Absence of Certain Regulatory Actions Sample Clauses

Absence of Certain Regulatory Actions. Except as described in the Registration Statement, the General Disclosure Package and the Prospectus, or as would not, individually or in the aggregate, have a Material Adverse Effect, the Company and its subsidiaries have not had any product or manufacturing site (whether Company-owned or that of a contract manufacturer for Company products or product candidates) subject to a governmental authority (including, without limitation, the FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other governmental authority notice of inspectional observations, “warning letters,” “untitled letters,” requests to make changes to the Company products, processes or operations, or similar correspondence or notice from the FDA or other governmental authority alleging or asserting material noncompliance with any applicable laws. To the Company’s knowledge, neither the FDA nor any other governmental authority has threatened such action. Neither the Company nor its subsidiaries have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court, arbitrator, Regulatory Agency, or other governmental authority or third party alleging that any product operation or activity is in violation of any health care laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened.
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Absence of Certain Regulatory Actions. Except as described in the Registration Statement, the General Disclosure Package and the Prospectus, or as would not, individually or in the aggregate, have a Material Adverse Effect, the Company has not had any product or manufacturing site (whether Company-owned or that of a contract manufacturer for Company products or product candidates) subject to a governmental authority (including, without limitation, the FDA, the EMA or the IMH) shutdown or import or export prohibition, nor received any FDA Form 483 or other governmental authority notice of inspectional observations, “warning letters,” “untitled letters,” requests to make changes to the Company products, processes or operations, or similar correspondence or notice from the FDA, EMA, IMH or other governmental authority alleging or asserting material noncompliance with any applicable laws. To the Company’s knowledge, none of the FDA, the EMA or IMH nor any other governmental authority have threatened such action. Neither the Company nor its subsidiaries have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court, arbitrator, Regulatory Agency or other governmental authority or third party alleging that any product operation or activity is in violation of any health care laws, nor to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened, except as would not, individually or in the aggregate, have a Material Adverse Effect.
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Absence of Certain Regulatory Actions. Except as described in the Registration Statement, the General Disclosure Package and the Prospectus, or as would not, individually or in the aggregate, have a Material Adverse Effect, the Company has not had any product or manufacturing site (whether Company-owned or that of a contract manufacturer for Company products or product candidates) subject to a governmental authority (including, without limitation, the Food and Drug Administration of the U.S. Department of Health and Human Services (the “FDA”) shutdown or import or export prohibition, nor received any FDA Form 483 or other governmental authority notice of inspectional observations, “warning letters,” “untitled letters,” requests to make changes to the Company products, processes or operations, or similar correspondence or notice from the FDA or other governmental authority alleging or asserting material noncompliance with any applicable laws. To the Company’s knowledge, neither the FDA nor any other governmental authority has threatened such action. Neither the Company nor its subsidiaries have received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court, arbitrator, Regulatory Agency or other governmental authority or third party alleging that any product operation or activity is in violation of any health care laws, nor to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened.
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Absence of Certain Regulatory Actions. Except as described in the Exchange Act Documents or as would not, individually or in the aggregate, have a Material Adverse Effect, the Issuer has not (a) had any product or manufacturing site (whether Issuer-owned or that of a contract manufacturer for Issuer products or product candidates) subject to a Governmental Authority (including the FDA) shutdown or import or export prohibition or (b) received any FDA Form 483 or other Governmental Authority notice of inspectional observations, “warning letters”, “untitled letters”, requests to make changes to the Issuer products, processes or operations, or similar written correspondence or notice from the FDA or other Governmental Authority alleging or asserting material noncompliance with any applicable Laws. To the Issuer’s knowledge, neither the FDA nor any other Governmental Authority has threatened such action. The Issuer has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Regulatory Agency or other Governmental Authority alleging that any product operation or activity is in violation of any health care Laws, and, to the Issuer’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened, except where such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect.
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Absence of Certain Regulatory Actions. Except as described in the Registration Statement, the General Disclosure Package and the Prospectus, or as would not, individually or in the aggregate, have a Material Adverse Effect, the Company has not had any product or manufacturing site (whether Company-owned or that of a contract manufacturer for Company products) subject to a governmental authority (including, without limitation, the FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other governmental authority notice of inspectional observations, “warning letters,” “untitled letters,” requests to make changes to the Company products, processes or operations, or similar correspondence or notice from the FDA or other governmental authority alleging or asserting material noncompliance with any applicable laws. To the Company’s knowledge, neither the FDA nor any other governmental authority has threatened such action.
Sample 1
Absence of Certain Regulatory Actions. Except as described in the Registration Statement, the General Disclosure Package and the Prospectus, or as would not, individually or in the aggregate, have a Material Adverse Effect, the Company and its subsidiary, have not had any product or manufacturing site (whether Company-owned or that of a contract manufacturer for Company product candidates) subject to a governmental authority (including, without limitation, the FDA) shutdown or import or export prohibition, nor have the Company and its subsidiary received any FDA Form 483 or other governmental authority notice of inspectional observations, “warning letters,” “untitled letters,” requests to make changes to the Company products, processes or operations, or similar correspondence or notice from the FDA or other governmental authority alleging or asserting material noncompliance with any applicable laws. To the Company’s knowledge, neither the FDA nor any other governmental authority has threatened such action. Neither the Company nor its subsidiary, has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court, arbitrator, Regulatory Agency, or other governmental authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. (yy) Emerging Growth Company Status. From the time of initial confidential submission of the registration statement relating to the Company’s initial public offering to the Commission (or, if earlier, the first date on which the Company engaged directly or through any Person authorized to act on its behalf in any Testing-the-Waters Communication) through the date hereof, the Company has been and is an “emerging growth company,” as defined in Section 2(a) of the Act (an “Emerging Growth Company”).
Sample 1
Absence of Certain Regulatory Actions. The Bank shall not be a party or subject to any written agreement, or Order of any Regulatory Agency, including the FDIC or the OTS, unless the applicable Regulatory Agency has confirmed that such written agreement, memorandum of understanding or order will be terminated as of the Closing Date.
Sample 1
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Related to Absence of Certain Regulatory Actions

