FDA Compliance. Except in each case, as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company: (A) is, and has since February 1, 2020 been, in compliance with all applicable statutes, rules or regulations of the FDA relating to 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 the Company (“Applicable Laws”); (B) has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any similar governmental entity in each case 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 (“Authorizations”); (C) possesses all Authorizations required for the conduct of its business 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; except as described in the Registration Statement and the Prospectus, (D) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA or any governmental entity or third party has threatened any such claim, litigation, arbitration, action, suit, investigation or proceeding; and (E) has not received written notice that the FDA or any governmental entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity is considering such action.
Appears in 1 contract
Samples: Sales Agreement (Annexon, Inc.)
FDA Compliance. Except in each case, as would not, individually or described in the aggregateRegistration Statement, reasonably be expected to have a Material Adverse Effectthe General Disclosure Package and the Prospectus, the Company: (A) is, is and for the previous five (5) years has since February 1, 2020 been, been in material compliance with all applicable statutes, rules or regulations of the FDA relating and other comparable Governmental Entities applicable to 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 manufactured. marketed or distributed by the Company (“Applicable Laws”); (B) has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any similar governmental entity in each case Governmental Authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits permits, FDA’s letter stating the agency’s intent to exercise enforcement discretion for the Avance Nerve Graft assuming certain conditions are met, and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possesses all material Authorizations required for the conduct of its business 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; except as described in the Registration Statement and the Prospectus, (D) has not received written notice of any 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 product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority or third party has threatened is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; and (E) has not received written notice that the FDA or any governmental entity Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority is considering such action; and (F) 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 materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission).
Appears in 1 contract
FDA Compliance. Except as described in each casethe Registration Statement, the General Disclosure Package and the Prospectus or as would not, individually singly or in the aggregate, reasonably be expected to have result in a Material Adverse Effect, the Company: (A) is, is and at all times has since February 1, 2020 been, been in material compliance with all applicable statutes, rules or regulations of the FDA relating and other comparable Governmental Entities applicable to 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 the Company (“Applicable Laws”); (B) has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any similar governmental entity in each case 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 (“Authorizations”); (C) possesses all material Authorizations required for the conduct of its business 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; except as described in the Registration Statement and the Prospectus, (D) has not received written notice of any 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 product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that and, to the Company’s knowledge, neither the FDA or nor any governmental entity Governmental Authority or third party has threatened is threatening to initiate any such claim, litigation, arbitration, action, suit, investigation or proceeding; and (E) has not received written notice that the FDA or any governmental entity Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that and, to the Company’s knowledge, neither the FDA or nor any governmental entity Governmental Authority is considering threatening to initiate such action; and (F) 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 materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission).
Appears in 1 contract
FDA Compliance. Except in each case, as would not, individually or described in the aggregate, reasonably be expected to have a Material Adverse EffectRegistration Statement, the CompanyTime of Sale Disclosure Package and the Prospectus, the Company and its subsidiaries: (A) is, are and has since February 1, 2020 been, at all times have been in full compliance with all applicable statutes, rules rules, regulations, or regulations of the FDA relating guidances applicable to Company and its subsidiaries and the ownership, testing, research, design, 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 the Company (“Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) has except as previously disclosed to the Underwriter, have not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any similar governmental entity in each case Governmental Authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, exemptionsauthorizations, authorizationsregistrations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possesses possess all material Authorizations required for the conduct of its business 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; except as described in the Registration Statement and the Prospectus, (D) has have not received written notice of any 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 product operation or activity is in material violation of any Applicable Laws or Authorizations and has have no knowledge that the FDA or any governmental entity such Governmental Authority or third party has threatened is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; and (E) has have not received written notice that the FDA or any governmental entity Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and the Company has no knowledge that the FDA or any governmental entity such Governmental Authority is considering such action; and (F) 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 and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission).
