Manufacture and Delivery of Api
Manufacture and Delivery of Api Sample Clauses
Related to Manufacture and Delivery of Api
Execution and Delivery of Receipts Upon receipt by any Custodian of any deposit pursuant to Section 2.2 hereunder (and in addition, if the transfer books of the Issuer or the Foreign Registrar, if applicable, are open, the Depositary may in its sole discretion require a proper acknowledgment or other evidence from the Issuer that any Deposited Securities have been recorded upon the books of the Issuer or the Foreign Registrar, if applicable, in the name of the Depositary or its nominee or such Custodian or its nominee), together with the other documents required as above specified, such Custodian shall notify the Depositary of such deposit and the person or persons to whom or upon whose written order a Receipt or Receipts are deliverable in respect thereof and the number of American Depositary Shares to be evidenced thereby. Such notification shall be made by letter or, at the request, risk and expense of the person making the deposit, by cable, telex or facsimile transmission. Upon receiving such notice from such Custodian, or upon the receipt of Shares by the Depositary, the Depositary, subject to the terms and conditions of this Deposit Agreement, shall execute and deliver at its Corporate Trust Office, to or upon the order of the person or persons entitled thereto, a Receipt or Receipts, registered in the name or names and evidencing any authorized number of American Depositary Shares requested by such person or persons, but only upon payment to the Depositary of the fees and expenses of the Depositary for the execution and delivery of such Receipt or Receipts as provided in Section 5.9, and of all taxes and governmental charges and fees payable in connection with such deposit and the transfer of the Deposited Securities.
Execution and Delivery of Agreement Each of the parties shall be entitled to rely on delivery by fax transmission of an executed copy of this agreement by the other party, and acceptance of such fax copies shall create a valid and binding agreement between the parties.
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.
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.
Authorization, Execution and Delivery of Agreement This Agreement has been duly authorized and validly executed and delivered by each of the Enterprise Parties.
Execution and Delivery of Documents IT WAS RESOLVED that: (a) it would promote the success of the Company for the benefit of its members as a whole to enter into the transactions contemplated by the Documents and it is to the further benefit and advantage of the Company to grant the guarantees as set out in the Interim Facilities Agreement and the security as set out in the Interim Debenture; (b) the terms of the transactions and matters contemplated by each Document be and they are hereby approved; (c) the execution, delivery and performance on behalf of the Company of any of the Documents to which the Company is a party be and it is hereby authorised (in the form of the drafts produced to the meeting or with such amendments thereto as the person executing or sealing them pursuant to the authority conferred by these resolutions may in their absolute discretion think fit); (d) each director of the Company (each an “Authorised Signatory”) acting alone be and is hereby authorised to sign on behalf of the Company any of the Documents to which the Company is a party and which require execution under hand and to do such other things as he may consider necessary or desirable arising out of or in connection therewith (in each case in such manner or form as such Authorised Signatory may in their absolute discretion think fit) and to confirm that the resolutions passed at this meeting are still in effect and have not been varied or rescinded; (e) each Authorised Signatory acting alone be and is hereby authorised to do all acts and things necessary or desirable to give effect to these resolutions and to agree, execute and deliver any and all other documents, instruments, certificates, notices and confirmations that the Interim Lenders or any other person may require in connection with any of the Documents or any matter or transaction contemplated by the Documents or these resolutions (including, without limitation, any certificate, bank mandate, any drawdown notice or utilisation request, any hedging agreement, any fee letter, any designation notice, any deeds of release, any payment instructions and any document or resolution on behalf of the Company in its capacity as a shareholder) and which is approved by the person or persons so authorised and executing each such other agreement or document; the approval of each such person in any such case to be conclusively evidenced by his signing such document or witnessing the affixation of the Company's seal thereto or execution of such document as a deed (as the