Manufacture and Supply As between the Parties, Otsuka shall be responsible for, shall bear all costs associated with, and shall have all decision-making authority over, all Manufacturing Activities (subject to discussion of CMC matters with Acucela through the JDC or applicable Operating Team as discussed below); provided, that Otsuka shall supply Licensed Product to Acucela or its permitted subcontractors for use in clinical trials conducted in accordance with each Development Plan and, if applicable, Commercialization Plan (i.e., Phase 3b Clinical Trials or Post-Approval Studies, if any), free of charge and in such quantities as are agreed by the JDC or the JCC (as applicable) or are otherwise required to seek or obtain Regulatory Approval. In addition, if and after Acucela exercises an Opt-In Right under Section 3.1, Otsuka shall supply promotional samples of Licensed Product to Acucela for use in its performance of Co-Promotion, in such quantities and on such terms as are determined by the JCC. The cost of promotional samples of Licensed Product, which shall be included in Commercialization Costs, shall be established by the JCC based on Otsuka’s per-unit cost to manufacture such promotional samples (but, for the avoidance of doubt, Otsuka shall have no obligation to disclose any information relating to its manufacturing costs), but in no event shall such promotional sample cost exceed * per promotional sample unless mutually agreed otherwise by the Parties. Acucela’s and its permitted subcontractors’ obligations to conduct Development activities, and upon Acucela’s exercise of its Opt-in Right pursuant to Section 3.1, to conduct Development and Commercialization activities, shall be expressly conditioned upon Otsuka fulfilling its Licensed Product supply obligations as set forth in the Development Plan or the Commercialization Plan, as applicable. To the extent that Otsuka reasonably believes is necessary for performance of Development or Commercialization, Otsuka agrees to keep Acucela reasonably informed from time to time, through the JDC, JCC or applicable Operating Team, regarding the general status of Manufacturing Activities related to the Licensed Product (including Other Indication Product(s), as applicable) and from time to time shall update Acucela on any foreseeable delays and/or other material issues relating to Manufacturing the Licensed Product (including Other Indication Product(s), as applicable). Through the JDC or applicable Operating Team, Otsuka and Acucela shall confer and discuss CMC matters, and Otsuka agrees to consider suggestions of Acucela regarding CMC matters.
Delivery of Products 4.1 The Supplier shall ensure that:
(a) Products are properly packed and secured in such manner as to enable them to reach their destination in good condition;
(b) each delivery of Products is accompanied by a delivery note which shows the date of the Order, the Order number (if any), the type and quantity of Products (including the code number of the Products, where applicable), special storage instructions (if any) and, if the Products are being delivered in instalments, the outstanding balance of Products remaining to be delivered; and
(c) it states clearly on the delivery note any requirement for Ornua to return any packaging material for the Products to the Supplier. Any such packaging material shall only be returned to the Supplier at the cost of the Supplier.
4.2 The Supplier shall deliver the Products:
(a) to the location set out in the Order or such other location as the parties may agree which may include delivery to a carrier (Delivery Location); and
(b) on the date specified in the Order or, if no such date is specified, on a date agreed with Ornua in advance (Delivery Date). Delivery shall be on a Business Day during normal business hours, unless agreed otherwise with Ornua or otherwise instructed by Ornua.
4.3 Delivery of Products shall be completed when the Supplier unloads and stacks the Products at the Delivery Location, unless different delivery terms (or Incoterms®) are specified in the Order.
4.4 Ornua operates a “Just-in-Time” delivery system. Time shall be of the essence in relation to the Delivery Date and any agreed delivery time. If the Products are not delivered on time by the Supplier, clause 6.1 shall apply.
4.5 If the Supplier delivers more that the quantity of Products ordered, Ornua shall not be bound to pay for the excess and any excess shall be and shall remain at the Supplier’s risk and shall be returnable at the Supplier’s expense.
4.6 The Supplier shall not deliver Products in instalments without Ornua's prior written consent. Where it is agreed that Products are to be delivered in instalments, they may be invoiced and paid for separately. Failure by the Supplier to deliver any one instalment on time or at all or any defect in an instalment shall entitle Ornua to the remedies set out in clause 6.1.
4.7 Title and risk in the Products shall pass to Ornua on completion of delivery.
Delivery of Product 11.1 Subject to Clause 25 (Capacity Constraints), GSK (or the Nominated Supplier) shall Deliver the Products on the date specified in the relevant Firm Order, provided that:
(A) the quantity of Product Delivered by GSK may vary by [***] from the quantity specified in the relevant Firm Order; and
(B) the date of Delivery may vary by [***] from the date specified in the relevant Firm Order, and such variance shall not constitute a breach of this Agreement by GSK or entitle the Purchaser to reject such Delivery. Delivery of Commercial API and Commercial Products shall take place following release by GSK of such Products in accordance with (and the extent required by) the Quality Agreement, provided that, for clarity, the Purchaser shall only be required to pay for the quantity of Product that is actually Delivered.
11.2 In respect of Commercial API, the Parties may agree that some or all of the quantities of such Commercial API Delivered pursuant to Clause 11.1 shall remain in the possession of GSK or its Affiliate on [***]. The Purchaser shall pay GSK a storage fee to cover any GSK costs and expenses incurred in connection with holding and storing such [***] stock (“Storage Fee”). The Storage Fee is set forth in Schedule 4 (Fees). For the avoidance of doubt, no Storage Fee is payable in respect of quantities of Commercial API required for the Manufacture of the Commercial Product shown in the Firm Zone and that are held by GSK at designated Manufacturing Site in respect of Commercial Product for the purposes of such Manufacture. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.