Appears in 1 contract
FDA Compliance. Except as described in each caseRegistration Statement, as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse EffectGeneral Disclosure Package and the Prospectus, the Company: (A) is, is and for the previous five (5) years has since February 1, 2020 been, been in material compliance with all applicable statutes, rules or regulations of the FDA relating and other comparable Governmental Entities applicable to 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 manufactured. marketed or distributed by the Company (“Applicable Laws”); (B) has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any similar governmental entity in each case Governmental Authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits permits, FDA’s letter stating the agency’s intent to exercise enforcement discretion for the Avance Nerve Graft assuming certain conditions are met, and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possesses all material Authorizations required for the conduct of its business 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; except as described in the Registration Statement and the Prospectus, (D) has not received written notice of any 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 product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority or third party has threatened is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; and (E) has not received written notice that the FDA or any governmental entity Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority is considering such action; and (F) 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 materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission).
Appears in 1 contract
FDA Compliance. Except in each case, as would not, individually or described in the aggregateRegistration Statement, reasonably be expected to have a Material Adverse Effectthe General Disclosure Package and the Prospectus, the Company: (A) is, are and has since February 1, 2020 been, at all times have been in material compliance with all applicable statutes, rules or regulations of the FDA relating and other comparable Governmental Entities applicable to 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 (“Applicable Laws”); (B) has have not received any Form FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other written correspondence or written notice from the FDA or any similar governmental entity in each case other Governmental Entity alleging or asserting material noncompliance with any Applicable Laws or the terms of any licenses, certificates, approvals, registrations, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), except in each case as would not, individually or in the aggregate have a Material Adverse Effect; (C) possesses possess all material Authorizations required for the conduct of its business 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; except as described in the Registration Statement and the Prospectus, (D) has have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity other Governmental Entity or third party alleging that any product operation operation, research program, or activity is in material violation of any Applicable Laws or Authorizations and has have no knowledge that the FDA or any governmental entity other Governmental Entity or third party has threatened is threatening any such claim, litigation, arbitration, action, suit, investigation or proceeding, except in each case as would not, individually or in the aggregate have a Material Adverse Effect; and (E) has not received written notice that the FDA or any governmental entity other Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity other Governmental Entity is considering threatening such action, except in each case as would not, individually or in the aggregate have a Material Adverse Effect; and (F) 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 materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission).
Appears in 1 contract
FDA Compliance. Except as described in each case, as would not, individually or in of the aggregate, reasonably be expected to have a Material Adverse Effecteach of the Time of Sale Information and the Offering Memorandum, the Company: (A) is, is and at all times has since February 1, 2020 been, been in material compliance with all applicable statutes, rules or regulations of the FDA relating U.S. Food and Drug Administration (“FDA”) and other comparable federal, state, local or foreign governmental or regulatory authority (“Governmental Authority”) applicable to 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 the Company (“Applicable Laws”); (B) has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any similar governmental entity in each case 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 (“Authorizations”), which would, individually or in the aggregate, result in a Material Adverse Effect; (C) possesses all material Authorizations required for the conduct of its business 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; except as described in the Registration Statement and the Prospectus, (D) has not received written notice of any 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 product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority or third party has threatened is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; and (E) has not received written notice that the FDA or any governmental entity Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity Governmental Authority is considering such action; and (F) 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 materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission).
Appears in 1 contract
Samples: Purchase Agreement (Immunogen Inc)
FDA Compliance. Except as described in each casethe Registration Statement, the General Disclosure Package and the Final Prospectus or as would not, individually singly or in the aggregate, reasonably be expected to have result in a Material Adverse Effect, the Company: (A) is, is and at all times has since February 1, 2020 been, been in material compliance with all applicable statutes, rules or regulations of the FDA relating and other comparable Governmental Entities applicable to 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 the Company (“Applicable Laws”); (B) has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any similar governmental entity in each case 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 (“Authorizations”); (C) possesses all material Authorizations required for the conduct of its business 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; except as described in the Registration Statement and the Prospectus, (D) has not received written notice of any 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 product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that and, to the Company’s knowledge, neither the FDA or nor any governmental entity Governmental Authority or third party has threatened is threatening to initiate any such claim, litigation, arbitration, action, suit, investigation or proceeding; and (E) has not received written notice that the FDA or any governmental entity Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that and, to the Company’s knowledge, neither the FDA or nor any governmental entity Governmental Authority is considering threatening to initiate such action; and (F) 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 materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission).
