Compliance Program. The Company has established and administers a compliance program applicable to the Company, to assist the Company and the directors, officers and employees of the Company in complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA, the EMA, and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA or EMA); except where such noncompliance would not reasonably be expected to have a Material Adverse Effect.
Appears in 57 contracts
Samples: At Market Issuance Sales Agreement (Nanoviricides, Inc.), Sales Agreement (Cumberland Pharmaceuticals Inc), Sales Agreement (BioSig Technologies, Inc.)
Compliance Program. The Except as disclosed in the Registration Statement and the Prospectus, the Company has established and administers a compliance program applicable to the Company, to assist the Company and the directors, officers and employees of the Company in complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA, the EMA, FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA or EMAFDA); except where such noncompliance would not reasonably be expected to have a Material Adverse Effect.
Appears in 18 contracts
Samples: At Market Issuance Sales Agreement (Fortress Biotech, Inc.), Equity Distribution Agreement (Repros Therapeutics Inc.), At the Market Issuance Sales Agreement (Ligand Pharmaceuticals Inc)
Compliance Program. The Company has established and administers a compliance program applicable to the Company, to assist the Company and the directors, officers and employees of the Company in complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA, the EMA, FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA or EMAFDA); except where such noncompliance would not reasonably be expected to have a Material Adverse Effect.
Appears in 13 contracts
Samples: At the Market Issuance Sales Agreement (Vical Inc), At Market Issuance Sales Agreement (Mannkind Corp), At the Market Issuance Sales Agreement (Synta Pharmaceuticals Corp)
Compliance Program. The Company has established and administers a compliance program applicable to the Company, to assist the Company and the directors, officers and employees of the Company in complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA, the EMA, and any other foreign, federal, state or local governmental or regulatory authority having jurisdiction over the Company and performing functions similar to those performed by the FDA or EMA); except where such noncompliance would not reasonably be expected to have a Material Adverse Effect.
Appears in 12 contracts
Samples: At Market Issuance Sales Agreement (Evoke Pharma Inc), At Market Issuance Sales Agreement (Conatus Pharmaceuticals Inc.), At Market Issuance Sales Agreement (Medicinova Inc)
Compliance Program. The Company has established and administers a compliance program applicable to the Company, to assist the Company and the directors, officers and employees of the Company in complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA, the EMA, and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA or EMA); , except where such noncompliance would not reasonably be expected to have a Material Adverse Effect.
Appears in 8 contracts
Samples: Sales Agreement (CorMedix Inc.), Capital on Demand Sales Agreement (Virios Therapeutics, Inc.), Underwriting Agreement (CorMedix Inc.)
Compliance Program. The Except as disclosed in the Registration Statement and the Prospectus, the Company has established and administers a compliance program applicable to the Company, to assist the Company and the directors, officers and employees of the Company in complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA, the EMA, FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA or EMA); FDA) except where such noncompliance would not reasonably be expected to have a Material Adverse Effect.
Appears in 4 contracts
Samples: At Market Issuance Sales Agreement (Aeterna Zentaris Inc.), At Market Issuance Sales Agreement (Aeterna Zentaris Inc.), At Market Issuance Sales Agreement (Aeterna Zentaris Inc.)
Compliance Program. The Company has established and administers a compliance program applicable to the Company, to assist the Company and the directors, officers and employees of the Company in complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA, the EMA, and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA or EMA); except the Company does not have an independent QA/compliance function as party of its compliance program and except where such noncompliance would not reasonably be expected to have a Material Adverse EffectChange.
Appears in 2 contracts
Samples: Sales Agreement (GeoVax Labs, Inc.), Sales Agreement (Processa Pharmaceuticals, Inc.)
Compliance Program. The Company has established and administers a compliance program applicable to the Company, to assist the Company and the directors, officers and employees of the Company in complying in all material respects with applicable regulatory guidelines (including, without limitation, those administered by the FDA, the EMA, and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA or EMA); except where such noncompliance would not reasonably be expected to have a Material Adverse Effect.
