Pregnancy Exposure Reports Sample Clauses

Pregnancy Exposure Reports. While exposure via pregnancy itself is not a serious adverse event, Aptalis and Strakan will exchange all reports of exposure via pregnancy by Calendar Day 7 from Receipt Date preferably using on FDA 3500 A MedWatch form or Council for International Organizations of Medical Sciences’ (CIOMS) I form via designated e-mail. Both Parties shall perform due diligence to obtain follow-up information regarding the course and outcome of the pregnancy and condition of the infant. All follow-up reports concerning the outcome of the pregnancy shall be forwarded as indicated previously for initial reports (see above).
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Pregnancy Exposure Reports. Institution shall inform Amgen of any pregnancy occurring and/or existing during exposure to the Study Drug and potential infant exposure within […***…] from its initial received date. Amgen may request the patient’s physician’s contact information in order to follow-up the pregnancy until birth outcome. Institution also understands and acknowledges that there could be Study Drug-related SAEs (experienced by the mother, the child, or both) associated with pregnancies and pregnancy outcomes occurring during exposure to the Study Drug. In such instances, Institution also shall prepare, and transmit to Amgen, SADR Reports for those related SAEs. The SAE Reports for all SAEs associated with pregnancy exposures Spontaneously Reported or occurring during clinical trials shall be provided by Institution to Amgen within the same time frames that it is required to provide SAEs pursuant to Section 4 of this Schedule. Additionally, Institution shall use the same study-specific SAE reporting form that it uses to report all other SAEs to Amgen under this Schedule.

Related to Pregnancy Exposure Reports

  • Availability of Earnings Statements The Company shall make generally available to holders of its securities as soon as may be practicable but in no event later than the last day of the fifteenth (15th) full calendar month following the calendar quarter in which the most recent effective date occurs in accordance with Rule 158 of the Rules and Regulations, an earnings statement (which need not be audited but shall be in reasonable detail) for a period of twelve (12) months ended commencing after the effective date, and satisfying the provisions of Section 11(a) of the Act (including Rule 158 of the Rules and Regulations).

  • Required Reports The Company covenants that it will file the reports required to be filed by it under the Securities Act and the Exchange Act (or, if the Company is not required to file such reports, it will, upon the request of any Holder, make publicly available such information), and it will take such further action as any Holder may reasonably request, all to the extent required from time to time to enable such Holder to sell shares of Registrable Securities without registration under the Securities Act within the limitation of the exemptions provided by (a) Rule 144 under the Securities Act, as such Rule may be amended from time to time, or (b) any similar rule or regulation hereafter adopted by the SEC. Upon the request of any Holder, the Company will deliver to such Holder a written statement as to whether it has complied with such requirements.

  • Financial Statements; Financial Condition; Undisclosed Liabilities; Projections; etc (a) (i) The audited consolidated balance sheet of (x) the Company and its Subsidiaries for the fiscal year of the Company ended November 30, 2009 and the related consolidated statements of income, cash flows and shareholders’ equity of the Company and its Subsidiaries for such fiscal year, and (y) the Acquired Business and its Subsidiaries for the fiscal year of the Acquired Business ended December 31, 2009 and the related consolidated statements of income, cash flows and shareholders’ equity of the Acquired Business and its Subsidiaries for such fiscal year, and (ii) the unaudited consolidated balance sheet of (x) the Company and its Subsidiaries for the three fiscal quarters of the Company ended August 31, 2010 and the related consolidated statements of income and cash flows of the Company and its Subsidiaries for such fiscal quarters and (y) the Acquired Business and its Subsidiaries for the eight months of the Acquired Business ended August 31, 2010 and the related consolidated statements of income and cash flows of the Acquired Business and its Subsidiaries for such fiscal period, copies of which in each case have been furnished to the Administrative Agent and each Lender prior to the Restatement Effective Date, present fairly in all material respects the consolidated financial condition of the Company and its Subsidiaries or the Acquired Business and its Subsidiaries, as the case may be, at the dates of said financial statements and the results for the periods covered thereby, subject, in the case of the unaudited financial statements, to normal year-end adjustments. All such financial statements have been prepared in accordance with generally accepted accounting principles consistently applied, except to the extent provided in the notes to said financial statements.

