Generic Drug Act. Pursuant to the Generic Drug Enforcement Act of 1992, 21 U.S.C. § 335a, as may be amended or supplemented (the “Generic Drug Act”), (i) none of Depomed, its Affiliates, or any Person under its direction or control is currently debarred by the FDA under the Generic Drug Act; (ii) none of Depomed, its Affiliates, or any Person under its direction or control is currently using or will use in any capacity in connection with the Products any Person that is debarred by FDA under the Generic Drug Act; and (iii) there have been no convictions of Depomed, its Affiliates, or any Person under its direction or control for any of the types of crimes set forth in the Generic Drug Act within the five years prior to the Effective Date.
Appears in 5 contracts
Samples: Commercialization Agreement (Salix Pharmaceuticals LTD), Commercialization Agreement (Depomed Inc), Commercialization Agreement (Santarus Inc)
Generic Drug Act. Pursuant to the Generic Drug Enforcement Act of 1992, 21 U.S.C. § 335a, as may be amended or supplemented (the “Generic Drug Act”),
(i) none of Depomed, S2 or its Affiliates, or any Person under its direction or control control, is currently debarred by the FDA under the Generic Drug Act;
(ii) none of Depomed, S2 or its Affiliates, or any Person under its direction or control is currently using or will use in any capacity in connection with the Products Product any Person that is debarred by FDA under the Generic Drug Act; and
(iii) there have been no convictions of Depomed, S2 or its Affiliates, or any Person under its direction or control for any of the types of crimes set forth in the Generic Drug Act within the five (5) years prior to the Effective Date.
Appears in 2 contracts
Samples: Distribution and License Agreement (Santarus Inc), Distribution and License Agreement (Santarus Inc)
Generic Drug Act. Pursuant to the Generic Drug Enforcement Act of 1992, 21 U.S.C. § 335a, as may be amended or supplemented (the “Generic Drug Act”),
(i) none of Depomed, its Affiliates, or any Person under its direction or control is currently debarred by the FDA under the Generic Drug Act;
(ii) none of Depomed, its Affiliates, or any Person under its direction or control is currently using or will use in any capacity in connection with the Products Product any Person that is debarred by FDA under the Generic Drug Act; and
(iii) there have been no convictions of Depomed, its Affiliates, or any Person under its direction or control for any of the types of crimes set forth in the Generic Drug Act within the five years prior to the Effective Date.
Appears in 2 contracts
Samples: Promotion Agreement (King Pharmaceuticals Inc), Promotion Agreement (Depomed Inc)
Generic Drug Act. Pursuant to the Generic Drug Enforcement Act of 1992, 21 U.S.C. § 335a, as may be amended or supplemented (the “Generic Drug Act”),):
(i) none of DepomedSomaxon, its Affiliates, or any Person under its direction or control is currently debarred by the FDA under the Generic Drug Act;
(ii) none of DepomedSomaxon, its Affiliates, or any Person under its direction or control is currently using or will use in any capacity in connection with the Products any Person that is debarred by FDA under the Generic Drug Act; and
(iii) there have been no convictions of DepomedSomaxon, its Affiliates, or any Person under its direction or control for any of the types of crimes set forth in the Generic Drug Act within the five years prior to the Effective Date.
Appears in 1 contract
Samples: Co Promotion Agreement (Somaxon Pharmaceuticals, Inc.)
Generic Drug Act. Pursuant to the Generic Drug Enforcement Act of 1992, 21 U.S.C. § 335a, as may be amended or supplemented (the “Generic Drug Act”),
(i) none of DepomedPediatRx, its Affiliates, or any Person under its direction or control is currently debarred by the FDA under the Generic Drug Act;
(ii) none of DepomedPediatRx, its Affiliates, or any Person under its direction or control is currently using or will use in any capacity in connection with the Products Product any Person that is debarred by FDA under the Generic Drug Act; and
(iii) there have been no convictions of DepomedPediatRx, its Affiliates, or any Person under its direction or control for any of the types of crimes set forth in the Generic Drug Act within the five years prior to the Effective Date.
Appears in 1 contract