Appears in 2 contracts
Samples: Underwriting Agreement (Tg Therapeutics, Inc.), Underwriting Agreement (Tg Therapeutics, Inc.)
Compliance Program. The Company has established and administers a compliance program applicable to the Company, to assist the Company and the directors, officers and employees of the Company in complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA, the EMA, and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA or EMA); except where such noncompliance would not reasonably be expected to have a Material Adverse Effect..
Appears in 2 contracts
Samples: Sales Agreement (Cassava Sciences Inc), Capital on Demand Sales Agreement (Pain Therapeutics Inc)
Compliance Program. The Company has established and administers a compliance program applicable to the Company, to assist the Company and the directors, officers and employees of the Company in complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA, the EMA, and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA or EMA); except where such noncompliance would not reasonably be expected to have result in a Material Adverse Effect.
Appears in 2 contracts
Samples: Securities Purchase Agreement (Innovate Biopharmaceuticals, Inc.), Securities Purchase Agreement (Innovate Biopharmaceuticals, Inc.)
Compliance Program. The Company has established and administers a compliance program applicable to the Company, to assist the Company and the directors, officers and employees of the Company in complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA, the EMAHC, EMA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA or EMA); FDA) except where such noncompliance would not reasonably be expected to have a Material Adverse Effect.
Appears in 2 contracts
Samples: At Market Issuance Sales Agreement (Acasti Pharma Inc.), At Market Issuance Sales Agreement (Acasti Pharma Inc.)
Compliance Program. The Company has established and administers a compliance program applicable to the Company, to assist the Company and the directors, officers and employees of the Company in complying with applicable Health Care Laws and regulatory guidelines (including, without limitation, those administered by the FDA, the EMA, and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA or EMA); except where such noncompliance would not reasonably be expected to have a Material Adverse Effect.
Appears in 2 contracts
Samples: Underwriting Agreement (EyePoint Pharmaceuticals, Inc.), Underwriting Agreement (EyePoint Pharmaceuticals, Inc.)
Compliance Program. The Company has established and administers a compliance program applicable to the Company, to assist the Company and the directors, officers and employees of the Company in complying with applicable regulatory guidelines (including, without limitation, if applicable, those administered by the FDA, the EMA, and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA or EMA); except where such noncompliance would not reasonably be expected to have a Material Adverse Effect.
Appears in 2 contracts
Samples: Financing Agreement (Luminar Technologies, Inc./De), Financing Agreement (Luminar Technologies, Inc./De)
Compliance Program. The To the Company’s knowledge, the Company has established and administers a compliance program applicable to the Company, to assist the Company and the directors, officers and employees of the Company in complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA, the EMA, and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA or EMA); except where such noncompliance would not reasonably be expected to have a Material Adverse Effect.
Appears in 1 contract
Compliance Program. The Company has established and administers a compliance program program, applicable to the Company, to assist the Company and the directors, officers and employees of the Company in complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA, the EMA, FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions function similar to those performed by the FDA or EMAFDA); except where such noncompliance would not reasonably be expected to have a Material Adverse Effect.
Appears in 1 contract
Samples: At Market Issuance Sales Agreement (Acelrx Pharmaceuticals Inc)
Compliance Program. The Company has established and administers a compliance program applicable to the Company, to assist the Company and the directors, officers and employees of the Company in complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA, the EMA, and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA or EMA); except where such noncompliance would not reasonably be expected to have result in a Material Adverse EffectChange.
Appears in 1 contract
Compliance Program. The Company has established and administers a compliance program applicable to the Company, Company reasonably designed to assist the Company and the directors, officers and employees of the Company in complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA, the EMA, and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA or EMA); except where such noncompliance would not reasonably be expected to have a Material Adverse Effect.
Appears in 1 contract
Samples: At Market Issuance Sales Agreement (Teligent, Inc.)
