TERMS & CONDITIONS OF SALE (503B PRODUCTS)

Effective Date/Last Updated: April 13, 2026

These Terms & Conditions of Sale (the “Terms”) apply to all offers, sales, and supplies of Products (as defined below) by Wilcrest Pharmaceuticals, Inc. (“Provider” or “Wilcrest”) to the purchaser identified on an Order (as defined below) (“Buyer”). Wilcrest and Buyer may be

referred to individually as a “Party” and collectively as the “Parties.”

NOTICE/CONDITION OF SALE. ALL SALES OF PRODUCTS ARE EXPRESSLY CONDITIONED ON BUYER’S ASSENT TO THESE TERMS. WILCREST EXPRESSLY OBJECTS TO AND REJECTS ANY

ADDITIONAL OR DIFFERENT TERMS PROPOSED BY BUYER (INCLUDING TERMS IN ANY PURCHASE ORDER, PROCUREMENT PORTAL, VENDOR FORM, OR OTHER DOCUMENT), UNLESS WILCREST EXPRESSLY AGREES TO SUCH TERMS IN A WRITTEN INSTRUMENT SIGNED BY WILCREST. NO COURSE OF PERFORMANCE, COURSE OF DEALING, OR USAGE OF TRADE WILL MODIFY THESE TERMS.

PORTAL ASSENT. If Buyer places an Order through Wilcrest’s online ordering portal (or any

electronic ordering interface designated by Wilcrest), Buyer’s click on an “I Agree,” “Accept,” or similar button (or completion of checkout) constitutes Buyer’s electronic signature and affirmative assent to these Terms. Buyer represents that the individual completing checkout has authority to bind Buyer.

If Buyer and Wilcrest have a separately negotiated and signed master agreement governing Product purchases (an “Institutional MSA”), that Institutional MSA will control only to the extent it expressly supersedes these Terms.

ARTICLE 1: DEFINITIONS

  1. 503B Outsourcing Facility” means a facility registered with the U.S. Food and Drug Administration (“FDA”) under Section 503B of the Federal Food, Drug, and Cosmetic Act (“FDCA”).
  2. Adverse Event” means any undesirable experience associated with the use of a Product, including any serious adverse drug experiences reportable to the FDA.
  3. Buyer” means the entity purchasing Products from Wilcrest.
  4. Critical Quality Attributes” or “CQAs” means product attributes and release characteristics relevant to identity, strength, quality, purity, and safety, which may include (as applicable) appearance, pH, particulate matter, fill volume, sterility, endotoxin, container-closure integrity, assay/potency, osmolarity, viscosity, and other attributes appropriate to the Product.
  5. Expiration Date” means the date after which a Product should not be used, as determined by Wilcrest based on stability data/scientific justification and CGMP requirements, and as shown on the Product label.
  6. Beyond-Use Date” or “BUD” means Expiration Date. For purposes of these Terms, “BUD” and “Expiration Date” are used interchangeably.
  7. Order” means any purchase order, order request, online order, quote acceptance, order acknowledgement, Work Order, or other ordering instrument for Products submitted by Buyer and accepted by Wilcrest.
  8. Products” means sterile or non-sterile drug products compounded by Wilcrest as an FDA-registered 503B outsourcing facility and supplied under these Terms and an accepted Order.

1. “CGMP” means current good manufacturing practice requirements applicable to outsourcing facilities and drug products, including 21 C.F.R. Parts 210 and 211, and, to the extent applicable, the requirements of Section 503B of the FDCA and implementing FDA regulations.

  1. Facility(ies)” means Buyer’s healthcare location(s) that receive, store, handle, and/or administer Products.

ARTICLE 2: SCOPE; ORDERS; ACCEPTANCE

  1. Scope. These Terms govern all sales of Products by Wilcrest to Buyer unless replaced by an Institutional MSA for that Buyer.
  2. Order Acceptance. Buyer may submit Orders, but no Order is binding unless accepted by Wilcrest, which may be shown by written acceptance, shipment, or other confirmation.
  3. Right to Refuse/Allocate. Wilcrest may refuse, cancel, limit, or allocate Orders (in whole or part) due to regulatory restrictions, capacity constraints, supply chain limitations, quality

concerns, or Wilcrest’s determination that fulfilling the Order may violate applicable law, FDA guidance, or Wilcrest policies.

