Reporting Adverse Sample Clauses

Reporting Adverse. Drug Reactions. Alexion and XOMA will develop and agree upon safety data exchange procedures governing the collection, investigation, reporting, and exchange of information concerning Adverse Drug Reactions, product quality and product complaints involving Adverse Drug Reactions, sufficient to permit each Party to comply with its legal obligations, including to the extent applicable, those obligations contained in ICH guidelines E2A, E2B and E2C and the FDC Act. The safety data exchange procedures will be promptly updated if required by changes in legal requirements or by agreement between the Parties. Alexion will be responsible for reporting all Adverse Drug Reactions to the appropriate Regulatory Authorities in the Territory in accordance with applicable laws and regulations.
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Reporting Adverse. Drug Reactions/Experiences and exchange of safety information
Reporting Adverse. Drug Reactions/Experiences. Except as required prior to transfer of responsibility for the Existing Licensed Product to MGI under Section 5.2.1 to permit SuperGen to comply with its regulatory obligations, as between the Parties, MGI shall be solely responsible for the collection, investigation, and reporting of information concerning adverse drug reactions, Licensed Product quality and Licensed Product complaints, sufficient to comply with the applicable laws and regulations of the relevant countries and authorities with respect to the Licensed Products. MGI shall ensure that its Affiliates and Licensees comply with such reporting obligations. These reporting obligations shall apply to non-serious adverse events as well, which shall mean adverse events that must be reported under the laws, rules, regulations that are applicable in the particular country. MGI shall keep SuperGen fully informed about all serious adverse drug reactions of which MGI, its Affiliates, or Licensees becomes aware or is informed regarding the Licensed Products.

Related to Reporting Adverse

  • Material Adverse Effect The occurrence of any event or condition that has had, or could reasonably be expected to have, a Material Adverse Effect.

  • No Material Adverse Event Since the respective dates as of which information is disclosed in the Registration Statement, the Prospectus and the Incorporated Documents, except as otherwise stated therein, there shall not have been (i) any change or decrease in previously reported results specified in the letter or letters referred to in paragraph (d) of this Section 6 or (ii) any change, or any development involving a prospective change, in or affecting the condition (financial or otherwise), earnings, business or properties of the Company and its subsidiaries taken as a whole, whether or not arising from transactions in the ordinary course of business, except as set forth in or contemplated in the Registration Statement, the Prospectus and the Incorporated Documents (exclusive of any amendment or supplement thereto) the effect of which, in any case referred to in clause (i) or (ii) above, is, in the sole judgment of the Manager, so material and adverse as to make it impractical or inadvisable to proceed with the offering or delivery of the Shares as contemplated by the Registration Statement (exclusive of any amendment thereof), the Incorporated Documents and the Prospectus (exclusive of any amendment or supplement thereto).

  • No Adverse Events Between the date hereof and the Closing Date, neither the business, assets or condition, financial or otherwise, of the Company taken as a whole shall have been materially adversely affected in any manner.

  • Company Material Adverse Effect Since the date of this Agreement, there shall not have been any Company Material Adverse Effect or any event, change, or effect that would, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect.

  • Material Adverse Changes Except as disclosed in the Prospectus and the Time of Sale Information, (a) in the judgment of the Agent there shall not have occurred any Material Adverse Change; and (b) there shall not have occurred any downgrading, nor shall any notice have been given of any intended or potential downgrading or of any review for a possible change that does not indicate the direction of the possible change, in the rating accorded any securities of the Company or any of its subsidiaries by any “nationally recognized statistical rating organization” as such term is defined for purposes of Section 3(a)(62) of the Exchange Act.

  • Notice of Material Adverse Change Firm agrees to notify Citizens in writing of any “Material Adverse Change” to Firm within ten (10) days of said change. A “Material Adverse Change” means: (i) a change in the business operations or financial condition of Firm which negatively impacts its capacity to meet its professional or financial obligations;

  • Material Adverse Change A Material Adverse Change occurs;

  • Notice of Material Adverse Effect The Company shall notify the Buyer (and any subsequent holder of the Debentures), as soon as practicable and in no event later than three (3) business days of the Company’s knowledge of any Material Adverse Effect on the Company. For purposes of the foregoing, “knowledge” means the earlier of the Company’s actual knowledge or the Company’s constructive knowledge upon due inquiry.

  • No Adverse Selection No selection procedures adverse to Noteholders have been employed in selecting the Contracts.

  • Financial Condition; No Material Adverse Effect (a) The Audited Financial Statements (i) were prepared in accordance with GAAP consistently applied throughout the period covered thereby, except as otherwise expressly noted therein and (ii) fairly present in all material respects the financial condition of the Acquired Company and its Subsidiaries as of the respective dates thereof and their results of operations for the period covered thereby in accordance with GAAP consistently applied throughout the period covered thereby, except as otherwise expressly noted therein. (b) The Unaudited Financial Statements (i) were prepared in accordance with GAAP consistently applied throughout the period covered thereby, except as otherwise expressly noted therein, and (ii) fairly present in all material respects the financial condition of the Acquired Company and its Subsidiaries as of the dates thereof and their results of operations for the periods covered thereby, subject, in the case of clauses (i) and (ii), to the absence of footnotes and to normal year-end audit adjustments. (c) The Borrower has heretofore furnished to the Joint Lead Arrangers the consolidated pro forma balance sheet of the Borrower and its Subsidiaries as of March 31, 2015, and the related consolidated pro forma statement of operations of the Borrower as of and for the twelve-month period then ended (such pro forma balance sheet and statement of operations, the “Pro Forma Financial Statements”), which have been prepared giving effect to the Transactions (excluding the impact of purchase accounting effects required by GAAP) as if such Transactions had occurred as of such date (in the case of such balance sheet) or at the beginning of such period (in the case of such statement of operations). The Pro Forma Financial Statements have been prepared in good faith, based on assumptions believed by the Borrower to be reasonable as of the date of delivery thereof, and present fairly in all material respects on a pro forma basis and in accordance with GAAP the estimated financial position of the Borrower and its Subsidiaries as of March 31, 2015, and their estimated results of operations for the periods covered thereby, assuming that the Transactions had actually occurred as of such date (in the case of such balance sheet) or at the beginning of such period (in the case of such statement of operations). (d) Since the Closing Date, there has been no Material Adverse Effect.

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