Palvella Responsibilities Licensing Reporting
Palvella Responsibilities Licensing Reporting Sample Clauses
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Specific Responsibilities In addition to its overall responsibility for monitoring and providing a forum to discuss and coordinate the Parties’ activities under this Agreement, the JSC shall in particular:
Financial Responsibility You understand that you remain, solely and exclusively responsible for any and all financial risks, including, without limitation, insufficient funds associated with accessing the Service. The Credit Union shall not be liable in any manner for such risk unless Credit Union fails to follow the procedures described in materials for use of the service. You assume exclusive responsibility for the consequences of any instructions you give to the Credit Union, for your failures to access the Service properly in a manner prescribed by the Credit Union, and for your failure to supply accurate input information, including, without limitation, any information contained in an application.
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.
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.
Regulatory Responsibilities 3.4.1 Prior to receipt of Regulatory Approval in the U.S. for the Initial Indication for Contrave: (a) Orexigen shall prepare, file, maintain, and own all Regulatory Filings, including the IND and the NDA for Contrave in the U.S., and related submissions with respect to Contrave in the U.S.; and (b) Orexigen shall promptly notify Takeda of all material Regulatory Filings with respect to Contrave that it proposes to submit to Regulatory Authorities, or that it receives from Regulatory Authorities, in the Territory (including all substantive correspondence with such Regulatory Authorities, responses from such Regulatory Authorities, requests for information from such Regulatory Authorities, briefing documents and other materials relating to interactions with such Regulatory Authorities, and summaries of outputs resulting from substantive correspondence/conversations or meetings with such Regulatory Authorities), and shall promptly provide Takeda with a copy (which may be wholly or partly in electronic form) of such Regulatory Filings for review by Takeda. Takeda shall provide any comments promptly, but in no event later than [***] ([***]) Business Days after receiving such Regulatory Filings, Orexigen shall reasonably consider and give due consideration to any such comments provided by Takeda, and, as necessary, it shall discuss such comments with Takeda, and each Party shall use good faith efforts to mutually agree on the content of any communications that relate to or contain commitments made or to be made by Orexigen to Regulatory Authorities for the purpose of obtaining Regulatory Approvals; provided, however, (i) Orexigen shall retain the right to make any final decisions with respect to the content of any such communications, which shall be compliant with the Development Plan, this Agreement and applicable Law, and (ii) in the event any interaction with a Regulatory Authority is time-sensitive, Orexigen shall have the right to communicate with such Regulatory Authority within the time frame requested by such Regulatory Authority. Orexigen shall provide Takeda with reasonable advance notice of any scheduled meeting with any Regulatory Authority relating to the Product or any Regulatory Approval in the Territory, and Takeda shall have the right to have up to [***] ([***]) individuals attend and participate in any such meeting; provided, however, Orexigen will retain the lead role and responsibility in any such meetings.
Contractor Responsibilities Contractor shall:
