FDA Compliance. Except as would not, individually or in the aggregate, result in a Material Adverse Effect or as disclosed described in or referred to in the SEC Documents: (i) the Company is and has been in compliance with statutes, laws, ordinances, rules and regulations applicable to the Company for the ownership, testing, development, manufacture, packaging, processing, use, labeling, storage, or disposal of any product manufactured by or on behalf of the Company (a “Company Product”), including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., the Public Health Service Act, 42 U.S.C. § 262, similar laws of other governmental entities and the regulations promulgated pursuant to such laws (collectively, “Applicable Laws”); (ii) the Company possesses all licenses, certificates, approvals, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws and/or for the ownership of its properties or the conduct of its business as it relates to a Company Product and as described in the SEC Documents (collectively, “Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iii) the Company has not received any written notice of adverse finding, warning letter or other written correspondence or notice from the U.S. Food and Drug Administration (the “FDA”) or any other governmental entity alleging or asserting noncompliance with any Applicable Laws or Authorizations relating to a Company Product; (iv) the Company has not received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental entity or third party alleging that any Company Product, operation or activity related to a Company Product is in violation of any Applicable Laws or Authorizations or has any knowledge that any such governmental entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any noncompliance with or violation of any Applicable Laws by the Company that would reasonably be expected to require the issuance of any such written notice or result in an investigation, corrective action, or enforcement action by the FDA or similar governmental entity with respect to a Company Product; (v) the Company has not received written notice that any governmental entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such governmental entity has threatened or is considering such action with respect to a Company Product; and (vi) the Company has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission) in all material respects. To the Company’s knowledge, neither the Company nor any of its directors, officers, employees or agents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of the FDA or any other governmental entity related to a Company Product.
Appears in 2 contracts
Samples: Securities Purchase Agreement (ARCA Biopharma, Inc.), Securities Purchase Agreement (ARCA Biopharma, Inc.)
FDA Compliance. (a) Except as would not, individually or in the aggregate, result in a Material Adverse Effect or as disclosed described in or referred to in the SEC Documents, the Company: (i) the Company is and has been in material compliance with all statutes, laws, ordinances, rules and or regulations applicable to the Company for the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product that is under development, manufactured or distributed by or on behalf of the Company (a “Company Product”), including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., the Public Health Service Act, 42 U.S.C. § 262, similar laws of other governmental entities and the regulations promulgated pursuant to such laws (collectively, “Applicable Laws”); (ii) the Company possesses all licenses, certificates, approvals, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws and/or for the ownership of its properties or the conduct of its business as it relates to a Company Product and as described in the SEC Documents (collectively, “Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iii) the Company has not received any written FDA Form 483, notice of adverse finding, warning letter, untitled letter or other written correspondence or notice from the U.S. Food and Drug Administration (the “FDA”) or any other federal, state, local or foreign governmental entity or regulatory authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), which would not, individually or in the aggregate, result in a Material Adverse Effect; (iii) possesses all material Authorizations relating to a necessary for the operation of its business as described in the SEC Documents and such Authorizations are valid and in full force and effect and the Company Productis not in material violation of any term of any such Authorizations; and (iv) the Company since January 1, 2017: (A) has not received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other federal, state, local or foreign governmental entity or regulatory authority or third party alleging that any Company Product, product operation or activity related to a Company Product is in material violation of any Applicable Laws or Authorizations or and has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, ; (B) has there been any noncompliance with or violation of any Applicable Laws by the Company not received notice that would reasonably be expected to require the issuance of any such written notice or result in an investigation, corrective action, or enforcement action by the FDA or similar any other federal, state, local or foreign governmental entity with respect to a Company Product; (v) the Company has not received written notice that any governmental entity or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations or and has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity has threatened or regulatory authority is considering such action with respect to a Company Productaction; and (viC) the Company has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, materially complete and correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission); and (D) in all material respects. To has not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post-sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the Company’s knowledge, neither no third party has initiated, conducted or intends to initiate any such notice or action.
(b) Since January 1, 2017, and except to the extent disclosed in the SEC Documents, the Company nor has not received any of its directors, officers, employees notices or agents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of correspondence from the FDA or any other federal, state, local or foreign governmental entity related to a Company Productor regulatory authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company.
