Clinical Supply Takeda will provide to Licensee[***] the amount of TAK-385 Licensed Compound or TAK-385 Licensed Products needed by Licensee to complete all Clinical Trials contemplated by the TAK-385 Development Plan (estimated by Licensee as of the Effective Date to be [***]), solely to the extent that Takeda can supply such TAK-385 [***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406. Licensed Compound or TAK-385 Licensed Products (a) from its supply of TAK-385 Licensed Compound or TAK-385 Licensed Products in existence as of the Effective Date and which supply can be used for its intended purposes without further re-processing (the “Initial Clinical Supply”) and (b) after retaining the amount needed by Takeda for Clinical Trials in the Takeda Territory. Takeda will also provide to Licensee, at [***] any additional supplies of TAK-385 Licensed Compound or TAK-385 Licensed Products in excess of the Initial Clinical Supply needed by Licensee to complete all Clinical Trials contemplated by the TAK-385 Development Plan. Within [***] days after the Effective Date, the Parties will enter into a manufacturing and supply agreement (the “Takeda Clinical Manufacturing and Supply Agreement”), which will govern the terms and conditions of the Manufacturing and supply of the TAK-385 Licensed Compound and TAK-385 Licensed Products (including the Initial Clinical Supply) by Takeda to Licensee for Development purposes, including the exact quantities and the timelines for delivery. The Parties will negotiate the terms and conditions of such Takeda Clinical Manufacturing and Supply Agreement in good faith for a period of [***] days (as may be extended upon agreement of the Parties). As part of the negotiation related to the Takeda Clinical Manufacturing and Supply Agreement, the Parties shall discuss in good faith the ability of Takeda to supply to Licensee [***]. If the Parties have not entered into a definitive agreement within such negotiation period, then the final terms and conditions of such agreement will be resolved in accordance with Section 8.2 (Arbitration for Failure to Agree).
API A. Reliant shall supply to Cardinal Health for Manufacturing and Packaging, at Reliant’s sole cost, the API and applicable reference standards in quantities sufficient to meet Reliant’s requirements for each Product as further set forth in Article 4. Prior to delivery of any of the API or reference standard to Cardinal Health for Manufacturing and Packaging, Reliant shall provide to Cardinal Health a copy of the API Material Safety Data Sheet (“MSDS”), as amended, and any subsequent revisions thereto. Reliant shall supply the API, reference standards, and Certificate of Analysis FOB the Facility no later than thirty (30) days before the scheduled Manufacture Date upon which such API will be used by Cardinal Health. Upon receipt of the API, Cardinal Health shall conduct identification testing of the API. Cardinal Health shall use the API solely and exclusively for Manufacturing and Packaging under this Agreement. The maximum volume of API that Reliant supplies to Cardinal Health shall not exceed the amount reflected in the Firm Commitment and the next six (6) months of the Rolling Forecast.
Defective Products None of the Group Companies has manufactured, sold or supplied products which are, or were, in any material respect, faulty or defective, or which do not comply in any material respect with any representations or warranties expressly made by such Group Company, or with all applicable regulations, standards and requirements.
Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].
Commercial Supply Celgene shall Manufacture and supply all Commercial Supplies.
Borrower Products Except as described on Schedule 5.11, no Intellectual Property owned by Borrower or Borrower Product has been or is subject to any actual or, to the knowledge of Borrower, threatened litigation, proceeding (including any proceeding in the United States Patent and Trademark Office or any corresponding foreign office or agency) or outstanding decree, order, judgment, settlement agreement or stipulation that restricts in any manner Borrower’s use, transfer or licensing thereof or that may affect the validity, use or enforceability thereof. There is no decree, order, judgment, agreement, stipulation, arbitral award or other provision entered into in connection with any litigation or proceeding that obligates Borrower to grant licenses or ownership interest in any future Intellectual Property related to the operation or conduct of the business of Borrower or Borrower Products. Borrower has not received any written notice or claim, or, to the knowledge of Borrower, oral notice or claim, challenging or questioning Borrower’s ownership in any Intellectual Property (or written notice of any claim challenging or questioning the ownership in any licensed Intellectual Property of the owner thereof) or suggesting that any third party has any claim of legal or beneficial ownership with respect thereto nor, to Borrower’s knowledge, is there a reasonable basis for any such claim. Neither Borrower’s use of its Intellectual Property nor the production and sale of Borrower Products infringes the Intellectual Property or other rights of others.
