(a) There are no actions, suits or proceedings by or before any arbitrator or Governmental Authority (including the United States Food and Drug Administration and the corresponding Governmental Authorities in Canada and the Republic of Ireland) pending against or, to the knowledge of the Company, threatened against or affecting the Company or any of the Subsidiaries (i) as to which there is a reasonable likelihood of an adverse determination and that, if adversely determined, could reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect or (ii) that involve any of the Loan Documents or the making of the Loans thereunder.