Compliance Program. The Company has established and administers a compliance program applicable to the Company, to assist the Company and the directors, officers and employees of the Company in complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA, the EMA, and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA or EMA); except where such noncompliance would not reasonably be expected to have a Material Adverse Effect.
Appears in 1 contract
Compliance Program. The Company has established and administers a compliance program applicable to the Company, to assist the Company and the directors, officers and employees of the Company in complying with applicable regulatory guidelines (including, without limitation, those administered by the Food and Drug Administration (the “FDA”), the European Medicines Agency (the “EMA”), and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA or EMA); except where such noncompliance would not reasonably be expected to have result in a Material Adverse EffectChange.
Appears in 1 contract
Samples: Open Market Sale Agreement (Achieve Life Sciences, Inc.)
Compliance Program. The Company has established and administers a compliance program applicable to the Company, to assist the Company and the directors, officers and employees of the Company in complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA, the European Medicines Agency (the “EMA”), and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA or EMA); except where such noncompliance would not reasonably be expected to have a Material Adverse Effect.
Appears in 1 contract
Compliance Program. The Company has established and administers a compliance program applicable to the Company, to assist the Company and the its directors, officers and employees of the Company in complying with applicable regulatory guidelines (including, without limitation, if applicable, those administered by the FDA, the EMA, and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA or EMA); except where such noncompliance would not reasonably be expected to have a Material Adverse Effect.
Appears in 1 contract
Compliance Program. The Company has established and administers initiated a compliance program applicable to the Company, to assist the Company and the directors, officers and employees of the Company in complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA, the EMA, and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA or EMA); except where such noncompliance would not reasonably be expected to have a Material Adverse Effect.
Appears in 1 contract
Samples: At Market Issuance Sales Agreement (Biota Pharmaceuticals, Inc.)
Compliance Program. The Company has established and administers a compliance program applicable to the Company, to assist the Company and the directors, officers and employees of the Company in complying with applicable regulatory guidelines (including, without limitation, those administered by the U.S. Food and Drug Administration (“FDA”), the European Medicines Agency (“EMA”), and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA or EMA); except where such noncompliance would not reasonably be expected to have a Material Adverse Effect.
Appears in 1 contract
Compliance Program. The Company has established and administers a compliance program applicable to the Company, to assist the Company and the its directors, officers and employees of the Company in complying with applicable regulatory guidelines (including, without limitation, if applicable, those administered by the FDA, the EMA, and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA or EMA); , except where such noncompliance would not reasonably be expected to have a Material Adverse Effect.
Appears in 1 contract
Compliance Program. The Company has established and administers initiated a compliance program applicable to the Company, to assist the Company and the directors, officers and employees of the Company in complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA, the EMA, and any other foreign, federal, state or local governmental or regulatory authority having jurisdiction over the Company performing functions similar to those performed by the FDA or EMA); except where such noncompliance would not reasonably be expected to have a Material Adverse Effect.
Appears in 1 contract
Samples: At Market Issuance Sales Agreement (Bellerophon Therapeutics, Inc.)
Compliance Program. The Company has established and administers a compliance program applicable to the Company, to assist the Company and the directors, officers and employees of the Company in complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA, the EMA, FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA or EMA); except where the failure to maintain such noncompliance compliance would not reasonably be expected to have a Material Adverse EffectChange.
Appears in 1 contract
Compliance Program. The Company has established and administers a compliance program applicable to the Company, to assist the Company and the directors, officers and employees of the Company in complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA, the EMA, and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA or EMA); except where such noncompliance would not reasonably be expected to have a Material Adverse Effect. uu.
Appears in 1 contract
Samples: At the Market Issuance Sales Agreement (Biodel Inc)
Compliance Program. The Company has established and administers a compliance program applicable to the Company, to assist the Company and the directors, officers and employees of the Company in complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA, the EMA, FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA or EMAFDA); except where such noncompliance would not reasonably be expected to have a Material Adverse EffectChange.
Appears in 1 contract
Samples: Sales Agreement (G Medical Innovations Holdings Ltd.)