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SEC Filings

S-1
PROTEON THERAPEUTICS INC filed this Form S-1 on 09/16/2014
Entire Document
 

 

material environmental records, reports, notifications, certificates of need, permits, pending permit applications, correspondence, engineering studies, and environmental studies or assessments.

 

For purposes of this Section 3.23, “Environmental Laws” means any law, regulation, or other applicable requirement relating to (a) releases or threatened release of Hazardous Substance; (b) pollution or protection of employee health or safety, public health or the environment; or (c) the manufacture, handling, transport, use, treatment, storage, or disposal of Hazardous Substances.

 

3.24.                     No General Solicitation.  Neither the Company, nor any of is officers, directors, employees, agents, managers, stockholders or other equity holders has either directly or indirectly, including through a broker or finder (a) engaged in any general solicitation, or (b) published any advertisement in connection with the offer and sale of the Shares.

 

3.25.                     Disclosure.  The Company has made available to the Purchasers all the information reasonably available to the Company that the Purchasers have requested for deciding whether to acquire the Shares.  No representation or warranty of the Company contained in this Agreement, as qualified by the Disclosure Schedule, and no certificate furnished or to be furnished to Purchasers at the Closings contains or will contain any untrue statement of a material fact or omits or will omit to state a material fact necessary in order to make the statements contained herein or therein not misleading in light of the circumstances under which they were made.

 

3.26.                     Regulatory Compliance.

 

(a)                                 The Company, and to the Company’s knowledge, the Company’s agents, are in material compliance with all statutes, rules and regulations of the Federal Food and Drug Administration (the “FDA”) with respect to the evaluation, testing, manufacturing, and distribution of each of the Company s products, in whatever stage of development, to the extent that the same are applicable to the Company’s business as it is currently conducted and proposed to be conducted, including, but not limited to, those relating to investigational use, current “Good Manufacturing Practices,” current “Good Laboratory Practice,” current “Good Clinical Practice,” labeling, record keeping, reporting of adverse events and filing of reports.

 

(b)                                 Section 3.26(b) of the Disclosure Schedule sets forth a true, complete and accurate list of the material products that are currently being developed, tested, manufactured, distributed or licensed in or out by the Company as of the date of this Agreement.

 

(c)                                  Section 3.26(c) of the Disclosure Schedule sets forth a true, complete and accurate list of each of the Company s pending and approved Investigational New Drug Applications (“INDs”) and similar state and foreign regulatory filings as of the date of this Agreement.  As to each drug for which such an IND application has become effective, and to the extent applicable, the Company is in substantial compliance with 21 U.S.C. § 355 or 21 C.F.R. Parts 312 and 600, respectively, and similar state and foreign laws and regulations and all terms and conditions of such applications.

 

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