Compliance; Permits; Restrictions. (a) Eiger and each Eiger Subsidiary are, and since January 1, 2010 have been, in compliance in all material respects with all applicable Legal Requirements. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of Eiger, threatened against Eiger or any Eiger Subsidiary, nor has any Governmental Body or authority indicated to Eiger an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Eiger or any Eiger Subsidiary which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Eiger or any Eiger Subsidiary, any acquisition of material property by Eiger or any Eiger Subsidiary or the conduct of business by Eiger or any Eiger Subsidiary as currently conducted, (ii) may have an adverse effect on Eiger’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Eiger and the Eiger Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Eiger (the “Eiger Permits”) as currently conducted. Part 2.11(b) of the Eiger Disclosure Schedule identifies each Eiger Permit. Each of Eiger and each Eiger Subsidiary is in material compliance with the terms of the Eiger Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of Eiger, threatened, which seeks to revoke, limit, suspend, or materially modify any Eiger Permit. The rights and benefits of each material Eiger Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Eiger and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or threatened with respect to an alleged violation by Eiger or any of its Subsidiaries of the Federal Food, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”). (d) Eiger and each of its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Eiger or such Subsidiary as currently conducted, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Eiger Product Candidates”) (collectively, the “Eiger Regulatory Permits”), and no such Eiger Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. Eiger and each Eiger Subsidiary is in compliance in all material respects with the Eiger Regulatory Permits and has not received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Eiger Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Eiger Regulatory Permit. Except for the information and files identified in Part 2.11(d) of the Eiger Disclosure Schedule, Eiger has made available to Celladon all information requested by Celladon in Eiger’s or its Subsidiaries’ possession or control relating to the Eiger Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Eiger Product Candidates, including complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Eiger or its Subsidiaries or in which Eiger or its Subsidiaries or their respective current products or product candidates, including the Eiger Product Candidates, have participated were, and if still pending are being, conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2010, neither Eiger nor any of its Subsidiaries has received any notices, correspondence or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of Eiger threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Eiger or any of its Subsidiaries or in which Eiger or any of its Subsidiaries or their respective current products or product candidates, including the Eiger Product Candidates, have participated. (f) Neither Eiger nor any of the Eiger Subsidiaries is the subject of any pending, or to the Knowledge of Eiger or the Eiger Subsidiaries, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Eiger or any of the Eiger Subsidiaries, neither Eiger nor any of the Eiger Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Eiger, any of its Subsidiaries or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of Eiger, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Eiger, any Eiger Subsidiary or any of their respective officers, employees or agents.
Appears in 1 contract
Samples: Merger Agreement (Celladon Corp)
Compliance; Permits; Restrictions. (a) Eiger and each Eiger Subsidiary areInnovate is, and since January 1December 31, 2010 have 2016 has been, in compliance in all material respects with all applicable Legal RequirementsRequirements except for any non-compliance that would not constitute an Innovate Material Adverse Effect. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of EigerInnovate, threatened against Eiger or any Eiger Subsidiary, nor has any Governmental Body or authority indicated to Eiger an intention to conduct the sameInnovate. There is no agreementContract, judgment, injunction, order or decree binding upon Eiger or any Eiger Subsidiary Innovate which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Eiger Innovate or any Eiger Innovate Subsidiary, any acquisition of material property by Eiger or any Eiger Subsidiary Innovate or the conduct of business by Eiger or any Eiger Subsidiary Innovate as currently conducted, (ii) may would reasonably be expected to have an adverse effect on EigerInnovate’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may would reasonably be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions.
(b) Eiger and the Eiger Subsidiaries hold Innovate holds all required Governmental Authorizations which are material to the operation of the business of Eiger Innovate (the “Eiger Innovate Permits”) as currently conducted. Part 2.11(bSection 2.12(b) of the Eiger Innovate Disclosure Schedule identifies each Eiger Innovate Permit. Each As of Eiger and each Eiger Subsidiary the date of this Agreement, Innovate is in material compliance with the terms of the Eiger Innovate Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of EigerInnovate, threatened, which seeks to revoke, limit, suspend, revoke or materially modify suspend any Eiger Innovate Permit. The rights and benefits of each material Eiger Innovate Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Eiger and its Subsidiaries as of the date of this Agreement and Innovate immediately prior to the Effective Time.
(c) There are no proceedings pending or or, to the Knowledge of Innovate, threatened with respect to an alleged violation by Eiger or any of its Subsidiaries Innovate of the Federal Food, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Substances Act or any other similar Legal Requirements promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”).
(d) Eiger and each of its Subsidiaries Innovate holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Eiger or such Subsidiary Innovate as currently conducted, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Eiger Innovate Product Candidates”) (collectively, the “Eiger Innovate Regulatory Permits”), and no such Eiger Innovate Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled canceled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modificationsterminated. Eiger and each Eiger Subsidiary Innovate is in compliance in all material respects with the Eiger Innovate Regulatory Permits and has not received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Eiger Innovate Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellationcancelation, or termination or material modification of any Eiger Innovate Regulatory Permit. Except for the information and files identified in Part 2.11(d) of the Eiger Disclosure Schedule, Eiger Innovate has made available to Celladon Monster all information requested by Celladon Monster in EigerInnovate’s or its Subsidiaries’ possession or control relating to the Eiger Innovate Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Eiger Innovate Product Candidates, including complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Eiger or its Subsidiaries Innovate or in which Eiger Innovate or its Subsidiaries or their respective current products or product candidates, including the Eiger Innovate Product Candidates, have participated were, and if still pending are being, conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1December 31, 20102016, neither Eiger nor any of its Subsidiaries Innovate has not received any notices, correspondence or other written communications from any Drug Regulatory Agency requiring, or to the Knowledge of Eiger Innovate threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Eiger or any of its Subsidiaries Innovate or in which Eiger Innovate or any of its Subsidiaries or their respective current products or product candidates, including the Eiger Innovate Product Candidates, have participated.
(f) Neither Eiger nor any of the Eiger Subsidiaries Innovate is not the subject of any pending, or to the Knowledge of Eiger or the Eiger SubsidiariesInnovate, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Eiger or any of the Eiger SubsidiariesInnovate, neither Eiger nor any of the Eiger Subsidiaries Innovate has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products Innovate Product Candidates that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None Neither Innovate nor to the Knowledge of EigerInnovate, any of its Subsidiaries or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could would reasonably be expected to result in a debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of EigerInnovate, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Eiger, any Eiger Subsidiary Innovate or any of their its respective officers, employees or agents.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Eiger Gem and each Eiger Subsidiary areof its Subsidiaries is, and since January 1the Gem Effective Date, 2010 have been, has been in material compliance in all material respects with all applicable Legal RequirementsLaws. No investigation, claim, suit, proceeding, audit audit, Order, or other action by any Governmental Body or authority Authority is pending or, to the Knowledge of EigerGem, threatened against Eiger Gem or any Eiger Subsidiary, nor has any Governmental Body or authority indicated to Eiger an intention to conduct the sameof its Subsidiaries. There is no agreement, judgment, injunction, order agreement or decree Order binding upon Eiger Gem or any Eiger Subsidiary of its Subsidiaries which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Eiger or any Eiger SubsidiaryGem, any acquisition of material property by Eiger Gem or any Eiger Subsidiary of its Subsidiaries or the conduct of business by Eiger Gem or any Eiger Subsidiary of its Subsidiaries as currently conducted, (ii) may is reasonably likely to have an adverse effect on EigerGem’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) may is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions.
(b) Eiger Each of Gem and the Eiger its Subsidiaries hold holds all required Governmental Authorizations which that are material to the operation of the business of Eiger Gem and Merger Sub as currently conducted (collectively, the “Eiger Gem Permits”) as currently conducted). Part 2.11(bSection 4.14(b) of the Eiger Gem Disclosure Schedule identifies each Eiger Gem Permit. Each of Eiger Gem and each Eiger Subsidiary its Subsidiaries is in material compliance with the terms of the Eiger Gem Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of EigerGem, threatenedthreatened in writing, which seeks to revoke, substantially limit, suspend, or materially modify any Eiger Gem Permit. The rights and benefits of each material Eiger Gem Permit will be available to the Gem and Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Eiger Gem and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time.
(c) There are no proceedings Legal Proceedings pending or or, to the Knowledge of Gem, threatened with respect to an alleged material violation by Eiger Gem or any of its Subsidiaries of the Federal FoodFDCA, DrugPHSA, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) FDA regulations adopted thereunder, the Controlled Substance Substances Act or any other similar Legal Requirements Law promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“a Drug Regulatory Agency”).
(d) Eiger Each of Gem and each of its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Eiger or such Subsidiary Gem and Merger Sub as currently conducted, and and, as applicable, the development, clinical testing, manufacturing, marketingprocessing, storage, labeling, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Eiger Gem Product Candidates”) (collectively, the “Eiger Gem Regulatory Permits”), ) and no such Eiger Gem Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, manner other than immaterial adverse modifications. Eiger Gem has timely maintained and each Eiger Subsidiary is in compliance in all material respects with the Eiger Gem Regulatory Permits and has not neither Gem nor or any of its Subsidiaries has, since the Gem Effective Date, received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Eiger Gem Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Eiger Gem Regulatory Permit. Except for the information and files identified in Part 2.11(dSection 4.14(d) of the Eiger Gem Disclosure Schedule, Eiger Gem has made available to Celladon the Company all information reasonably requested by Celladon the Company in EigerGem’s or its Subsidiaries’ possession or control relating to the Eiger Gem Product Candidates and the development, clinical testing, manufacturing, processing, storage, labeling, distribution and importation and or exportation of the Eiger Gem Product Candidates, including including, but not limited to, complete copies of the following (to the extent there are any): (x) adverse event reports; pre-clinical, clinical and other study reports and material study data; inspection reports, notices of adverse findings, untitled letters, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; Agency and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. All such information are accurate and complete in all material respects.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Eiger Gem or its Subsidiaries or Subsidiaries, in which Eiger Gem or its Subsidiaries subsidiaries or their respective current products or product candidates, including the Eiger Gem Product Candidates, have participated werewere and, and if still pending pending, are being, being conducted in all material respects in accordance with standard medical and scientific research procedures procedures, in material compliance with the applicable protocols, and in compliance in all material respects with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal RequirementsLaw, including including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2010Other than as set forth on Section 4.14(e) of the Gem Disclosure Schedule, neither Eiger Gem nor any of its Subsidiaries has received any written notices, correspondence correspondence, or other communications from any Drug Regulatory Agency requiringrequiring or, or to the Knowledge of Eiger threatening Gem, any action to initiateplace a clinical hold order on, the termination or suspension of otherwise terminate, delay, or suspend any clinical studies conducted by or on behalf of, or sponsored by, Eiger Gem or any of its Subsidiaries or in which Eiger Gem or any of its Subsidiaries or their respective its current products or product candidates, including the Eiger Gem Product Candidates, have participated. Further, no clinical investigator, researcher, or clinical staff participating in any clinical study conducted by or, to the Knowledge of Gem, on behalf of Gem has been disqualified from participating in studies involving the Gem Product Candidates, and to the Knowledge of Gem, no such administrative action to disqualify such clinical investigators, researchers or clinical staff has been threatened or is pending.
