Part 2.13(d) of the Disclosure Schedule (the “Employee Benefit Plans”). Each Employee Benefit Plan has been established and administered in all material respects in accordance with its terms and the applicable provisions of ERISA, the Code and other Applicable Law. Except as set forth in Part 2.13(d) of the Disclosure Schedule:
(i)copies of all Employee Benefit Plans have been made available to Purchaser or Purchaser’s legal or financial advisor;
(ii)With respect to the Business, Seller Parties and the Company have received no notice, and to the Knowledge of the Seller Parties and the Company, no Employee Benefit Plan, and no trustee or administrator thereof, engaged in any material breach of fiduciary responsibility or any “prohibited transaction” (as such term is defined in Section 406 of ERISA or Section 4975 of the Code) to which Section 406 of ERISA or Section 4975 of the Code applies and which could subject such Employee Benefit Plan or trustee or administrator thereof to a material Tax or penalty on prohibited transactions imposed by Section 4975 of the Code;
(iii)no Employee Benefit Plan is or has within the last six (6) years been subject to the minimum funding requirements of Section 412 of the Code or Title IV of ERISA;
(iv)each Employee Benefit Plan intended to qualify under Section 401(a) of the Code has received a favorable determination letter from the IRS that such Employee Benefit Plan is a “qualified plan” under Section 401(a) of the Code, and the related trusts are exempt from Tax under Section 501(a) of the Code;
(v)with respect to each Employee Benefit Plan, all required contributions have been made or properly accrued on the financial statements of the applicable Seller Party or the Company; and
(vi)neither of the Seller Parties nor the Company has any liability under any Employee Benefit Plan to provide medical or death benefits with respect to employees of the Seller Party beyond their termination of employment (other than coverage mandated by law or regulation), and there are no reserve assets, surplus or prepaid premiums under any such Employee Benefit Plan.
(e)Neither of the Seller Parties nor the Company has any obligation to contribute to any “multiemployer plan” within the meaning of Section 3(37) of ERISA.
(a)The Company has obtained all clearances, authorizations, licenses and registrations required by any foreign or domestic Governmental Body to permit the conduct of its Business (the “Regulatory Licenses”), each of which is listed on Part 2.14(a) of the Disclosure Schedule.
(b)To the Seller Parties’ and the Company’s Knowledge, all pre-clinical and clinical investigations conducted by or on behalf of the Seller Parties or the Company with respect to each Product have been, and are being, conducted in compliance with all applicable Legal Requirements, including those with respect to good laboratory practices, investigational new drug requirements, good clinical practice requirements (including informed consent and institutional review boards designed to ensure the protection of the rights and welfare of human subjects), and federal and state laws restricting the use and disclosure of protected health information, including but not limited to the Health Information
[*** ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.