Each product that is developed, produced, manufactured, tested, packaged, labeled, marketed, sold, and/or distributed by a Credit Party or any of its Subsidiaries that is subject to the Federal Food, Drug and Cosmetic Act (the "FFDCA"), the FDA regulations promulgated thereunder, or similar Applicable Law, is being developed, produced, tested, packaged, labeled, marketed, sold, and/or distributed in compliance in all material respects with all Applicable Laws under the FFDCA or similar Applicable Laws, including those relating to the importation of FDA-regulated products, current good manufacturing practices (cGMPs), and corresponding facility registration, recall, recordkeeping, and reporting obligations, and is not adulterated or misbranded within the meaning of the FFDCA.

“ “Division” means, in reference to any Person which is an entity, the division of such Person into two (2) or more separate Persons, with the dividing Person either continuing or terminating its existence as part of such division, including, without limitation, as contemplated under Section 18-217 of the Delaware Limited Liability Company Act for limited liability companies formed under Delaware law, or any analogous action taken pursuant to any other applicable law with respect to any corporation, limited liability company, partnership or other entity.”

Part I of [Schedule 1.1(B)] to the Facility Agreement shall be amended by replacing the reference to $130,924,545.13 therein with "$93,915,128.06".

The new ​ pricing schedule ​ is agreed as follows

“IND” means # an Investigational New Drug Application as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA, or # the equivalent application to the equivalent Regulatory Authority in any other regulatory jurisdiction, the filing of which is necessary to initiate or conduct clinical testing of a pharmaceutical product in humans in such jurisdiction.

Gary C. Evans, in the capacity of the representative of the Sellers (“Sellers’ Representative”) in accordance with this Agreement.

[Section C.1-2]2] Eligibility of [Schedule C.1] Retirement Contributions – Certain Participating Affiliates shall be amended effective as of January 1, 2021, to read as follows:

[Schedule C]. [Schedule C] to the 1st Amendment is hereby deleted in its entirety and replaced with new [Schedule C] attached hereto.

(iii) ​ percent (​) if the sub-license is granted upon or after the first regulatory approval of Products based on a 505(b)2 New Drug Application ((not a 505(b)1 New Drug Application)) filed with the FDA or equivalent thereof; or

it is not debarred or disqualified under the U.S. Federal Food, Drug and Cosmetic Act, as may be amended, or comparable laws in any country or jurisdiction other than the U.S., and it does not, and will not during the Term, employ or use the services of any person who is debarred or disqualified, in connection with activities relating to any Compound or Product, and in the event that either party