  • Required Filings; Absence of Certain Commission Actions If filing of the Prospectus, or any amendment or supplement thereto, or any issuer free writing prospectus, is required under the Securities Act or the Rules and Regulations, the Company shall have filed the Prospectus (or such amendment or supplement) or such issuer free writing prospectus with the Commission in the manner and within the time period so required (without reliance on Rule 424(b)(8) or Rule 164(b)); the Registration Statement shall remain effective; no stop order suspending the effectiveness of the Registration Statement or any part thereof, any Rule 462(b) Registration Statement, or any amendment thereof, nor suspending or preventing the use of the Time of Sale Disclosure Package, the Prospectus or any issuer free writing prospectus shall have been issued; no proceedings for the issuance of such an order shall have been initiated or threatened; any request of the Commission for additional information (to be included in the Registration Statement, the Time of Sale Disclosure Package, the Prospectus, any issuer free writing prospectus or otherwise) shall have been complied with to your satisfaction.

  • Absence of Certain Developments (i) Except as expressly contemplated by this Agreement or as set forth on the attached "Developments Schedule," since the date of the Latest Balance Sheet, neither the Company nor any Subsidiary have (a) issued any notes, bonds or other debt securities or any capital stock or other equity securities or any securities convertible, exchangeable or exercisable into any capital stock or other equity securities; (b) borrowed any amount or incurred or become subject to any liabilities, except current liabilities incurred in the ordinary course of business and liabilities under contracts entered into in the ordinary course of business; (c) discharged or satisfied any Lien or paid any obligation or liability, other than current liabilities paid in the ordinary course of business; (d) declared or made any payment or distribution of cash or other property to its stockholders with respect to its capital stock or other equity securities or purchased or redeemed any shares of its capital stock or other equity securities (including, without limitation, any warrants, options or other rights to acquire its capital stock or other equity securities); (e) mortgaged or pledged any of its properties or assets or subjected them to any Lien, except Liens for current property taxes not yet due and payable; (f) sold, assigned or transferred any of its tangible assets, except in the ordinary course of business, or canceled any debts or claims; (g) sold, assigned or transferred any patents or patent applications, trademarks, service marks, trade names, corporate names, copyrights or copyright registrations, trade secrets or other intangible assets; (h) suffered any extraordinary losses or waived any rights of value, whether or not in the ordinary course of business or consistent with past practice; (i) made capital expenditures or commitments therefor that aggregate in excess of $10,000; (j) made any loans or advances to, guarantees for the benefit of, or any Investments in, any Persons in excess of $10,000 in the aggregate; (k) made any charitable contributions or pledges in excess of $10,000 in the aggregate; (l) suffered any damage, destruction or casualty loss exceeding in the aggregate $10,000, whether or not covered by insurance; (m) made any Investment in or taken steps to incorporate any Subsidiary; or (n) entered into any other transaction other than in the ordinary course of business. (ii) Neither the Company nor any Subsidiary has at any time made any payments for political contributions or made any bribes, kickback payments or other illegal payments.

