Regulatory Responsibility The preparation, filing, prosecution and maintenance of INDs, BLAs and other regulatory filings required to be filed with any Regulatory Authority with regard to each Product will be in the name of and the responsibility of Alexion. Alexion shall own the Regulatory Approvals. The costs incurred by the Parties in the preparation, filing and submission of such regulatory filings will be deemed Development Expenses and subject to the terms of Section 3.6. Except as otherwise provided in an applicable Development Plan, Alexion shall oversee, monitor and coordinate all regulatory actions, communications and filings with and submissions, including filings and submissions of supplements and amendments thereto, to Regulatory Authorities with respect to each Product and shall give XOMA a reasonable opportunity for prior review of all such material communications, filings and submissions.
Own responsibility Without affecting the responsibility of any Obligor for information supplied by it or on its behalf in connection with any Finance Document, each Secured Party confirms to the Security Agent that it has been, and will continue to be, solely responsible for making its own independent appraisal and investigation of all risks arising under or in connection with any Finance Document including but not limited to:
Trustee Not Responsible The Trustee shall not be responsible in any manner whatsoever for or in respect of the validity or sufficiency of this [First] Supplemental Indenture or for or in respect of the recitals contained herein, all of which are made solely by the Company and the Guarantors.
Tax Responsibility The Fund shall be liable for all taxes (including Taxes, as defined below) relating to its investment activity, including with respect to any cash or securities held by the Custodian on behalf of the Fund or any transactions related thereto. Subject to compliance by the Fund with its obligations under Section 7.1, the Custodian shall withhold (or cause to be withheld) the amount of any Tax which is required to be withheld under applicable law in connection with the collection on behalf of the Fund pursuant to this Agreement of any dividend, interest income or other distribution with respect to any security and the proceeds or income from the sale or other transfer of any security held by the Custodian. If any Taxes become payable with respect to any prior payment made to the Fund by the Custodian or otherwise, the Custodian may apply any credit balance in the Fund’s deposit account to the extent necessary to satisfy such Tax obligation. The Fund shall remain liable for any tax deficiency. The Custodian is not liable for any tax obligations relating to the Portfolio or the Fund, other than those Tax services as set out specifically in this Section 7. The Fund agrees that the Custodian is not, and shall not be deemed to be, providing tax advice or tax counsel. The capitalized terms “Tax” or “Taxes” means any withholding or capital gains tax, stamp duty, levy, impost, charge, assessment, deduction or related liability, including any addition to tax, penalty or interest imposed on or in respect of (i) cash or securities, (ii) the transactions effected under this Agreement, or (iii) the Fund.
Regulatory Responsibilities The Parties will share responsibility for leading regulatory matters relating to the SYNGAP1 Co-Co Products, as described in this Section 6.9 (each Party, when designated as provided herein to provide such leadership with respect to designated activities is the “Lead Regulatory Party” with respect to such activities). With respect to each SYNGAP1 Co-Co Product, Acadia shall (x) lead the overall strategy for obtaining Regulatory Approval of such SYNGAP1 Co-Co Product (including labeling for such SYNGAP1 Co-Co Product), including by selecting the jurisdictions within which XXXx will be pursued and Execution Version the timing and order in which such approvals will be sought (“Regulatory Strategy”), and will be the Lead Regulatory Party with respect to such strategic activities with respect to such SYNGAP1 Co-Co Product, (y) be the Lead Regulatory Party with respect to the submission of any MAA for such SYNGAP1 Co-Co Product, and (z) following the first Regulatory Approval of such SYNGAP1 Co-Co Product, be the Lead Regulatory Party in connection with such SYNGAP1 Co-Co Product and with respect to Commercialization and regulatory activities (including post-marketing studies). Subject to the foregoing, the JSC shall designate a Party to lead all other pre-Regulatory Approval regulatory matters relating to each SYNGAP1 Co-Co Product in accordance with the applicable SYNGAP1 Co-Development Plan (each Party in such capacity will be deemed the Lead Regulatory Party with respect to such activities). The Lead Regulatory Party shall be responsible for (i) filing for in its name, and owning, all Regulatory Materials relating to regulatory activities with respect to such SYNGAP1 Co-Co Product in the relevant country, (ii) overseeing, monitoring, and coordinating all regulatory actions, communications and filings with, and submissions to, each Regulatory Authority with respect to such activities; and (iii) interfacing, corresponding, and meeting with each Regulatory Authority with respect to such activities, in each case consistent with the Regulatory Strategy and applicable SYNGAP1 Co-Development Plan or SYNGAP1 Co-Commercialization Plan.
Additional Responsibilities You agree to: reasonably clean and maintain Covered Items; not harm/damage a Covered Item or Component; provide a safe working environment for Contractors; not damage property of a Contractor; and not threaten/harm us or a Contractor via phone, email, personal interaction, internet, social media or otherwise.
Legal Responsibility Nothing herein contained shall render any Party liable for the obligations of any other Party hereunder and the rights, obligations and liabilities of the Parties are several in accordance with their respective obligations, and not joint.
Primary Responsibility The Company acknowledges that to the extent Indemnitee is serving as a director on the Company’s board of directors at the request or direction of a venture capital fund or other entity and/or certain of its affiliates (collectively, the “Secondary Indemnitors”), Indemnitee may have certain rights to indemnification and advancement of expenses provided by such Secondary Indemnitors. The Company agrees that, as between the Company and the Secondary Indemnitors, the Company is primarily responsible for amounts required to be indemnified or advanced under the Company’s certificate of incorporation or bylaws or this Agreement and any obligation of the Secondary Indemnitors to provide indemnification or advancement for the same amounts is secondary to those Company obligations. To the extent not in contravention of any insurance policy or policies providing liability or other insurance for the Company or any director, trustee, general partner, managing member, officer, employee, agent or fiduciary of the Company or any other Enterprise, the Company waives any right of contribution or subrogation against the Secondary Indemnitors with respect to the liabilities for which the Company is primarily responsible under this Section 15. In the event of any payment by the Secondary Indemnitors of amounts otherwise required to be indemnified or advanced by the Company under the Company’s certificate of incorporation or bylaws or this Agreement, the Secondary Indemnitors shall be subrogated to the extent of such payment to all of the rights of recovery of Indemnitee for indemnification or advancement of expenses under the Company’s certificate of incorporation or bylaws or this Agreement or, to the extent such subrogation is unavailable and contribution is found to be the applicable remedy, shall have a right of contribution with respect to the amounts paid. The Secondary Indemnitors are express third-party beneficiaries of the terms of this Section 15.
Custodial Responsibilities ARTICLE IX
General Responsibilities Issuer hereby engages Distributor to act as exclusive distributor of the shares of each class of the Funds. The Funds subject to this Agreement as of the date hereof are identified on SCHEDULE A, which may be amended from time to time in accordance with Section 11 below. Sales of a Fund's shares shall be made only to investors residing in those states in which such Fund is registered. After effectiveness of each Fund’s registration statement, Distributor will hold itself available to receive, as agent for the Fund, and will receive by mail, telex, telephone, or such other method as may be agreed upon between Distributor and Issuer, orders for the purchase of Fund shares, and will accept or reject such orders on behalf of the Fund in accordance with the provisions of the applicable Fund’s prospectus. Distributor will be available to transmit orders, as promptly as possible after it accepts such orders, to the Fund’s transfer agent for processing at the shares’ net asset value next determined in accordance with the prospectuses.