  • Product Availability The Insurance Companies have qualified the Products for offer and sale under the applicable insurance laws of various states and other jurisdictions. Producers and Registered Representatives shall solicit applications for the Products only in states and jurisdictions where such Products have been so qualified. Producers shall, upon request, be provided with a list of those states and jurisdictions in which the Products have been qualified for sale. The Insurance Companies shall file and make all statements or reports as are or may be required by the laws of such state or jurisdiction to maintain these qualifications in effect.

  • Annual Compliance Statements The Master Servicer, the Special Servicer, the Certificate Administrator, the Custodian and, if it has made an Advance during the applicable calendar year, the Trustee shall furnish (and each of the Master Servicer, the Special Servicer, the Custodian and the Certificate Administrator (i) with respect to any Additional Servicer of such party that is a Mortgage Loan Seller Sub-Servicer, shall use commercially reasonable efforts to cause such Additional Servicer to furnish, and (ii) with respect to any other Additional Servicer of such party (other than any party to this Agreement), shall cause such Additional Servicer to furnish) (each such Additional Servicer and each of the Master Servicer, the Special Servicer, the Custodian, the Certificate Administrator and the Trustee (if applicable), a “Certifying Servicer”) to the Certificate Administrator, the Serviced Companion Loan Holders (or, in the case of a Serviced Companion Loan that is part of an Other Securitization Trust, the applicable Other Depositor and Other Exchange Act Reporting Party), the Operating Advisor (only in the case of an Officer’s Certificate furnished by the Special Servicer and after the occurrence and during the continuance of a Control Termination Event) and the Depositor on or before March 1 of each year, commencing in March 2017, an Officer’s Certificate (together with a copy thereof in XXXXX compatible format, or in such other format as otherwise agreed upon by the Depositor, the Certificate Administrator, the applicable Other Depositor, the applicable Other Exchange Act Reporting Party and the applicable Certifying Servicer) stating, as to the signer thereof, that (A) a review of such Certifying Servicer’s activities during the preceding calendar year or portion thereof and of such Certifying Servicer’s performance under this Agreement, or the applicable Sub-Servicing Agreement or primary servicing agreement in the case of an Additional Servicer, has been made under such officer’s supervision and (B) to the best of such officer’s knowledge, based on such review, such Certifying Servicer has fulfilled all its obligations under this Agreement, or the applicable Sub-Servicing Agreement or primary servicing agreement in the case of an Additional Servicer, in all material respects throughout such year or portion thereof, or, if there has been a failure to fulfill any such obligation in any material respect, specifying each such failure known to such officer and the nature and status thereof. The Master Servicer and the Special Servicer shall, and the Master Servicer and the Special Servicer shall cause (or, in the case of an Additional Servicer that is a Mortgage Loan Seller Sub-Servicer, shall use its commercially reasonable efforts to cause) each Additional Servicer hired by it to, forward a copy of each such statement to, prior to the occurrence and continuance of a Consultation Termination Event, the Controlling Class Representative and, for posting to the Rule 17g-5 Information Provider’s Website pursuant to Section 12.13, the Rule 17g-5 Information Provider. Promptly after receipt of each such Officer’s Certificate, the Depositor (and, in the case of a Serviced Companion Loan that is part of an Other Securitization Trust, the applicable Other Depositor and Other Exchange Act Reporting Party) may review each such Officer’s Certificate and, if applicable, consult with the Certifying Servicer, as applicable, as to the nature of any failures by such Certifying Servicer, respectively, or any related Additional Servicer with which the Master Servicer or the Special Servicer, as applicable, has entered into a servicing relationship with respect to the Mortgage Loans or the Companion Loans in the fulfillment of any Certifying Servicer’s obligations hereunder or under the applicable sub-servicing or primary servicing agreement. The obligations of each Certifying Servicer under this Section apply to each Certifying Servicer that serviced a Mortgage Loan or Companion Loan during the applicable period, whether or not the Certifying Servicer is acting in such capacity at the time such Officer’s Certificate is required to be delivered. With respect to each Outside Serviced Mortgage Loan serviced under the applicable Outside Servicing Agreement, the Certificate Administrator shall request, and upon receipt deliver to the Depositor, from a “Servicing Officer” or “Responsible Officer” (as such terms are defined in the applicable Outside Servicing Agreement), as applicable, of the related Outside Servicer, Outside Special Servicer, Outside Custodian, Outside Trustee and Outside Paying Agent or Outside Certificate Administrator an Officer’s Certificate in form and substance similar to the Officer’s Certificate described in this Section or such other form as is set forth in the Outside Servicing Agreement.

