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.
Appears in 3 contracts
Samples: Quality Agreement (Akero Therapeutics, Inc.), Quality Agreement (Akero Therapeutics, Inc.), Quality Agreement (Akero Therapeutics, Inc.)
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. collectivelyWhere SCC is to supply Products to the Customer pursuant to an Order, the Parties agree that the provisions in Clauses to (inclusive) will apply to such Order in respect of Products only. • Delivery of the Products (Hardware only) shall take place at the location(s) agreed by the Parties and specified in the relevant Order (the “Product LotsLocation(s)”). • When Products (other than any Third Party Software) set forth are delivered to the Customer, the Customer shall inspect the Products immediately upon their arrival to check whether: • the Products have been damaged in Exhibit A attached hereto transit; and • the Products are those, and in the quantity, specified in the relevant Order. • Regarding: • any discrepancy between the Products delivered and those specified in the relevant Order and/or any damage to the Products in transit, the Customer shall notify SCC in writing within two (2) Business Days of delivery of the Products to the Location; or • non-delivery of any Products (whether a partial delivery or where there has been no delivery at all), the Customer shall notify SCC in writing within two (2) Business Days of receipt by the Customer of SCC's delivery note or invoice (whichever is earlier). • SCC shall not consider any claim for damage in transit, non-compliance with the description of the Products in the relevant Order or non-delivery unless the Customer has complied with the notice requirements in Clauses or (as promptly as reasonably practicable following applicable) in making such claim. • In the Effective Dateevent of any valid claim by the Customer: • under Clause , SCC shall (upon return of the defective Products at SCC’s cost), at SCC’s option and cost, either replace the relevant Products or arrange for a repair of the same, within a reasonable time; providedor • under Clause , SCC shall arrange for redelivery of the undelivered Products at no extra cost to the Customer within a reasonable time. • SCC shall use reasonable endeavours to ensure that delivery of Products is on time, however, that neither delivery dates are always subject to change and are given by the relevant Third Party shall Vendor and SCC as estimates only, without being binding on SCC. The time of delivery will not be of the essence in relation to any such delivery dates given by SCC to the Customer. • If the Customer fails to take delivery of any of the Products when they are ready for delivery or to provide any instructions, documents, licences or authorisations required to pay money enable the Products 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 on time (Ex Worksexcept solely on account of SCC’s default), the Products will be deemed to have been delivered or performed on the due date and (without prejudice to its other rights) SCC may: • store or arrange for storage of the Products until actual delivery or sale and charge the Customer for all related costs and expenses (Incoterms 2010) AMGENincluding, Thousand Oakswithout limitation, California. Any expense for shipment shall be borne by AKERO (including any import or export duties or taxesstorage and insurance). Subject ; and/or • following written notice to the terms Customer, sell any 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 Products at the best price reasonably obtainable in the form attached hereto circumstances and charge the Customer for any shortfall below the Charges or account to the Customer for any excess achieved over the Charges, in both cases having taken into account any charges related to the sale. • Unless otherwise specified in an Order, the Customer will provide at its expense at the Location(s) adequate and appropriate equipment and manual labour for off-loading the Products. • Except as Exhibit Fprovided herein, dated as of the date hereof, governing the quality of the Product Lots Customer shall not be entitled to be supplied pursuant to this Section 5.4return any Products without SCC’s prior written agreement. 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 • The Customer shall be responsible for the cost of carriage and insurance in respect of all costs Products returned to SCC, which Products shall also be at the Customer’s risk until actual receipt by SCC. • Risk of damage to or loss of the Products will pass to the Customer on delivery. • Title to and expenses property in any Products (Hardware only) will remain vested in SCC until payment in full of the Charges (together with any interest and VAT on the same) and in cleared funds has been received by SCC in respect of those Products and any other Products supplied to the Customer by SCC. • The Customer acknowledges that SCC does not manufacture any of the Products and therefore, any warranties (including any warranty period) given by the relevant Third Party Vendor for any Products will (where applicable) be as specified in the relevant Third Party Vendor’s standard warranty documentation or end user licence/subscription terms (as applicable) for such Products. Any such Third Party Vendor’s warranty for any Products will apply directly between the Customer and the relevant Third Party Vendor, so SCC (to the extent permitted by applicable law) does not give any warranty itself in respect of such Products and provides such Products “as-is”. However, SCC will (where such warranties are assignable) pass on to the Customer the benefit of any warranties which SCC has received itself from the relevant Third Party Vendor under SCC’s separate contract with such Third Party Vendor. Unless otherwise specified in an Order for Services, any validation and warranty claims relating to any such Third Party Vendor’s warranty for Products are the responsibility of the Customer. • Regarding any Products which are Third Party Software, the Customer acknowledges and agrees that its use of such Third Party Software will be subject to and governed by the relevant Third Party Vendor's End User Terms. • The Third Party Vendor (or the licensor) owns and shall retain all Intellectual Property Rights in the Products. • SCC shall invoice the Customer for any Products on or at any time after despatch of the relevant Products. The Customer shall pay the Charges for any such Products in accordance with Clause 0 (payment). • Unless otherwise specified in an Order for Services, the Customer shall be entirely responsible