(f) Neither Eiger nor Gem nor, to the Knowledge of Gem, any of the Eiger Subsidiaries contract manufacturer with respect to any Gem Product Candidate is the subject of any pendingpending or, or to the Knowledge of Eiger or the Eiger SubsidiariesGem, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Eiger or Gem, Gem and any of the Eiger Subsidiaries, neither Eiger nor contract manufacturer with respect to any of the Eiger Subsidiaries Gem Product Candidate has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of EigerGem, and, to the Knowledge of Gem, any of its Subsidiaries contract manufacturer with respect to any Gem Product Candidate, or any of their respective officers, directors, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion under (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal RequirementLaw, or is or has ever been debarred or excluded. To the Knowledge of EigerGem, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against EigerGem, and to the Knowledge of Gem, any Eiger Subsidiary contract manufacturer with respect to any Gem Product Candidate, or any of their respective its officers, employees or agents.
(g) All manufacturing operations conducted by, or to the Knowledge of Gem, for the benefit of, Gem in connection with any Gem Product Candidate, since the Gem Effective Date, have been and are being conducted in compliance in all material respects with applicable Laws, including the FDA’s standards for current good manufacturing practices, including applicable requirements contained in 21 C.F.R. Parts 210 and 211, and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States.
(h) No manufacturing site owned by Gem, and to the Knowledge of Gem, no manufacturing site of a contract manufacturer, with respect to any Gem Product Candidate, (i) is subject to a Drug Regulatory Agency shutdown or import or export prohibition or (ii) has received any Form FDA 483, notice of violation, warning letter, untitled letter, or similar correspondence or notice from the FDA or other Governmental Authority alleging or asserting noncompliance with any applicable Law, in each case, that have not been complied with or closed to the satisfaction of the relevant Governmental Authority, and, to the Knowledge of Gem, neither the FDA nor any other Governmental Authority is considering such action.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Eiger and each Eiger Subsidiary areCellect is, and since January 1, 2010 have been2016, each of Cellect and its Subsidiaries has been in material compliance in all material respects with all applicable Legal RequirementsRequirements except for any non-compliance that would not constitute a Cellect Material Adverse Effect. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of EigerCellect, threatened against Eiger Cellect or any Eiger Cellect Subsidiary, nor has any Governmental Body or authority indicated to Eiger an intention to conduct the same. There is no agreementContract, judgment, injunction, order or decree binding upon Eiger Cellect or any Eiger Cellect Subsidiary which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Eiger Cellect or any Eiger Cellect Subsidiary, any acquisition of material property by Eiger Cellect or any Eiger Cellect Subsidiary or the conduct of business by Eiger Cellect or any Eiger Cellect Subsidiary as currently conducted, (ii) may would reasonably be expected to have an adverse effect on EigerCellect’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) may would reasonably be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions.
(b) Eiger To the Knowledge of Cellect, Cellect and the Eiger Cellect Subsidiaries hold all required Governmental Authorizations which that are material to the operation of the business of Eiger Cellect (collectively, the “Eiger Cellect Permits”) as currently conducted. Part 2.11(bSection 3.12(b) of the Eiger Cellect Disclosure Schedule identifies each Eiger Cellect Permit. Each As of Eiger and each Eiger Subsidiary the date of this Agreement, Cellect is in material compliance with the terms of the Eiger Cellect Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of EigerCellect, threatened, which seeks to revoke, limit, suspend, or materially modify any Eiger Cellect Permit. The rights and benefits of each material Eiger Cellect Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Eiger Cellect and its the Cellect Subsidiaries as of the date of this Agreement and immediately prior to the Effective TimeTime except where the unavailability of such Cellect Permit would not constitute a Cellect Material Adverse Effect.
(c) There are no proceedings pending or or, to the Knowledge of Cellect, threatened with respect to an alleged violation by Eiger Cellect or any of its Subsidiaries Cellect Subsidiary of the Federal FoodFDCA, DrugPHSA, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) FDA regulations adopted thereunder, the Controlled Substance Substances Act or any other similar Legal Requirements promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”).
(d) Eiger To the Knowledge of Cellect, Cellect and each of its Subsidiaries holds hold all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Eiger Cellect or such Subsidiary as currently conducted, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Eiger Cellect Product Candidates”) ). Cellect holds all required Governmental Authorizations issuable by any Governmental Body necessary for the conduct of its business as currently conducted (collectively, the “Eiger Cellect Regulatory Permits”), ) and no such Eiger Cellect Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled canceled or terminated or (ii) modified in any materially adverse manner, other than immaterial adverse modifications. Eiger and each Eiger Subsidiary is in compliance in all material respects with the Eiger Regulatory Permits and Cellect has not received any written notice or other written communication from any Drug Regulatory Agency Governmental Body regarding (A) any material violation of or failure to comply materially with any term or requirement of any Eiger Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellationcancelation, termination or material modification of any Eiger Cellect Regulatory Permit. Except for the information and files identified in Part 2.11(d) of the Eiger Disclosure Schedule, Eiger Cellect has made available to Celladon Quoin all information requested by Celladon in Eiger’s or its Subsidiaries’ possession or control relating to the Eiger Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Eiger Cellect Product Candidates, including complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(e) All To the Knowledge of Cellect, all clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Eiger Cellect or its Subsidiaries any Cellect Subsidiary or in which Eiger Cellect or its Subsidiaries or their respective current products or product candidates, including the Eiger Product Candidates, services have participated were, and if still pending are being, conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 20102012, neither Eiger Cellect nor any of its Subsidiaries Cellect Subsidiary has received any notices, correspondence or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of Eiger Cellect threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Eiger or any of its Subsidiaries Cellect or in which Eiger Cellect or any of its Subsidiaries or their respective current products or product candidates, including the Eiger Cellect Product Candidates, have participated.
(f) Neither Eiger nor any of the Eiger Subsidiaries Cellect is not the subject of any pending, or to the Knowledge of Eiger or the Eiger SubsidiariesCellect, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Eiger or any of the Eiger SubsidiariesCellect, neither Eiger nor any of the Eiger Subsidiaries Cellect has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products Cellect Product Candidates that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None Neither Cellect, nor to the Knowledge of EigerCellect, any of its Subsidiaries or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could would reasonably be expected to result in a debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of EigerCellect, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Eiger, any Eiger Subsidiary Cellect or any of their respective its officers, employees or agents.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Eiger and each Eiger Subsidiary areQuoin is, and since January 1, 2010 have 2016, has been, in material compliance in all material respects with all applicable Legal RequirementsRequirements except for any non-compliance that would not constitute a Quoin Material Adverse Effect. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of EigerQuoin, threatened against Eiger or any Eiger Subsidiary, nor has any Governmental Body or authority indicated to Eiger an intention to conduct the sameQuoin. There is no agreementContract, judgment, injunction, order or decree binding upon Eiger or any Eiger Subsidiary Quoin which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Eiger or any Eiger SubsidiaryQuoin, any acquisition of material property by Eiger or any Eiger Subsidiary Quoin or the conduct of business by Eiger or any Eiger Subsidiary Quoin as currently conducted, (ii) may would reasonably be expected to have an adverse effect on EigerQuoin’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may would reasonably be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions.
(b) Eiger and the Eiger Subsidiaries hold Quoin holds all required Governmental Authorizations which are material to the operation of the business of Eiger Quoin (the “Eiger Quoin Permits”) as currently conducted. Part 2.11(bSection 2.12(b) of the Eiger Quoin Disclosure Schedule identifies each Eiger Quoin Permit. Each As of Eiger and each Eiger Subsidiary the date of this Agreement, Quoin is in material compliance with the terms of the Eiger Quoin Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of EigerQuoin, threatened, which seeks to revoke, limit, suspend, or materially modify any Eiger Quoin Permit. The rights and benefits of each material Eiger Quoin Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Eiger and its Subsidiaries as of the date of this Agreement and Quoin immediately prior to the Effective TimeTime except where the unavailability of such Quoin Permit would not constitute a Quoin Material Adverse Effect.
(c) There are no proceedings pending or or, to the Knowledge of Quoin, threatened with respect to an alleged violation by Eiger or any of its Subsidiaries Quoin of the Federal Food, Drug, and Cosmetic Act (“FDCA”), the Public Health Service Act (“PHSA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Substances Act or any other similar Legal Requirements promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”).
(d) Eiger and each To the Knowledge of its Subsidiaries Quoin, Quoin holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Eiger or such Subsidiary Quoin as currently conducted, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Eiger Quoin Product Candidates”) ). Quoin holds all required Governmental Authorizations issuable by any Governmental Body necessary for the conduct of its business as currently conducted (collectively, the “Eiger Quoin Regulatory Permits”), and no such Eiger Quoin Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled canceled or terminated or (ii) modified in any materially adverse manner, other than immaterial adverse modifications. Eiger and each Eiger Subsidiary is in compliance in all material respects with the Eiger Regulatory Permits and Quoin has not received any written notice or other written communication from any Drug Regulatory Agency Governmental Body regarding (A) any material violation of or failure to comply materially with any term or requirement of any Eiger Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellationcancelation, termination or material modification of any Eiger Quoin Regulatory Permit. Except for the information and files identified in Part 2.11(d) of the Eiger Disclosure Schedule, Eiger Quoin has made available to Celladon Cellect all information requested by Celladon in Eiger’s or its Subsidiaries’ possession or control relating to the Eiger Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Eiger Quoin Product Candidates, including complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(e) All To the Knowledge of Quoin, all clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Eiger or its Subsidiaries Quoin or in which Eiger Quoin or its Subsidiaries or their respective current products or product candidates, including the Eiger Quoin Product Candidates, have participated were, and if still pending are being, conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 20102012, neither Eiger nor any of its Subsidiaries Quoin has not received any notices, correspondence or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of Eiger Quoin threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Eiger or any Quoin or, to the Knowledge of its Subsidiaries or Quoin, in which Eiger Quoin or any of its Subsidiaries or their respective current products or product candidates, including the Eiger Quoin Product Candidates, have participated.