  • Absence of Certain Changes From December 31, 1997 until the date hereof, (a) there has not occurred any event, change or development which has had or would be reasonably likely to have a Company Material Adverse Effect and (b) except as disclosed in the Company SEC Documents or Section 2.8 of the Company Disclosure Schedule, and except for the performance of this Agreement and the transactions contemplated hereby, the Company and its Subsidiaries have: (i) conducted its business and operations only in the ordinary course of business consistent with past practices; (ii) used reasonable efforts to preserve intact the business organizations, rights, licenses, permits and franchises of the Company and its Subsidiaries, maintain their existing relationships with customers, suppliers and other Persons having business dealings with them and keep available the services of its officers and employees; (iii) used reasonable efforts to keep in full force and effect adequate insurance coverages and maintain and keep its properties and assets in good repair, working order and condition, normal wear and tear excepted; (iv) not amended or modified its articles of association, certificate of incorporation, by-laws or comparable governing documents; (v) not authorized for issuance, issued, sold, granted, delivered, pledged or encumbered or agreed or committed to issue, sell, grant, deliver, pledge or encumber (to or with any party other than the Company and 7 any of its wholly-owned Subsidiaries) any shares of any class or series of capital stock of the Company or any of its Subsidiaries or any other equity or voting security or equity or voting interest of the Company or any of its Subsidiaries, any securities convertible into or exercisable or exchangeable for any such shares, securities or interests, or any options, warrants, calls, commitments, subscriptions or rights to purchase or acquire any such shares, securities or interests (other than issuances of Company Shares (i) upon exercise of outstanding Stock Options granted to directors, officers, employees and consultants of the Company in accordance with the Option Plans as currently in effect and (ii) pursuant to conversion of the TOPrS); (vi) except for conversion of the TOPrS in accordance with their terms, (i) split, combined or reclassified any shares of its capital stock or issued or authorized or proposed the issuance of any other securities in respect of, in lieu of, or in substitution for, shares of its capital stock, (ii) in the case of the Company or any Subsidiary of the Company that is not wholly-owned by the Company, declared, set aside or paid any dividends on, or made other distributions in respect of, any capital stock or (iii) repurchased, redeemed or otherwise acquired, or agreed or committed to repurchase, redeem or otherwise acquire, any shares of capital stock or other equity or debt securities or equity interests of the Company or any of its Subsidiaries (other than to fulfill its obligations under the Option Plans as currently in effect); (vii) not amended or otherwise modified the terms of any Stock Options or any Option Plan the effect of which was to make such terms more favorable to the holders thereof or Persons eligible for participation therein, or reserved any additional Company Shares for issuance under any such Plan; (viii) except as required by law or existing written agreements, entered into, adopted or materially amended any incentive, compensation, option or severance plan or arrangement (including, without limitation, any Benefit Plan) for the benefit or welfare of any current or former director, officer or employee of the Company or any of its Subsidiaries, or (except for normal increases in the ordinary course of business that are consistent with past practices) increased the compensation or benefits of any persons or pay any benefit not required by any existing plan and arrangement; (ix) not acquired or agreed to acquire (by merger, consolidation, acquisition of stock or assets or otherwise) from any Person, any corporation, partnership, joint venture, association or other business organization or division thereof or otherwise acquired or agreed to acquire any assets of another Person other than the purchase of assets in the ordinary course of business consistent with past practice or in an aggregate amount of less than $5,000,000; (x) not sold, leased, licensed, encumbered or otherwise disposed of, or agreed to sell, lease, license, encumber or otherwise dispose of, any material properties or assets of the Company or any of its Subsidiaries, except as intercompany transactions between the Company and any of its wholly-owned Subsidiaries or in transactions with any other Person in the ordinary course of business, consistent with past practice and in an aggregate amount of less than $5,000,000. (xi) not made any material change in any of its accounting or financial reporting methods, principles or practices, except as may be required by GAAP; (xii) except in the ordinary course of business consistent with past practices, not amended, modified or terminated any Material Contract required to be listed in Section 2.16 of the Company Disclosure Schedule (other than in response to Section 2.16(a)(iii) thereof) or waived, released or assigned any material rights or claims thereunder; (xiii) not adopted a plan of complete or partial liquidation, dissolution, merger, consolidation, restructuring, recapitalization or other reorganization of the Company or any of its Subsidiaries; (xiv) not made any loans, advances or capital contributions to any Person other than as required by existing agreements or in the ordinary course of business consistent with past practice; or 8