  • Non-Reliance on Company Estimates, Projections, Forecasts, Forward-Looking Statements and Business Plans In connection with the due diligence investigation of the Company by Parent and Merger Subsidiary, Parent and Merger Subsidiary have received and may continue to receive from the Company certain estimates, projections, forecasts and other forward-looking information, as well as certain business plan information, regarding the Company and its business and operations. Parent and Merger Subsidiary hereby acknowledge that there are uncertainties inherent in attempting to make such estimates, projections, forecasts and other forward-looking statements, as well as in such business plans, with which Parent and Merger Subsidiary are familiar, that Parent and Merger Subsidiary are taking full responsibility for making their own evaluation of the adequacy and accuracy of all estimates, projections, forecasts and other forward-looking information, as well as such business plans, so furnished to them (including the reasonableness of the assumptions underlying such estimates, projections, forecasts, forward-looking information or business plans), and that Parent and Merger Subsidiary will have no claim, right or obligation under this Agreement or otherwise (including under Article 9) against the Company or any of its Subsidiaries, or any of their respective Representatives, or any other Person, with respect thereto. Accordingly, Parent and Merger Subsidiary hereby acknowledge that none of the Company nor any of its Subsidiaries, nor any of their respective Representatives, nor any other Person, has made or is making any representation or warranty with respect to such estimates, projections, forecasts, forward-looking statements or business plans (including the reasonableness of the assumptions underlying such estimates, projections, forecasts, forward-looking statements or business plans).

  • Check and complete if Transferee will take delivery of a beneficial interest in the IAI Global Note or a Restricted Definitive Note pursuant to any provision of the Securities Act other than Rule 144A or Regulation S. The Transfer is being effected in compliance with the transfer restrictions applicable to beneficial interests in Restricted Global Notes and Restricted Definitive Notes and pursuant to and in accordance with the Securities Act and any applicable blue sky securities laws of any state of the United States, and accordingly the Transferor hereby further certifies that (check one):

  • ACCOUNTS SUBJECT TO ERISA The ERISA Rider is applicable to all Customers Under Section II of this Schedule A. T. Rowe Price Trust Company, as Trustee for the Johnson Matthey Salaried Employee Savings Plan Common Trust Funds T. Rowe Price Trust Company, as Trustee for the International Common Trust Fund on behalf of the Underlying Trusts: Emerging Markets Equity Trust Global Proxy Service Rider Foreign Discovery Trust Global Proxy Service Rider Foreign Discovery Trust - B Global Proxy Service Rider India Trust Global Proxy Service Rider International Small-Cap Trust Global Proxy Service Rider Japan Discovery Trust Global Proxy Service Rider Taiwan Trust Global Proxy Service Rider AMENDMENT AGREEMENT The Global Custody Agreement of January 3, 1994, as amended April 18, 1994, August 15, 1994, November 28, 1994, May 31, 1995, November 1, 1995, July 31, 1996, July 23, 1997, September 3, 1997, October 29, 1997, December 15, 1998, October 6, 1999, February 9, 2000, April 19, 2000, July 18, 2000, October 25, 2000 and July 24, 2001 (the “Custody Agreement”) by and between each of the Entities listed in Schedule A, as amended thereto, severally and not jointly (each such entity referred to hereinafter as the “Customer”) and JPMorgan Chase Bank, whose contracts have been assumed by JPMORGAN CHASE BANK (the “Bank”) is hereby further amended, as of April 24, 2002 (the “Amendment Agreement”). Terms defined in the Custody Agreement are used herein as therein defined.

  • Availability of Tax Returns The Company has made available to Parent complete and accurate copies of all federal, state, local and foreign income, franchise and other material Tax Returns filed by or on behalf of the Company or its Subsidiaries for any Tax period ending after December 31, 2011.

  • Foreign Assets/Account Reporting Information Italian residents who, during the fiscal year, hold investments abroad or foreign financial assets (e.g., cash, Shares and RSUs) which may generate income taxable in Italy are required to report such on their annual tax returns (UNICO Form, RW Schedule) or on a special form if no tax return is due. The same reporting obligations apply to Italian residents who, even if they do not directly hold investments abroad or foreign financial assets (e.g., cash, Shares and RSUs), are beneficial owners of the investment pursuant to Italian money laundering provisions.

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