Appears in 1 contract
FDA Compliance. Except as described in each casethe Registration Statement, the Time of Sale Prospectus and the Prospectus or as would not, individually singly or in the aggregate, reasonably be expected to have result in a Material Adverse Effect, the Company: (A) is, is and at all times has since February 1, 2020 been, been in material compliance with all applicable statutes, rules or regulations of the FDA relating and other comparable Governmental Entities applicable to 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 the Company (“Applicable Laws”); (B) has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any similar governmental entity in each case 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 (“Authorizations”); (C) possesses all material Authorizations required for the conduct of its business 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; except as described in the Registration Statement and the Prospectus, (D) has not received written notice of any 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 product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that and, to the Company’s knowledge, neither the FDA or nor any governmental entity Governmental Authority or third party has threatened is threatening to initiate any such claim, litigation, arbitration, action, suit, investigation or proceeding; and (E) has not received written notice that the FDA or any governmental entity Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that and, to the Company’s knowledge, neither the FDA or nor any governmental entity Governmental Authority is considering threatening to initiate such action; and (F) 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 materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission).
Appears in 1 contract
FDA Compliance. Except as described in each casethe Registration Statement or the Prospectus, as or would not, individually singly or in the aggregate, reasonably be expected to have result in a Material Adverse Effect, the Company: (Ai) is, is and at all times has since February 1, 2020 been, been in material compliance with all applicable statutes, rules or regulations of the FDA relating U.S. Food and Drug Administration (“FDA”) and other comparable governmental or regulatory agencies applicable to 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 the Company (“Applicable Regulatory Laws”); (Bii) has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any similar other comparable governmental entity in each case or regulatory agencies alleging or asserting material noncompliance non-compliance with any Applicable Regulatory Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws (“Authorizations”); (Ciii) possesses all material Authorizations required for the conduct of its business 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; except as described in the Registration Statement and the Prospectus, (Div) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other comparable governmental entity or regulatory agency or third party alleging that any product operation or activity is in material violation of any Applicable Regulatory Laws or Authorizations and has no knowledge that the FDA or any other comparable governmental entity or regulatory agency or third party has threatened is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; and (Ev) has not received written notice that the FDA or any other comparable governmental entity or regulatory agency has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any other comparable governmental entity or regulatory agency is considering such action; and (vi) 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 Regulatory Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission).
Appears in 1 contract
Samples: Common Stock Purchase Agreement (Imago BioSciences, Inc.)
FDA Compliance. Except Since June 1, 2018, except as otherwise described in each case, as the Disclosure Documents or would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company: (A) is, is and has since February 1, 2020 been, been in compliance with all applicable statutes, rules or regulations of the FDA relating U.S. Food and Drug Administration (“FDA”) and other comparable governmental entities applicable to 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 the Company (collectively, “Applicable Laws”); (B) has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other written correspondence or written notice from the FDA or any similar governmental entity in each case 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 (“Authorizations”); (C) possesses all Authorizations required for the conduct of its business 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; except as described in the Registration Statement and the Prospectus, (D) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any applicable governmental entity or third party alleging that any product operation product, operation, or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA or any governmental entity or third party has threatened is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; and (E) has not received written notice that the FDA or any governmental entity has taken, is taking or to the knowledge of the Company, intends to take action to limit, suspend, modify suspend or revoke any material Authorizations; and (F) has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and has no knowledge that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct on the FDA date filed (or any governmental entity is considering such actionwere corrected or supplemented by a subsequent submission).
