Terms and Conditions

For optimal processing, please direct all orders and shipment-related correspondence to: Cellution Biologics Customer Service Department Tel: 1-888 575-7357 | E-mail: customerservice@cellutionbiologics.com

The Customer Service Department operates on weekdays from 8 a.m. EST to 5 p.m. EST (excluding U.S. national holidays).

Terms and Conditions of Sale

These Terms and Conditions of Sale (“Terms”) govern the purchase of Cellution Biologics (“Cellution”) products. If the Customer and Cellution have entered a separate written agreement (“Purchase Agreement”), the Purchase Agreement will control to the extent of a conflict with these Terms. Otherwise, Cellution rejects any and all terms proposed by the customer, whether included in the customer’s purchase order or elsewhere. Unless otherwise noted, all communications to Cellution shall be to Cellution’s Customer Service email address: customerservice@cellutionbiologics.com (the “Cellution Email”).

• Customer Account.

  Before placing any order for Products, the Customer must first register for a Cellution account (“Account”) by contacting Cellution Customer Services via the Cellution Email.

• Ordering Requirements.
  

  All orders for Products must (a) be submitted directly to Cellution via the Cellution Email, using Cellution’s current purchase order form; (b) comply with Cellution’s current lead time, payment, and delivery requirements; (c) incorporate these Terms; (d) identify the Products and quantity being purchased; and (e) include the requested shipping destination and shipping date. Any provisions in a purchase order that conflict with or add to these Terms will be ineffective and not binding on either Cellution or the Customer. Cellution reserves the right, at its sole discretion, to accept or decline any order for Products, in whole or in part.

• Delivery, Risk of Loss, and Inspection.

  Products will be packed appropriately in Cellution’s standard shipping cartons and labeled for delivery to the destination indicated in the Customer’s purchase order. All sales are FOB Cellution shipping point unless otherwise noted. Customer shall pay all shipping and freight costs which will be in addition to Cellution’s invoice. Customer shall bear all risk of loss or damage after Cellution’s delivery from its shipping point, including, but not limited to all damages occurring in transit. Upon Customer’s receipt of any Product(s) shipped hereunder, Customer shall inspect the Product(s) and notify Cellution in writing to the Cellution Email within ten (10) business days of receipt of any claims for shortages, defects, or damages and shall hold such Product(s) for Cellution written instructions concerning disposition. If Customer fails to notify Cellution within ten (10) business days of receipt, all Product(s) in the shipment shall conclusively be deemed to conform to these Terms and to have been irrevocably accepted by Customer.

• Rejected Products.

  If a Product shipped directly from Cellution is received in a damaged condition, the issue must be handled solely by Cellution and in accordance with Section 3. Customer should report all damaged Products to the Cellution Email immediately, but in no event later than ten (10) business days from receipt. All returns will be handled in accordance with Section 9. If a Product purchased directly from Cellution or through a distributor is unusable due to manufacturing quality issues (e.g., deviations from the physical characteristics described in the instructions for use (IFU) or Product specifications), the matter will be managed exclusively by Cellution. Customer should report all non-conforming Products to the Cellution Email immediately, but in no event later than ten (10) business days from receipt.

• Products Ordered in Error.

  Products ordered or received from Cellution by mistake are eligible for return if the Customer notifies Cellution in writing within ten (10) business days of receiving the shipment and Cellution confirms the return request. To initiate the process, email the Returns Material Authorization Form to the Cellution Email. The Product must be returned unused, in its original packaging, and without any additional labels or materials. Returns for Products ordered in error will not be accepted after ten (10) business days from receipt.

• Pricing and Payment Terms.

