Terms & Conditions of Sale

The Customer agrees to abide by the Standard Terms of Sales as shown on True Marker Pharmaceuticals, Inc. invoices or by an agreement with True Marker Pharmaceuticals governing the Customer's Account or any other terms of sales upon which True Marker Pharmaceuticals, Inc. and the Customer should agree in writing. The Customer agrees to pay for all purchases, fees, and other charges incurred by the Customer or an authorized user on any account of the Customer with True Marker Pharmaceuticals, Inc., including service charges on past due amounts at the highest rate permitted by law.

True Marker Pharmaceuticals, Inc., and Customer endeavored to structure any Discounts and Rebates set forth herein as a discount consistent with the Federal Anti-kickback statute, including the statutory discount exception (42 U.S.C. §1320a-7b(b)(3)(A)) and the regulatory discount safe harbor (42 C.F.R. §1001.952(h)), and Customer acknowledges that it must fully and accurately disclose and report in accordance with the statutory discount exception and regulatory discount safe harbor, as well as any other applicable state law or payer reimbursement requirements, any discounts or price reductions provided by True Marker Pharmaceuticals, Inc. to Customer. Moreover, the Customer must provide information on all discounts and price concessions upon request to Medicare, Medicaid, and other federal or state healthcare programs. Confidential treatment shall be requested for any disclosures made to C.M.S. or Medicare Part D Plans to the extent permitted by law. The Customer shall retain invoices and other documentation of discounts received from True Marker Pharmaceuticals, Inc., and shall ensure documentation is available to state and federal authorities upon request.

True Marker Pharmaceuticals, Inc. reserves the right, in its sole discretion, to change a payment term (including requiring cash payment upon delivery) or limit total credit if (i) True Marker Pharmaceuticals, Inc. concludes there has been a material change in the Customer's financial condition or any unsatisfactory payment performance; or (ii) Customer ceases to meet True Marker Pharmaceuticals, Inc. credit requirements or True Marker Pharmaceuticals, Inc. determines that the Customer is likely to cease meeting such requirements. Upon the occurrence of any above-specified events, True Marker Pharmaceuticals, Inc. shall be entitled to suspend or discontinue the shipment of additional orders to Customer. The Customer agrees to pay all reasonable attorney fees and expenses or costs incurred by True Marker Pharmaceuticals, Inc. in enforcing its rights to collect any amounts due from the Customer.

The federal Equal Credit Opportunity Act prohibits creditors from discriminating against credit applicants based on race, color, religion, national origin, sex, marital status, or age (provided that the applicant has the capacity to enter into a binding contract); because all or part of the applicant's income derives from any public assistance program; or because the applicant has, in good faith, exercised any right under the Consumer.

Products may be exchanged or returned for a full refund within seven (7) days. Products returned between 8 and 30 days are subject to a 30% restocking fee. No returns are accepted after 30 days. TMP must authorize all returns before shipment. TMP will inspect all returned products, and any products that do not pass TMP's return validation process will not be eligible for a refund. Temperature-controlled products cannot be returned - all sales are final. Expired and short-dated products do not qualify for return credit. Refunds will be issued as credit only, which may be used to offset an outstanding balance or applied toward future purchases. Credits have no cash value and are not redeemable for cash or reimbursement by check. If credit is not used within twelve (12) months from the date of issuance, it will expire and no longer be redeemable. TMP reserves the right to modify or change the return policy from time to time without notice or customer conset; however, the return policy in effect at the time of purchase will govern should there be a conflict. In no event shall Wholesaler be liable for any consequential, incidental, indirect, special, or punitive damages arising out of or in connection with this Agreement, even if advised of the possibility of such damages.

These Terms and Conditions of Purchase (“Agreement”) apply to all purchase orders issued by True Marker Pharmaceuticals, Inc. (“TMP”), a licensed pharmaceuticals wholesale distributor, to any manufacturer, repackager, relabeler, labeler, distributor, or supplier of finished drug products (“Manufacturer”) unless a separate executed Supply Agreement, Distribution Agreement, Quality Agreement, or other governing agreement exists. If such an agreement exists and is in effect, it supersedes all other agreements. Otherwise, Manufacturer’s acceptance of a purchase order or shipment of Products constitutes acceptance of these Terms & Conditions.