  1. No Minimum Commitments. Buyer has no minimum purchase obligation unless expressly stated in a written commitment signed by Wilcrest.
  2. Precedence. In the event of conflict, the following order of precedence applies:
    1. an executed Institutional MSA (if any), but only to the extent it expressly supersedes these Terms;
    2. an executed Account Enrollment & Purchasing Authorization (if any);
    3. these Terms;
    4. accepted Order details commercial-only (Product, quantity, ship-to, price, delivery).
  3. Electronic Transactions; Authority. Buyer agrees that Orders may be formed and accepted electronically, including through Wilcrest’s portal. Buyer consents to the use of electronic records and signatures. Buyer represents that each individual who submits an Order, accepts a quote, or completes checkout on Buyer’s behalf is authorized to bind Buyer.

ARTICLE 3: REGULATORY COMPLIANCE

  1. 503B and CGMP. Wilcrest represents that it is registered as a 503B outsourcing facility and will manufacture Products in compliance with applicable CGMP (as defined herein), Section 503B of the FDCA, and other applicable FDA requirements. Wilcrest’s quality system is designed to align with applicable FDA guidance for outsourcing facilities as implemented by Wilcrest in its quality management system; provided, however, that FDA guidance documents are nonbinding and do not create additional obligations beyond applicable law.
  2. Buyer Compliance; Permitted Use. Buyer will store, handle, and administer Products in accordance with label instructions, applicable standards of care, and applicable laws and regulations.
  3. No Wholesaling / Redistribution. Buyer shall not sell, transfer, broker, redistribute, or otherwise furnish Products to any third party, except for administration to patients at Buyer Facilities and as otherwise permitted by applicable law. Buyer acknowledges that Wilcrest may refuse or cancel any Order Wilcrest reasonably believes may violate Section 503B of the FDCA, applicable FDA guidance, or applicable state laws, rules, or regulations (including state board of pharmacy requirements) regarding the purchase, receipt, or distribution of Products.
  4. Licensure / Shipment Restrictions. Wilcrest may restrict shipments to certain jurisdictions or Buyer locations based on licensure, registration, injunctions, enforcement actions, or Wilcrest’s compliance determinations.

ARTICLE 4: QUALITY; RELEASE; DOCUMENTATION

  1. Quality System. Wilcrest maintains a quality management system and independent quality function with authority to approve or reject components, in-process materials, labeling/packaging, and finished Products.
  2. Product Release. Wilcrest releases Products based on specifications, including applicable CQAs, and provides documentation consistent with Wilcrest’s policies and regulatory requirements.
  3. Certificates of Analysis. Where applicable, Wilcrest will provide a certificate of analysis (“COA”) or release documentation with shipment or make it available through a portal.
  4. Inspections / Audits. Any Buyer audit requests are subject to Wilcrest’s audit program, confidentiality requirements, safety/security requirements, and scheduling availability. Wilcrest may require an NDA and may limit disclosure/redact confidential or privileged information.