Appears in 2 contracts
Samples: Debt Conversion Agreement (Oragenics Inc), Securities Purchase Agreement (Oragenics Inc)
FDA Compliance. (a) Except as would not, individually or in the aggregate, result in a Material Adverse Effect or as disclosed described in or referred to in the SEC Documents, the Company: (i) the Company is and has been in material compliance with all statutes, laws, ordinances, rules and or regulations applicable to the Company for the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product that is under development, manufactured or distributed by or on behalf of the Company (a “Company Product”), including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., the Public Health Service Act, 42 U.S.C. § 262, similar laws of other governmental entities and the regulations promulgated pursuant to such laws (collectively, “Applicable Laws”); (ii) the Company possesses all licenses, certificates, approvals, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws and/or for the ownership of its properties or the conduct of its business as it relates to a Company Product and as described in the SEC Documents (collectively, “Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iii) the Company has not received any written FDA Form 483, notice of adverse finding, warning letter, untitled letter or other written correspondence or notice from the U.S. Food and Drug Administration (the “FDA”) or any other federal, state, local or foreign governmental entity or regulatory authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), which would not, individually or in the aggregate, result in a Material Adverse Effect; (iii) possesses all material Authorizations relating to a necessary for the operation of its business as described in the SEC Documents and such Authorizations are valid and in full force and effect and the Company Productis not in material violation of any term of any such Authorizations; and (iv) the Company since January 1, 2012: (A) has not received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other federal, state, local or foreign governmental entity or regulatory authority or third party alleging that any Company Product, product operation or activity related to a Company Product is in material violation of any Applicable Laws or Authorizations or and has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, ; (B) has there been any noncompliance with or violation of any Applicable Laws by the Company not received notice that would reasonably be expected to require the issuance of any such written notice or result in an investigation, corrective action, or enforcement action by the FDA or similar any other federal, state, local or foreign governmental entity with respect to a Company Product; (v) the Company has not received written notice that any governmental entity or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations or and has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity has threatened or regulatory authority is considering such action with respect to a Company Productaction; and (viC) the Company has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, materially complete and correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission); and (D) in all material respects. To has not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the Company’s knowledge, neither no third party has initiated, conducted or intends to initiate any such notice or action.
(b) Since January 1, 2012, and except to the extent disclosed in the SEC Documents, the Company nor has not received any of its directors, officers, employees notices or agents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of correspondence from the FDA or any other federal, state, local or foreign governmental entity related to a Company Productor regulatory authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company.
Appears in 2 contracts
Samples: Underwriting Agreement (Oragenics Inc), Stock Purchase Agreement (Oragenics Inc)
FDA Compliance. (a) Except as would not, individually or described in the aggregateCommission Documents, result in a Material Adverse Effect or as disclosed described in or referred to in the SEC DocumentsCompany: (i) the Company is and has been in material compliance with all statutes, laws, ordinances, rules and or regulations applicable to the Company for the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product that is under development, manufactured or distributed by or on behalf of the Company (a “Company Product”), including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., the Public Health Service Act, 42 U.S.C. § 262, similar laws of other governmental entities and the regulations promulgated pursuant to such laws (collectively, “Applicable Laws”); (ii) the Company possesses all licenses, certificates, approvals, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws and/or for the ownership of its properties or the conduct of its business as it relates to a Company Product and as described in the SEC Documents (collectively, “Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iii) the Company has not received any written FDA Form 483, notice of adverse finding, warning letter, untitled letter or other written correspondence or notice from the U.S. Food and Drug Administration (the “FDA”) or any other federal, state, local or foreign governmental entity or regulatory authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), which would not, individually or in the aggregate, result in a Material Adverse Effect; (iii) possesses all material Authorizations relating to a necessary for the operation of its business as described in the Commission Documents and such Authorizations are valid and in full force and effect and the Company Productis not in material violation of any term of any such Authorizations; and (iv) the Company since January 1, 2008: (A) has not received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other federal, state, local or foreign governmental entity or regulatory authority or third party alleging that any Company Product, product operation or activity related to a Company Product is in material violation of any Applicable Laws or Authorizations or and has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, ; (B) has there been any noncompliance with or violation of any Applicable Laws by the Company not received notice that would reasonably be expected to require the issuance of any such written notice or result in an investigation, corrective action, or enforcement action by the FDA or similar any other federal, state, local or foreign governmental entity with respect to a Company Product; (v) the Company has not received written notice that any governmental entity or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations or and has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity has threatened or regulatory authority is considering such action with respect to a Company Productaction; and (viC) the Company has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, materially complete and correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission); and (D) in all material respects. To has not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the Company’s knowledge, neither no third party has initiated, conducted or intends to initiate any such notice or action.
(b) Since January 1, 2008, and except to the extent disclosed in the Commission Documents, the Company nor has not received any of its directors, officers, employees notices or agents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of correspondence from the FDA or any other federal, state, local or foreign governmental entity related to a Company Productor regulatory authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company.
Appears in 2 contracts
Samples: Stock Purchase Agreement (Ziopharm Oncology Inc), Stock Purchase Agreement (Adeona Pharmaceuticals, Inc.)
