FDA As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.
Royalty Payments and Reports Payments for Coal mined and sold hereunder shall be made on a timely basis, when due and without demand by COLT, on or before the twentieth (20th) day of each month (“Payment Deadline”) for all Coal mined or produced from the Premises, shipped and sold, or used, together with all Foreign Coal transported and sold by Lessee or its Affiliates, or assigns during the preceding month as to Coal, as evidenced by a report or reports furnished by Lessee to COLT tendered contemporaneously with payment. Payments shall be made by check or wire transfer. If by check, payment shall be made to the following address: 000 Xxxxxx Xxxx Drive Beckley, WV 25801 If by wire transfer, payment shall be to the following address: Bank: Huntington Bank ABA: 000000000 Credit To: Colt LLC Account #: 01221137324 Copies of the reports required in this section 14 and evidence of the wire transfer or check shall be forwarded by mail or fax to: Colt LLC 0000 XXX Xxxx., Xxxxx 000 Xxxx Xxxxx Xxxxxxx, XX 00000 The addresses for payment by check or wire transfer and/or for submitting reports may be amended from time to time by COLT upon notice to Lessee. Not later than the Payment Deadline, Lessee shall report to COLT showing the actual amount for each and every mining method of Coal mined, processed, stockpiled, loaded, shipped, and sold from the Premises by Lessee and/or its Affiliates or contractors during the preceding month and shall also include individual sales of Coal by Lessee, the customers to which Coal was sold, the Gross Sales Prices of Coal for each sale, itemization of allowable deductions for each sale, calculations of Actual Production Royalty due COLT for each sale and for the preceding month, and the location, by Quarter-Quarter Section, Township, and Range, of the lands of COLT from which such Coal was mined. Such report or reports shall be made either on a form or forms of COLT supplied to Lessee or on a form or forms of Lessee that are approved by COLT. Each report shall be certified to be true, accurate, and correct by Lessee and shall be to the satisfaction of COLT. In any event, all of the aforementioned items shall be made available to COLT by Lessee, at all times upon COLT’s request, for any month during the term of this Lease. Such reports shall, at COLT’s request, be accompanied by copies of invoices, purchase orders, sales receipts, bills of lading, truck weight tickets, railroad weight tickets, barge weight tickets, statements of transportation, washing and handling charges, and other forms of verification as may be deemed necessary by COLT.
Royalties 1. Royalties arising in a Contracting State and paid to a resident of the other Contracting State may be taxed in that other State.
Royalty Payments (i) Royalties shall accrue when Licensed Products are invoiced, or if not invoiced, when delivered to a third party or Affiliate.
Royalty Reports After the first commercial sale of a Licensed Product anywhere in the world, LICENSEE shall submit to UNIVERSITY quarterly royalty reports on or before each February 28, May 31, August 31 and November 30 of each year. Each royalty report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s) most recently completed calendar quarter and shall show:
Sublicense Revenue In the event Licensee or an Affiliate of Licensee sublicenses under Section 2.2, Licensee shall pay CareFusion **THE CONFIDENTIAL PORTION HAS BEEN SO OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT AND HAS BEEN FILED SEPARATELY WITH THE COMMISSION.** of any Sublicense Revenues resulting from sublicense agreements executed by Licensee.
Reports and Royalty Payments Within [* * *] days after the beginning of each Contract Quarter during the Royalty Term, Celgene shall deliver to Acceleron a report setting forth for the previous Contract Quarter the following information on a Licensed Product-by-Licensed Product and country-by-country basis in the Territory: (a) the gross sales and Net Sales of Licensed Product, (b) the number of units sold by Celgene, its Affiliates or Sublicensees, (c) the basis for any adjustments to the royalty payable for the sale of each Licensed Product, and (d) the royalty due hereunder for the sales of each Licensed Product (the “Royalty Report”). The total royalty due for the sale of Licensed Products during such Contract Quarter shall be remitted at the time such report is made. No such reports or royalty shall be due for any Licensed Product before the First Commercial Sale of such Licensed Product.
Royalty Fees In further consideration of the distribution rights and related rights granted by Shengqu to the Licensees hereunder, the Licensees shall pay to Shengqu a royalty fee equal to 35% of revenues on a monthly basis.
Royalty Report The term “Royalty Report” shall have the meaning ascribed to such term as provided in Section 5.4.
Royalty Reports and Accounting 10 6.1 "Royalty Reports; Records".................................... 10 6.2 "Payment Due Dates"........................................... 10 6.3 "Right to Audit Licensee"..................................... 11 6.4 "Right to Audit Cellegy"...................................... 11 6.5 "Overpayment or Underpayment of Burdened Cost"................ 11 6.6 "Disagreement with Auditor Findings".......................... 11