  Pricing and payment terms will be as detailed on the invoice, unless Customer and Cellution have a Purchase Agreement in effect, which will control. Notwithstanding anything to the contrary in a particular invoice, the following payment terms apply to all purchases: (a) payment is due 30 days from date of the invoice regardless of any insurance reimbursement; (b) Customer is solely responsible for any use tax, sales tax, excise tax, duty, custom, inspection or testing fee, or any other tax, fee or charge of any nature assessed on Customer’s purchase and shall defend and indemnify Cellution against liability for any such tax, fee or charge; (c) any unpaid balance after thirty (30) days will accrue interest at a rate of 1.5% per month, or the highest rate allowed by law, calculated on a 360-day year basis. The Customer is responsible for all costs incurred by Cellution in collecting any outstanding amounts, including reasonable attorneys’ fees and costs. Payments will be applied in the following order: first to fees, costs, and expenses; second to accrued and unpaid interest; and third to the outstanding principal balance. Invoice pricing represents the net price of the Product(s) after applying discounts and other reductions. Any invoice price that is less than Cellution’s list price for the Product is a “discount” within the meaning of 42 U.S.C. § 1320a-7b(b)(3)(A) and 42 C.F.R. § 1001.952(h), or other applicable protections regarding discounted product pricing, whether or not the invoice includes language indicating that a price is “discounted.” Listing the invoice price constitutes Cellution’s notice to Customer of the amount and value of all discounts given on Product(s) purchased under these Terms. This net price, along with any discount received, may need to be reported under federal regulations at 42 C.F.R. §1001.952(h). Customer agrees to fully and accurately report this discount on any claims or cost reports submitted to Medicare or any State Medicaid program and to provide, upon request by Medicare or any State Medicaid program, all information provided by Cellution regarding the discount.

• Product Complaints, Adverse Reactions, and Adverse Reaction Reporting.

  The Customer must (a) notify Cellution within 24 hours of learning about any Product complaint or unintended response or Adverse Reaction related or possibly related to a Product by emailing the Cellution Email and (b) promptly provide any assistance and information that Cellution reasonably requests to fulfill its Adverse Reaction reporting obligations for the Product. For purposes of this section, “Adverse Reaction” means an undesirable response in the recipient to transplanted cells, tissues or organs, including the transmission of a disease or disease agent. If Cellution requests that the Customer suspend the recommendation, use, or application of any Product, the Customer must promptly comply and suspend such recommendation, use, or application until Cellution provides written notice that the suspension may be lifted.

• Product Recalls.

  If (a) a government authority issues a request, directive, or order for a product recall, (b) a court with proper jurisdiction orders a recall, or (c) Cellution reasonably determines, after consulting with the Customer, that a recall is necessary, the Customer must cooperate with Cellution in carrying out the recall as reasonably requested. Cellution will handle the administrative aspects of the recall.

• Product Returns.

  Products must be returned if instructed by Cellution or a governmental entity (e.g., FDA) due to reasons such as recalls, natural disasters, or regulatory requirements. Returns will be authorized only if approved by Cellution’s Legal Department or a relevant governmental authority. Customer is to contact Cellution at the Cellution Email for further instructions. Customer shall, prior to the return of any Product for any cause, notify Cellution of the intended return and mark such Products (or containers of Products) so returned with a return authorization number provided by Cellution. The following are not eligible for replacement, credit, or other relief from Cellution: (a) Products damaged due to shipping issues after delivery from Cellution’s shipping point; (b) Products deteriorated from improper storage by the Customer (e.g., exposure to water, heat, cold, fire); (c) Products previously designated as “non-returnable” by the Company through contract or notice outside of this Policy; (d) repackaged Products; (e) Products damaged or rendered unusable due to Customer mishandling or error; (f) Products involved in a fire, flood, natural disaster, or obtained through a sale due to sacrifice or bankruptcy; (g) expired Product; and (h) Products purchased for research or clinical trials or provided at no cost. Except as otherwise stated herein, Cellution will not replace or issue any credit or other release from payment unless the Product is in its original packaging with the original label, lot number, and expiration. Cellution may, in its discretion, replace or credit the Customer’s account for an otherwise ineligible Product if the Customer certifies (a) return circumstances that negate the need for physical return and (b) proper disposal, if applicable. Cellution will, at its discretion, either replace or credit Products damaged due to Company shipping issues and Products returned under Sections 3, 4 and 5. For the Return Management Authorization (RMA), please contact the Cellution Email for further instructions. For Cellution consigned and non-consigned Products, please contact your Cellution Sales Representative or email the Cellution Email. For more details, please refer to Cellution’s Return Policy. Private-labeled products manufactured by Cellution but sold by a third party should be returned under the terms provided by the selling entity.