(f) Neither Eiger nor any of the Eiger Subsidiaries Quoin is not the subject of any pending, or to the Knowledge of Eiger or the Eiger SubsidiariesQuoin, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Eiger or any of the Eiger SubsidiariesQuoin, neither Eiger nor any of the Eiger Subsidiaries Quoin has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products Quoin Product Candidates that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None Neither Quoin, and to the Knowledge of EigerQuoin, nor any of its Subsidiaries or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could would reasonably be expected to result in a debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of EigerQuoin, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Eiger, any Eiger Subsidiary Quoin or any of their respective its officers, employees or agents.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Eiger and each Eiger Subsidiary areOpexa is, and since January 1, 2010 have been2011, each of Opexa and its Subsidiaries has been in material compliance in all material respects with all applicable Legal Requirements. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of EigerOpexa, threatened against Eiger or any Eiger Subsidiary, nor has any Governmental Body or authority indicated to Eiger an intention to conduct the sameOpexa. There is no agreementContract, judgment, injunction, order or decree binding upon Eiger or any Eiger Subsidiary Opexa which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Eiger or any Eiger SubsidiaryOpexa, any acquisition of material property by Eiger or any Eiger Subsidiary Opexa or the conduct of business by Eiger or any Eiger Subsidiary Opexa as currently conducted, (ii) may would reasonably be expected to have an adverse effect on EigerOpexa’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) may would reasonably be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions.
(b) Eiger and the Eiger Subsidiaries hold Opexa holds all required Governmental Authorizations which that are material to the operation of the its business of Eiger (collectively, the “Eiger Opexa Permits”) as currently conducted. Part 2.11(bSection 3.12(b) of the Eiger Opexa Disclosure Schedule identifies each Eiger Opexa Permit. Each As of Eiger and each Eiger Subsidiary the date of this Agreement, Opexa is in material compliance with the terms of the Eiger Opexa Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of EigerOpexa, threatened, which seeks to revoke, limit, suspend, or materially modify any Eiger Opexa Permit. The rights and benefits of each material Eiger Opexa Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Eiger and its Subsidiaries Opexa as of the date of this Agreement and immediately prior to the Effective Time.
(c) There are no proceedings pending or or, to the Knowledge of Opexa, threatened with respect to an alleged violation by Eiger or any of its Subsidiaries Opexa of the Federal FoodFDCA, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) FDA regulations adopted thereunder, the Controlled Substance Substances Act or any other similar Legal Requirements promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”).
(d) Eiger and each of its Subsidiaries Opexa holds all required Governmental Authorizations issuable by any Drug Regulatory Agency Governmental Body necessary for the conduct of the its business of Eiger or such Subsidiary as currently conducted, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates conducted (the “Eiger Product Candidates”) (collectively, the “Eiger Opexa Regulatory Permits”), ) and no such Eiger Opexa Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled canceled or terminated or (ii) modified in any materially adverse manner, other than immaterial adverse modifications. Eiger and each Eiger Subsidiary is in compliance in all material respects with the Eiger Regulatory Permits and Opexa has not received any written notice or other written communication from any Drug Regulatory Agency Governmental Body regarding (A) any material violation of or failure to comply materially with any term or requirement of any Eiger Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellationcancelation, termination or material modification of any Eiger Opexa Regulatory Permit. Except for the information and files identified in Part 2.11(d) of the Eiger Disclosure Schedule, Eiger Opexa has made available to Celladon Acer all information requested by Celladon in Eiger’s or its Subsidiaries’ possession or control relating to the Eiger Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Eiger Product Candidates, including complete copies of the following (to the extent there are any): (xA) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory AgencyGovernmental Body; and meeting minutes with any Drug Regulatory AgencyGovernmental Body; and (yB) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental AuthorityBody.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Eiger or its Subsidiaries Opexa or in which Eiger Opexa or its Subsidiaries or their respective current products or product candidates, including the Eiger Product Candidates, services have participated were, and if still pending are being, were conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2010, neither Eiger nor any of its Subsidiaries has received any notices, correspondence or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of Eiger threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Eiger or any of its Subsidiaries or in which Eiger or any of its Subsidiaries or their respective current products or product candidates, including the Eiger Product Candidates, have participated.
(f) Neither Eiger nor any of the Eiger Subsidiaries is the subject of any pending, or to the Knowledge of Eiger or the Eiger Subsidiaries, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Eiger or any of the Eiger Subsidiaries, neither Eiger nor any of the Eiger Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Eiger, any of its Subsidiaries or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of EigerOpexa, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Eiger, any Eiger Subsidiary Opexa or any of their respective its officers, employees or agents.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Eiger and each Eiger Subsidiary areMarker is, and since January 1December 11, 2010 have 2015 has been, in compliance in all material respects with all applicable Legal RequirementsRequirements except for any non-compliance that would not constitute a Marker Material Adverse Effect. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of EigerMarker, threatened against Eiger or any Eiger Subsidiary, nor has any Governmental Body or authority indicated to Eiger an intention to conduct the sameMarker. There is no agreementContract, judgment, injunction, order or decree binding upon Eiger or any Eiger Subsidiary Marker which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any current business practice of Eiger or any Eiger SubsidiaryMarker, any acquisition of material property by Eiger or any Eiger Subsidiary Marker or the conduct of business by Eiger or any Eiger Subsidiary Marker as currently conducted, (ii) may would reasonably be expected to have an adverse effect on EigerMarker’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may would reasonably be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions.
(b) Eiger and the Eiger Subsidiaries hold Marker holds all required Governmental Authorizations which are material to the operation of the business of Eiger Marker (the “Eiger Marker Permits”) as currently conducted. Part 2.11(bSection 2.12(b) of the Eiger Marker Disclosure Schedule identifies each Eiger Marker Permit. Each As of Eiger and each Eiger Subsidiary the date of this Agreement, Marker is in material compliance with the terms of the Eiger Marker Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of EigerMarker, threatened, which seeks to revoke, limit, suspend, or materially modify any Eiger Marker Permit. The rights and benefits of each material Eiger Marker Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Eiger and its Subsidiaries as of the date of this Agreement and Marker immediately prior to the Effective Time.
(c) There are no proceedings pending or or, to the Knowledge of Marker, threatened with respect to an alleged violation by Eiger or any of its Subsidiaries Marker of the Federal Food, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Substances Act or any other similar Legal Requirements promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”).
(d) Eiger and each of its Subsidiaries Marker holds all required no Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Eiger or such Subsidiary as currently conducted, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of Agency. Marker holds no Governmental Authorizations issuable by any of its products or product candidates (the “Eiger Product Candidates”) (collectively, the “Eiger Regulatory Permits”), and no such Eiger Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modificationsGovernmental Body. Eiger and each Eiger Subsidiary is in compliance in all material respects with the Eiger Regulatory Permits and has not received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Eiger Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Eiger Regulatory Permit. Except for the information and files identified in Part 2.11(d) of the Eiger Disclosure Schedule, Eiger Marker has made available to Celladon TapImmune all information requested by Celladon TapImmune in EigerMarker’s or its Subsidiaries’ possession or control relating relating, to the Eiger Product Candidates and extent they exist, the development, clinical testing, manufacturing, importation and exportation of the Eiger Marker Product Candidates, including complete copies of the following (to the extent there are any): (xx)copies of all investigational new drug applications (INDs) submitted to the FDA, and all supplements to and amendments of such INDs; new drug applications; adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental AuthorityBody.
(e) All clinicalSince December 11, pre-clinical and other studies and tests conducted by or on behalf of2015, or sponsored by, Eiger or its Subsidiaries or in which Eiger or its Subsidiaries or their respective current products or product candidates, including the Eiger Product Candidates, have participated were, and if still pending are being, conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2010, neither Eiger nor any of its Subsidiaries Marker has not received any notices, correspondence or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of Eiger Marker threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Eiger or any of its Subsidiaries Marker or in which Eiger Marker or any of its Subsidiaries or their respective current products or product candidates, including the Eiger Marker Product Candidates, have participated.
(f) Neither Eiger nor any To the Knowledge of the Eiger Subsidiaries Marker, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Marker or its officers, employees or agents. Marker is not the subject of any pending, or to the Knowledge of Eiger or the Eiger SubsidiariesMarker, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Eiger or any of the Eiger SubsidiariesMarker, neither Eiger nor any of the Eiger Subsidiaries Marker has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products Marker Product Candidates that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None Neither Marker, and to the Knowledge of EigerMarker, nor any of its Subsidiaries or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could would reasonably be expected to result in a debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of Eiger, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Eiger, any Eiger Subsidiary or any of their respective officers, employees or agents.
Appears in 1 contract
Samples: Merger Agreement (Tapimmune Inc.)
Compliance; Permits; Restrictions. (a) Eiger Miragen and each Eiger Miragen Subsidiary are, and since January 1, 2010 2011 have been, in compliance in all material respects with all applicable Legal RequirementsRequirements except for any non-compliance that would not constitute an Miragen Material Adverse Effect. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of EigerMiragen, threatened against Eiger Miragen or any Eiger Miragen Subsidiary, nor has any Governmental Body or authority indicated to Eiger an intention to conduct the same. There is no agreementContract, judgment, injunction, order or decree binding upon Eiger Miragen or any Eiger Miragen Subsidiary which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Eiger Miragen or any Eiger Miragen Subsidiary, any acquisition of material property by Eiger Miragen or any Eiger Miragen Subsidiary or the conduct of business by Eiger Miragen or any Eiger Miragen Subsidiary as currently conducted, (ii) may would reasonably be expected to have an adverse effect on EigerMiragen’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may would reasonably be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions.
(b) Eiger Miragen and the Eiger Miragen Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Eiger Miragen (the “Eiger Miragen Permits”) as currently conducted. Part 2.11(bSection 2.12(b) of the Eiger Miragen Disclosure Schedule identifies each Eiger Miragen Permit. Each As of Eiger the date of this Agreement, each of Miragen and each Eiger Miragen Subsidiary is in material compliance with the terms of the Eiger Miragen Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of EigerMiragen, threatened, which seeks to revoke, limit, suspend, or materially modify any Eiger Miragen Permit. The rights and benefits of each material Eiger Miragen Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Eiger Miragen and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time.
(c) There are no proceedings pending or or, to the Knowledge of Miragen, threatened with respect to an alleged violation by Eiger Miragen or any of its Subsidiaries of the Federal Food, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Substances Act or any other similar Legal Requirements promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”).
