Product Related Sample Clauses

Product Related. Within five (5) Business Days of receipt, copies of all material correspondence, reports, documents and other filings with any Governmental Authority that could reasonably be expected to have a material adverse effect on any Governmental Approvals required for the manufacturing, marketing, testing or sale of Products (as determined in good faith by the Borrower Representative) or which could have a Material Adverse Effect.
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Product Related. Within three (3) Business Days of receipt, copies of all material correspondence, reports, documents and other filings with any Governmental Authority that could reasonably be expected to have a material adverse effect on any Governmental Approvals required for the manufacturing, marketing, testing or sale of Products or which could have a Material Adverse Effect.
Product Related. All reference manuals, CD-ROMs, and other materials and products published, marketed or licensed; product catalogs, product sheets and documentation, product displays; and telephone numbers specifically used in the support of the products and services of the Business;
Product Related. Within five (5) Business Days of receipt, copies of all material correspondence, reports, documents and other filings with any Governmental Authority that could reasonably be expected to have a material adverse effect on any Governmental Approvals required for the manufacturing, marketing, testing or sale of Products or which could have a Material Adverse Effect. Agent may require Borrowers to provide any required reports, notices and certificates through various electronic means, including Agent’s portfolio monitoring online portal.
Product Related. Within five (5) Business Days of receipt, copies of all material correspondence, reports, documents and other filings with any Governmental Authority that could reasonably be expected to have a material adverse effect on any Governmental Approvals required for the manufacturing, marketing, testing or sale of Products or which could have a Material Adverse Effect. Notwithstanding the foregoing, no consolidating financial statements, reports or projections shall be required in respect of any Immaterial Subsidiary in accordance with the foregoing, and instead, Borrower Representative shall deliver such reports, projections or other financial information with respect to any Immaterial Subsidiary (including without limitation reports as to cash balance or revenue by legal entity) as Administrative Agent may reasonably request from time to time.
Product Related. Within three Business Days of receipt, copies of all material correspondence, reports, documents and other filings with any Governmental Authority that could reasonably be expected to have a material adverse effect on any Governmental Approvals required for the manufacturing, marketing, testing or sale of Products or which could have a Material Adverse Effect. Additionally, documents required to be delivered pursuant to this Section 6.2 may be delivered electronically and if so, shall be deemed to have been delivered on the date on which the Borrower posts such documents, or provides a link thereto, on the Borrower’s investor relations or the SEC’s website.
Product Related 
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Related to Product Related

  • Product Supply The Parties shall reasonably cooperate and assist each other in transferring ownership of Product drug product and/or Product drug substance (such material, CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. collectively, the “Product Lots”) set forth in Exhibit A attached hereto as promptly as reasonably practicable following the Effective Date; provided, however, that neither Party shall be required to pay money to any Third Party, commence any litigation with, or offer or grant any accommodation (financial or otherwise) to any Third Party. Such Product Lots shall be delivered EXW (Ex Works) (Incoterms 2010) AMGEN, Thousand Oaks, California. Any expense for shipment shall be borne by AKERO (including any import or export duties or taxes). Subject to the terms of this Section 5.4 and Section 6.2 (Additional AMGEN Warranties), AMGEN transfers the Product Lots to AKERO “as is”, and makes no other representation to AKERO in connection therewith. The Parties have entered into a Quality Agreement substantially in the form attached hereto as Exhibit F, dated as of the date hereof, governing the quality of the Product Lots to be supplied pursuant to this Section 5.4. For the avoidance of doubt, Product Lots consisting of drug product as set forth in Exhibit A supplied pursuant to this Section 5.4 shall be labeled for their intended clinical use as set forth in Exhibit A and the labeling of any Product drug product manufactured after the Effective Date shall be the responsibility of AKERO. Except for the Licensed Materials and such Product Lots to be transferred to AKERO, AKERO shall be responsible for, and shall bear the cost of, obtaining (whether by manufacturing or causing to be manufactured) research, clinical and commercial supplies of the Product. From and after the Effective Date, AKERO shall be responsible for all costs and expenses in connection with the storage of, and any stability studies performed on, the Product Lots.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

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