Changes by DPT Sample Clauses

Changes by DPT. DPT agrees that any changes developed by DPT, which may be incorporated into the Product shall require the written approval of COMPANY via a CCR prior to such incorporation. At the time of such incorporation, such changes shall become part of the Specifications. It is also agreed that any regulatory filings incident to any such change shall be the sole responsibility of COMPANY.
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Changes by DPT. DPT agrees that any changes developed by DPT which may be incorporated into the Product shall require the written approval of Connetics via a PCR prior to implementation of the change. At the time of such incorporation, such changes shall become part of the Specifications. No such change may be instituted except in compliance with this Agreement and the Quality Agreement. It is also agreed that any regulatory filings incident to any such change shall be the sole responsibility of Connetics. Connetics shall have the option of obtaining, or having DPT obtain, any required FDA approval or other regulatory approval prior to implementation of such a change.
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Changes by DPT. DPT agrees that any changes developed by DPT, which may be incorporated into the Product shall require the written approval of COMPANY via a PCR prior to such incorporation. If such changes require a revision to the Specifications, such revised Specifications must be approved in writing by COMPANY before they are implemented. It is also agreed that any regulatory filings incident to any such change shall be the sole responsibility of COMPANY. DPT further agrees to notify COMPANY within three (3) business days of any confirmed out of specifications findings, changes to batch records or processes, release testing changes, investigations, or supply chain interruptions for product of greater than one week.
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Changes by DPT. DPT agrees that any changes developed by DPT, which may be incorporated into the Product shall require the written approval of AUXILIUM via a change control prior to such incorporation. At the time of such incorporation, such changes shall become part of the Specifications. It is also agreed that any regulatory filings incident to any such change shall be the sole responsibility of AUXILIUM.
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Related to Changes by DPT

  • Changes, etc This instrument and the provisions hereof may be changed, waived, discharged or terminated only by an instrument in writing signed by the party against which enforcement of the change, waiver, discharge or termination is sought.

  • Changes, Waivers, Etc Neither this Agreement nor any provision hereof may be changed, waived, discharged or terminated orally, but only by a statement in writing signed by the party against which enforcement of the change, waiver, discharge or termination is sought.

  • Amendments, Changes and Modifications This Agreement may be amended, changed, modified, altered or terminated only by written instrument or written instruments signed by all of the parties hereto.

  • Changes and Modifications (i) DST shall have the right, at any time, to modify any systems, programs, procedures or facilities used in performing its obligations hereunder; provided that the Fund will be notified as promptly as possible prior to implementation of such modifications and that no such modification or deletion shall materially adversely change or affect the operations and procedures of the Fund in using the TA2000 System hereunder, the Services or the quality thereof, or the reports to be generated by such system and facilities hereunder, unless the Fund is given thirty (30) days’ prior notice to allow the Fund to change its procedures and DST provides the Fund with revised operating procedures and controls.

  • CHANGES AND ADDITIONS BY LANDLORD Landlord reserves the right to make alterations or additions to the Building or the Project, or to the attendant fixtures, equipment and Common Areas. Landlord may at any time relocate or remove any of the various buildings, parking areas, and other Common Areas, and may add buildings and areas to the Project from time to time. No change shall entitle Tenant to any abatement of rent or other claim against Landlord, provided that the change does not deprive Tenant of reasonable access to or use of the Premises.

  • Absence of Certain Changes, Events and Conditions Since the Balance Sheet Date, and other than in the ordinary course of business consistent with past practice, there has not been, with respect to the Company, any:

  • Changes; Amendments This Agreement may be changed or amended only by written instrument signed by both parties.

  • Absence of Certain Changes and Events Except as set forth in Part 3.16 of the Disclosure Letter, since the date of the Balance Sheet, the Company has conducted its business only in the Ordinary Course of Business and there has not been any:

  • Absence of Changes or Events Except as set forth in Section 3.7 of the Company Disclosure Letter, since December 31, 2000 through the date of this Agreement, the Company and its Subsidiaries have not incurred any liability or obligation that has resulted or would reasonably be expected to result in a Company Material Adverse Effect, and there has not been any change in the business, financial condition or results of operations of the Company or any of its Subsidiaries which has had, or would reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, and the Company and its Subsidiaries have conducted their respective businesses in the ordinary course consistent with their past practices.

  • Absence of Certain Changes or Events Except as disclosed in the SEC Documents (including exhibits thereto) filed and publicly available prior to the date of this Agreement and the proof dated June 13, 1998 of Amendment No. 1 to the Registration Statement on Form S-3 of the Company (Registration No. 333-55883) (the "S-3 Amendment") in the form heretofore delivered to Purchaser (the "Filed SEC Documents"), or in the Disclosure Letter, from the date of the most recent audited financial statements included in the Filed SEC Documents to the date of this Agreement, the Company and each of its Subsidiaries has conducted its business only in the ordinary course and there has not been (i) any material adverse effect on the Company and its Subsidiaries taken as a whole, (ii) any event or occurrence that would have a material adverse effect on the Company and its Subsidiaries taken as a whole, (iii) any declaration, setting aside or payment of any dividends or distributions in respect of the Shares other than the regular quarterly dividend in the amount of $0.70 per Share, (iv) any split, combinations or reclassification of any of its capital stock or any issuance or the authorization of any issuance of any other securities in respect of, in lieu of or in substitution for shares of its capital stock, (v) except as contemplated by Section 7.4 hereof, (A) any granting by the Company or any of its Subsidiaries to any executive officer of the Company or any of its Subsidiaries of any increase in compensation, except as was required under employment agreements or benefit plans in effect as of the date of the most recent audited financial statements included in the Filed SEC Documents, (B) any granting by the Company or any of its Subsidiaries to any such officer of any increase in severance or termination pay, except as was required under employment, severance or termination agreements in effect as of the date of the most recent audited financial statements included in the Filed SEC Documents, (C) any entry by the Company or any of its Subsidiaries into any employment, severance or termination agreement or arrangement with any officer or employee or (D) any increase in benefits available under or establishment of any Benefit Plan (as defined in Section 4.10) (including the granting of stock options, stock appreciation rights, performance awards or restricted stock awards or the amendment or acceleration of vesting of any existing stock options, stock appreciation rights, performance awards or restricted stock awards), except in the ordinary course of business consistent with past practice, (vi) any damage, destruction or loss to physical properties owned or used by the Company, whether or not covered by insurance, that would have a material adverse effect on the Company and its Subsidiaries, taken as a whole, (vii) any revaluation by the Company of any of its material assets, (viii) except as provided in Section 7.4, any actual or approved acceleration of vesting or conversion of contingent restricted shares of stock or other amendment to or modification of outstanding Company Stock Options, DSCs, phantom stock units or contingent of performance-based restricted stock, or (ix) any material change by the Company in its accounting principles or practices except insofar as may have been required by a change in generally accepted accounting principles. Except as and to the extent set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 1997, or in any subsequent Filed SEC Document or the Disclosure Letter, neither the Company nor any of its Subsidiaries has any liabilities or obligations of any nature, whether or not accrued, contingent or otherwise, that would be required by generally accepted accounting principles to be reflected on a consolidated balance sheet of the Company and its Subsidiaries (including the notes thereto), except for liabilities or obligations incurred in the ordinary course of business since December 31, 1997, that would not, individually or in the aggregate, have a material adverse effect.

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