(d) Eiger Miragen and each of its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Eiger Miragen or such Subsidiary as currently conducted, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Eiger Miragen Product Candidates”) (collectively, the “Eiger Miragen Regulatory Permits”), and no such Eiger Miragen Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled canceled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. Eiger Miragen and each Eiger Miragen Subsidiary is in compliance in all material respects with the Eiger Miragen Regulatory Permits and has not received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Eiger Miragen Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellationcancelation, termination or material modification of any Eiger Miragen Regulatory Permit. Except for the information and files identified in Part 2.11(d) of the Eiger Disclosure Schedule, Eiger Miragen has made available to Celladon Signal all information requested by Celladon Signal in EigerMiragen’s or its Subsidiaries’ possession or control relating to the Eiger Miragen Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Eiger Miragen Product Candidates, including complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Eiger Miragen or its Subsidiaries or in which Eiger Miragen or its Subsidiaries or their respective current products or product candidates, including the Eiger Miragen Product Candidates, have participated were, and if still pending are being, conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 20102011, neither Eiger Miragen nor any of its Subsidiaries has received any notices, correspondence or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of Eiger Miragen threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Eiger Miragen or any of its Subsidiaries or in which Eiger Miragen or any of its Subsidiaries or their respective current products or product candidates, including the Eiger Miragen Product Candidates, have participated.
(f) Neither Eiger Miragen nor any of the Eiger Miragen Subsidiaries is the subject of any pending, or to the Knowledge of Eiger Miragen or the Eiger Miragen Subsidiaries, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Eiger Miragen or any of the Eiger Miragen Subsidiaries, neither Eiger Miragen nor any of the Eiger Miragen Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products Miragen Product Candidates that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of EigerMiragen, any of its Subsidiaries or to the Knowledge of Miragen, any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could would reasonably be expected to result in a debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of EigerMiragen, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against EigerMiragen, any Eiger Miragen Subsidiary or any of their respective officers, employees or agents.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Eiger and each Eiger Subsidiary areBombshell is, and since January 1, 2010 have has been, in compliance in all material respects with all applicable Legal RequirementsRequirements except for any non-compliance that would not constitute a Bombshell Material Adverse Effect. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of EigerBombshell, threatened against Eiger or any Eiger Subsidiary, nor has any Governmental Body or authority indicated to Eiger an intention to conduct the sameBombshell. There is no agreementContract, judgment, injunction, order or decree binding upon Eiger or any Eiger Subsidiary Bombshell which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any current business practice of Eiger or any Eiger SubsidiaryBombshell, any acquisition of material property by Eiger or any Eiger Subsidiary Bombshell or the conduct of business by Eiger or any Eiger Subsidiary Bombshell as currently conducted, (ii) may would reasonably be expected to have an adverse effect on EigerBombshell’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may would reasonably be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger Exchange or any of the Contemplated Transactions.
(b) Eiger and the Eiger Subsidiaries hold Bombshell holds all required Governmental Authorizations which are material to the operation of the business of Eiger Bombshell (the “Eiger Bombshell Permits”) as currently conducted. Part 2.11(bSection 2.12(b) of the Eiger Bombshell Disclosure Schedule identifies each Eiger Permit. Each Bombshell Permit As of Eiger and each Eiger Subsidiary the date of this Agreement, Bombshell is in material compliance with the terms of the Eiger Bombshell Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of EigerBombshell, threatened, which seeks to revoke, limit, suspend, or materially modify any Eiger Bombshell Permit. The rights and benefits of each material Eiger Bombshell Permit will be available to the Surviving Corporation Bombshell and CG immediately after the Effective Time on terms substantially identical to those enjoyed by Eiger and its Subsidiaries as of the date of this Agreement and Bombshell immediately prior to the Effective Time.
(c) There are no proceedings pending or threatened with respect to an alleged violation by Eiger or any of its Subsidiaries of the Federal Food, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”).
(d) Eiger and each of its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Eiger or such Subsidiary as currently conducted, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Eiger Product Candidates”) (collectively, the “Eiger Regulatory Permits”), and no such Eiger Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. Eiger and each Eiger Subsidiary is in compliance in all material respects with the Eiger Regulatory Permits and has not received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Eiger Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Eiger Regulatory Permit. Except for the information and files identified in Part 2.11(d) of the Eiger Disclosure Schedule, Eiger has made available to Celladon all information requested by Celladon in Eiger’s or its Subsidiaries’ possession or control relating to the Eiger Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Eiger Product Candidates, including complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Eiger or its Subsidiaries or in which Eiger or its Subsidiaries or their respective current products or product candidates, including the Eiger Product Candidates, have participated were, and if still pending are being, conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2010, neither Eiger nor any of its Subsidiaries has received any notices, correspondence or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of Eiger threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Eiger or any of its Subsidiaries or in which Eiger or any of its Subsidiaries or their respective current products or product candidates, including the Eiger Product Candidates, have participated.
(f) Neither Eiger nor any of the Eiger Subsidiaries is the subject of any pending, or to the Knowledge of Eiger or the Eiger Subsidiaries, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Eiger or any of the Eiger Subsidiaries, neither Eiger nor any of the Eiger Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Eiger, any of its Subsidiaries or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of Eiger, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Eiger, any Eiger Subsidiary or any of their respective officers, employees or agents.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Eiger and each Eiger Subsidiary areNSC is not in conflict with, and since January 1or in default or violation of (i) any law, 2010 rule, regulation, order, judgment or decree applicable to NSC or by which its properties is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which NSC is a party or by which NSC or its property is bound or affected, except for any conflicts, defaults or violations which would not reasonably be expected to have been, in compliance in all material respects with all applicable Legal Requirementsa Material Adverse Effect on NSC. No investigation, claim, suit, proceeding, audit investigation or other action review by any Governmental Body governmental or regulatory body or authority is pending or, to the Knowledge knowledge of EigerNSC, threatened against Eiger or any Eiger SubsidiaryNSC, nor has any Governmental Body governmental or regulatory body or authority indicated to Eiger NSC an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Eiger or any Eiger Subsidiary which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Eiger or any Eiger Subsidiary, any acquisition of material property by Eiger or any Eiger Subsidiary or the conduct of business by Eiger or any Eiger Subsidiary as currently conducted, (ii) may have an adverse effect on Eiger’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions.
(b) Eiger NSC holds all permits, licenses, variances, exemptions, orders and the Eiger Subsidiaries hold all required Governmental Authorizations approvals from governmental authorities which are material necessary to the operation of the business of Eiger NSC (collectively, the “Eiger "NSC Permits”) as currently conducted"). Part 2.11(b) of the Eiger Disclosure Schedule identifies each Eiger Permit. Each of Eiger and each Eiger Subsidiary NSC is in material compliance with the terms of the Eiger NSC Permits, except where the failure to so comply would not reasonably be expected to have a Material Adverse Effect on NSC. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge knowledge of EigerNSC, threatened, which seeks to revokerevoke or limit any NSC Permit. A true, limit, suspend, or materially modify any Eiger Permitcomplete and correct list of the material NSC Permits is set forth in Section 2.9(b) of the NSC. Disclosure Schedule. The rights and benefits of each material Eiger NSC Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Eiger and its Subsidiaries as of the date of this Agreement and NSC immediately prior to the Effective Time.
(c) There are no proceedings pending All clinical trials or threatened with respect to an alleged violation biological specimen collection conducted by Eiger or any on behalf of its Subsidiaries of the Federal Food, DrugNSC have been, and Cosmetic Act (“FDCA”)are being conducted in material 'compliance with the applicable requirements of Good Clinical Practice, Food Informed Consent, and Drug Administration (“FDA”) regulations adopted thereunderall applicable requirements relating to protection of human subjects contained in 21 CFR Parts 50, the Controlled Substance Act or any other similar Legal Requirements promulgated by the FDA 54, and 56 or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation state or exportation of drug products (“Drug Regulatory Agency”)local. requirements.
(d) Eiger and each Neither NSC nor any representative of its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for NSC, nor to the conduct knowledge of the business of Eiger or such Subsidiary as currently conductedNSC, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products licensees or product candidates (the “Eiger Product Candidates”) (collectively, the “Eiger Regulatory Permits”), and no such Eiger Regulatory Permit assignees of NSC IP Rights has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. Eiger and each Eiger Subsidiary is in compliance in all material respects with the Eiger Regulatory Permits and has not received any written notice that the FDA or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Eiger Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Eiger Regulatory Permit. Except for the information and files identified in Part 2.11(d) of the Eiger Disclosure Schedule, Eiger has made available to Celladon all information requested by Celladon in Eiger’s or its Subsidiaries’ possession or control relating to the Eiger Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Eiger Product Candidates, including complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental AuthorityEntity has initiated, or threatened to initiate, any action to suspend any clinical trial, suspend or terminate any Investigational New Drug Application sponsored by NSC or otherwise restrict the preclinical research on or clinical study of any NSC product or any biological, medical device or drug product being developed by any licensee or assignee of NSC FP Rights based on such intellectual property, or to recall, suspend or otherwise restrict the manufacture of any NSC product.
(e) All clinicalNeither NSC nor, pre-clinical and other studies and tests conducted by or on behalf ofto the knowledge of NSC, or sponsored by, Eiger or its Subsidiaries or in which Eiger or its Subsidiaries or their respective current products or product candidates, including the Eiger Product Candidates, have participated were, and if still pending are being, conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2010, neither Eiger nor any of its Subsidiaries officers, key employees, agents or clinical investigators acting for NSC, has received committed any noticesact, correspondence made any statement or other communications from failed to make any Drug Regulatory Agency requiring, or statement that would reasonably be expected to the Knowledge of Eiger threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Eiger or any of its Subsidiaries or in which Eiger or any of its Subsidiaries or their respective current products or product candidates, including the Eiger Product Candidates, have participated.
(f) Neither Eiger nor any of the Eiger Subsidiaries is the subject of any pending, or to the Knowledge of Eiger or the Eiger Subsidiaries, threatened investigation in respect of its business or products by provide a basis for the FDA pursuant to invoke its “policy with respect to "Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy " set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments theretothereof. To the Knowledge of Eiger or any of the Eiger SubsidiariesAdditionally, neither Eiger NSC, nor any to the knowledge of the Eiger Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of EigerNSC, any officer, key employee or agent of its Subsidiaries or any of their respective officers, employees or agents NSC has been convicted convicted. of any crime or engaged in any conduct that could would reasonably be expected to result in a debarment or exclusion (i) debarment under 21 U.S.C. Section 335a or any similar state law or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar applicable Legal Requirementstate law or regulation.
