Absence of Debarment. Cyclerion represents and warrants that it, its Affiliates, Representatives, any Permitted Subcontractors and any other person used by Cyclerion to perform the Services (a) has not been debarred, convicted, and is not subject to any pending debarment or conviction, pursuant to section 306 of the United States Food Drug and Xxxxxxxx Xxx, 00 X.X.X. § 000x, (x) has not been listed by any government or regulatory agencies as (i) ineligible to participate in any government healthcare programs or government procurement or non-procurement programs (as that term is defined in 42 U.S.C. 1320a-7b(f)) or excluded, debarred, suspended or otherwise made ineligible to participate in any such programs, or (ii) disqualified or restricted, from receiving investigational products pursuant to the government or regulatory agency’s regulations, or (c) has not been convicted of a criminal offense related to the provision of healthcare items or services, and is not the subject of any such pending action, suit, claim, investigation or proceeding. Cyclerion will promptly inform Ironwood in writing if Cyclerion or any person who is performing Services has been or becomes subject to any of the foregoing, or if any action, suit, claim, investigation, or proceeding relating to the foregoing is pending or threatened.
Appears in 2 contracts
Samples: Development Agreement (Cyclerion Therapeutics, Inc.), Development Agreement (Cyclerion Therapeutics, Inc.)
Absence of Debarment. Cyclerion represents and warrants that it, its Affiliates, Representatives, any Permitted Subcontractors and any other person used by Cyclerion to perform the Services (a) has not been debarred, convicted, and is not subject to any pending debarment or conviction, pursuant to section 306 of the United States Food Drug and Xxxxxxxx XxxCosmetic Act, 00 X.X.X. 21 U.S.C. § 000x335a, (xb) has not been listed by any government or regulatory agencies as (i) ineligible to participate in any government healthcare programs or government procurement or non-procurement programs (as that term is defined in 42 U.S.C. 1320a-7b(f)) or excluded, debarred, suspended or otherwise made ineligible to participate in any such programs, or (ii) disqualified or restricted, from receiving investigational products pursuant to the government or regulatory agency’s regulations, or (c) has not been convicted of a criminal offense related to the provision of healthcare items or services, and is not the subject of any such pending action, suit, claim, investigation or proceeding. Cyclerion will promptly inform Ironwood Xxxxxxxx in writing if Cyclerion or any person who is performing Services has been or becomes subject to any of the foregoing, or if any action, suit, claim, investigation, or proceeding relating to the foregoing is pending or threatened.
Appears in 1 contract
Samples: Development Agreement
Absence of Debarment. Cyclerion represents and warrants that it, its Affiliates, Representatives, any Permitted Subcontractors and any other person used by Cyclerion to perform the Services (a) has not been debarred, convicted, and is not subject to any pending debarment or conviction, pursuant to section 306 of the United States Food Drug and Xxxxxxxx Cxxxxxxx Xxx, 00 X.X.X. § 000x, (x) has not been listed by any government or regulatory agencies as (i) ineligible to participate in any government healthcare programs or government procurement or non-procurement programs (as that term is defined in 42 U.S.C. 1320a-7b(f)) or excluded, debarred, suspended or otherwise made ineligible to participate in any such programs, or (ii) disqualified or restricted, from receiving investigational products pursuant to the government or regulatory agency’s regulations, or (c) has not been convicted of a criminal offense related to the provision of healthcare items or services, and is not the subject of any such pending action, suit, claim, investigation or proceeding. Cyclerion will promptly inform Ironwood in writing if Cyclerion or any person who is performing Services has been or becomes subject to any of the foregoing, or if any action, suit, claim, investigation, or proceeding relating to the foregoing is pending or threatened.
Appears in 1 contract
Samples: Development Agreement (Cyclerion Therapeutics, Inc.)