ACCORTO REGULATORY SOLUTIONS, LLC GENERAL TERMS AND CONDITIONS

Effective: May 16, 2024

1. APPLICABILITY.

These General Terms and Conditions (these “Terms”) govern the provision of services by Accorto Regulatory Solutions, LLC, a Virginia limited liability company (“Accorto”), to the entity that has accepted a Proposal (as hereinafter defined) from Accorto (“Client”, and together with Accorto, the “Parties”), all in accordance with the provisions contained herein. Accorto reserves the right to amend these Terms by making such updated Terms available on its website. Such updated Terms shall be deemed to replace these Terms upon their effective date. Client agrees that its payment of any invoice from Accorto with respect to services performed after the effective date of any updated Terms shall be considered Client’s acknowledgment and acceptance of such updated Terms.

2. DEFINED TERMS.

Capitalized terms shall have the meanings ascribed to them herein, or if not so defined, the meanings assigned to them in this Section 2:

“Confidential Information” means, with respect to a Party, all non-public, confidential, or proprietary information of such Party, including the terms of and existence of this Agreement, and all plans, documents, data, customer lists, pricing, or other materials disclosed to the other Party, whether disclosed orally or in written, electronic or other form, and whether or not marked or designated as “confidential,” in connection with this Agreement is confidential, solely for the use of performing this Agreement, and includes information regarding the disclosing Party’s business, goods, and services, and its Intellectual Property.

“Intellectual Property” means any and all rights created under laws governing patents, copyrights, mask works, trade secrets, trademarks, and any other law that grants a right to control or preclude another person’s or entity’s right to use, copy, display, distribute, manufacture, sell, access or otherwise exploit works, inventions, materials, or information on the basis of the holder-of-right’s interest therein, and includes software and all know-how, trade secrets, copyrightable material, copyrights, applications, patentable inventions, materials, notes, designs, technical data, ideas, research, reports, documentation, and other similar information relating thereto.

“Proposal” means a written proposal, project estimate, or quotation from Accorto delivered to Client for the provision of Services and includes any Scope of Work included therein.

“Scope of Work” means a written detailed description of proposed Services included within a Proposal.

“Services” means the services to be performed by Accorto as set forth in an Order.

3. PROCEDURE.

Client shall have thirty (30) days following receipt of a Proposal in which to accept the Proposal by returning an executed copy to Accorto. If Client returns an executed Proposal within such period, and Client has not changed, supplemented, or deleted any of its terms (including by appending any additional terms), then, upon receipt by Accorto, the Proposal shall be converted to a purchase order (“Order”) and upon such date (“Effective Date”) shall become subject to these Terms. If any terms have been removed, changed, or supplemented, the Proposal shall be null and void and of no further effect, notwithstanding that Client may have returned an executed copy.

4. ENTIRE AGREEMENT.

Integration; Order of Preference. These Terms, the accompanying Order, and any nondisclosure agreement between the Parties (“NDA”) comprise the entire agreement between the Parties (collectively, “Agreement”), and supersede all prior or contemporaneous understandings, agreements, negotiations, representations and warranties, and written and oral communications. In the event of any conflict between these Terms and any Order, these Terms shall govern, and in the event of any conflict between these Terms and any NDA, the terms of the NDA shall govern.

Notwithstanding anything herein to the contrary, if the Parties enter into an agreement after the Effective Date related to the Services governed by an Order, the terms and conditions of such subsequent agreement shall prevail to the extent they are inconsistent with these Terms.

No Effect Given to Client-Provided Terms. These Terms prevail over and supersede any preprinted terms of any Client-generated purchase order, request for quote, acceptance, or acknowledgment, and any additional or contrary terms contained in any other document or communication from Client. Any attempt by Client to modify, supplement, or otherwise alter any Proposal, Order, or these Terms are deemed rejected by Accorto and will not modify these Terms or be binding on the Parties unless mutually agreed otherwise between the Parties in writing.

5. TERM; TERMINATION AND EFFECT.

Term. The term of this Agreement (“Term”) shall commence on the Effective Date and, unless earlier terminated pursuant to the following paragraph, shall continue until the latest to occur of: (i) the period of time necessary for Accorto to provide the Services specified in an Order; or (ii) the date on which all payment and other obligations of Client under an Order have been fulfilled.

Termination. Notwithstanding anything in this Section 5 to the contrary, Accorto may terminate this Agreement if Client: (a) fails to pay any amount when due hereunder; or (b) is in material breach of any representation, warranty, or covenant of Client hereunder and either the breach cannot be cured or, if the breach can be cured, Client does not cure such breach within 10 days after Client’s receipt of written notice of such breach.

Effect of Expiration or Termination. Upon the expiration or earlier termination of this Agreement, all accrued and unpaid amounts due under Section 8 shall become immediately due and payable to Accorto without further notice to Client. Client acknowledges and agrees that: (a) Accorto shall not be liable for any damage (whether direct or indirect) incurred by Client by reason of the expiration or earlier termination of this Agreement; and (b) Accorto’s termination of this Agreement will not constitute a waiver of any of its rights, remedies, or defenses under this Agreement, at law, in equity, or otherwise. Client further acknowledges and agrees that termination of this Agreement shall not result in a refund of any payment made by Client to Accorto.

