disclose any Confidential Information by a court or governmental authority, the receiving Party shall provide the disclosing Party with prompt written notice and take all reasonable and lawful actions to avoid or minimize the extent of such disclosure.

11.5 IP Filing Restriction: Neither Party shall file a patent application or any other Intellectual Property title including any Confidential Information belonging to the other Party without the prior written authorization of said Party.

11.6 Survival and Return: The confidentiality obligations shall survive the termination of the Agreement. Upon termination, each Party will, at the other Party's written request, return or destroy all Confidential Information. The Customer may not disclose any prices or other financial terms of an Agreement to any third party without InSimili’s prior written consent, except where required by law.

12. Term and Termination

12.1 Term: These GTCS will be effective as of the signature date of the Agreement, and shall be valid until completion of the delivery of the Products, unless earlier terminated in accordance with this Section 12. The obligations which by their nature are intended to survive termination shall survive.

12.2 Termination for Cause: Each Party may terminate the Agreement for:

(i) Material Breach: Material breach by the other Party, provided the Party has given the other Party written notice of the breach and at least thirty (30) days to cure the breach; or

(ii) Insolvency: The filing or institution of bankruptcy, liquidation, or receivership proceedings of the other Party or if its business is discontinued.

12.3 Termination for Technical Difficulties: InSimili may terminate the Agreement in the event that unforeseen technical or material difficulties occur regarding the delivery of the Products, which cannot be addressed without significant changes to the timelines or prices under the Agreement.

12.4 Consequences of Termination: In the event of termination by either Party prior to the completion of the delivery, InSimili shall invoice the Customer for the costs of the Products performed by InSimili prior to the effective date of termination. The Customer shall reimburse InSimili for all non-cancellable commitments to third parties incurred as a result of the early termination.

13. Liability

13.1 Liability Scope: InSimili is liable for damages in accordance with Italian statutory provisions, but is liable for simple negligence only in the breach of essential contractual obligations (those fundamental to the contract's purpose).

13.2 Limitation: In the case of simple negligence in the breach of essential contractual obligations, InSimili's liability is strictly limited to compensation for typical, foreseeable damages. Liability for non-essential breaches is excluded.

13.3 Exclusion of Consequential Damages: InSimili shall not be liable for any indirect, incidental, special, punitive, or consequential damages (including, but not limited to, loss of profits, loss of data, or research interruption), regardless of the legal basis.

13.4 Maximum Liability: In any case, InSimili's total aggregate liability shall not exceed the amount paid by the Customer for the specific Products giving rise to the claim.

14. Force Majeure

Should events and circumstances beyond InSimili's control (such as natural disasters, war, labor disputes, shortages of raw materials and energy, transport disruptions, fire, explosion damage, or public orders) reduce the availability of goods or prevent InSimili from fulfilling its contractual obligations, InSimili: (i) is released from its contractual obligations for the duration and extent of the disruption, and (ii) is not obligated to procure the goods from third parties. If these events last longer than three (3) months, InSimili is entitled to withdraw from the contract.

15. Limitation Period (Prescription)

The limitation period (prescription) for all claims arising from defects of title and material defects, and for contractual and tortious claims for damages, shall be one year from the date of delivery of the Products. This does not apply to damages resulting from intent, gross negligence, injury to life, body or health, or to the extent that InSimili has assumed a guarantee.

16. Governing Law and Jurisdiction

16.1 Governing Law: The contractual relationship is governed by the laws of the Italian Republic, excluding its conflict of law principles and the United Nations Convention of 11 April 1980 on Contracts for the International Sale of Goods (CISG).

16.2 Place of Jurisdiction: The exclusive place of jurisdiction for all disputes arising from this Agreement is the competent court at the registered office of InSimili (Italy). InSimili is, however, also entitled to bring legal action at the Customer's general place of jurisdiction.

17. Miscellaneous

17.1 Entire Agreement and Precedence: These GTCS, together with the Agreement (offer/order confirmation), constitute the entire agreement between the Parties. The Agreement shall prevail over these GTCS, and these GTCS shall prevail over any terms stated on the Customer’s purchase order.

17.2 Amendments: No provision of this Agreement may be amended, modified, or otherwise changed, other than in writing duly executed by an authorized representative of both Parties.

17.3 Independent Contractor: InSimili is an independent contractor. Nothing in this Agreement shall be construed as establishing a principal-agent, partnership, or joint venture relationship between the Parties.

17.4 Assignment: The Customer shall not be entitled to assign or transfer any of the rights or obligations hereunder to a third party except with the prior written consent of InSimili. InSimili is entitled to assign and transfer any of the rights or obligations hereunder to any of its Affiliates or to a third party that acquires all or substantially all of its business or assets.

17.5 Severability: If any provision of these GTCS is or becomes invalid or unenforceable, the validity and enforceability of the remaining provisions shall not in any way be affected or impaired thereby. The Parties agree to replace the invalid provision with a valid, enforceable provision that best reflects the Parties' original intention.

17.6 Waiver: No waiver by a Party of a failure by the other Party to perform any provision shall operate or be construed as a waiver in respect of any other or further failure.