• Compliance with Law.

  Cellution and Customer shall comply with all applicable statutes, rules, regulations, and standards of any and all governmental authorities and regulatory and accreditation bodies relating physicians, products, biologics, the delivery of health care services and supplies and the billing and payment therefore. Without limiting the generality of the foregoing, the Parties shall comply with applicable provisions of the Stark law, 42 U.S.C. § 1395nn, 42 C.F.R. Part 411, Subpart J; the Federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b), 42 C.F.R. § 1001.952; and the regulations governing human cells, tissues, and cellular and tissue-based products (“HCT/P”) at 21 C.F.R Part 1271. Any licenses, permits, certificates or other documents that are required by any governmental authority for the supply and use of the Products hereunder shall be the respective responsibility of Cellution and the Customer. Cellution is not responsible for any violations of applicable laws and regulations by Customer with regard to the use of the Products.

• Customer Obligations.

  The Customer (a) shall (i) ensure that all Products are stored, handled, and used at all times in strict compliance with Cellution’s instructions for use (IFU), Applicable Laws, the Standards for Tissue Banking, and all other guidance issued by the American Association of Tissue Banks (collectively, “AATB Guidance”); (ii) review the IFU and all other package inserts and labels provided with the Product immediately upon receipt; and (iii) ensure that all use of the Products to treat patients is medically necessary as determined in the sole discretion of the treating provider, pursuant to his or her professional medical judgement; (b) agrees not to (i) use Products outside of the United States (including its territories and possessions) unless otherwise agreed upon in writing by Cellution; (ii) use or recommend the Products for any purpose other than individual homologous use or application; (iii) resell or redistribute any Product; (iv) modify, repackage, adulterate, misbrand, alter, or add or remove labels to or from any Product, or otherwise make any changes to the Products or to Cellution’s packaging, package inserts, trademarks, or labels; or (v) engage in deceptive, misleading, or unethical practices that are or might be detrimental to, or disparage or injure the reputation and good standing of, Cellution, its products (including the Products), or its affiliates, employees, agents, or representatives; and (c) provide prompt written notice to Cellution if it becomes aware of any entity or person offering, selling, or purchasing diverted Products.

• Promotional Information and Communications.

  Subject to these Terms, the Customer may provide educational information about the Products to patients and health care providers within its organization, but only if such information (a) aligns with the Product labeling and documentation, including the IFU, provided by Cellution, or (b) has been supplied by Cellution for distribution to patients and health care providers. The Customer expressly agrees not to offer any medical advice, training, or instruction regarding the Products to patients, health care providers, or any third party, unless the Customer is a health care provider who is fully qualified, licensed, and registered under applicable laws to provide medical advice about allograft products (including the Products) to the relevant patient, health care provider, or third party (each, a “Qualified Clinician”). All advice, training, and instruction provided by the Customer shall be in the Customer’s independent capacity as a Qualified Clinician and not as a representative or agent of Cellution. The Customer shall ensure that all communications to patients, health care providers, and other third parties are true, accurate, complete, and consistent with all Product labeling and documentation provided by Cellution.

• Customer’s Representations and Warranties.

  The Customer represents and warrants that (a) neither it nor any of its employees, agents, or representatives has received any notice or communication from the FDA or any other federal, state, or local regulatory or law enforcement agency requiring, recommending, or threatening to initiate any action related to the activities contemplated under these Terms; (b) the Customer has obtained and will maintain, at its own expense, all governmental approvals, licenses, or permits required for the purchase, handling, storage, use, and application of the Products until all Products ordered under these Terms have been used, applied, or otherwise finally disposed of; and (c) the Customer shall comply with all federal, state, and local laws, regulations, and rulings, including health care laws, relevant to its activities concerning the Products.