6. SERVICES.

Provision of Services. During the Term, Accorto shall provide to Client the Services specified in an applicable Order, in each case subject to these Terms. Unless otherwise specified, all Accorto services shall be considered to be consulting services performed and provided exclusively from the United States.

Client Information and Responses. Client shall promptly deliver all information and documents that Accorto reasonably requests and to respond to all inquiries related to Accorto’s performance of Services, and all such information shall be true and accurate to the best knowledge of Client.

Acknowledgment Regarding Payment. Client acknowledges and agrees that: (a) Accorto shall have no obligation to commence any Services until Client has paid the down payment set forth in any Order; and (b) if Client has engaged Accorto to perform subsequent Services, Accorto shall have no obligation to commence any subsequent Services until Client has paid the applicable fees for the initial Services as indicated on such Order.

7. CERTAIN UNDERSTANDINGS WITH RESPECT TO THE SERVICES.

Performance of Services. Accorto shall use commercially reasonable efforts in its performance of the Services. Client acknowledges and agrees that: (a) Accorto may subcontract with one or more appropriately qualified vendors or contract research organizations (“CROs”) to perform certain aspects of the Services so long as a nondisclosure agreement is in place to govern the handling of Client’s Confidential Information; (b) Accorto may perform services for the account of others, including entities which may be in competition with Client; and (c) the Services provided do not constitute, nor has Accorto represented that the Services shall constitute, legal advice or legal services.

Time is of the Essence. Client acknowledges and agrees that time is of the essence with respect to its obligations hereunder, including its delivery of information and documents to Accorto, and its responses to Accorto’s inquiries and requests, and that prompt and timely performance of all such obligations is strictly required. Client will utilize its best efforts in performing its obligations.

Assumption of Risk and No Guarantee of Approval. Client acknowledges and agrees that: (a) Accorto’s provision of Services may not result in Client obtaining regulatory approval of any applicable submission or application, and that Accorto may not be able to obtain such approval.

8. FEES; PAYMENT TERMS.

As consideration payable to Accorto for providing the Services, Client shall pay to Accorto the amounts set forth on each applicable Order, as well as any amounts incurred by Accorto to engage any CRO in connection with the Services (regardless of whether such amounts are specified on any Order), in the manner described on such Order. In order for Accorto to be paid in full, all payments to Accorto must be net of any duties, taxes, processing fees, sender wire fees or any other holdback of any kind. Wired or ACH payments are only considered to have been made once funds in full reach Accorto’s account.

9. DISCLAIMER; LIMITATION OF LIABILITY.

Disclaimer. Accorto makes no representations or warranties, express or implied, in respect of the Services.

Limitation of Liability. Neither Accorto nor any of its officers, managers, members, representatives, or affiliates (collectively, “Related Parties”) shall be liable to Client or its officers, directors, managers, owners, representatives, or affiliates for any loss, claim, action, damage, liability, or expense (“Loss”) arising out of or in connection with the performance of any Services, unless such Loss shall be proven to result directly from Accorto’s or a Related

Party’s willful misconduct. IN NO EVENT SHALL ACCORTO OR ANY RELATED PARTY BE LIABLE TO CLIENT FOR CONSEQUENTIAL, INCIDENTAL, INDIRECT, PUNITIVE, OR SPECIAL DAMAGES, OR LOSS OF PROFITS, DATA, BUSINESS OR GOODWILL, ARISING OUT OF OR RELATING TO ANY BREACH HEREOF, REGARDLESS OF THE THEORY OF LIABILITY.

10. CONFIDENTIALITY.

Exclusion from Definition of Confidential Information.

Confidential Information does not include information that: (a) Accorto provides to a regulator or to a CRO in performing the Services; (b) is or becomes generally available to and known by the public other than as a result of any breach of this Section 10 by the recipient Party or its representatives; (c) is or becomes available to recipient Party on a non-confidential basis from a third party, provided that such third party is and was not prohibited from making such disclosure; (d) was known by or in the possession of recipient Party prior to being disclosed by or on behalf of disclosing Party; (e) was or is independently developed by receiving Party without reference to or use of any Confidential Information; or (f) is required to be disclosed under applicable law.

Use and Protection.

Each Party may use the other Party’s Confidential Information only as expressly permitted by this Agreement in exercising its rights or performing its obligations hereunder. A recipient Party shall not disclose or permit access to Confidential Information other than to its representatives who need to know such Confidential Information in order for such Party to exercise its rights or perform its obligations hereunder. Each recipient Party shall safeguard the Confidential Information from unauthorized use, access, or disclosure using at least the degree of care it uses to protect its own Confidential Information and in no event less than a reasonable degree of care, and shall be liable for its representatives’ noncompliance with the terms hereof. Notwithstanding anything to the contrary herein, Client acknowledges and agrees that Accorto’s disclosure to regulators in performing the Services shall not constitute a breach of this Section 10. Upon disclosing Party’s request, recipient Party shall promptly return all documents and other materials received from disclosing Party.