ARTICLE 5: LABELING; PACKAGING; SHIPPING; RISK OF LOSS; ACCEPTANCE

  1. Labeling. Wilcrest will label Products in compliance with Section 503B of the FDCA and applicable requirements. Labels will include, as applicable, Product identification, lot/batch, Expiration Date, storage conditions, and other required information.
  2. Packaging; Cold Chain. Wilcrest will package Products to maintain integrity and (as applicable) temperature requirements during normal shipment conditions. Where temperature control is required, Wilcrest may use monitoring devices and validated methods.
  3. Delivery Terms; Shipping Charges. Shipping terms and charges are as stated in the Order. Unless otherwise stated, shipping/handling may be invoiced separately.
  4. Risk of Loss / FOB.
    1. FOB Destination (Wilcrest Arranges Shipment). If Wilcrest arranges shipment using its carriers and Buyer does not control the carrier selection/account, risk of loss transfers upon delivery to the ship-to location.
    2. FOB Shipping Point (Buyer Controls Shipment). If Buyer provides its own carrier account number or directs the carrier, risk of loss transfers upon tender to that carrier at Wilcrest’s facility.
  5. Inspection and Notice of Nonconformance. Buyer shall inspect Products promptly upon receipt and notify Wilcrest in writing of any shortage, damage, temperature excursion, or nonconformance within ten (10) business days after receipt (or such shorter period required by the carrier for damage claims). Failure to notify within the notice period constitutes acceptance, except for latent defects not reasonably discoverable on inspection, which must be reported within a reasonable time after discovery and before Expiration Date.
  6. Returns. Products are not returnable except with Wilcrest’s prior written return

authorization and in accordance with Wilcrest’s return procedures. Buyer acknowledges that for patient safety and regulatory reasons, Wilcrest may require destruction in lieu of return and may condition credit on investigation results.

ARTICLE 6: PRICING; TAXES; PAYMENT

  1. Pricing. Pricing is as stated in the Order or Wilcrest’s then-current price schedule/quote.
  2. Price Changes. Wilcrest may change prices upon notice; however, if an Order includes a defined term/volume commitment accepted by Wilcrest, pricing will remain firm for that Order term except where required by law/regulatory action or due to documented, material increases in input costs outside Wilcrest’s reasonable control. In such case, Buyer may terminate the affected Order if the Parties cannot agree on an adjustment.
  3. Invoices. Wilcrest will invoice per the Order (typically upon shipment). Invoices may include Product details, quantities, lot/batch, price, taxes, shipping, and payment due date.
  4. Payment Terms. Unless otherwise agreed in writing, payment is due Net 30 from invoice date for undisputed amounts.
  5. Payment Methods; Fees. Payment may be made by ACH, wire, check, or credit card (if permitted). Credit card payments may be subject to a processing fee disclosed at payment time.
  6. Disputed Amounts. Buyer must notify Wilcrest in writing of any invoice dispute within fifteen (15) days of invoice date and pay undisputed amounts when due. The Parties will work in good faith to resolve disputes.
  7. Late Payments; Suspension. Late amounts accrue interest at 1.5% per month (or maximum permitted). Wilcrest may suspend shipments for delinquent accounts.
  8. Taxes. Buyer is responsible for all sales/use/excise and similar taxes (excluding taxes on Wilcrest’s net income), unless Buyer provides a valid exemption certificate.

ARTICLE 7: WARRANTIES; DISCLAIMER

  1. Limited Warranty. Wilcrest warrants that, at the time of shipment, Products will conform in all material respects to Wilcrest’s release specifications and will be manufactured in compliance with applicable CGMP.
  2. Warranty Exclusions. The warranty does not apply to issues caused by Buyer or third parties, including improper storage/handling, temperature excursions after risk of loss transfers, misuse, administration beyond Expiration Date, or use inconsistent with labeling.
  3. Exclusive Remedy. For breach of the limited warranty, Wilcrest’s sole obligation and Buyer’s exclusive remedy is, at Wilcrest’s option, replacement of nonconforming Products or refund/credit of the purchase price for the affected Products.
  4. DISCLAIMER. EXCEPT AS EXPRESSLY PROVIDED IN THIS ARTICLE, WILCREST DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. WILCREST DOES NOT WARRANT CLINICAL OUTCOMES FOR ANY PATIENT OR INDICATION.

ARTICLE 8: ADVERSE EVENTS; COMPLAINTS; RECALLS

  1. Adverse Events. Buyer shall notify Wilcrest of any Adverse Event related to Products promptly and, where applicable, within twenty-four (24) hours after becoming aware of such event, and shall provide reasonably requested information to support Wilcrest’s investigation and regulatory reporting obligations, subject to applicable privacy laws. Buyer acknowledges that Wilcrest may have FDA reporting obligations that run from the time Wilcrest is notified.
  2. Product Complaints. Buyer shall report product complaints (including suspected defects, contamination, labeling/packaging issues, or deviations) promptly and in any event within ten

(10) business days after discovery.