  • Absence of Certain Relationships No relationship, direct or indirect, exists between or among the Company or its subsidiaries, on the one hand, and the directors, officers or stockholders of the Company, on the other hand, which is required to be described in the Registration Statement or the Prospectus which is not so described. The Company has not, directly or indirectly, including through any subsidiary, extended credit, arranged to extend credit, or renewed any extension of credit, in the form of a personal loan, to or for any executive officer of the Company or the Operating Partnership, or to or for any family member or affiliate of any director or executive officer of the Company or the Operating Partnership.

  • Absence of Certain Events No Event of Default or Potential Event of Default or, to its knowledge, Termination Event with respect to it has occurred and is continuing and no such event or circumstance would occur as a result of its entering into or performing its obligations under this Agreement or any Credit Support Document to which it is a party.

  • Absence of Certain Business Practices Neither the Seller, nor any Affiliate of the Seller, nor to the knowledge of the Seller, any agent or employee of the Seller, any other Person acting on behalf of or associated with the Seller, or any individual related to any of the foregoing Persons, acting alone or together, has: (a) received, directly or indirectly, any rebates, payments, commissions, promotional allowances or any other economic benefits, regardless of their nature or type, from any customer, supplier, trading company, shipping company, governmental employee or other Person with whom the Seller has done business directly or indirectly; or (b) directly or indirectly, given or agreed to give any gift or similar benefit to any customer, supplier, trading company, shipping company, governmental employee or other Person who is or may be in a position to help or hinder the business of the Seller (or assist the Seller in connection with any actual or proposed transaction) which (i) may subject the Seller to any damage or penalty in any civil, criminal or governmental litigation or proceeding, (ii) if not given in the past, may have had an adverse effect on the Seller or (iii) if not continued in the future, may adversely affect the assets, business, operations or prospects of the Seller or subject the Seller to suit or penalty in any private or governmental litigation or proceeding.

  • Absence of Certain Changes and Events Except as set forth on Schedule 3.14, since the date of the Interim Financial Statements, and, to the extent not fully reflected in the Interim Financial Statements, since the date of the Year End Financial Statements, the Company has conducted its business only in the ordinary course of business consistent with past practices, and there has not been any: (a) change in the Company’s authorized or issued capital stock or the ownership thereof; grant of any stock option or right to purchase shares of capital stock of the Company; issuance of any security convertible into such capital stock; grant of any registration rights; purchase, redemption, retirement, or other acquisition by the Company of any shares of any such capital stock; (b) amendment to the Organizational Documents of the Company; (c) acquisition of any stock or business of, or merger or consolidation with, another Person, or any action with respect to liquidating, dissolving, recapitalizing, reorganizing or otherwise winding up the Company’s business; (d) payment or increase by the Company of any bonuses, salaries, or other compensation to any stockholder, director, officer, or employee (except, with respect to non-executive employees, in the ordinary course of business consistent with past practice) or entry into any new, or material amendment of any existing, employment, consulting, independent contractor, severance, change of control or similar Contract; (e) adoption of any profit sharing, bonus, deferred compensation, savings, insurance, pension, retirement, or other employee benefit plan; (f) damage to or destruction or loss of any asset or property of the Company, whether or not covered by insurance, which has had, or would reasonably be expected to have, a Material Adverse Effect on the Company; (g) sale (other than sales of Inventory in the ordinary course of business), lease, license, distribution or other disposition of any material asset(s) or property of the Company, or any waiver, release, transfer or assignment of any right of material value, or any mortgage, pledge, or imposition of any lien or other Encumbrance on any material asset(s) or property of the Company except as noted on Schedule 3.6 or except as explicitly permitted under Section 6.2 or required under any other provision of this Agreement; (h) entry into any Contract or other agreement providing for payments by the Company in an aggregate amount exceeding $25,000 that is not terminable by the Company, without penalty, upon sixty (60) days notice, with the exception of agreements for the purchase of fuel entered into by the Company in the ordinary course of its business and consistent with past practice; (i) any capital expenditure in excess of $25,000; (j) change in any annual accounting period or accounting methods used by the Company; (k) any modification, termination or amendment to a Material Contract or waiver of any right or claim thereunder; (l) loss of use of any Company Intellectual Property Assets; (m) change in methods, practices, principles or timing regarding the purchase of inventory or the payment or accrual of operating expenses, including accounts payable; or (n) entry into any Contract, whether oral or written, by the Company to do any of the foregoing.