(f) NSC has made available to Azurel copies of any and all written notices of inspectional observations, establishment inspection reports and any other documents received from the FDA, that indicate or suggest lack of compliance with the regulatory requirements of the FDA. To NSC has made available to Azurel for review all correspondence to or from the Knowledge FDA, minutes of Eigermeetings, written reports of phone conversations, visits or other contact with the FDA, notices of inspectional observations, establishment inspection reports, and all other documents concerning communications to or from the FDA, or prepared by the FDA or which bear in any way on NSC's compliance with regulatory requirements of the FDA, or on the likelihood of timing of approval of any NSC drug or medical device products. 9
(g) There are no debarment or exclusionary claimsproceedings pending with respect to a violation by NSC of the FDCA, actionsFDA regulations adopted thereunder, proceedings or investigations in respect of their business or products are pending or threatened against Eiger, any Eiger Subsidiary the Controlled Substance Act or any of their respective officers, employees other legislation or agents.regulation promulgated by any• other United States governmental entity..
Appears in 1 contract
Samples: Merger Agreement (Proteonomix, Inc.)
Compliance; Permits; Restrictions. (a) Eiger and each Eiger Subsidiary areGC is, and since January July 1, 2010 have been2016, each of GC and the GC Subsidiaries has been in compliance in all material respects with all applicable Legal RequirementsRequirements except for any non-compliance that would not constitute a GC Material Adverse Effect. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of EigerGC, threatened against Eiger GC or any Eiger GC Subsidiary, nor has any Governmental Body or authority indicated to Eiger an intention to conduct the same. There is no agreementContract, judgment, injunction, order or decree binding upon Eiger GC or any Eiger GC Subsidiary which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Eiger GC or any Eiger GC Subsidiary, any acquisition of material property by Eiger GC or any Eiger GC Subsidiary or the conduct of business by Eiger GC or any Eiger GC Subsidiary as currently conducted, (ii) may would reasonably be expected to have an adverse effect on EigerGC’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) may would reasonably be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger Exchange or any of the Contemplated Transactions.
(b) Eiger GC and the Eiger GC Subsidiaries hold all required Governmental Authorizations which that are material to the operation of the its business of Eiger (collectively, the “Eiger GC Permits”) as currently conducted. Part 2.11(bSection 3.12(b) of the Eiger GC Disclosure Schedule identifies each Eiger GC Permit. Each As of Eiger the date of this Agreement, each of GC and each Eiger Subsidiary is the GC Subsidiaries are in material compliance with the terms of the Eiger GC Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of EigerGC, threatened, which seeks to revoke, limit, suspend, or materially modify any Eiger GC Permit. The rights and benefits of each material Eiger GC Permit will be available to the Surviving Corporation GC immediately after the Effective Time on terms substantially identical to those enjoyed by Eiger GC and its the GC Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time.
(c) There are no proceedings pending or threatened with respect to an alleged violation by Eiger or any of its Subsidiaries of the Federal Food, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”).
(d) Eiger and each of its Subsidiaries GC holds all required Governmental Authorizations issuable by any Drug Regulatory Agency Governmental Body necessary for the conduct of the its business of Eiger or such Subsidiary as currently conducted, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates conducted (the “Eiger Product Candidates”) (collectively, the “Eiger GC Regulatory Permits”), ) and no such Eiger GC Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled canceled or terminated or (ii) modified in any materially adverse manner, other than immaterial adverse modifications. Eiger and each Eiger Subsidiary is in compliance in all material respects with the Eiger Regulatory Permits and GC has not received any written notice or other written communication from any Drug Regulatory Agency Governmental Body regarding (A) any material violation of or failure to comply materially with any term or requirement of any Eiger Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellationcancelation, termination or material modification of any Eiger GC Regulatory Permit. Except for the information and files identified in Part 2.11(d) of the Eiger Disclosure Schedule, Eiger has made available to Celladon all information requested by Celladon in Eiger’s or its Subsidiaries’ possession or control relating to the Eiger Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Eiger Product Candidates, including complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Eiger or its Subsidiaries or in which Eiger or its Subsidiaries or their respective current products or product candidates, including the Eiger Product Candidates, have participated were, and if still pending are being, conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2010, neither Eiger nor any of its Subsidiaries has received any notices, correspondence or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of Eiger threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Eiger or any of its Subsidiaries or in which Eiger or any of its Subsidiaries or their respective current products or product candidates, including the Eiger Product Candidates, have participated.
(f) Neither Eiger nor any of the Eiger Subsidiaries is the subject of any pending, or to the Knowledge of Eiger or the Eiger Subsidiaries, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Eiger or any of the Eiger Subsidiaries, neither Eiger nor any of the Eiger Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Eiger, any of its Subsidiaries or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of Eiger, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Eiger, any Eiger Subsidiary or any of their respective officers, employees or agents.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Eiger and each Eiger Subsidiary areVital is, and since January 1, 2010 have been2018, Vital has been in compliance in all material respects with all applicable Legal RequirementsRequirements except for any non-compliance that would not constitute a Vital Material Adverse Effect. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of EigerVital, threatened against Eiger or any Eiger Subsidiary, nor has any Governmental Body or authority indicated to Eiger an intention to conduct the sameVital. There is no agreementContract, judgment, injunction, order or decree binding upon Eiger or any Eiger Subsidiary Vital which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Eiger or any Eiger Subsidiary, any acquisition of material property by Eiger or any Eiger Subsidiary or the conduct of business by Eiger or any Eiger Subsidiary as currently conducted, (ii) may have an adverse effect on Eiger’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger Transaction or any of the other Contemplated Transactions.
(b) Eiger and the Eiger Subsidiaries hold Vital holds all required Governmental Authorizations which that are material to the operation of the its business of Eiger (collectively, the “Eiger Vital Permits”) as currently conducted. Part 2.11(b) As of the Eiger Disclosure Schedule identifies each Eiger Permit. Each date of Eiger and each Eiger Subsidiary this Agreement, Vital is in material compliance with the terms of the Eiger Vital Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of EigerVital, threatened, which seeks to revoke, limit, suspend, or materially modify any Eiger Vital Permit. The rights and benefits of each material Eiger Vital Permit will be available to the Surviving Corporation Vital immediately after the Effective Time on terms substantially identical to those enjoyed by Eiger and its Subsidiaries Vital as of the date of this Agreement and immediately prior to the Effective Time.
(c) There are no proceedings pending or or, to the Knowledge of Vital, threatened with respect to an alleged material violation by Eiger or any of its Subsidiaries Vital of the Federal FoodFDCA, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) FDA regulations adopted thereunder, the Controlled Substance Act Substances Act, EMEA or any other similar Legal Requirements promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”).
(d) Eiger and each of its Subsidiaries Vital holds all required Governmental Authorizations issuable by any Drug Regulatory Agency Governmental Body necessary for the conduct of the its business of Eiger or such Subsidiary as currently conducted, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates conducted (the “Eiger Product Candidates”) (collectively, the “Eiger Vital Regulatory Permits”), ) and no such Eiger Vital Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled canceled or terminated or (ii) modified in any materially adverse manner. Except as set forth in Section 3.8(d) of the Vital Disclosure Schedule, other than immaterial adverse modifications. Eiger and each Eiger Subsidiary is in compliance in all material respects with the Eiger Regulatory Permits and Vital has not received any written notice or other written communication from any Drug Regulatory Agency Governmental Body regarding (A) any material violation of or failure to comply materially with any term or requirement of any Eiger Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellationcancelation, termination or material modification of any Eiger Vital Regulatory Permit. Except for the information and files identified in Part 2.11(d) of the Eiger Disclosure Schedule, Eiger has made available to Celladon all information requested by Celladon in Eiger’s or its Subsidiaries’ possession or control relating to the Eiger Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Eiger Product Candidates, including complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(e) All Except as set forth in Section 3.8(d) of the Vital Disclosure Schedule, all clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Eiger or its Subsidiaries Vital or in which Eiger Vital or its Subsidiaries or their respective current products or product candidates, including the Eiger Product Candidates, services have participated were, and if still pending are being, were conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2010, neither Eiger nor any of its Subsidiaries has received any notices, correspondence or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of Eiger threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Eiger or any of its Subsidiaries or in which Eiger or any of its Subsidiaries or their respective current products or product candidates, including the Eiger Product Candidates, have participated.
(f) Neither Eiger nor any of the Eiger Subsidiaries is the subject of any pending, or to the Knowledge of Eiger or the Eiger Subsidiaries, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Eiger or any of the Eiger Subsidiaries, neither Eiger nor any of the Eiger Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Eiger, any of its Subsidiaries or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of Eiger, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Eiger, any Eiger Subsidiary or any of their respective officers, employees or agents.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Eiger and each Eiger Subsidiary areMolecular is, and since January 1, 2010 have 2012 has been, in compliance in all material respects with all applicable Legal RequirementsRequirements except for any non-compliance that would not constitute a Molecular Material Adverse Effect. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of EigerMolecular, threatened against Eiger or any Eiger Subsidiary, nor has any Governmental Body or authority indicated to Eiger an intention to conduct the sameMolecular. There is no agreementContract, judgment, injunction, order or decree binding upon Eiger or any Eiger Subsidiary Molecular which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Eiger or any Eiger SubsidiaryMolecular, any acquisition of material property by Eiger or any Eiger Subsidiary Molecular or the conduct of business by Eiger or any Eiger Subsidiary Molecular as currently conducted, (ii) may would reasonably be expected to have an adverse effect on EigerMolecular’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may would reasonably be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions.
(b) Eiger and the Eiger Subsidiaries hold Molecular holds all required Governmental Authorizations which are material to the operation of the business of Eiger Molecular (the “Eiger Molecular Permits”) as currently conducted. Part 2.11(bSection 2.12(b) of the Eiger Molecular Disclosure Schedule identifies each Eiger Molecular Permit. Each As of Eiger and each Eiger Subsidiary the date of this Agreement, Molecular is in material compliance with the terms of the Eiger Molecular Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of EigerMolecular, threatened, which seeks to revoke, limit, suspend, or materially modify any Eiger Molecular Permit. The rights and benefits of each material Eiger Molecular Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Eiger and its Subsidiaries as of the date of this Agreement and Molecular immediately prior to the Effective Time.
(c) There are no proceedings pending or or, to the Knowledge of Molecular, threatened with respect to an alleged violation by Eiger or any of its Subsidiaries Molecular of the Federal Food, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Substances Act or any other similar Legal Requirements promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”).