Ownership. Each Party acknowledges and agrees that this Agreement does not constitute any license of conveyance of any rights with respect to any Confidential Information and that, as between the Parties, such Confidential Information is and shall remain the sole and exclusive property of disclosing Party. Neither Party shall, nor shall such Party allow its representatives to, take any action inconsistent with the other Party’s ownership in and to its Confidential Information.

Remedies. If either Party violates any of the provisions of this Section 10, the other Party, at its option, may seek equitable or injunctive relief, seek damages, or pursue any and all other rights and remedies that may be available at law, in equity or otherwise, all of which shall be cumulative and not mutually exclusive.

11. INTELLECTUAL PROPERTY.

Ownership. Each Party acknowledges and agrees that the other Party is and will remain the exclusive owner of all right, title, and interest in and to its Intellectual Property. Additionally, Client acknowledges and agrees that Accorto is and will remain the exclusive owner of all right, title, and interest in and to: (i) the Services, including all strategies, procedures, and methodologies in connection therewith; and (ii) the identity of any CRO and the nature of any testing methodologies employed in connection with the Services.

Use. Each Party shall, during the Term and thereafter: (i) use the other Party’s Intellectual Property only in accordance with this Agreement and any instructions of the Party owning such IP Rights; and (ii) safeguard the other Party’s Intellectual Property from infringement, misappropriation, theft, misuse, or unauthorized access.

Protection. Each Party acknowledges and agrees that such Party shall not, whether during the Term or thereafter: (i) acquire any ownership interest in the other Party’s Intellectual Property; (ii) take any action that interferes with the other Party’s Intellectual Property, including the other Party’s ownership or exercise thereof; (iii) challenge any right, title, or interest of the other Party in or to its Intellectual Property; or (iv) make any claim or take any action adverse to the other Party’s ownership of its Intellectual Property.

12. FORCE MAJEURE.

Client acknowledges and agrees that Accorto shall not be responsible for any failures or delays in performing Services which are caused by or arise from any action or event outside of Accorto’s reasonable control (“Force Majeure Event”). If Accorto’s ability to render Services is impaired by a Force Majeure Event, Accorto may elect, in its sole discretion, but upon written notice to Client, cease to render any Services.

13. INDEMNIFICATION.

Client shall indemnify and hold harmless Accorto and the Related Parties (each an “Indemnified Party”) from and against any and all Losses, joint or several, to which such Indemnified Party may become subject under any applicable law, made by any third party or otherwise, relating to or arising out of the Services, unless such Loss is determined to have resulted solely from the willful misconduct of such Indemnified Party. The obligations of Client under this Section 13 shall be in addition to any liability which Client may otherwise have under this Agreement.

14. MISCELLANEOUS.

Governing Law; Jurisdiction. This Agreement shall be governed in all respects by the internal laws of the Commonwealth of Virginia without regard to its conflicts of law principles. Any litigation arising from the terms of this Agreement, or any agreement between the Parties, or work performed, or actions taken hereunder, shall be brought in the courts of the Commonwealth of Virginia.

Interpretation. As used herein, unless a clear contrary intention applies: (a) references to “Section” are to a section of these Terms, and references to “hereunder,” “hereof,” “hereto,” and words of similar import are references to these Terms as a whole and not to any particular Section hereof; (b) references to the singular includes the plural, and vice versa; (c) the term “including” is deemed to be followed by “without limitation” whether or not followed by such words; and (d) section headings are for convenience only and shall not modify, define, or limit any of the terms or provisions hereof.

Relationship of the Parties. Nothing contained herein shall create a contractual relationship between the Parties other than that of an independent contractor. This Agreement shall not be deemed to make either Party in any way or for any purpose a partner, employer, or employee of the other Party.

Severability; Survival. If any term or provision of this Agreement is invalid, illegal, or unenforceable in any jurisdiction, such invalidity, illegality, or unenforceability shall not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction. Provisions of this Agreement which by their nature should apply beyond their terms will remain in force notwithstanding the expiration or earlier termination of this Agreement.

Notices. To be effective, any notice or other communication required or permitted hereunder must be in writing and shall be deemed delivered to the Parties at the addresses set forth on the face of an Order. All notices shall be delivered by overnight courier (fees pre-paid), certified or registered mail (in each case, return receipt requested, postage prepaid), or by e-mail (with confirmation of transmission).

Amendment; Waiver. No amendment hereto is effective unless contained in writing signed by an authorized representative of each Party and specifically provides that it amends these Terms. The failure of Accorto to enforce any provisions of this Agreement shall not be deemed a waiver or limitation of its right to subsequently enforce and compel strict compliance with every provision hereof.

Assignment; Binding Agreement. Neither Party shall assign any of its rights or delegate any of its obligations hereunder without the prior written consent of the other Party. This Agreement is binding on and inures to the benefit of the Parties and their successors and permitted assigns. Except as expressly set forth herein, this Agreement benefits the Parties and their respective successors and permitted assigns and nothing herein, express or implied, confers on any other party any right, benefit, or remedy under or by reason of this Agreement.