I. Scope of Supply. Manufacturer shall supply finished pharmaceutical products (“Products”) in accordance with: (a) TMP’s purchase order, (b) approved FDA regulatory filings; (c) Product specifications and approved labeling; (d) all applicable Quality or Technical Agreements.

II. Compliance with Law. Manufacturer represents, warrants, and covenants that it: (a) Holds all federal and state licenses and permits; (b) Complies with the FDCA, DSCSA, cGMP (21 CFR Parts 210 & 211), and all application laws; (c) Complies with USP, ICH, DEA (if applicable), and all regulatory requirements; (d) Will immediately notify TMP of any recalls, warning letter, import alert, regulatory inspection findings, or enforcement actions related to the Product or facility.

III. Regulatory Filing, DSCSA, and Labeling Compliance. The manufacturer represents and warrants that all Products comply with FDA and DSCSA legal requirements.

A. FDA Filing Status – NDA/ANDA/BLA/OTC Monograph. Each Product is lawfully marketed in the U.S. under one of the following: (a) approved NDA; (b) approved ANDA; (c) approved BLA; (d) Final or deemed-final OTC Monograph; (e) any FDA-recognized legal marketing pathway. The manufacturer warrants that all regulatory filings are current, accurate, and in good standing.

B. DSCSA Compliance – Authorized Trading Partner, Serialization & T3 Data. Manufacturer shall: (a) maintain Authorized Trading Partner status; (b) Serialize all prescription drug packages and cases with compliant product identifiers; (c) Provide complete and accurate Transaction Information (TI), Transaction Statement (TS), and Transaction History (TH) (if applicable); (d) cooperate with all TMP requests for DSCSA verification or suspect product investigations; (e)immediately notify TMP of any suspect or illegitimate product.

C. Labeling & Packaging Compliance. Manufacturer warrants that all labeling and packaging: (a) conform to the approved NDA/ANDA/BLA/Monograph; (b) comply with 21 CFR Parts 201 & 211; (c) match all TI/TS and serialization data: (d) are not false, misleading, or misbranded; (e) are produced under validated, cGMP-compliant label control and reconciliation procedures.

D. Legal Marketability & Authenticity. Manufacturer warrants that all Products: (a) are genuine, non-counterfeit, and authorized for U.S. sale; (b) are not adulterated, misbranded, diverted, stolen, expired, or violative of any law; (c) meet all USP, ICH, and stability requirements; (d) are lawful and saleable for wholesale distribution. These warranties survive delivery, resale, and payment.

IV. Product Quality, Release, and Documentation. All products delivered to TMP shall: (a) meet all specification and PO requirements; (b) be manufactured, packaged, labeled, and tested under cGMP’ (c) be released by Manufacturer’s Quality Unit; (d) include, if requested, Certificate of Analysis (COA) and Certificate of Compliance; (e) include complete DSCSA transaction data.

V. Delivery and Title Transfer. Products shall ship F.O.B. Destination, unless otherwise agreed. Title and risk of loss transfer to TMP upon physical receipt of the conforming Product. Shipments must include a packing slip, lot numbers, expiration dates, and DSCSA documentation.

VI. Packaging, Labeling, and Serialization Requirements. Manufacturer shall ensure that all Products: (a) use validated packaging components and tamper-evident systems; (b) are labeled exactly per approved labeling and requirements; (c) include FDA- and DSCSA-compliant serialization and aggregated data where available.

VII. Inspection and Rejection. TMP may inspect Products within 30 days and reject any Product that: (a) fails specifications or regulatory requirements; (b) violates FDA, DSCSA, or cGMP; (c) has incomplete or inaccurate DSCSA data; (d) is damaged, adulterated, or misbranded. TMP may return, replace, or receive a full refund/credit for rejected Product.

VIII. Return, Credit, and Refund Policy (Non-Compliant or Illegal Product)

A. Right to Return at any time. TMP may return any non-conforming, adulterated, illegitimate, illegal, counterfeit, suspect, misbranded, or non-compliant Product at any time, including downstream resale.

B. Full Credit or Cash Refund. Upon TMP’s election, Manufacturer shall provide (a) Full credit, or (b) Full cash refund, including freight, taxes, and all amounts paid.