(d) Eiger and each of its Subsidiaries Molecular holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Eiger or such Subsidiary Molecular as currently conducted, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Eiger Molecular Product Candidates”) ). Molecular holds all required Governmental Authorizations issuable by any Governmental Body necessary for the conduct of its business as currently conducted (collectively, the “Eiger Molecular Regulatory Permits”), ) and no such Eiger Molecular Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled canceled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. Eiger and each Eiger Subsidiary Molecular is in compliance in all material respects with the Eiger Molecular Regulatory Permits and has not received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Eiger Molecular Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellationcancelation, termination or material modification of any Eiger Molecular Regulatory Permit. Except for the information and files identified in Part 2.11(d) of the Eiger Disclosure Schedule, Eiger Molecular has made available to Celladon Threshold all information requested by Celladon Threshold in EigerMolecular’s or its Subsidiaries’ possession or control relating to the Eiger Molecular Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Eiger Molecular Product Candidates, including complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Eiger or its Subsidiaries Molecular or in which Eiger Molecular or its Subsidiaries or their respective current products or product candidates, including the Eiger Molecular Product Candidates, have participated were, and if still pending are being, conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 20102012, neither Eiger nor any of its Subsidiaries Molecular has not received any notices, correspondence or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of Eiger Molecular threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Eiger or any of its Subsidiaries Molecular or in which Eiger Molecular or any of its Subsidiaries or their respective current products or product candidates, including the Eiger Molecular Product Candidates, have participated.
(f) Neither Eiger nor any To the Knowledge of the Eiger Subsidiaries Molecular, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Molecular or its officers, employees or agents. Molecular is not the subject of any pending, or to the Knowledge of Eiger or the Eiger SubsidiariesMolecular, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Eiger or any of the Eiger SubsidiariesMolecular, neither Eiger nor any of the Eiger Subsidiaries Molecular has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products Molecular Product Candidates that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None Neither Molecular, and to the Knowledge of EigerMolecular, nor any of its Subsidiaries or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could would reasonably be expected to result in a debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of EigerMolecular, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Eiger, any Eiger Subsidiary Molecular or any of their respective its officers, employees or agents.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Eiger and each Eiger Subsidiary areEPIX is not in conflict with, and since January 1or in default or violation of (i) any law, 2010 rule, regulation, order, judgment or decree applicable to it or by which its properties are bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which EPIX is a party or by which EPIX or its properties are bound or affected, except for any conflicts, defaults or violations which would not reasonably be expected to have been, in compliance in all material respects with all applicable Legal Requirementsa Material Adverse Effect on EPIX. No investigation, claim, suit, proceeding, audit investigation or other action review by any Governmental Body governmental or regulatory body or authority is pending or, to the Knowledge knowledge of EigerEPIX, threatened against Eiger or any Eiger SubsidiaryEPIX, nor has any Governmental Body governmental or regulatory body or authority indicated to Eiger EPIX an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Eiger or any Eiger Subsidiary which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Eiger or any Eiger Subsidiary, any acquisition of material property by Eiger or any Eiger Subsidiary or the conduct of business by Eiger or any Eiger Subsidiary as currently conducted, (ii) may have an adverse effect on Eiger’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions.
(b) Eiger EPIX holds all permits, licenses, variances, exemptions, orders and the Eiger Subsidiaries hold all required Governmental Authorizations approvals from governmental authorities which are material to the operation of the its business of Eiger (collectively, the “Eiger EPIX Permits”) as currently conducted). Part 2.11(b) of the Eiger Disclosure Schedule identifies each Eiger Permit. Each of Eiger and each Eiger Subsidiary EPIX is in material compliance with the terms of the Eiger EPIX Permits, except where the failure to so comply would not reasonably be expected to have a Material Adverse Effect on EPIX. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge knowledge of EigerEPIX, threatened, which seeks to revokerevoke or limit any EPIX Permit. A true, limit, suspend, or materially modify any Eiger Permitcomplete and correct list of the material EPIX Permits is set forth in Section 3.15 of the EPIX Disclosure Schedule. The rights and benefits of each material Eiger EPIX Permit will be available to the Surviving Corporation or its subsidiaries immediately after the Effective Time on terms substantially identical to those enjoyed by Eiger and its Subsidiaries as of the date of this Agreement and EPIX immediately prior to the Effective Time.
(c) There All products being manufactured, distributed, developed or tested by or on behalf of EPIX (“EPIX Products”) that are no proceedings pending or threatened with respect subject to an alleged violation by Eiger or any of its Subsidiaries the jurisdiction of the Federal FoodFDA are being manufactured, Druglabeled, stored, tested, distributed, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”).
(d) Eiger and each of its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Eiger or such Subsidiary as currently conducted, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Eiger Product Candidates”) (collectively, the “Eiger Regulatory Permits”), and no such Eiger Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. Eiger and each Eiger Subsidiary is marketed in compliance in all material respects with all applicable requirements under the Eiger Regulatory Permits FDCA, the Public Health Service Act, their applicable implementing regulations, and has not received any written notice all comparable state laws and regulations.
(d) All clinical trials conducted by or other written communication from any Drug Regulatory Agency regarding (A) any on behalf of EPIX are being conducted in material violation compliance with the applicable requirements of or failure to comply materially with any term or requirement of any Eiger Regulatory Permit or (B) any revocationGood Clinical Practice, withdrawalInformed Consent, suspension, cancellation, termination or material modification of any Eiger Regulatory Permit. Except for the information and files identified in Part 2.11(d) of the Eiger Disclosure Schedule, Eiger has made available to Celladon all information requested by Celladon in Eiger’s or its Subsidiaries’ possession or control applicable requirements relating to the Eiger Product Candidates protection of human subjects contained in 21 CFR Parts 50, 54, and the development, clinical testing, manufacturing, importation and exportation of the Eiger Product Candidates, including complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority56.
(e) All clinical, pre-clinical and other studies and tests manufacturing operations for EPIX Products conducted by or on behalf offor the benefit of EPIX are being conducted in accordance, or sponsored by, Eiger or its Subsidiaries or in which Eiger or its Subsidiaries or their respective current products or product candidates, including the Eiger Product Candidates, have participated were, and if still pending are being, conducted in all material respects respects, with the FDA’s current Good Manufacturing Practices. In addition, EPIX is in accordance with standard medical and scientific research procedures and in material compliance with the all applicable regulations of the Drug Regulatory Agencies registration and other listing requirements set forth in 21 U.S.C. Section 360 and 21 CFR Part 207 and all similar applicable Legal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 laws and 312. Since January 1, 2010, neither Eiger nor any of its Subsidiaries has received any notices, correspondence or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of Eiger threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Eiger or any of its Subsidiaries or in which Eiger or any of its Subsidiaries or their respective current products or product candidates, including the Eiger Product Candidates, have participatedregulations.
(f) Neither Eiger EPIX, nor any representative of EPIX, nor, to the Eiger Subsidiaries is knowledge of EPIX, any of EPIX’s licensees or assignees of EPIX IP Rights has received any notice that the subject FDA or any other Governmental Authority has initiated, or threatened to initiate, any action to suspend any clinical trial sponsored by EPIX or otherwise restrict the preclinical research on or clinical study of any pendingEPIX Product being developed by any licensee or assignee of EPIX IP Rights based on such intellectual property, or to recall, suspend or otherwise restrict the Knowledge development or manufacture of Eiger or any EPIX Product.
(g) Neither EPIX, nor, to the Eiger Subsidiariesknowledge of EPIX, threatened investigation in respect any of its business officers, employees, agents or products by clinical investigators acting for EPIX has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA pursuant to invoke its policy with respect to Table of Contents “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments theretothereof. To the Knowledge of Eiger or any of the Eiger SubsidiariesAdditionally, neither Eiger nor any EPIX, nor, to the knowledge of the Eiger Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of EigerEPIX, any of its Subsidiaries or any of their respective officers, key employees or agents has been convicted of any crime or engaged in any conduct that could would reasonably be expected to result in a debarment or exclusion (i) debarment under 21 U.S.C. Section 335a or any similar state law or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar state law or regulation.
(h) All animal studies or other preclinical tests performed as the basis for any regulatory approval required for the EPIX Products (1) either (x) have been conducted in accordance, in all material respects, with applicable Legal RequirementGood Laboratory Practice requirements contained in 21 CFR Part 58, or (y) were not required to be conducted in accordance with Good Laboratory Practice requirements contained in 21 CFR Part 58 and (2) have employed the procedures and controls generally used by qualified experts in animal or preclinical study of products comparable to those being developed by EPIX.
(i) EPIX has made available to Predix copies of any and all written notices of inspectional observations, establishment inspection reports and any other documents received from the FDA, that indicate or suggest lack of compliance with the regulatory requirements of the FDA. To EPIX has made available to Predix for review all correspondence to or from the Knowledge FDA, minutes of Eigermeetings, written reports of phone conversations, visits or other contact with the FDA, notices of inspectional observations, establishment inspection reports, and all other documents concerning communications to or from the FDA, or prepared by the FDA or which bear in any way on EPIX’s compliance with regulatory requirements of the FDA, or on the likelihood of timing of approval of any EPIX Products.
(j) There are no debarment or exclusionary claimsproceedings pending with respect to a violation by EPIX of the FDCA, actionsFDA regulations adopted thereunder, proceedings or investigations in respect of their business or products are pending or threatened against Eiger, any Eiger Subsidiary the Controlled Substance Act or any of their respective officers, employees other legislation or agentsregulation promulgated by any other United States Governmental Authority.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Eiger and each Eiger Subsidiary areArcturus is, and since January 1, 2010 have 2014 has been, in material compliance in all material respects with all applicable Legal RequirementsRequirements except for any non-compliance that would not constitute an Arcturus Material Adverse Effect. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of EigerArcturus, threatened against Eiger or any Eiger Subsidiary, nor has any Governmental Body or authority indicated to Eiger an intention to conduct the sameArcturus. There is no agreementContract, judgment, injunction, order or decree binding upon Eiger or any Eiger Subsidiary Arcturus which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Eiger or any Eiger SubsidiaryArcturus, any acquisition of material property by Eiger or any Eiger Subsidiary Arcturus or the conduct of business by Eiger or any Eiger Subsidiary Arcturus as currently conducted, (ii) may would reasonably be expected to have an adverse effect on EigerArcturus’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may would reasonably be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions.
(b) Eiger and the Eiger Subsidiaries hold Arcturus holds all required Governmental Authorizations which are material to the operation of the business of Eiger Arcturus (the “Eiger Arcturus Permits”) as currently conducted. Part 2.11(bSection 2.12(b) of the Eiger Arcturus Disclosure Schedule identifies each Eiger Arcturus Permit. Each As of Eiger and each Eiger Subsidiary the date of this Agreement, Arcturus is in material compliance with the terms of the Eiger Arcturus Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of EigerArcturus, threatened, which seeks to revoke, limit, suspend, or materially modify any Eiger Arcturus Permit. The rights and benefits of each material Eiger Arcturus Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Eiger and its Subsidiaries as of the date of this Agreement and Arcturus immediately prior to the Effective TimeTime except where the unavailability of such Arcturus Permit would not constitute an Arcturus Material Adverse Effect.