  1. Investigations; Cooperation. Wilcrest will investigate complaints in accordance with its quality system. Buyer will cooperate with investigations and provide requested records reasonably necessary for traceability and regulatory reporting, including, as available, administration date, Facility, and Product lot/batch number.
  2. Recalls. If a recall is initiated, the Parties will cooperate to execute recall actions. Allocation of direct recall costs will be handled as follows: (a) if caused by Wilcrest nonconformance, Wilcrest bears reasonable direct recall costs; (b) if caused by Buyer handling/storage/admin or Buyer instructions, Buyer bears such costs; (c) if mixed/unclear, costs are allocated reasonably based on causation.

ARTICLE 9: INDEMNIFICATION

  1. Wilcrest Indemnity. Wilcrest will indemnify, defend, and hold harmless Buyer and its officers, directors, and employees from third-party claims to the extent arising from Wilcrest’s gross negligence or willful misconduct or Wilcrest’s material breach of these Terms, subject to the limitations in Article 10.
  2. Buyer Indemnity. Buyer will indemnify, defend, and hold harmless Wilcrest and its officers, directors, and employees from third-party claims to the extent arising from Buyer’s negligence, gross negligence, willful misconduct, or breach of these Terms, including improper handling/storage/administration after risk of loss transfers.
  3. Procedures. The indemnified party must promptly notify the indemnifying party and allow control of defense/settlement, with consent required for any settlement that imposes non-monetary obligations or admissions on the indemnified party.

ARTICLE 10: LIMITATION OF LIABILITY

  1. NO CONSEQUENTIAL DAMAGES. TO THE MAXIMUM EXTENT PERMITTED BY LAW, NEITHER PARTY IS LIABLE FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY, OR PUNITIVE DAMAGES, INCLUDING LOST PROFITS OR REVENUE, EVEN IF ADVISED OF POSSIBILITY.
  2. CAP. TO THE MAXIMUM EXTENT PERMITTED BY LAW, EACH PARTY’S TOTAL AGGREGATE LIABILITY ARISING OUT OF OR RELATING TO PRODUCTS SOLD UNDER THESE TERMS WILL NOT EXCEED THE AMOUNTS PAID BY BUYER TO WILCREST FOR THE SPECIFIC PRODUCTS GIVING RISE TO THE CLAIM DURING THE TWELVE (12) MONTHS PRECEDING THE EVENT.
  3. Exceptions. The limitations above do not apply to (a) bodily injury claims to the extent caused by a Party’s gross negligence or willful misconduct, or (b) a Party’s fraud.

ARTICLE 11: CONFIDENTIALITY; HIPAA

  1. Confidentiality. Each Party may disclose Confidential Information. The receiving Party will use it only to perform under these Terms, protect it using reasonable care, and disclose only to personnel/advisors with a need to know bound by confidentiality.
  2. Exclusions. Confidentiality does not apply to information that is public without breach, previously known, independently developed, or required to be disclosed by law (with prompt notice where permitted).
  3. HIPAA/PHI. If the Parties determine that Wilcrest will receive Protected Health Information on Buyer’s behalf, the Parties will execute a Business Associate Agreement before PHI is exchanged.

ARTICLE 12: INTELLECTUAL PROPERTY; NO DEVELOPMENT

  1. Wilcrest Technology. Wilcrest retains all right, title, and interest in its manufacturing methods, quality systems, analytical methods, know-how, and related IP. Buyer receives no license except as necessary to use Products as permitted.
  2. No Development / CDMO. These Terms do not obligate Wilcrest to develop any Product exclusively for Buyer or transfer ownership of any formulation or related IP. Any CDMO/CMO/ development or customer-owned formulation manufacturing must be governed by a separate written agreement signed by Wilcrest.