Appears in 1 contract
FDA Compliance. Except in each caseThe Company and its Subsidiaries, as would notsince July 1, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company2019: (Ai) is, and has since February 1, 2020 been, in compliance with all applicable statutes, rules or regulations of the FDA relating to 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 the Company (“Applicable Laws”); (B) has have not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other written correspondence or written notice from the FDA or any other similar federal, state, local or foreign governmental entity in each case or regulatory authority alleging or asserting material noncompliance with any Applicable Health Care Laws (defined below) or any licenses, certificates, approvals, clearances, authorizations, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Health Care Laws to conduct the Company’s business as described in Prospectus Supplement (“Authorizations”); (Cii) possesses possess all applicable Authorizations required for the conduct of its business and such Authorizations are valid and in full force and effect and neither the Company nor its Subsidiaries is not in violation of any term of any such Authorizations; Authorizations except as described where such violation would not, singly or in the Registration Statement and the Prospectusaggregate, have a Material Adverse Effect; (Diii) has have not received written notice of any pending or completed claim, actionAction, suit, proceedingProceeding, hearing, enforcement, investigation, arbitration or other action Action from the FDA or any other federal, state, local or foreign governmental entity or regulatory authority or third party alleging that any product candidate operation or activity is in material violation of any Applicable Health Care Laws or Authorizations and the Company has no knowledge that the FDA or any other federal, state, local or foreign governmental entity or regulatory authority or third party has threatened is considering any such claim, litigation, arbitration, actionAction, suit, investigation or proceedingProceeding; and (Eiv) has have not received written notice that the FDA or any other federal, state, local or foreign governmental entity or regulatory authority has taken, is taking or intends to take action Action to limit, suspend, materially modify or revoke any material Authorizations and has no knowledge that the FDA or any other federal, state, local or foreign governmental entity or regulatory authority is considering such actionAction; and (v) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws or Authorizations and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission).
Appears in 1 contract
FDA Compliance. Except in each case, as would not, individually or described in the aggregateRegistration Statement, reasonably be expected to have a Material Adverse Effectthe Prospectus Supplement or otherwise in the SEC Reports, the Company: (Ai) is, is and at all times has since February 1, 2020 been, been in material compliance with all applicable statutes, rules or regulations of the FDA relating U.S. Food and Drug Administration (“FDA”) and other comparable governmental or regulatory agencies applicable to 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 the Company (“Applicable Regulatory Laws”); (Bii) has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any similar other comparable governmental entity in each case or regulatory agencies alleging or asserting material noncompliance non-compliance with any Applicable Regulatory Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws (“Authorizations”); (Ciii) possesses all material Authorizations required for the conduct of its business 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; except as described in the Registration Statement and the Prospectus, (Div) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other comparable governmental entity or regulatory agency or third party alleging that any product operation or activity is in material violation of any Applicable Regulatory Laws or Authorizations and has no knowledge that the FDA or any other comparable governmental entity or regulatory agency or third party has threatened is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; and (Ev) has not received written notice that the FDA or any other comparable governmental entity or regulatory agency has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any other comparable governmental entity or regulatory agency is considering such action; and (vi) 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 Regulatory Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission).
Appears in 1 contract
Samples: Securities Purchase Agreement (Cardiff Oncology, Inc.)
FDA Compliance. Except as described in each casethe Registration Statement, as the Prospectus Supplement or otherwise in the SEC Reports, or would not, individually singly or in the aggregate, reasonably be expected to have result in a Material Adverse Effect, the Company: (Ai) is, is and at all times has since February 1, 2020 been, been in material compliance with all applicable statutes, rules or regulations of the FDA relating U.S. Food and Drug Administration ("FDA") and other comparable governmental or regulatory agencies applicable to 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 the Company (“"Applicable Regulatory Laws”"); (Bii) has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from the FDA or any similar other comparable governmental entity in each case or regulatory agencies alleging or asserting material noncompliance non-compliance with any Applicable Regulatory Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws (“"Authorizations”"); (Ciii) possesses all material Authorizations required for the conduct of its business 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; except as described in the Registration Statement and the Prospectus, (Div) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other comparable governmental entity or regulatory agency or third party alleging that any product operation or activity is in material violation of any Applicable Regulatory Laws or Authorizations and has no knowledge that the FDA or any other comparable governmental entity or regulatory agency or third party has threatened is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; and (Ev) has not received written notice that the FDA or any other comparable governmental entity or regulatory agency has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any other comparable governmental entity or regulatory agency is considering such action; and (vi) 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 Regulatory Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission).
Appears in 1 contract
Samples: Securities Purchase Agreement (Trillium Therapeutics Inc.)