FDA Compliance. (a) Except as would not, individually or in the aggregate, result in a Material Adverse Effect or as disclosed described in or referred to in the SEC Documents, the Company: (i) the Company is and has been in material compliance with all statutes, laws, ordinances, rules and or regulations applicable to the Company for the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product that is under development, manufactured or distributed by or on behalf of the Company (a “Company Product”), including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., the Public Health Service Act, 42 U.S.C. § 262, similar laws of other governmental entities and the regulations promulgated pursuant to such laws (collectively, “Applicable Laws”); (ii) the Company possesses all licenses, certificates, approvals, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws and/or for the ownership of its properties or the conduct of its business as it relates to a Company Product and as described in the SEC Documents (collectively, “Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iii) the Company has not received any written FDA Form 483, notice of adverse finding, warning letter, untitled letter or other written correspondence or notice from the U.S. Food and Drug Administration (the “FDA”) or any other federal, state, local or foreign governmental entity or regulatory authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), which would not, individually or in the aggregate, result in a Material Adverse Effect; (iii) possesses all material Authorizations relating to a necessary for the operation of its business as described in the SEC Documents and such Authorizations are valid and in full force and effect and the Company Productis not in material violation of any term of any such Authorizations; and (iv) the Company since January 1, 2016: (A) has not received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other federal, state, local or foreign governmental entity or regulatory authority or third party alleging that any Company Product, product operation or activity related to a Company Product is in material violation of any Applicable Laws or Authorizations or and has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, ; (B) has there been any noncompliance with or violation of any Applicable Laws by the Company not received notice that would reasonably be expected to require the issuance of any such written notice or result in an investigation, corrective action, or enforcement action by the FDA or similar any other federal, state, local or foreign governmental entity with respect to a Company Product; (v) the Company has not received written notice that any governmental entity or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations or and has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity has threatened or regulatory authority is considering such action with respect to a Company Productaction; and (viC) the Company has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, materially complete and correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission); and (D) in all material respects. To has not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the Company’s knowledge, neither no third party has initiated, conducted or intends to initiate any such notice or action.
(b) Since January 1, 2016, and except to the extent disclosed in the SEC Documents, the Company nor has not received any of its directors, officers, employees notices or agents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of correspondence from the FDA or any other federal, state, local or foreign governmental entity related to a Company Productor regulatory authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company.
Appears in 2 contracts
Samples: Stock Purchase Agreement (Oragenics Inc), Stock Purchase Agreement
FDA Compliance. (a) Except as would not, individually or in the aggregate, result in a Material Adverse Effect or as disclosed described in or referred to in the SEC Documents, the Company: (i) the Company is and has been in material compliance with all statutes, laws, ordinances, rules and or regulations applicable to the Company for the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product that is under development, manufactured or distributed by or on behalf of the Company (a “Company Product”), including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., the Public Health Service Act, 42 U.S.C. § 262, similar laws of other governmental entities and the regulations promulgated pursuant to such laws (collectively, “Applicable Laws”); (ii) the Company possesses all licenses, certificates, approvals, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws and/or for the ownership of its properties or the conduct of its business as it relates to a Company Product and as described in the SEC Documents (collectively, “Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iii) the Company has not received any written FDA Form 483, notice of adverse finding, warning letter, untitled letter or other written correspondence or notice from the U.S. Food and Drug Administration (the “FDA”) or any other federal, state, local or foreign governmental entity or regulatory authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), which would not, individually or in the aggregate, result in a Material Adverse Effect; (iii) possesses all material Authorizations relating to a necessary for the operation of its business as described in the SEC Documents and such Authorizations are valid and in full force and effect and the Company Productis not in material violation of any term of any such Authorizations; and (iv) the Company since December 31, 2011: (A) has not received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other federal, state, local or foreign governmental entity or regulatory authority or third party alleging that any Company Product, product operation or activity related to a Company Product is in material violation of any Applicable Laws or Authorizations or and the Company has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, ; (B) has there been any noncompliance with or violation of any Applicable Laws by the Company not received notice that would reasonably be expected to require the issuance of any such written notice or result in an investigation, corrective action, or enforcement action by the FDA or similar any other federal, state, local or foreign governmental entity with respect to a Company Product; (v) the Company has not received written notice that any governmental entity or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations or and has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity has threatened or regulatory authority is considering such action with respect to a Company Productaction; and (viC) the Company has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, materially complete and correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission); and (D) in all material respects. To has not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the Company’s knowledge, neither the Company nor no third party has initiated, conducted or intends to initiate any of its directors, officers, employees such notice or agents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of the FDA or any other governmental entity related to a Company Productaction.
Appears in 2 contracts
Samples: Stock Issuance Agreement, Stock Issuance Agreement (Synthetic Biologics, Inc.)
