IMPORTANT NOTICE — PLEASE READ BEFORE PROCEEDING
These Terms and Conditions of Sale constitute a legally binding agreement. By accessing this Website or placing any order, you acknowledge that you have read, understood, and agree to be bound by these Terms. If you do not agree, please do not use this Website or place any order.
1. Scope and Acceptance.
These Terms and Conditions of Sale (“Terms”) govern all purchases of Edetate Calcium Disodium Injection, USP (“Product”) through edetaterising.com (the “Website”), operated by Rising Pharma Holdings, Inc. d/b/a Rising Pharmaceuticals (“Rising”, “we”, “us”, or “our”), and constitute a legally binding agreement between Rising and the purchasing entity (“Purchaser”, “you”, or “your”). Orders may also be facilitated through Rising's authorized specialty distribution partner, IPD Pharma, subject to these Terms and any applicable distributor agreement.
2. Purchaser Eligibility
2.1 Authorized Purchasers Only. The Website and Product are available exclusively to entities holding valid federal and state licenses or registrations to purchase, handle, store, dispense, or administer prescription pharmaceutical products — including licensed pharmacies, hospitals, outpatient infusion centers, and other authorized healthcare institutions. This Website is not for use by individual patients or the general public.
2.2 Representations and Warranties of Purchaser. The Website and Product are available exclusively to entities holding valid federal and state licenses or registrations to purchase, handle, store, dispense, or administer prescription pharmaceutical products — including licensed pharmacies, hospitals, outpatient infusion centers, and other authorized healthcare institutions. This Website is not for use by individual patients or the general public.
2.3 Verification and Refusal of Orders. Rising may, at its sole discretion and without liability, verify Purchaser eligibility before processing any order and may decline, suspend, or cancel any order where valid licensure cannot be demonstrated or compliance with applicable law is in question.
3. Product Description and Conditions of Use
3.1 Prescription Drug — Rx Only. The Product is a prescription-only (Rx only) pharmaceutical product. Under the Federal Food, Drug, and Cosmetic Act and applicable law, it may be dispensed only upon the prescription of a practitioner licensed to prescribe such products.
3.2 For Use by Licensed Professionals Only. This Product is intended solely for use by, or under the direct supervision of, licensed healthcare professionals — including physicians, pharmacists, and trained clinical staff — with appropriate training and authorization to handle, prepare, and administer injectable pharmaceutical agents. It is not intended for self-administration by patients or any unlicensed person.
3.3 Dilution Required Before Administration. CAUTION: THIS PRODUCT MUST BE DILUTED PRIOR TO INTRAVENOUS INFUSION. THE PRODUCT IS A CONCENTRATED SOLUTION AND MUST BE DILUTED BEFORE INTRAVENOUS ADMINISTRATION IN STRICT ACCORDANCE WITH THE PRESCRIBING INFORMATION. FAILURE TO DILUTE MAY RESULT IN SERIOUS ADVERSE EVENTS, INCLUDING DEATH. THE ADMINISTERING HEALTHCARE PROFESSIONAL BEARS SOLE RESPONSIBILITY FOR PROPER PREPARATION AND DILUTION. RISING ASSUMES NO LIABILITY FOR ANY ADVERSE OUTCOME RESULTING FROM FAILURE TO DILUTE THE PRODUCT AS REQUIRED.
3.4 Prescribing Information. All practitioners who prescribe, dispense, prepare, or administer this Product must review the full Prescribing Information — including the Boxed Warning — prior to use. The Prescribing Information is available on this Website and through FDA's DailyMed database. In the event of any inconsistency between Website content and the Prescribing Information, the Prescribing Information governs.
3.5 Boxed Warning. This Product carries an FDA-required Boxed Warning. Edetate calcium disodium is capable of producing toxic effects that can be fatal. Purchasers must ensure the Boxed Warning is communicated to all relevant clinical staff and observed in clinical practice.
4. Geographic Restriction — United States Only
The Website and Product are available exclusively for sale and delivery within the United States (including Alaska and Hawaii). Orders for delivery outside the United States will not be processed. Rising does not export this Product, and any attempt to import or re-export it in violation of applicable law is the sole responsibility of the Purchaser. Purchasers outside the United States are not eligible to use this Website. Rising makes no representation that the Product or Website content complies with the laws of any other country.
5. Orders and Acceptance
5.1 Order Submission. Orders may be placed through the Website or Rising's authorized distribution partner(s). Submission of an order constitutes an offer to purchase on these Terms and does not create a binding obligation on Rising until accepted.
5.2 Order Confirmation and Right to Decline. An order is accepted only upon written or electronic confirmation from Rising or its authorized distributor. Rising may, in its sole discretion, decline, modify, or cancel any order prior to shipment — including where the Product is unavailable, pricing errors exist, eligibility cannot be confirmed, or fulfillment would be inconsistent with applicable law or these Terms.