• Limited Product Warranty.

  The Customer acknowledges and agrees that the literature included with the Product contains all specifications, warranties, representations, and disclosures regarding the Product and its use (collectively, the “Customer Warranty”). The Customer does not have the authority, whether express or implied, to make any warranties, representations or disclosures beyond those provided by Cellution within the Customer Warranty, nor can the Customer authorize any of its Representatives to do so. Cellution makes no other warranty, express or implied, other than or in addition to the Customer Warranty. Subject to the exclusions, disclaimers, and other limitations in these Terms or Purchase Agreement (as applicable), Cellution hereby warrants to Customer that the Product shall comply with and perform in accordance with the Customer Warranty. Customer’s sole and exclusive remedy under the Customer Warranty shall be for Cellution to replace any non-complying Product without charge within a reasonable time period or, at Cellution’s option, to credit the Customer’s account. In no event shall Cellution’s the total cumulative liability for any warranty claim on a Product exceed the purchase price of the affected Product. The Customer Warranty does not apply to any Product which has (a) been subjected to abuse, misuse, tampering, mishandling, accident or negligence; (b) been modified, altered, mislabeled, or mishandled by anyone other than Cellution; (c) been used for or subjected to applications, environments, stress, or conditions other than as intended and recommended by Cellution; (d) been improperly stored, transported, installed, or used; (e) been used in any manner not approved by regulatory authorities or not as directed in the IFU, specifications, or claims for use of the Product; or (f) been used past its expiration date.

• Disclaimers; Limitation of Liability.

  to the maximum extent permitted by applicable law, cellution hereby disclaims all warranties not contained in these terms, whether express, implied, statutory, or arising by custom, trade usage, or course of dealing, or otherwise, including without limitation any implied warranties of merchantability or fitness for a particular purpose. no product subject to these terms has been approved by, and is not subject to approval by, the fda or other regulatory authorities. all information available on the cellution website, including but not limited to product, service, business, or medical information, is provided for informational purposes only and should not be used for diagnosing or treating any health problem or disease, or for prescribing any medication or course of treatment. any statements made about the products have not been evaluated by the fda, and the reported results, if any, may not occur in all individuals. cellution makes no representations and assumes no responsibility for the accuracy of the information on or available through the cellution website. this information is subject to change without notice. cellution shall have no liability to customer for any claim or damage arising from the sale of products to customer, or any breach of the terms set forth herein, other than to replace the product, or credit the purchase price of the product to customer’s account, at supplier’s sole option. cellution shall not in any event be liable to customer directly, or for any claim against customer by a third party, for incidental, punitive, exemplary, indirect, consequential, or special damages of any kind, regardless of the form of action, whether in contract, tort (including negligence), strict product liability, or otherwise, resulting from any use or failure or acquisition of the product(s) (even if cellution has been advised of the possibility of such damage), including without limitation, liability for loss of use, loss of work in progress, down time, loss of revenue or profits, failure to realize savings, loss or damage to customer property, loss or damage to reputation or goodwill, or labor or any other expense. cellution shall not be liable for personal injury or property damage unless such personal injury or property damage is caused by cellution’s gross negligence or willful misconduct. in no event shall the total liability of cellution under any theory of liability exceed the purchase price paid for the applicable product(s). the parties expressly acknowledge that the preceding limitations on liability are a fair compromise and waive any right to later challenge them as unreasonable, unconscionable, or otherwise. claims must be brought within one (1) year of shipment, regardless of their nature.

• Indemnification.