C. Downstream Customer Reimbursement. If TMP issues credits, refunds, penalties, or replacements to downstream customers due to the Manufacturer’s non-compliance, the Manufacturer shall fully reimburse TMP for all such amounts.

D. No Fees or Restrictions. The manufacturer shall not impose penalties, restocking fees, or time limits on returns of this nature.

E. Survival. These obligations survive delivery, resale, and payment.

IX. Change Notification. The Manufacturer shall not change the manufacturing site, suppliers, components, processes, formulations, or labeling without providing prior written notice to TMP and obtaining approval where required.

X. Regulatory Inspections, Audit Access, and Disclosure

A. Required Disclosure of Regulatory Inspections. The manufacturer shall provide TMP, upon request, with copies of: (a) FDA Form 483s, Warning Letters, EIRs, close-out letters, and FDA correspondence; (b) State Board of Pharmacy of State Health Department inspection reports; (c) any regulatory deficiency, observation, or enforcement notice.

B. Third-Party cGMP Audits. The manufacturer shall provide TMP with: (a) Third-party cGMP audit reports or executive summaries; (b) ISO, NSF, or other quality certification audit reports; (c) internal quality audit summaries (if requested).

C. Notification Obligation. The manufacturer shall notify TMP within five business days of any: (a) FDA inspection or inquiry, (b) State agency inspection, (c) enforcement action, (d) cGMP, quality, DSCSA, or labeling finding, or (e) issue that may impact product quality or legal marketability.

D. Right to Audit. TMP, its designees, or regulatory authorities may perform: (a) on-site audits, or (b) remote/desktop quality assessments, upon reasonable notice. Manufacture shall fully cooperate.

E. Survival. These obligations survive delivery, resale, and payment.

XI. Record Retention and Access. Manufacturers shall retain all batch, testing, quality, and regulatory records for a minimum of five (5) years and provide access as required by law.

XII. Confidentiality. All TMP-provided information is confidential and may only be used to fulfill purchase orders.

XIII. Indemnification. The manufacturer shall indemnify TMP against any loss, recall, liability, or expense arising from: (a) product defects or non-compliance; (b) regulatory violations; (c) breach of warranty; (d) DSCSA or cGMP non-compliance.

XIV. Insurance. The manufacturer shall, at its own expense, maintain commercially reasonable and industry-standard insurance coverage, including but not limited to: (a) commercial general liability insurance (including bodily injury, property damage, and contractual liability); (b) product liability insurance covering all products supplied to TMP; (c) professional liability insurance covering all Products supplied to TMP; (c) Professional liability/ Errors & Omissions Insurance (if applicable); (d) recall Insurance (if available or reasonably obtainable).

All required policies must be written with limits adequate for the scope of the Products and risks involved.

A. Additional Insured Requirement. At TMP’s request, Manufacturer shall name True Marker Pharmaceuticals, Inc. (“TMP”) as an additional insured on the manufacturer's commercial general liability and product liability policies. The manufacturer shall provide TMP with written proof of such additional insured status, including certificates and endorsements.

XV. Payment Terms. Payment terms shall be those stated on TMP’s purchase order, or, if none are stated, Net 30 days from the date of a correct and complete invoice. If TMP elects to pay by credit card, such payment shall be invoice-specific. The Manufacturer shall not impose any surcharge, fee, or additional cost for payments made by credit card or for any other payment methods, such as wire transfer, ACH, or check. TMP has no obligations to pay invoices that do not match the purchase order, the product delivered, or the required supporting documentation. No changes to payment terms are valid unless agreed to in writing by TMP.

XVI. Termination. TMP may terminate any purchase order immediately for breach or regulatory issues, or with 30 days’ notice for convenience.

XVII. Governing Law. The laws of the State of Arizona govern this agreement. Disputes shall be resolved exclusively in Maricopa County, Arizona.

XVIII. Entire Agreement & Order of Precedence. Order of precedence:

1. Executed Supply/Distribution Agreement

2. Quality Agreement

3. The Purchase Order and these Terms and Conditions, which together constitute a single integrated agreement

4. Any other documents or communication related to the order

If any inconsistency exists between the Purchase Order and these Terms & Conditions, the Purchase Order shall control with respect to pricing, quantities, delivery dates, and item-specific commercial terms.