case may be); (f) any two directors, or a director and secretary, or a director signing in the presence of a witness be and they are hereby authorised to sign on behalf of the Company: (i) those Documents to which the Company is a party and which require execution as a deed; (ii) any and all deeds which may be required pursuant to or in connection with the Documents or the Acquisition, in each case, in the form of the drafts produced to the meeting or in such form as the person executing or sealing them pursuant to the authority conferred by these resolutions may in their absolute discretion think fit; (g) the Parent be authorised to act as agent for the Obligors in connection and in accordance with the Interim Facilities Agreement; (h) each Authorised Signatory be and is hereby authorised to delegate in writing to any person all or any of the functions described in paragraphs (c), (d), (e) or (f) above; (i) the omission from these resolutions of any agreement, document or other arrangement contemplated by any of the agreements, documents or instruments described in the foregoing resolutions or any action to be taken in accordance with any requirement of any of the agreements, documents or instruments described in the foregoing resolutions shall in no manner derogate from the authority of the Authorised Signatories to take all actions necessary, desirable, advisable or appropriate to consummate, effectuate, carry out or further the transactions contemplated by, and the intent and purposes of, the foregoing resolutions; and (j) all acts and things heretofore done by any Authorised Signatory or by any employees or agents of the Company and any subsidiary or any of its subsidiaries, on or before the date hereof in connection with the transactions contemplated by the foregoing resolutions be, and hereby are, ratified, approved and confirmed in all respects.
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.
Execution and Delivery The Guaranteeing Subsidiary agrees that the Guarantee shall remain in full force and effect notwithstanding the absence of the endorsement of any notation of such Guarantee on the Notes.
Execution and Delivery of Guarantee To further evidence its Guarantee set forth in Section 10.01, each Guarantor hereby agrees that a notation of such Guarantee, substantially in the form of Exhibit E hereto (each, a “Notation of Guarantee”), shall be endorsed on each Note authenticated and delivered by the Trustee. Such Notation of Guarantee shall be executed on behalf of each Guarantor by either manual or facsimile signature of one Officer or other person duly authorized by all necessary corporate action of such Guarantor who shall have been duly authorized to so execute by all requisite corporate action. The validity and enforceability of any Notation of Guarantee shall not be affected by the fact that it is not affixed to any particular Note. Each of the Guarantors hereby agrees that its Note Guarantee set forth in Section 10.01 shall remain in full force and effect notwithstanding any failure to endorse on each Note a Notation of Guarantee. If an Officer of a Guarantor whose signature is on this Indenture or a Notation of Guarantee no longer holds that office at the time the Trustee authenticates the Note on which such Notation of Guarantee is endorsed or at any time thereafter, such Guarantor’s Notation of Guarantee of such Note shall nevertheless be valid. The delivery of any Note by the Trustee, after the authentication thereof hereunder, shall constitute due delivery of any Note Guarantee set forth in this Indenture on behalf of each Guarantor.
Execution and Delivery of Guarantees To further evidence its Guarantee set forth in Section 10.01, each of the Subsidiary Guarantors hereby agrees that a notation relating to such Guarantee (the “Notation of Guarantee”), substantially in the form attached hereto as Annex A, shall be endorsed on each Security of the series entitled to the benefits of such Guarantee authenticated and delivered by the Trustee, which Notation of Guarantee shall be executed by either manual or facsimile signature of an Officer of such Subsidiary Guarantor. Each of the Subsidiary Guarantors hereby agrees that its Guarantee set forth in Section 10.01 shall remain in full force and effect notwithstanding any failure to endorse on each Security the Notation of Guarantee relating to such Guarantee. If any Officer of such Subsidiary Guarantor, whose signature is on this Indenture or the Notation of Guarantee no longer holds that office at the time the Trustee authenticates such Security or at any time thereafter, the Guarantee of such Security shall be valid nevertheless. The delivery of any Security of a series entitled to the benefits of a Guarantee under this Article X by the Trustee, after the authentication thereof hereunder, shall constitute due delivery of the Guarantee set forth in this Indenture on behalf of each Subsidiary Guarantor.