FDA Compliance. (a) Except as would not, individually or in the aggregate, result in a Material Adverse Effect or as disclosed described in or referred to in the SEC Documents, the Company: (i) the Company is and has been in material compliance with all statutes, laws, ordinances, rules and or regulations applicable to the Company for the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product that is under development, manufactured or distributed by or on behalf of the Company (a “Company Product”), including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., the Public Health Service Act, 42 U.S.C. § 262, similar laws of other governmental entities and the regulations promulgated pursuant to such laws (collectively, “Applicable Laws”); (ii) the Company possesses all licenses, certificates, approvals, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws and/or for the ownership of its properties or the conduct of its business as it relates to a Company Product and as described in the SEC Documents (collectively, “Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iii) the Company has not received any written FDA Form 483, notice of adverse finding, warning letter, untitled letter or other written correspondence or notice from the U.S. Food and Drug Administration (the “FDA”) or any other federal, state, local or foreign governmental entity or regulatory authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), which would not, individually or in the aggregate, result in a Material Adverse Effect; (iii) possesses all material Authorizations relating to a necessary for the operation of its business as described in the SEC Documents and such Authorizations are valid and in full force and effect and the Company Productis not in material violation of any term of any such Authorizations; and (iv) the Company since January 1, 2017: (A) has not received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other federal, state, local or foreign governmental entity or regulatory authority or third party alleging that any Company Product, product operation or activity related to a Company Product is in material violation of any Applicable Laws or Authorizations or and has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, ; (B) has there been any noncompliance with or violation of any Applicable Laws by the Company not received notice that would reasonably be expected to require the issuance of any such written notice or result in an investigation, corrective action, or enforcement action by the FDA or similar any other federal, state, local or foreign governmental entity with respect to a Company Product; (v) the Company has not received written notice that any governmental entity or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations or and has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity has threatened or regulatory authority is considering such action with respect to a Company Productaction; and (viC) the Company has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, materially complete and correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission); and (D) in all material respects. To has not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the Company’s knowledge, neither no third party has initiated, conducted or intends to initiate any such notice or action.
(b) Since January 1, 2017, and except to the extent disclosed in the SEC Documents, the Company nor has not received any of its directors, officers, employees notices or agents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of correspondence from the FDA or any other federal, state, local or foreign governmental entity related to a Company Productor regulatory authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company.
Appears in 1 contract
FDA Compliance. Except as would not, individually or in the aggregate, result in a Material Adverse Effect or as disclosed described in or referred to in the SEC Documents, the Company: (i) the Company is and has been in material compliance with all statutes, laws, ordinances, rules and or regulations applicable to the Company for the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product that is under development, manufactured or distributed by or on behalf of the Company (a “Company Product”), including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., the Public Health Service Act, 42 U.S.C. § 262, similar laws of other governmental entities and the regulations promulgated pursuant to such laws (collectively, “Applicable Laws”); (ii) the Company possesses all licenses, certificates, approvals, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws and/or for the ownership of its properties or the conduct of its business as it relates to a Company Product and as described in the SEC Documents (collectively, “Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iii) the Company has not received any written FDA Form 483, notice of adverse finding, warning letter, untitled letter or other written correspondence or notice from the U.S. Food and Drug Administration (the “FDA”) or any other federal, state, local or foreign governmental entity or regulatory authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), which would not, individually or in the aggregate, result in a Material Adverse Effect; (iii) possesses all material Authorizations relating to a necessary for the operation of its business as described in the SEC Documents and such Authorizations are valid and in full force and effect and the Company Productis not in material violation of any term of any such Authorizations; and (iv) the Company since January 1, 2010: (A) has not received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other federal, state, local or foreign governmental entity or regulatory authority or third party alleging that any Company Product, product operation or activity related to a Company Product is in material violation of any Applicable Laws or Authorizations or and has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, ; (B) has there been any noncompliance with or violation of any Applicable Laws by the Company not received notice that would reasonably be expected to require the issuance of any such written notice or result in an investigation, corrective action, or enforcement action by the FDA or similar any other federal, state, local or foreign governmental entity with respect to a Company Product; (v) the Company has not received written notice that any governmental entity or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations or and has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity has threatened or regulatory authority is considering such action with respect to a Company Productaction; and (viC) the Company has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, materially complete and correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission); and (D) in all material respects. To has not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the Company’s knowledge, neither no third party has initiated, conducted or intends to initiate any such notice or action. Since January 1, 2010, and except to the extent disclosed in the SEC Documents, the Company nor has not received any of its directors, officers, employees notices or agents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of correspondence from the FDA or any other federal, state, local or foreign governmental entity related to a Company Productor regulatory authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company.
Appears in 1 contract
Samples: Stock Purchase and Issuance Agreement (Oragenics Inc)
FDA Compliance. Except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus or as would not, individually singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect or as disclosed described in or referred to in Effect, the SEC DocumentsCompany and its subsidiaries: (iA) the Company is are and has at all times have been in material compliance with all statutes, laws, ordinances, rules or regulations of the FDA and regulations other comparable Governmental Entities applicable to the Company for the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by or on behalf of the Company or any of its subsidiaries (a “Company Product”), including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., the Public Health Service Act, 42 U.S.C. § 262, similar laws of other governmental entities and the regulations promulgated pursuant to such laws (collectively, “Applicable Laws”); (iiB) have not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the Company possesses all FDA or any Governmental Authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws and/or for the ownership of its properties or the conduct of its business as it relates to a Company Product and as described in the SEC Documents (collectively, “Authorizations”); (C) possess all material Authorizations and such Authorizations are valid and in full force and effect and neither the Company nor any of its subsidiaries is not in material violation of any term of any such Authorizations; (iiiD) the Company has have not received any written notice of adverse finding, warning letter or other written correspondence or notice from the U.S. Food and Drug Administration (the “FDA”) or any other governmental entity alleging or asserting noncompliance with any Applicable Laws or Authorizations relating to a Company Product; (iv) the Company has not received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity Governmental Authority or third party alleging that any Company Product, product operation or activity related to a Company Product is in material violation of any Applicable Laws or Authorizations or has and, to the Company’s knowledge, neither the FDA nor any knowledge that any such governmental entity Governmental Authority or third party is considering threatening to initiate any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any noncompliance with or violation of any Applicable Laws by the Company ; (E) have not received notice that would reasonably be expected to require the issuance of any such written notice or result in an investigation, corrective action, or enforcement action by the FDA or similar governmental entity with respect to a Company Product; (v) the Company has not received written notice that any governmental entity Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations or has and, to the Company’s knowledge, neither the FDA nor any knowledge that any Governmental Authority is threatening to initiate such governmental entity has threatened or is considering such action with respect to a Company Productaction; and (viF) the Company has have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, materially complete and correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission) in all material respects. To the Company’s knowledge, neither the Company nor any of its directors, officers, employees or agents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of the FDA or any other governmental entity related to a Company Product).