  The Customer agrees to defend, indemnify, and hold harmless Cellution, including its members, directors, officers, employees, successors agents and assigns, against any claims, suits, actions, causes of action, liabilities, losses, expenses, damages, judgments, costs, and expenses including reasonable attorney’s fees arising from or related to (a) Customer’s breach of its representations, warranties and obligations under these Terms; (b) any actual or asserted violations of federal. State or local law or regulation by Customer in connection with Customer’s use of the Products; and (c) any negligent, intentional, or otherwise wrongful acts or omissions of the Customer, its employees, agents, consultants, or subcontractors.

• Force Majeure.

  Cellution shall not be held responsible for any delays caused by events beyond its control, including but not limited to acts of God, war, civil unrest, riots, strikes, labor disputes, extreme weather, shortages of materials, embargoes, actions by civil or military authorities, declared or undeclared states of emergency, fires, floods, accidents, quarantine restrictions, carrier conditions, delays in transportation, requirements of any governmental authority or any other circumstances of Force Majeure. In such cases, Cellution will provide reasonable notice to the Customer of the delay or non-delivery. This notification will render the order terminated, and Cellution will have no further obligation to ship the Products covered by the order. However, if the Customer agrees in writing to a new delivery date, the order will remain in effect as amended and subject to these Terms, and Cellution agrees to deliver the Products subject to the order on that future date.

• Attorney’s Fees.

  If Cellution initiates legal action to enforce the terms of this Agreement, protect its interests, or collect any outstanding amounts, whether in bankruptcy, receivership, insolvency proceedings, or otherwise, it will be entitled to recover all reasonable costs and expenses incurred, including attorney’s fees for pre-trial, trial, appeal, and post-judgment proceedings. Interest on any amounts owed by the Customer to Cellution will accrue at the rate of 1.5% per month or a lower rate permitted by law, both before and after a legal judgment, as allowed by applicable law.

• Proprietary Rights.

  Cellution retains all rights, title, and interest in all patents, trademarks, trade names, inventions, copyrights, know-how, and trade secrets related to the Products and their design, processing, manufacturing, operation, or service. Customer shall not remove, alter, cover, or obscure any proprietary rights notices placed or embedded by Cellution on or within any Product. Customer may not use Cellution’s name in any advertising or publicity without obtaining prior written permission from Cellution.

• Confidential Information.

  Customer agrees (a) to hold in strict confidence all information given to it by Cellution, and (b) that it will not, without Cellution’s prior written approval, disclose such information or use it for any purpose other than as expressly provided in these Terms. The obligations set forth herein shall not apply with respect to any information which is (i) publicly available, (ii) available to Customer without restriction or breach of any confidentiality agreement, (iii) independently developed by Customer, or (iv) (A) disclosed pursuant to the requirement of a governmental agency or any law requiring disclosure thereof and (B) Customer has provided prior written notice of any such disclosure to Cellution and has given Cellution the opportunity to contest or minimize such disclosure.

• Notices.

  All notices and other communications to Cellution shall be made exclusively through the Cellution Customer Service email: customerservice@cellutionbiologics.com. All notices or other communications to Customer must be in writing and delivered to Customer at the address specified in the relevant order as follows: (a) in person; (b) via confirmed facsimile or electronic mail in “portable document format” (.pdf) or any other electronic format that maintains the original document’s graphic and pictorial appearance; (c) through prepaid certified or registered mail with return receipt requested; or (d) using a prepaid, recognized next business day delivery service. Notices will be effective upon receipt during the recipient’s normal business hours, or if received after normal business hours, on the following business day. Either Party may update their address by providing written notice to the other party in accordance with this Section.

• Record Keeping.

  Cellution and the Customer will maintain books and records related to the purchases and sales of Products in compliance with FDA regulatory requirements and AATB guidelines. All records of tissue utilization must be returned to Cellution. Additionally, for a period of four years following the provision of products and services under this Agreement, Cellution will make available to the Secretary of the U.S. Department of Health and Human Services, the U.S. Comptroller General, and their representatives, this Agreement along with all relevant books, documents, and records necessary to verify the nature and extent of the costs associated with the products or services provided.