(c) There are no proceedings pending or or, to the Knowledge of Arcturus, threatened with respect to an alleged violation by Eiger or any of its Subsidiaries Arcturus of the Federal Food, Drug, and Cosmetic Act (“FDCA”), the Public Health Service Act (“PHSA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Substances Act or any other similar Legal Requirements promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”).
(d) Eiger and each To the Knowledge of its Subsidiaries Arcturus, Arcturus holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Eiger or such Subsidiary Arcturus as currently conducted, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Eiger Arcturus Product Candidates”) ). Arcturus holds all required Governmental Authorizations issuable by any Governmental Body necessary for the conduct of its business as currently conducted (collectively, the “Eiger Arcturus Regulatory Permits”), and no such Eiger Arcturus Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled canceled or terminated or (ii) modified in any materially adverse manner, other than immaterial adverse modifications. Eiger and each Eiger Subsidiary is in compliance in all material respects with the Eiger Regulatory Permits and has Arcturus not received any written notice or other written communication from any Drug Regulatory Agency Governmental Body regarding (A) any material violation of or failure to comply materially with any term or requirement of any Eiger Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellationcancelation, termination or material modification of any Eiger Arcturus Regulatory Permit. Except for the information and files identified in Part 2.11(d) of the Eiger Disclosure Schedule, Eiger Arcturus has made available to Celladon Alcobra all information requested by Celladon in Eiger’s or its Subsidiaries’ possession or control relating to the Eiger Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Eiger Arcturus Product Candidates, including complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(e) All To the Knowledge of Arcturus, all clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Eiger or its Subsidiaries Arcturus or in which Eiger Arcturus or its Subsidiaries or their respective current products or product candidates, including the Eiger Arcturus Product Candidates, have participated were, and if still pending are being, conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 20102012, neither Eiger nor any of its Subsidiaries Arcturus has not received any notices, correspondence or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of Eiger Arcturus threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Eiger or any Arcturus or, to the Knowledge of its Subsidiaries or Arcturus, in which Eiger Arcturus or any of its Subsidiaries or their respective current products or product candidates, including the Eiger Arcturus Product Candidates, have participated.
(f) Neither Eiger nor any of the Eiger Subsidiaries Arcturus is not the subject of any pending, or to the Knowledge of Eiger or the Eiger SubsidiariesArcturus, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Eiger or any of the Eiger SubsidiariesArcturus, neither Eiger nor any of the Eiger Subsidiaries Arcturus has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products Arcturus Product Candidates that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None Neither Arcturus, and to the Knowledge of EigerArcturus, nor any of its Subsidiaries or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could would reasonably be expected to result in a debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of EigerArcturus, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Eiger, any Eiger Subsidiary Arcturus or any of their respective its officers, employees or agents.
Appears in 1 contract
Samples: Merger Agreement (Alcobra Ltd.)
Compliance; Permits; Restrictions. (a) Eiger and each Eiger Subsidiary areGC is, and since January July 1, 2010 have been2017, each of GC and the GC Subsidiaries has been in compliance in all material respects with all applicable Legal RequirementsRequirements except for any non-compliance that would not constitute a GC Material Adverse Effect. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of EigerGC, threatened against Eiger GC or any Eiger GC Subsidiary, nor has any Governmental Body or authority indicated to Eiger an intention to conduct the same. There is no agreementContract, judgment, injunction, order or decree binding upon Eiger GC or any Eiger GC Subsidiary which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Eiger GC or any Eiger GC Subsidiary, any acquisition of material property by Eiger GC or any Eiger GC Subsidiary or the conduct of business by Eiger GC or any Eiger GC Subsidiary as currently conducted, (ii) may would reasonably be expected to have an adverse effect on EigerGC’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) may would reasonably be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger Exchange or any of the Contemplated Transactions.
(b) Eiger GC and the Eiger GC Subsidiaries hold all required Governmental Authorizations which that are material to the operation of the its business of Eiger (collectively, the “Eiger GC Permits”) as currently conducted. Part 2.11(bSection 3.12(b) of the Eiger GC Disclosure Schedule identifies each Eiger GC Permit. Each As of Eiger the date of this Agreement, each of GC and each Eiger Subsidiary is the GC Subsidiaries are in material compliance with the terms of the Eiger GC Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of EigerGC, threatened, which seeks to revoke, limit, suspend, or materially modify any Eiger GC Permit. The rights and benefits of each material Eiger GC Permit will be available to the Surviving Corporation GC immediately after the Effective Time on terms substantially identical to those enjoyed by Eiger GC and its the GC Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time.
(c) There are no proceedings pending or threatened with respect to an alleged violation by Eiger or any of its Subsidiaries of the Federal Food, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”).
(d) Eiger and each of its Subsidiaries GC holds all required Governmental Authorizations issuable by any Drug Regulatory Agency Governmental Body necessary for the conduct of the its business of Eiger or such Subsidiary as currently conducted, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates conducted (the “Eiger Product Candidates”) (collectively, the “Eiger GC Regulatory Permits”), ) and no such Eiger GC Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled canceled or terminated or (ii) modified in any materially adverse manner, other than immaterial adverse modifications. Eiger and each Eiger Subsidiary is in compliance in all material respects with the Eiger Regulatory Permits and GC has not received any written notice or other written communication from any Drug Regulatory Agency Governmental Body regarding (A) any material violation of or failure to comply materially with any term or requirement of any Eiger Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellationcancelation, termination or material modification of any Eiger GC Regulatory Permit. Except for the information and files identified in Part 2.11(d) of the Eiger Disclosure Schedule, Eiger has made available to Celladon all information requested by Celladon in Eiger’s or its Subsidiaries’ possession or control relating to the Eiger Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Eiger Product Candidates, including complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Eiger or its Subsidiaries or in which Eiger or its Subsidiaries or their respective current products or product candidates, including the Eiger Product Candidates, have participated were, and if still pending are being, conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2010, neither Eiger nor any of its Subsidiaries has received any notices, correspondence or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of Eiger threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Eiger or any of its Subsidiaries or in which Eiger or any of its Subsidiaries or their respective current products or product candidates, including the Eiger Product Candidates, have participated.
(f) Neither Eiger nor any of the Eiger Subsidiaries is the subject of any pending, or to the Knowledge of Eiger or the Eiger Subsidiaries, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Eiger or any of the Eiger Subsidiaries, neither Eiger nor any of the Eiger Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Eiger, any of its Subsidiaries or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of Eiger, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Eiger, any Eiger Subsidiary or any of their respective officers, employees or agents.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Eiger PTI and each Eiger PTI Subsidiary are, and since January 1, 2010 2019 have been, in compliance in all material respects with all applicable Legal Requirements. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of EigerPTI, threatened in writing against Eiger PTI or any Eiger PTI Subsidiary, nor has any Governmental Body or authority indicated to Eiger an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Eiger PTI or any Eiger PTI Subsidiary which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Eiger PTI or any Eiger PTI Subsidiary, any acquisition of material property by Eiger PTI or any Eiger PTI Subsidiary or the conduct of business by Eiger PTI or any Eiger PTI Subsidiary as currently conducted, (ii) may is reasonably likely to have an a material adverse effect on EigerPTI’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) may is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions.
(b) Eiger Except for matters regarding the FDA and except as would not reasonably be expected to have a PTI Material Adverse Effect, PTI and the Eiger PTI Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Eiger PTI (collectively, the “Eiger PTI Permits”) as currently conducted. Part 2.11(b3.9(b) of the Eiger PTI Disclosure Schedule identifies each Eiger PTI Permit. Each of Eiger PTI and each Eiger PTI Subsidiary is in material compliance with the terms of the Eiger PTI Permits, except as would not reasonably be expected to have a PTI Material Adverse Effect. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of EigerPTI, threatenedthreatened in writing, which seeks to revoke, substantially limit, suspend, or materially modify any Eiger PTI Permit. The rights and benefits of each material Eiger PTI Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Eiger PTI and its the PTI Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time.
(c) There are no proceedings pending or or, to the Knowledge of PTI, threatened in writing with respect to an alleged material violation by Eiger PTI or any of its the PTI Subsidiaries of the Federal FoodFDCA, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) FDA regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug a Drug/Device Regulatory Agency”).
(d) Eiger PTI and each of its the PTI Subsidiaries holds all required Governmental Authorizations issuable by any Drug Drug/Device Regulatory Agency necessary for the conduct of the business of Eiger PTI or such Subsidiary as currently conducted, and and, as applicable, development, clinical testing, manufacturing, marketing, distribution testing and importation or exportation, manufacturing as currently conducted, conducted of any of its products or product candidates (the “Eiger PTI Product Candidates”) (collectively, the “Eiger PTI Regulatory Permits”), and no such Eiger Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. Eiger and each Eiger Subsidiary is in compliance in all material respects with the Eiger Regulatory Permits and has not received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Eiger Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Eiger Regulatory Permit. Except for the information and files identified in Part 2.11(d) of the Eiger Disclosure Schedule, Eiger has made available to Celladon all information requested by Celladon in Eiger’s or its Subsidiaries’ possession or control relating to the Eiger Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Eiger Product Candidates, including complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Eiger or its Subsidiaries or in which Eiger or its Subsidiaries or their respective current products or product candidates, including the Eiger Product Candidates, have participated were, and if still pending are being, conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2010, neither Eiger nor any of its Subsidiaries has received any notices, correspondence or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of Eiger threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Eiger or any of its Subsidiaries or in which Eiger or any of its Subsidiaries or their respective current products or product candidates, including the Eiger Product Candidates, have participated.
(f) Neither Eiger nor any of the Eiger Subsidiaries is the subject of any pending, or to the Knowledge of Eiger or the Eiger Subsidiaries, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Eiger or any of the Eiger Subsidiaries, neither Eiger nor any of the Eiger Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that except as would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Eiger, any of its Subsidiaries or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of Eiger, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Eiger, any Eiger Subsidiary or any of their respective officers, employees or agents.not
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Eiger and each Eiger Subsidiary areThreshold is, and since January 1, 2010 have been2014, each of Threshold and its Subsidiaries has been in compliance in all material respects with all applicable Legal RequirementsRequirements except for any non-compliance that would not constitute a Threshold Material Adverse Effect. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of EigerThreshold, threatened against Eiger Threshold or any Eiger Threshold Subsidiary, nor has any Governmental Body or authority indicated to Eiger an intention to conduct the same. There is no agreementContract, judgment, injunction, order or decree binding upon Eiger Threshold or any Eiger Threshold Subsidiary which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Eiger Threshold or any Eiger Threshold Subsidiary, any acquisition of material property by Eiger Threshold or any Eiger Threshold Subsidiary or the conduct of business by Eiger Threshold or any Eiger Threshold Subsidiary as currently conducted, (ii) may would reasonably be expected to have an adverse effect on EigerThreshold’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) may would reasonably be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions.