Appears in 1 contract
FDA Compliance. (a) Except as would not, individually or described in the aggregateCommission Documents, result in a Material Adverse Effect or as disclosed described in or referred to in the SEC DocumentsCompany: (i) the Company is and has been in material compliance with all statutes, laws, ordinances, rules and or regulations applicable to the Company for the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product that is under development, manufactured or distributed by or on behalf of the Company (a “Company Product”), including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., the Public Health Service Act, 42 U.S.C. § 262, similar laws of other governmental entities and the regulations promulgated pursuant to such laws (collectively, “Applicable Laws”); (ii) the Company possesses all licenses, certificates, approvals, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws and/or for the ownership of its properties or the conduct of its business as it relates to a Company Product and as described in the SEC Documents (collectively, “Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iii) the Company has not received any written FDA Form 483, notice of adverse finding, warning letter, untitled letter or other written correspondence or notice from the U.S. Food and Drug Administration (the “FDA”) or any other federal, state, local or foreign governmental entity or regulatory authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), which would not, individually or in the aggregate, result in a Material Adverse Effect; (iii) possesses all material Authorizations relating to a necessary for the operation of its business as described in the Commission Documents and such Authorizations are valid and in full force and effect and the Company Productis not in material violation of any term of any such Authorizations; and (iv) the Company since January 1, 2008: (A) has not received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other federal, state, local or foreign governmental entity or regulatory authority or third party alleging that any Company Product, product operation or activity related to a Company Product is in material violation of any Applicable Laws or Authorizations or and has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, ; (B) has there been any noncompliance with or violation of any Applicable Laws by the Company not received notice that would reasonably be expected to require the issuance of any such written notice or result in an investigation, corrective action, or enforcement action by the FDA or similar any other federal, state, local or foreign governmental entity with respect to a Company Product; (v) the Company has not received written notice that any governmental entity or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations or and has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity has threatened or regulatory authority is considering such action with respect to a Company Productaction; and (viC) the Company has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, materially complete and correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission); and (D) in all material respects. To has not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the Company’s knowledge, neither no third party has initiated, conducted or intends to initiate any such notice or action. 8.
(b) Since January 1, 2008, and except to the extent disclosed in the Commission Documents, the Company nor has not received any of its directors, officers, employees notices or agents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of correspondence from the FDA or any other federal, state, local or foreign governmental entity related to a Company Productor regulatory authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company.
Appears in 1 contract
Samples: Stock Purchase Agreement
FDA Compliance. (a) Except as would not, individually or in the aggregate, result in a Material Adverse Effect or as disclosed described in or referred to in the SEC Documents, the Company: (i) the Company is and has been in material compliance with all statutes, laws, ordinances, rules and or regulations applicable to the Company for the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product that is under development, manufactured or distributed by or on behalf of the Company (a “Company Product”), including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., the Public Health Service Act, 42 U.S.C. § 262, similar laws of other governmental entities and the regulations promulgated pursuant to such laws (collectively, “Applicable Laws”); (ii) the Company possesses all licenses, certificates, approvals, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws and/or for the ownership of its properties or the conduct of its business as it relates to a Company Product and as described in the SEC Documents (collectively, “Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iii) the Company has not received any written FDA Form 483, notice of adverse finding, warning letter, untitled letter or other written correspondence or notice from the U.S. Food and Drug Administration (the “FDA”) or any other federal, state, local or foreign governmental entity or regulatory authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), which would not, individually or in the aggregate, result in a Material Adverse Effect; (iii) possesses all material Authorizations relating to a necessary for the operation of its business as described in the SEC Documents and such Authorizations are valid and in full force and effect and the Company Productis not in material violation of any term of any such Authorizations; and (iv) the Company since December 31, 2014: (A) has not received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other federal, state, local or foreign governmental entity or regulatory authority or third party alleging that any Company Product, product operation or activity related to a Company Product is in material violation of any Applicable Laws or Authorizations or and the Company has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, ; (B) has there been any noncompliance with or violation of any Applicable Laws by the Company not received notice that would reasonably be expected to require the issuance of any such written notice or result in an investigation, corrective action, or enforcement action by the FDA or similar any other federal, state, local or foreign governmental entity with respect to a Company Product; (v) the Company has not received written notice that any governmental entity or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations or and has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity has threatened or regulatory authority is considering such action with respect to a Company Productaction; and (viC) the Company has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, materially complete and correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission); and (D) in all material respects. To has not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the Company’s knowledge, neither the Company nor no third party has initiated, conducted or intends to initiate any of its directors, officers, employees such notice or agents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of the FDA or any other governmental entity related to a Company Productaction.