  • Treatment of Certain Refunds If any party determines, in its sole discretion exercised in good faith, that it has received a refund of any Taxes as to which it has been indemnified pursuant to this Section 2.17 (including by the payment of additional amounts pursuant to this Section 2.17), it shall pay to the indemnifying party an amount equal to such refund (but only to the extent of indemnity payments made under this Section 2.17 with respect to the Taxes giving rise to such refund), net of all out-of-pocket expenses (including Taxes) of such indemnified party and without interest (other than any interest paid by the relevant Governmental Authority with respect to such refund). Such indemnifying party, upon the request of such indemnified party, shall repay to such indemnified party the amount paid over pursuant to this paragraph (g) (plus any penalties, interest or other charges imposed by the relevant Governmental Authority) in the event that such indemnified party is required to repay such refund to such Governmental Authority. Notwithstanding anything to the contrary in this paragraph (g), in no event will the indemnified party be required to pay any amount to an indemnifying party pursuant to this paragraph (g) the payment of which would place the indemnified party in a less favorable net after-Tax position than the indemnified party would have been in if the Tax subject to indemnification and giving rise to such refund had not been deducted, withheld or otherwise imposed and the indemnification payments or additional amounts with respect to such Tax had never been paid. This paragraph shall not be construed to require any indemnified party to make available its Tax returns (or any other information relating to its Taxes that it deems confidential) to the indemnifying party or any other Person.

  • Absence of Certain Agreements Neither Parent nor any of its Affiliates has entered into any agreement, arrangement or understanding (in each case, whether oral or written), or authorized, committed or agreed to enter into any agreement, arrangement or understanding (in each case, whether oral or written), pursuant to which: (i) (A) any stockholder of the Company (other than Parent and its Affiliates) would be entitled to receive consideration of a different amount or nature than the Per Share Merger Consideration, (B) except as set forth in Section 6.13, any stockholder of the Company agrees to vote to adopt this Agreement or the Merger or any stockholder of the Company agrees to vote against any Superior Proposal; or (ii) any current employee of the Company has agreed to (x) remain as an employee of the Company or any of its Subsidiaries following the Effective Time (other than pursuant to any employment Contracts in effect as of the date of this Agreement), (y) contribute or rollover any portion of such employee’s Shares, Company Stock Options, Company Restricted Stock and/or Phantom Stock Units to the Company or its Subsidiaries or Parent or any of its Affiliates or (z) receive any capital stock or equity securities of the Company or any of its Subsidiaries or Parent or any of its Affiliates.

  • Absence of Certain Proceedings Except as described in the SEC Reports, (i) there is no Action pending or, to the knowledge of the Company, threatened against the Company, in any such case wherein an unfavorable decision, ruling or finding could have or result in a Material Adverse Effect; (ii) neither the Company nor any Subsidiary, nor any director or officer thereof, is or has been the subject of any Action involving (A) a claim of violation of or liability under federal or state securities laws or (B) a claim of breach of fiduciary duty; (iii) the Company does not have pending before the Commission any request for confidential treatment of information and the Company has no knowledge of any expected such request that would be made prior to the Effectiveness Date (as defined in the Registration Rights Agreement); and (iv) there has not been, and to the best of the Company's knowledge there is not pending or contemplated, any investigation by the Commission involving the Company or any current or former director or officer of the Company.

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