definiens: means any lien, pledge, hypothecation, mortgage, security interest, claim, lease, charge, option, right of first refusal, easement, servitude, transfer, restriction under any stockholder or similaragreement, encumbrance or any other restrictions or limitations whatsoever . Edgemont shall provide [COMPANY] with atrue and complete copy of all regulatory filings made by Edgemont and all communications, relating to the Product, with the FDA . Except as permitted under 21 C.F.R. Sections 314.70(c ) or 314.70(d ), Edgemont shall not makechanges to the NDA for the Product which would materially change the NDA, including, without limitation, anychanges in indication, packaging, labeling, without consulting with and obtaining approval of [COMPANY], such approvalnot to be unreasonably withheld . Notwithstanding the foregoing or any text to the contrary contained herein, Edgemontshall have no right, ( other than in connection with a merger or acquisition or sale of all or substantially all of theassets of Edgemont ) to divest or sell the NDA to a Third Party during the Term of this Agreement.[EXECUTION COPY]3.2 Retention of Rights