Appears in 1 contract
Samples: Stock Issuance Agreement
FDA Compliance. Except as would not, individually or described in the aggregateRegistration Statement, result in a Material Adverse Effect or as disclosed described in or referred to in the SEC DocumentsPricing Disclosure Package and the Prospectus, the Company: (iA) the Company is and at all times has been in material compliance with all statutes, laws, ordinances, rules and or regulations applicable to the Company for the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product that is under development, manufactured or distributed by or on behalf of the Company (a “Company Product”), including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., the Public Health Service Act, 42 U.S.C. § 262, similar laws of other governmental entities and the regulations promulgated pursuant to such laws (collectively, “"Applicable Laws”"); (iiB) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the Company possesses all U.S. Food and Drug Administration (the "FDA") or any other federal, state, local or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws and/or ("Authorizations"), which would not, individually or in the aggregate, result in a Material Adverse Effect; (C) possesses all material Authorizations necessary for the ownership of its properties or the conduct operation of its business as it relates to a Company Product and as described in the SEC Documents (collectively, “Authorizations”) Registration Statement and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such Authorizations; (iiiD) the Company has not received any written notice of adverse finding, warning letter or other written correspondence or notice from the U.S. Food and Drug Administration (the “FDA”) or any other governmental entity alleging or asserting noncompliance with any Applicable Laws or Authorizations relating to a Company Product; (iv) the Company has not received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other federal, state, local or foreign governmental entity or regulatory authority or third party alleging that any Company Product, product operation or activity related to a Company Product is in material violation of any Applicable Laws or Authorizations or and has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, ; (E) has there been any noncompliance with or violation of any Applicable Laws by the Company not received notice that would reasonably be expected to require the issuance of any such written notice or result in an investigation, corrective action, or enforcement action by the FDA or similar any other federal, state, local or foreign governmental entity with respect to a Company Product; (v) the Company has not received written notice that any governmental entity or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations or and has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity has threatened or regulatory authority is considering such action with respect to a Company Productaction; and (viF) the Company has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, materially complete and correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission); and (G) in all material respects. To has not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post sale warning, "dear doctor" letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the Company’s 's knowledge, neither the Company nor no third party has initiated, conducted or intends to initiate any of its directors, officers, employees such notice or agents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of the FDA or any other governmental entity related to a Company Productaction.
Appears in 1 contract
Samples: Underwriting Agreement (Anacor Pharmaceuticals Inc)
FDA Compliance. (i) Except as would not, individually or in the aggregate, result in a Material Adverse Effect or as disclosed described in or referred to in the SEC Documents, the Company: (i) the Company is and has been in material compliance with all statutes, laws, ordinances, rules and or regulations applicable to the Company for the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product that is under development, manufactured or distributed by or on behalf of the Company (a “Company Product”), including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., the Public Health Service Act, 42 U.S.C. § 262, similar laws of other governmental entities and the regulations promulgated pursuant to such laws (collectively, “Applicable Laws”); (ii) the Company possesses all licenses, certificates, approvals, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws and/or for the ownership of its properties or the conduct of its business as it relates to a Company Product and as described in the SEC Documents (collectively, “Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iii) the Company has not received any written FDA Form 483, notice of adverse finding, warning letter, untitled letter or other written correspondence or notice from the U.S. Food and Drug Administration (the “FDA”) or any other federal, state, local or foreign governmental entity or regulatory authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), which would not, individually or in the aggregate, result in a Material Adverse Effect; (iii) possesses all material Authorizations relating to a necessary for the operation of its business as described in the SEC Documents and such Authorizations are valid and in full force and effect and the Company Productis not in material violation of any term of any such Authorizations; and (iv) the Company since January 1, 2017: (A) has not received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other federal, state, local or foreign governmental entity or regulatory authority or third party alleging that any Company Product, product operation or activity related to a Company Product is in material violation of any Applicable Laws or Authorizations or and has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, ; (B) has there been any noncompliance with or violation of any Applicable Laws by the Company not received notice that would reasonably be expected to require the issuance of any such written notice or result in an investigation, corrective action, or enforcement action by the FDA or similar any other federal, state, local or foreign governmental entity with respect to a Company Product; (v) the Company has not received written notice that any governmental entity or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations or and has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity has threatened or regulatory authority is considering such action with respect to a Company Productaction; and (viC) the Company has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, materially complete and correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission); and (D) in all material respects. To has not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the Company’s knowledge, neither the Company nor no third party has initiated, conducted or intends to initiate any of its directors, officers, employees such notice or agents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of the FDA or any other governmental entity related to a Company Productaction.