ARTICLE 13: TERM; TERMINATION; SUSPENSION

  1. Term. These Terms apply to each accepted Order and remain effective for so long as Wilcrest continues to accept Orders from Buyer.
  2. Termination / Account Closure. Either Party may stop doing business at any time upon written notice. Wilcrest may immediately suspend or cancel Orders for nonpayment, compliance concerns, suspected diversion/wholesaling, or where required to comply with law/regulatory obligations.
  3. Effect. Termination does not relieve Buyer of payment obligations for Products shipped/accepted and does not affect accrued rights/obligations.

ARTICLE 14: GENERAL PROVISIONS

  1. Independent Contractors. The Parties are independent contractors.
  2. Force Majeure. Neither Party is liable for delays due to events beyond reasonable control.
  3. Assignment. Buyer may not assign these Terms without Wilcrest’s prior written consent.

Wilcrest may assign to an affiliate or successor.

  1. Notices. Notices must be in writing and delivered to the addresses/designations on file or as posted on Wilcrest’s website for legal notices.
  2. Governing Law; Venue. These Terms and all Orders are governed by the laws of the State of Texas, without regard to conflict of law principles. Any action or proceeding arising out of or relating to these Terms, the Products, or any Order shall be brought exclusively in the state courts located in Harris County, Texas, or the United States District Court for the Southern District of Texas (Houston Division), and each Party irrevocably submits to the personal jurisdiction of such courts and waives any objection to venue or forum non conveniens.
  3. Dispute Resolution. The Parties will attempt in good faith to resolve any dispute, claim, or controversy arising out of or relating to these Terms, any Order, or the Products (a “Dispute”) by escalation to senior business representatives with authority to resolve the Dispute. Either Party may initiate this process by providing written notice describing the Dispute in reasonable detail. If the Parties are unable to resolve the Dispute within thirty (30) days after the notice is delivered (or such shorter period as may be commercially reasonable if immediate action is required), either Party may pursue any remedies available at law or in equity in accordance with Section 14.5 (Governing Law; Venue). Notwithstanding the foregoing, either Party may at any time seek temporary, preliminary, or permanent injunctive or other equitable relief in a court of competent jurisdiction to protect its Confidential Information, intellectual property, or other proprietary rights.
  4. Severability; Waiver. If any provision of these Terms is held to be invalid, illegal, or unenforceable by a court of competent jurisdiction, the remaining provisions will remain in full force and effect. The invalid, illegal, or unenforceable provision will be deemed modified to the minimum extent necessary to make it valid, legal, and enforceable while most closely reflecting the Parties’ original intent. No waiver of any provision or breach of these Terms will be effective unless in writing and signed by the Party against whom the waiver is asserted. No waiver of any breach will constitute a waiver of any other breach or any subsequent breach. A Party’s failure or delay to enforce any right or provision will not operate as a waiver of such right or provision. Any waiver permitted under these Terms will be construed narrowly and will not be deemed a continuing waiver.
  5. Entire Agreement for Website Sales. These Terms (and any Account Enrollment & Purchasing Authorization and accepted Orders) are the entire agreement for website/standard sales unless replaced by an Institutional MSA.
  6. Updates to Terms. Wilcrest may revise these Terms from time to time by posting an updated version on its website or portal with a new “Last Updated” date. Unless Wilcrest specifies a later effective date, updates are effective upon posting and apply to Orders accepted on or after the effective date of the update. BY PLACING ANY ORDER (INCLUDING BY COMPLETING PORTAL CHECKOUT) AFTER THE EFFECTIVE DATE OF UPDATED TERMS, BUYER ACKNOWLEDGES IT HAS REVIEWED THE UPDATED TERMS AND AGREES TO BE BOUND BY THEM. BUYER’S CONTINUED ORDERING CONSTITUTES ASSENT TO THE UPDATED TERMS. If Buyer does not agree to an update, Buyer must cease placing Orders.