• Third-Party Beneficiaries.

  None of the provisions of these Terms shall benefit or be enforceable by any third party, including but not limited to any creditor of either party. No third party shall acquire any rights under these Terms or make any claims against either party regarding any debt, liability, or obligation based on these provisions.

• Waiver.

  The failure of Cellution at any time to require the performance by the Customer of any provision of these Terms shall not affect in any way the right to require such performance at any later time nor shall the waiver by Cellution of a breach of any provision hereof be taken or held to be a waiver of such provision. No waiver of any term, provision, or condition of these Terms (whether through conduct or otherwise) in any instance shall be considered or interpreted as a further or continuing waiver of that term, provision, or condition in subsequent instances.

• Independent Relationship.

  Nothing in these Terms shall constitute or be construed as the creation of a partnership or joint venture between Customer and Cellution. Customer shall not represent Customer or Customer’s organization as having any relationship to Cellution other than that of an independent purchaser of Product for the limited purposes described in these Terms.

• Non Assignability.

  Customer may not assign these Terms without obtaining prior written consent from Cellution. Any attempt to assign or transfer rights, duties, or obligations under these Terms without such consent will be considered null and void. Cellution may assign these Terms in its sole discretion. These Terms may only be amended through a written agreement signed by both Cellution and Customer.

• Dispute Resolution.

  If the parties, despite acting in good faith, cannot resolve any dispute, controversy, or claim arising from or related to these Terms or any Product (collectively, a “Dispute”) within thirty (30) days of receiving written notice of such Dispute from either party, or at an earlier mutually agreed time, the Dispute shall be resolved through confidential, binding, and non-appealable arbitration in Fulton County, Georgia. This arbitration will be administered by the American Arbitration Association (AAA) under its Commercial Arbitration Rules in effect at that time (the “Rules”). The arbitration will be conducted in English and before a single arbitrator jointly selected by the Customer and Cellution. If the parties cannot agree on an arbitrator within thirty days of initiating arbitration, the AAA will appoint the arbitrator in accordance with the Rules, unless modified by mutual written agreement of the parties. The arbitrator’s authority is limited to enforcing the provisions of these Terms, including any limitations on damages, in accordance with the provisions of Section 26. The arbitration award shall be final, conclusive, and binding, and judgment on the award may be entered in any court with competent jurisdiction, subject to the right of the non-prevailing party(ies) to challenge the award on valid legal and procedural grounds, including the arbitrator exceeding his/her authority. During arbitration, either party may seek interim protective measures, including injunctive relief, from a court with competent jurisdiction in Fulton County, Georgia. Any issues regarding the scope of arbitration or the interpretation and enforceability of this paragraph, including any claims of invalidity or unenforceability, shall be governed by the Federal Arbitration Act and resolved exclusively by the arbitrator.

• Governing Law; Venue.T

  hese Terms will be governed by and interpreted in accordance with the laws of the State of Georgia, without regard to its conflict of laws principles. Subject to Section 25 above, any legal action, claim, or suit arising from these Terms must be filed in a state or federal court located in Fulton County, Georgia. Customer consents to the jurisdiction and venue of such court. notwithstanding the foregoing, the parties, after consultation with respective counsel, waive trial by jury in any proceeding or counterclaim brought by either party against the other on any matters arising out of or in any way connected to the product or purchase thereof, the relationship between the parties, or any injury or damage claim.

Entire Agreement/Severability/Modification.

Unless the Parties have a Purchase Agreement in effect, these Terms represent the entire understanding between the Parties relating to the subject matter hereof and supersedes all prior and collateral agreements and understandings, regardless of form or nature between the Parties. There are no terms or representations other than those stated herein. If any of these Terms is found to be invalid or void by a court of competent jurisdiction, that term will be considered null and void and will be severed from the Terms. All other Terms will remain in full force and effect. Except as specifically provided in these Terms, no extension, modification, or supplement to these Terms will be effective unless it is made in writing and signed by an authorized representative of each par