11.3 Subject to paragraph 2 of Schedule 3 (Toll Manufacturing Provisions), the risk in and title to the Commercial Products shall remain with GSK (or its Affiliate) until Delivered, at which point it shall pass to the Purchaser. Title to Commercial API shall pass to the Purchaser when such Commercial API is purchased by Purchaser, but risk in such Commercial API shall remain with GSK in accordance with Clause 8.5 for so long as such Commercial API is in GSK’s possession as Purchaser Materials.
11.4 Other than in respect of Commercial API that the Parties agree shall be retained by GSK on Consignment, the Purchaser shall collect the Products Delivered from the Manufacturing Site on the date of Delivery, or such date as GSK, the Nominated Supplier or the Nominated Manufacturer may notify to the Purchaser (provided that, and if the Delivery date notified to the Purchaser is earlier or later than the Delivery window contemplated by Clause 11.1, the Delivery date must be agreed with the Purchaser). Notwithstanding the foregoing, and without limiting Clause 20.2, Purchaser may, [***], elect to obtain Delivery at any point within [***] of the notified date of Delivery by providing notice to GSK of such revised Delivery date.
11.5 Commercial API that the Parties agree shall be retained by GSK [***] at the Manufacturing Site in respect of Commercial API shall be collected by the Purchaser from such Manufacturing Site on such date as may be agreed between the Parties.
11.6 For the avoidance of doubt, irrespective of whether or not any quantity of Commercial API is retained by GSK [***] for a period of time after Delivery, the Purchaser shall be responsible for the delivery of Toll Materials to the designated Manufacturing Site in respect of Commercial Product.
Manufacture of Products All Products marketed through Grantor's Web ------------------------- Site shall be manufactured, packaged, prepared, and shipped in accordance with the specifications and requirements described on Exhibit A hereto as it may be modified from time to time. Quality control standards relating to the Product's weight, color, consistency, micro-biological content, labeling and packaging are also set forth on Exhibit A. In the event that Exhibit A is incomplete, Products shall be manufactured and shipped in accordance with industry standards.
Delivery of Materials In the event of any expiration or termination of this Agreement, Contractor shall promptly provide the JBE with all originals and copies of the Deliverables, including any partially-completed Deliverables-related work product or materials, and any JBE-provided materials in its possession, custody, or control. In the event of any termination of this Agreement, the JBE shall not be liable to Contractor for compensation or damages incurred as a result of such termination; provided that if the JBE’s termination is not for cause, the JBE shall pay any fees due under this Agreement for Services performed or Deliverables completed and accepted as of the date of the JBE’s termination Notice.
Services and Deliverables The Services and the required Deliverables for the Services are specified below. Service Type Output Measure Quantity per annum Number of Service Users Funding amount per annum (excl. GST) $ $ $ Description of Services Funding amount one-off (excl. GST) $ Service Type Output Measure Quantity per annum Number of Service Users Funding amount (excl. GST) $ $ $ Description of Services Funding amount one-off (excl. GST) $ *Note: Refer to clause 4.8 in the Funding and Service Details about permitted variations in output quantities.
Tasks and Deliverables A description of and the schedule for each task and deliverable, illustrated by a Xxxxx chart. Start and completion dates for each task, milestone, and deliverable shall be indicated. Must include deliverables specified in SOW-RFP as well as other deliverables that may be proposed by Contractor.
Shipment and Delivery Seller grants the Company the right at any time to specify the carrier and/or method of transportation to be employed in conveying any part or all of the Goods covered herein. In the event that Seller uses an unauthorized carrier and/or method of transportation, then all shipping expenses shall be assumed by Seller. Unless otherwise stated in the Order, all Goods will be shipped FCA shipment point. FCA shall be interpreted in accordance with the version of Incoterms valid at the time of the Seller’s acceptance of the Order. The Seller shall be responsible for preparing and filing all export documentation for all shipments. The Company shall not be obligated to accept early deliveries, partial deliveries or excess deliveries. If Goods are incorrectly delivered, the Seller shall be responsible for any additional expense incurred in delivering the Goods to the correct destination. The delivery date set forth on the Order is of the essence of the Contract. If the Seller anticipates that it will not be able to deliver the Goods upon the agreed delivery date, then the Seller shall immediately notify the Company thereof in writing; provided, however, that such notice shall not relieve the Seller of its responsibilities and liabilities with respect to on-time delivery hereunder. In such event, the Company may request that the Seller expedite delivery to the maximum extent possible at the Seller’s sole expense. If the Seller does not deliver the Goods by the agreed delivery date, then the Company shall be entitled to liquidated damages as agreed between the parties, up to and including the total Order value. Notwithstanding the foregoing, the Company reserves the right to claim repayment for any and all costs, losses, expenses and damages incurred by the Company that are attributable to the Seller’s delay in delivery. Such liquidated damages shall be paid at the Company’s written demand. Partial deliveries shall not relieve the Seller from liability for any late delivery hereunder. If the Seller discovers that it has shipped any non-conforming Goods to the Company, it shall immediately (and not more than 24 hours after such discovery) notify the Company thereof in writing; provided, however, that such notice shall not relieve the Seller of its responsibilities and liabilities with respect to defective goods hereunder.
Delivery of Work If the Director terminates the Master Agreement and/or any Approved Service Order(s) – whether for convenience or for cause – the Director has the option of requiring the Consultant to provide to the City any finished or unfinished Work Product prepared by the Consultant up to the date of Consultant’s receipt of the written notice of termination.
Manufacture 2.1. The LED(s) on the LED module shall be equipped with suitable fixation elements.
2.2. The fixation elements shall be strong and firmly secured to the LED(s) and the LED module.