Appears in 1 contract
Samples: Share Purchase Agreement (Synthetic Biologics, Inc.)
FDA Compliance. (a) Except as would not, individually or in the aggregate, result in a Material Adverse Effect or as disclosed described in or referred to in the SEC Documents, the Company: (i) the Company is and has been in material compliance with all statutes, laws, ordinances, rules and or regulations applicable to the Company for the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product that is under development, manufactured or distributed by or on behalf of the Company (a “Company Product”), including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., the Public Health Service Act, 42 U.S.C. § 262, similar laws of other governmental entities and the regulations promulgated pursuant to such laws (collectively, “Applicable Laws”); (ii) the Company possesses all licenses, certificates, approvals, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws and/or for the ownership of its properties or the conduct of its business as it relates to a Company Product and as described in the SEC Documents (collectively, “Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iii) the Company has not received any written FDA Form 483, notice of adverse finding, warning letter, untitled letter or other written correspondence or notice from the U.S. Food and Drug Administration (the “FDA”) or any other federal, state, local or foreign governmental entity or regulatory authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), which would not, individually or in the aggregate, result in a Material Adverse Effect; (iii) possesses all material Authorizations relating to a necessary for the operation of its business as described in the SEC Documents and such Authorizations are valid and in full force and effect and the Company Productis not in material violation of any term of any such Authorizations; and (iv) the Company since December 31, 2014: (A) has not received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other federal, state, local or foreign governmental entity or regulatory authority or third party alleging that any Company Product, product operation or activity related to a Company Product is in material violation of any Applicable Laws or Authorizations or and the Company has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, ; (B) has there been any noncompliance with or violation of any Applicable Laws by the Company not received notice that would reasonably be expected to require the issuance of any such written notice or result in an investigation, corrective action, or enforcement action by the FDA or similar any other federal, state, local or foreign governmental entity with respect to a Company Product; (v) the Company has not received written notice that any governmental entity or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations or and has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity has threatened or regulatory authority is considering such action with respect to a Company Productaction; and (viC) the Company has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, materially complete and correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission); and (D) in all material respects. To has not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the Company’s knowledge, neither no third party has initiated, conducted or intends to initiate any such notice or action.
(b) Since January 1, 2015, and except to the extent disclosed in the SEC Documents, the Company nor has not received any of its directors, officers, employees notices or agents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of correspondence from the FDA or any other federal, state, local or foreign governmental entity related to a Company Productor regulatory authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company.
Appears in 1 contract
Samples: Stock Issuance Agreement (Synthetic Biologics, Inc.)
FDA Compliance. (a) Except as would not, individually or described in the aggregateCommission Documents, result in a Material Adverse Effect or as disclosed described in or referred to in the SEC DocumentsCompany: (i) the Company is and has been in material compliance with all statutes, laws, ordinances, rules and or regulations applicable to the Company for the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product that is under development, manufactured or distributed by or on behalf of the Company (a “Company Product”), including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., the Public Health Service Act, 42 U.S.C. § 262, similar laws of other governmental entities and the regulations promulgated pursuant to such laws (collectively, “Applicable Laws”); (ii) the Company possesses all licenses, certificates, approvals, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws and/or for the ownership of its properties or the conduct of its business as it relates to a Company Product and as described in the SEC Documents (collectively, “Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iii) the Company has not received any written FDA Form 483, notice of adverse finding, warning letter, untitled letter or other written correspondence or notice from the U.S. Food and Drug Administration (the “FDA”) or any other federal, state, local or foreign governmental entity or regulatory authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), which would not, individually or in the aggregate, result in a Material Adverse Effect; (iii) possesses all material Authorizations relating to a necessary for the operation of its business as described in the Commission Documents and such Authorizations are valid and in full force and effect and the Company Productis not in material violation of any term of any such Authorizations; and (iv) the Company since January 1, 2009: (A) has not received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other federal, state, local or foreign governmental entity or regulatory authority or third party alleging that any Company Product, product operation or activity related to a Company Product is in material violation of any Applicable Laws or Authorizations or and has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, ; (B) has there been any noncompliance with or violation of any Applicable Laws by the Company not received notice that would reasonably be expected to require the issuance of any such written notice or result in an investigation, corrective action, or enforcement action by the FDA or similar any other federal, state, local or foreign governmental entity with respect to a Company Product; (v) the Company has not received written notice that any governmental entity or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations or and has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity has threatened or regulatory authority is considering such action with respect to a Company Productaction; and (viC) the Company has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, materially complete and correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission); and (D) in all material respects. To has not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the Company’s knowledge, neither no third party has initiated, conducted or intends to initiate any such notice or action.
(b) Since January 1, 2009, and except to the extent disclosed in the Commission Documents, the Company nor has not received any of its directors, officers, employees notices or agents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of correspondence from the FDA or any other federal, state, local or foreign governmental entity related to a Company Productor regulatory authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company.