Product Orders All Product orders shall be submitted by the Operators to DISTRIBUTOR and shall specify the location of the Operator’s Stores, the type of Product, and the quantity desired. Operators may place orders electronically (“Electronic Orders”) or by telephoning or faxing DISTRIBUTOR’s customer service center in accordance with the guidelines detailed below. All shipment expenses from DISTRIBUTOR’s distribution center to the Operator’s location shall be at DISTRIBUTOR’s expense unless otherwise noted elsewhere in this Agreement. Product order guides will be provided by DISTRIBUTOR to the Operators monthly via DISTRIBUTOR’s website and with a hard copy delivered to each Store, with availability of such order guides to be made prior to the beginning of the month, but only after review and approval of the order guide by COMPANY. The order guides will be organized by Product categories and will include, among other things, the Product Sell Price (as defined herein), Product units and new Products. DISTRIBUTOR will assign one product code number to each stock-keeping unit (“SKU”) of each Product, which will be common throughout its entire distribution system and will be used on all documents such as order guides, invoices, monthly reports, etc. SKU’s, and, accordingly, the assigned product code number, must differ for equivalent Products supplied by different suppliers. DISTRIBUTOR will use its best efforts to utilize the existing TCBY product item numbers. Only Products approved for sale to its Operators by the COMPANY will be listed on this order guide. Electronic Orders will be placed via telephone modem or internet using DISTRIBUTOR’s automated order entry system. All orders are subject to the standard order cut-off time of 4:00 p.m. local time, one (1) day prior to their scheduled delivery day for Stores located in the states of Florida and Georgia and 4:00 p.m. local time. In no event will Electronic Orders be required more than two (2) days prior to the scheduled delivery day. Operators will be notified prior to the time of final order cut-off if a product is expected to be out of stock so that an alternative may be ordered, subject to the provisions of Section 3.02. Operators will have until 5:00 p.m. local time, one (1) day before their order shipping day to modify or add-on to their order. Notwithstanding the foregoing, Stores that do not place Electronic Orders and have scheduled delivery days of Monday in Florida and Georgia, must have their orders placed by 4 p.m. local time, on the preceding Friday. DISTRIBUTOR may schedule deliveries any day of the week. Where reasonably possible, DISTRIBUTOR will schedule ordering days and delivery days that are mutually agreed upon by and between DISTRIBUTOR and each Operator and will provide notice to the affected Operator at least fourteen (14) days before routing changes. On an exception basis, DISTRIBUTOR will consider shortening the permissible time frames for scheduled deliveries for those Operators that, given unique and compelling business needs, require the same. Operator will be notified of any Product shortages at the time of order placement or, in the case of an Electronic Order, one (1) day prior to the loading of the delivery truck.
Manufacturing Agreement Each of the Sellers (as applicable) shall have executed and delivered to the Buyer the Manufacturing Agreement with respect to the portion of the Business conducted at the applicable Facility.
Supply Agreements For a period of three years from the consummation of the IPO, Odetics shall not unilaterally terminate or assign its guarantee obligation with respect to any supply agreement pursuant to which it has guaranteed the performance by ATL of ATL's obligations, unless such suppliers have consented to the termination or assignment of such guarantee.
No Reliance on Administrative Agent’s Customer Identification Program Each Lender acknowledges and agrees that neither such Lender, nor any of its Affiliates, participants or assignees, may rely on the Administrative Agent to carry out such Lender’s, Affiliate’s, participant’s or assignee’s customer identification program, or other obligations required or imposed under or pursuant to the USA Patriot Act or the regulations thereunder, including the regulations contained in 31 CFR 103.121 (as hereafter amended or replaced, the “CIP Regulations”), or any other Anti-Terrorism Law, including any programs involving any of the following items relating to or in connection with any of the Loan Parties, their Affiliates or their agents, the Loan Documents or the transactions hereunder or contemplated hereby: (i) any identity verification procedures, (ii) any recordkeeping, (iii) comparisons with government lists, (iv) customer notices or (v) other procedures required under the CIP Regulations or such other Laws.