(b) Eiger Threshold and the Eiger Threshold Subsidiaries hold all required Governmental Authorizations which that are material to the operation of the its business of Eiger (collectively, the “Eiger Threshold Permits”) as currently conducted. Part 2.11(bSection 3.12(b) of the Eiger Threshold Disclosure Schedule identifies each Eiger Threshold Permit. Each As of Eiger the date of this Agreement, each of Threshold and each Eiger Subsidiary is the Threshold Subsidiaries are in material compliance with the terms of the Eiger Threshold Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of EigerThreshold, threatened, which seeks to revoke, limit, suspend, or materially modify any Eiger Threshold Permit. The rights and benefits of each material Eiger Threshold Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Eiger Threshold and its the Threshold Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time.
(c) There are no proceedings pending or or, to the Knowledge of Threshold, threatened with respect to an alleged violation by Eiger Threshold or any of its Subsidiaries of the Federal FoodFDCA, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) FDA regulations adopted thereunder, the Controlled Substance Substances Act or any other similar Legal Requirements promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”).
(d) Eiger Threshold and each of its Subsidiaries holds hold all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Eiger Threshold or such Subsidiary as currently conducted, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Eiger Threshold Product Candidates”) ). Threshold holds all required Governmental Authorizations issuable by any Governmental Body necessary for the conduct of its business as currently conducted (collectively, the “Eiger Threshold Regulatory Permits”), ) and no such Eiger Threshold Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled canceled or terminated or (ii) modified in any materially adverse manner, other than immaterial adverse modifications. Eiger and each Eiger Subsidiary is in compliance in all material respects with the Eiger Regulatory Permits and Threshold has not received any written notice or other written communication from any Drug Regulatory Agency Governmental Body regarding (A) any material violation of or failure to comply materially with any term or requirement of any Eiger Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellationcancelation, termination or material modification of any Eiger Threshold Regulatory Permit. Except for the information and files identified in Part 2.11(d) of the Eiger Disclosure Schedule, Eiger Threshold has made available to Celladon Molecular all information requested by Celladon in Eiger’s or its Subsidiaries’ possession or control relating to the Eiger Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Eiger Threshold Product Candidates, including complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Eiger Threshold or its any of the Threshold Subsidiaries or in which Eiger Threshold or its Subsidiaries or their respective current products or product candidates, including the Eiger Product Candidates, services have participated were, and if still pending are being, were conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 20102014, neither Eiger Threshold nor any of its the Threshold Subsidiaries has received any notices, correspondence or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of Eiger Threshold threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Eiger or any of its Subsidiaries Threshold or in which Eiger or any of its Subsidiaries or their respective current products or product candidates, including the Eiger Threshold Product Candidates, have participated.
(f) Neither Eiger nor any To the Knowledge of the Eiger Subsidiaries Threshold, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Threshold or its officers, employees or agents. Threshold is not the subject of any pending, or to the Knowledge of Eiger or the Eiger SubsidiariesThreshold, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Eiger or any of the Eiger SubsidiariesThreshold, neither Eiger nor any of the Eiger Subsidiaries Threshold has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products Threshold Product Candidates that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None Neither Threshold, nor to the Knowledge of EigerThreshold, any of its Subsidiaries or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could would reasonably be expected to result in a debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of Eiger, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Eiger, any Eiger Subsidiary or any of their respective officers, employees or agents.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Eiger and each Eiger Subsidiary arePERA is, and since January 1, 2010 have has been, in compliance in all material respects with all applicable Legal RequirementsRequirements except for any non-compliance that would not constitute a PERA Material Adverse Effect. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of EigerPERA, threatened against Eiger or any Eiger Subsidiary, nor has any Governmental Body or authority indicated to Eiger an intention to conduct the samePERA. There is no agreementContract, judgment, injunction, order or decree binding upon Eiger or any Eiger Subsidiary PERA which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any current business practice of Eiger or any Eiger SubsidiaryPERA, any acquisition of material property by Eiger or any Eiger Subsidiary PERA or the conduct of business by Eiger or any Eiger Subsidiary PERA as currently conducted, (ii) may would reasonably be expected to have an adverse effect on EigerPERA’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may would reasonably be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger Exchange or any of the Contemplated Transactions.
(b) Eiger and the Eiger Subsidiaries hold PERA holds all required Governmental Authorizations which are material to the operation of the business of Eiger PERA (the “Eiger PERA Permits”) as currently conducted. Part 2.11(bSection 2.12(b) of the Eiger PERA Disclosure Schedule identifies each Eiger PERA Permit. Each As of Eiger and each Eiger Subsidiary the date of this Agreement, PERA is in material compliance with the terms of the Eiger PERA Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of EigerPERA, threatened, which seeks to revoke, limit, suspend, or materially modify any Eiger PERA Permit. The rights and benefits of each material Eiger PERA Permit will be available to the Surviving Corporation PERA and GC immediately after the Effective Time on terms substantially identical to those enjoyed by Eiger and its Subsidiaries as of the date of this Agreement and PERA immediately prior to the Effective Time.
(c) There are no proceedings pending . Neither the execution, delivery or threatened performance of this Agreement, nor the consummation of the transactions contemplated hereunder, will result in the loss, suspension, or impairment of the PERA Permits, or require the consent of any Person with respect to an alleged violation by Eiger or any of its Subsidiaries of the Federal Food, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”)PERA Permits.
(d) Eiger and each of its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Eiger or such Subsidiary as currently conducted, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Eiger Product Candidates”) (collectively, the “Eiger Regulatory Permits”), and no such Eiger Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. Eiger and each Eiger Subsidiary is in compliance in all material respects with the Eiger Regulatory Permits and has not received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Eiger Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Eiger Regulatory Permit. Except for the information and files identified in Part 2.11(d) of the Eiger Disclosure Schedule, Eiger has made available to Celladon all information requested by Celladon in Eiger’s or its Subsidiaries’ possession or control relating to the Eiger Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Eiger Product Candidates, including complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Eiger or its Subsidiaries or in which Eiger or its Subsidiaries or their respective current products or product candidates, including the Eiger Product Candidates, have participated were, and if still pending are being, conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2010, neither Eiger nor any of its Subsidiaries has received any notices, correspondence or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of Eiger threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Eiger or any of its Subsidiaries or in which Eiger or any of its Subsidiaries or their respective current products or product candidates, including the Eiger Product Candidates, have participated.
(f) Neither Eiger nor any of the Eiger Subsidiaries is the subject of any pending, or to the Knowledge of Eiger or the Eiger Subsidiaries, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Eiger or any of the Eiger Subsidiaries, neither Eiger nor any of the Eiger Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Eiger, any of its Subsidiaries or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of Eiger, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Eiger, any Eiger Subsidiary or any of their respective officers, employees or agents.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Eiger and each Eiger Subsidiary arePivot is, and since January 1, 2010 have been, in compliance 2007 has complied in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal Requirements. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of EigerPivot, threatened against Eiger or any Eiger SubsidiaryPivot, nor has any Governmental Body or authority indicated to Eiger Pivot an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Eiger or any Eiger Subsidiary Pivot which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Eiger or any Eiger SubsidiaryPivot, any acquisition of material property by Eiger or any Eiger Subsidiary Pivot or the conduct of business by Eiger or Pivot and any Eiger Subsidiary as currently conducted, conducted (ii) may have an adverse effect on EigerPivot’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions.
(b) Eiger and the Eiger Subsidiaries hold Pivot holds all required Governmental Authorizations which are material to the operation of the business of Eiger their businesses (collectively, the “Eiger Pivot Permits”) as currently conducted. Part 2.11(b3.9(b) of the Eiger Pivot Disclosure Schedule identifies each Eiger Pivot Permit. Each of Eiger and each Eiger Subsidiary Pivot is in material compliance with the terms of the Eiger Pivot Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of EigerPivot, threatened, which seeks to revoke, limit, suspend, or materially modify any Eiger Pivot Permit. The rights and benefits of each material Eiger Pivot Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Eiger and its Subsidiaries Pivot as of the date of this Agreement and immediately prior to the Effective Time.
(c) There are no proceedings pending or or, to the Knowledge of Pivot, threatened with respect to an alleged material violation by Eiger or any of its Subsidiaries Pivot of the Federal FoodFDCA, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) FDA regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“a Drug Regulatory Agency”).
(d) Eiger and each of its Subsidiaries Pivot holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Eiger or such Subsidiary Pivot as currently conducted, and and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Eiger Pivot Product Candidates”) (collectively, the “Eiger Pivot Regulatory Permits”), ) and no such Eiger Pivot Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner, other than immaterial adverse modifications. Eiger and each Eiger Subsidiary is in compliance in all material respects with the Eiger Regulatory Permits and Pivot has not received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Eiger Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Eiger Pivot Regulatory Permit. Except for the information and files identified in Part 2.11(d3.9(d) of the Eiger Pivot Disclosure Schedule, Eiger Pivot has made available to Celladon Merger Partner all information requested by Celladon in Eiger’s or its Subsidiaries’ possession or control relating to the Eiger Pivot Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Eiger Pivot Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Eiger or its Subsidiaries Pivot or in which Eiger Pivot or its Subsidiaries or their respective current products or product candidates, including the Eiger Product Candidates, have participated were, and if still pending are being, were conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2010, neither Eiger nor any of its Subsidiaries has received any notices, correspondence or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of Eiger threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Eiger or any of its Subsidiaries or in which Eiger or any of its Subsidiaries or their respective current products or product candidates, including the Eiger Product Candidates, have participated.
(f) Neither Eiger nor any of the Eiger Subsidiaries Pivot is not the subject of any pending, or to the Knowledge of Eiger or the Eiger SubsidiariesPivot, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Eiger or any of the Eiger SubsidiariesPivot, neither Eiger nor any of the Eiger Subsidiaries Pivot has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Eiger, Neither Pivot nor any of its Subsidiaries or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of EigerPivot, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Eiger, any Eiger Subsidiary Pivot or any of their respective its officers, employees or agents.
Appears in 1 contract
Samples: Merger Agreement (Novacea Inc)