Appears in 1 contract
FDA Compliance. (a) Except as would not, individually or in the aggregate, result in a Material Adverse Effect or as disclosed described in or referred to in the SEC Documents, the Company: (i) the Company is and has been in material compliance with all statutes, laws, ordinances, rules and or regulations applicable to the Company for the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product that is under development, manufactured or distributed by or on behalf of the Company (a “Company Product”), including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., the Public Health Service Act, 42 U.S.C. § 262, similar laws of other governmental entities and the regulations promulgated pursuant to such laws (collectively, “Applicable Laws”); (ii) the Company possesses all licenses, certificates, approvals, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws and/or for the ownership of its properties or the conduct of its business as it relates to a Company Product and as described in the SEC Documents (collectively, “Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iii) the Company has not received any written FDA Form 483, notice of adverse finding, warning letter, untitled letter or other written correspondence or notice from the U.S. Food and Drug Administration (the “FDA”) or any other federal, state, local or foreign governmental entity or regulatory authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), which would not, individually or in the aggregate, result in a Material Adverse Effect; (iii) possesses all material Authorizations relating to a necessary for the operation of its business as described in the SEC Documents and such Authorizations are valid and in full force and effect and the Company Productis not in material violation of any term of any such Authorizations; and (iv) the Company since January 1, 2014: (A) has not received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other federal, state, local or foreign governmental entity or regulatory authority or third party alleging that any Company Product, product operation or activity related to a Company Product is in material violation of any Applicable Laws or Authorizations or and has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, ; (B) has there been any noncompliance with or violation of any Applicable Laws by the Company not received notice that would reasonably be expected to require the issuance of any such written notice or result in an investigation, corrective action, or enforcement action by the FDA or similar any other federal, state, local or foreign governmental entity with respect to a Company Product; (v) the Company has not received written notice that any governmental entity or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations or and has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity has threatened or regulatory authority is considering such action with respect to a Company Productaction; and (viC) the Company has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, materially complete and correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission); and (D) in all material respects. To has not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post-sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the Company’s knowledge, neither no third party has initiated, conducted or intends to initiate any such notice or action.
(b) Since December 31, 2014, and except to the extent disclosed in the SEC Documents, the Company nor has not received any of its directors, officers, employees notices or agents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of correspondence from the FDA or any other federal, state, local or foreign governmental entity related to a Company Productor regulatory authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company.
Appears in 1 contract
FDA Compliance. (a) Except as would not, individually or in the aggregate, result in a Material Adverse Effect or as disclosed described in or referred to in the SEC Documents, the Company: (i) the Company is and has been in material compliance with all statutes, laws, ordinances, rules and or regulations applicable to the Company for the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product that is under development, manufactured or distributed by or on behalf of the Company (a “Company Product”), including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., the Public Health Service Act, 42 U.S.C. § 262, similar laws of other governmental entities and the regulations promulgated pursuant to such laws (collectively, “Applicable Laws”); (ii) the Company possesses all licenses, certificates, approvals, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws and/or for the ownership of its properties or the conduct of its business as it relates to a Company Product and as described in the SEC Documents (collectively, “Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iii) the Company has not received any written FDA Form 483, notice of adverse finding, warning letter, untitled letter or other written correspondence or notice from the U.S. Food and Drug Administration (the “FDA”) or any other federal, state, local or foreign governmental entity or regulatory authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), which would not, individually or in the aggregate, result in a Material Adverse Effect; (iii) possesses all material Authorizations relating to a necessary for the operation of its business as described in the SEC Documents and such Authorizations are valid and in full force and effect and the Company Productis not in material violation of any term of any such Authorizations; and (iv) the Company since January 1, 2010: (A) has not received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other federal, state, local or foreign governmental entity or regulatory authority or third party alleging that any Company Product, product operation or activity related to a Company Product is in material violation of any Applicable Laws or Authorizations or and has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, ; (B) has there been any noncompliance with or violation of any Applicable Laws by the Company not received notice that would reasonably be expected to require the issuance of any such written notice or result in an investigation, corrective action, or enforcement action by the FDA or similar any other federal, state, local or foreign governmental entity with respect to a Company Product; (v) the Company has not received written notice that any governmental entity or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations or and has any no knowledge that the FDA or any such other federal, state, local or foreign governmental entity has threatened or regulatory authority is considering such action with respect to a Company Productaction; and (viC) the Company has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, materially complete and correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission); and (D) in all material respects. To has not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the Company’s knowledge, neither no third party has initiated, conducted or intends to initiate any such notice or action.
(b) Since January 1, 2010, and except to the extent disclosed in the SEC Documents, the Company nor has not received any of its directors, officers, employees notices or agents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of correspondence from the FDA or any other federal, state, local or foreign governmental entity related to a Company Productor regulatory authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company.
Appears in 1 contract
Samples: Stock Purchase and Issuance Agreement (Intrexon Corp)