5.3 Pricing. All prices are in U.S. dollars and subject to change without notice. The price at the time of order confirmation governs. Rising may correct pricing errors at any time; orders confirmed at an erroneous price may be cancelled or repriced with notice to the Purchaser.
5.4 Order Quantities. Rising may limit order quantities at its sole discretion. The Product is for institutional use only and may not be redistributed to unauthorized parties.
6. Payment Terms
Payment terms are governed by the applicable account agreement or as specified at order. All amounts are due in U.S. dollars. Rising may suspend or cancel orders if the Purchaser fails to meet payment obligations. Overdue amounts may accrue interest as permitted by applicable law.
7. Shipping, Title, and Risk of Loss
7.1 Shipping. Products will be shipped in accordance with applicable regulations, including temperature, cold chain, and handling requirements. The Purchaser must ensure appropriate receiving procedures and storage conditions are in place upon delivery.
7.2 Risk of Loss. Title and risk of loss pass to the Purchaser upon delivery to the carrier. Rising is not responsible for loss, damage, or delay in transit.
7.3 Inspection Upon Receipt. The Purchaser is responsible for promptly inspecting all Products upon receipt. Any claim for shortage, damage, or non-conformance must be reported to Rising in writing within five (5) business days of delivery. Failure to provide timely notice may constitute a waiver of such claim.
8. No Returns — All Sales Are Final
8.1 General No-Return Policy. Due to the nature of prescription pharmaceutical products and applicable regulatory requirements, ALL SALES ARE FINAL. Rising does not accept returns once Product has left Rising’s or its distributor’s custody, except as required by law or in connection with a product recall.
8.2 Claims for Defective or Non-Conforming Product. If the Purchaser receives Product that is defective or materially non-conforming at delivery, it must notify Rising in writing within five (5) business days, with supporting documentation and, if requested, a sample. Rising will investigate and determine, in its reasonable discretion, whether a replacement or credit is appropriate. This is the Purchaser’s exclusive remedy and Rising’s sole liability for defective or non-conforming Product.
8.3 Product Recalls. In the event of a product recall, Rising will comply with all applicable FDA requirements and notify affected Purchasers consistent with applicable law. Nothing in this Section limits Rising’s obligations under federal recall regulations.
9. Insurance and Reimbursement
Rising is not responsible for insurance, reimbursement, or coverage matters. The Product’s eligibility for reimbursement under Medicare, Medicaid, private insurance, or any other third-party payer arrangement is entirely outside Rising’s control. Rising makes no representations or warranties regarding coverage or reimbursement under any governmental or private payer program. Coverage, formulary status, prior authorization, and reimbursement determinations are solely between the Purchaser and the relevant payer(s). Rising has no obligation to provide coding, prior authorization, appeals, or other reimbursement-related assistance. The Purchaser assumes full responsibility for its own reimbursement and billing obligations.
10. DSCSA and Regulatory Compliance.
The Purchaser agrees to comply with all applicable requirements of the Drug Supply Chain Security Act (“DSCSA”), 21 U.S.C. § 360eee et seq., including maintaining accurate transaction information, transaction history, and transaction statements, and ensuring the Product is not transferred to any entity that does not qualify as an authorized trading partner under DSCSA. The Purchaser further agrees to comply with all applicable federal and state laws governing the purchase, storage, handling, dispensing, and administration of the Product, including requirements of the FDA, DEA, and applicable state boards of pharmacy.
11. Adverse Event Reporting
Purchasers are legally obligated to report suspected adverse reactions associated with this Product. To report an adverse event, contact: Rising Pharma Holdings, Inc.: 1-844-874-7464, FDA MedWatch: 1-800-FDA-1088 or www.fda.gov/medwatch. Rising will cooperate with all FDA requirements regarding adverse event reporting and pharmacovigilance.
12. Disclaimers of Warranties, Limitation of Liability
EXCEPT AS EXPRESSLY SET FORTH HEREIN, THE PRODUCT IS PROVIDED “AS IS.” RISING WARRANTS ONLY THAT THE PRODUCT WAS MANUFACTURED AND LABELED IN MATERIAL CONFORMANCE WITH FDA-APPROVED SPECIFICATIONS AND CURRENT GOOD MANUFACTURING PRACTICES (cGMP) AT THE TIME OF RELEASE. TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, RISING MAKES NO OTHER REPRESENTATION OR WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO ANY WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE, MERCHANTABILITY, NON-INFRINGEMENT, OR THAT USE OF THE PRODUCT WILL ACHIEVE ANY PARTICULAR CLINICAL OUTCOME. All clinical decisions regarding prescribing, dispensing, administering, dosing, patient monitoring, and clinical management of this Product are solely within the professional judgment and responsibility of the licensed healthcare professional. Rising does not practice medicine and makes no representation regarding the Product’s suitability for any individual patient.
TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT SHALL RISING OR ITS AFFILIATES, OFFICERS, DIRECTORS, EMPLOYEES, OR AGENTS BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, PUNITIVE, OR EXEMPLARY DAMAGES ARISING OUT OF THE SALE, DISTRIBUTION, USE, OR FAILURE TO SUPPLY THE PRODUCT, WHETHER BASED ON CONTRACT, TORT (INCLUDING NEGLIGENCE OR STRICT LIABILITY), STATUTE, OR ANY OTHER THEORY, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, RISING’S TOTAL AGGREGATE LIABILITY TO THE PURCHASER FOR ALL CLAIMS ARISING OUT OF OR RELATED TO THESE TERMS OR THE PRODUCT—REGARDLESS OF THE FORM OF ACTION—SHALL NOT EXCEED THE TOTAL AMOUNTS ACTUALLY PAID BY THE PURCHASER TO RISING FOR THE SPECIFIC ORDER(S) GIVING RISE TO THE APPLICABLE CLAIM DURING THE SIX (6) MONTHS IMMEDIATELY PRECEDING THE EVENT GIVING RISE TO THE CLAIM.
14. Indemnification.
The Purchaser agrees to defend, indemnify, and hold harmless Rising Pharma Holdings, Inc. and its affiliates, subsidiaries, officers, directors, employees, agents, successors, and assigns (“Rising Parties”) from and against all claims, damages, losses, liabilities, costs, and expenses (including reasonable attorneys’ fees) arising out of or relating to: (1) Any breach by the Purchaser of these Terms or any representation, warranty, or obligation hereunder; (2) Any violation by the Purchaser of applicable law in connection with the purchase, storage, handling, dispensing, preparation, or administration of the Product; (3) Any failure by the Purchaser or its personnel to dilute the Product prior to intravenous administration in accordance with the Prescribing Information; (4) Any administration of the Product by unlicensed or unqualified personnel; (5) Any improper or unauthorized use of the Product; or (6) Any third-party claims arising from the Purchaser’s use, handling, or dispensing of the Product.
15. Governing Law and Dispute Resolution
15.1 Governing Law, Arbitration. These Terms and all disputes arising out of or relating to them shall be governed by the laws of the State of New Jersey, without reference to its conflict-of-laws principles. Any dispute arising out of or relating to these Terms shall be resolved by binding arbitration administered by the American Arbitration Association (“AAA”) under its then-current Commercial Arbitration Rules, seated in East Brunswick, New Jersey. The arbitrator’s decision shall be final, binding, and enforceable in any court of competent jurisdiction.
15.2 Class Action Waiver. The Purchaser waives any right to participate in any class action, class arbitration, or representative proceeding under these Terms. All claims must be brought in the Purchaser’s individual capacity.
15.3 Exception for Injunctive Relief. Notwithstanding the foregoing, either party may seek injunctive relief from any court of competent jurisdiction to prevent irreparable harm, without waiving the right to arbitration on the merits.
16. Miscellaneous
16.1 Intellectual Property. All Website content — including product descriptions, text, graphics, logos, and trade dress — is the property of Rising or its licensors and is protected by applicable intellectual property laws. These Terms grant no license to use Rising’s intellectual property except as necessary to access the Website and place orders. Any reproduction, modification, distribution, or commercial use of Website content without Rising’s prior written consent is prohibited.
16.2 Website Use & Availability. This Website is provided for informational and ordering purposes only. Rising makes no warranty that the Website will be continuously available, error-free, or free of harmful components, and may modify, suspend, or discontinue the Website at any time without notice or liability. Purchasers agree not to use the Website for any unlawful purpose, attempt unauthorized access, or engage in conduct that could impair the Website or interfere with others’ use.
16.3 Privacy. Rising’s collection and use of information in connection with this Website is governed by our Privacy Policy, available on this Website and incorporated herein by reference. By using this Website, you consent to the practices described in the Privacy Policy.
16.4 Others. Rising shall not be liable for any failure or delay in performance caused by circumstances beyond its reasonable control, including acts of God, pandemics, natural disasters, government actions, supply chain disruptions, labor disputes, transportation delays, or failures of third-party suppliers. Rising will use commercially reasonable efforts to resume performance promptly following any such event. If any provision of these Terms is found invalid, illegal, or unenforceable, it shall be modified to the minimum extent necessary to make it enforceable; the remaining provisions shall remain in full force and effect. These Terms, together with any applicable account agreement and Rising’s Privacy Policy, constitute the entire agreement between the parties regarding the purchase of the Product through this Website and supersede all prior or contemporaneous negotiations, understandings, and agreements, whether written or oral, on the same subject matter. Rising may amend these Terms at any time by posting revised Terms on this Website with an updated effective date. Continued use of the Website or placement of any order after posting constitutes acceptance of the amended Terms.
16.5 Contact Information. For questions about these Terms or any matter covered herein, contact us:
Rising Pharma Holdings, Inc.
d/b/a Rising Pharmaceuticals
2 Tower Center Blvd., Suite 1401A
East Brunswick, NJ 08816
Phone: +1 (201) 961-9001
Email: contact-usa@risingpharma.com
Website: www.risingpharma.com
Adverse Event Hotline: 1-844-874-7464