for: • providing a suitable environment for the installation of the Products; • the installation of the Products; • using the Products in accordance with the manufacturer’s instructions and recommendations (including those contained in any applicable End User Terms), and • carrying out cleaning operations as recommended by the Product manufacturer or SCC. • In the event the Services include installation of the Products: • the Customer shall provide, free of charge, the following facilities to authorised personnel of SCC and its sub-contractors throughout the Customer’s normal business hours and at such other times as the Customer authorises after reasonable prior notice from SCC (such authorisation not to be unreasonably withheld or delayed): • access to and use of the Customer Equipment and unloading equipment, access to the Customer’s employees, the products and the site; • all electric power, lighting, heating and air conditioning reasonably needed by SCC to perform the Services; • office space suitable for this purpose and the provision of normal office services including first aid, photocopying, telephone and facsimile facilities (but excluding any secretarial support, typing and photocopying facilities needs to produce any documentation for which SCC is responsible), and such facilities may be used only for the purposes of providing the Services; • competent operators for the Products and any relevant Customer Equipment; and • the Customer shall be responsible for ensuring that the Customer’s existing hardware and software is properly installed and is sufficient and suitable for its purpose and that any adjustments which may be required are carried out expeditiously. CUSTOMER OBLIGATIONS • The Customer shall comply with the responsibilities and activities set out in this Clause 0, the relevant Order and Service Annex (together the "Customer Obligations" and individually a "Customer Obligation"). • The Customer shall: • provide SCC with: • all assistance, materials and information reasonably required by SCC for the purposes of enabling SCC to provide the Services, including providing access to staff and technical data, as SCC may reasonably need concerning the Customer’s operations; and • timely responses to queries, decisions and approvals which may be reasonably necessary for SCC to undertake any of the Services, and the Customer shall ensure that information and answers provided in accordance with this Clause (a) are accurate and complete. SCC shall, to the extent reasonably practicable, give the Customer reasonable prior notice of any information or answers it requires in accordance with this Clause (a) and shall promptly notify the Customer if it has reason to suspect that any information is inaccurate or incomplete; • provide full and safe access to the Customer Site, facilities, equipment, materials and telecommunications facilities as SCC shall reasonably require in order to provide the Services; • ensure that all personnel assigned by the Customer to provide assistance to SCC have the requisite skill, qualification and experience to perform the tasks assigned to them; • (unless otherwise specified in an Order) obtain all necessary permissions, consents, permits or licences for SCC to perform the Services at the Customer Site, including any consents required for any alterations to the Customer Site; • take up or remove any fittings or fixed floor coverings, ceiling tiles, suspended ceilings and partition covers as advised by SCC (or its representative) to permit installation of the Services and make good the same; • if an Order includes Supported Equipment the provisions below shall apply to such Order: • allow SCC (or Third Party Vendor), at SCC’s request and at no additional charge, to modify Supported Equipment to improve operation, supportability, and reliability, or to meet legislative requirements; • comply with any technical specifications relevant to the Supported Equipment and licence terms relevant to the Supported Equipment; • (where applicable to the Services) keep confidential any passwords, logon codes and other access methods to the Services. SCC shall not be liable for any disclosure by the Customer of the same, whether intentional or otherwise; • unless otherwise specified in an Order (including a Service Annex), provide all necessary computer hardware, software and/or telecommunications equipment and services necessary for the Customer to access and use the Services; and • where necessary for the access and use of the Services, obtain a licence from the relevant Third Party Vendor to use the software (including the Third Party Software). • In connection with any Services and/or Supported Equipment to be provided and/or located at the storage ofCustomer Site, the Customer shall: • at all times provide: • suitable secure accommodation, assistance, facilities and environmental conditions, including protection from weather and appropriate heating and ventilation, for the installation and housing of the Supported Equipment; and • all necessary electrical power supplies (including back-up) and other installations and fittings for the commissioning and provision of the Services, and the Customer shall at its own cost ensure that: • such preparation and provision is effected at the Customer’s sole cost before the Services and Supported Equipment are installed and are in accordance with any reasonable specifications provided by SCC; and • any restoration and re-decorating at the Customer Site is performed; • allow and/or procure that: • SCC has an unencumbered and free right of access to the Customer Site during Working Hours for the purpose of delivering the Services; and • SCC’s employees, subcontractors and/or agents have safe and sufficient access to the Supported Equipment to allow SCC to provide the Services. • Unless otherwise specified in the Order and if an Order includes Supported Equipment, the Customer shall: • ensure that any programs or data stored on the Supported Equipment are virus free and full back up copies of all such programs and data are made and retained by the Customer; • connect Supported Equipment with cables or connectors (including fibre optics if applicable) that are compatible with the Supported Equipment and, where relevant, interface with SCC's equipment and which are in accordance with the Third Party Vendor's and/or SCC's instructions; • ensure that all equipment connected to a Service is connected to and used with the Service in accordance with the Third Party Vendor's and/or SCC's instructions and any safety and security procedures notified to the Customer; • maintain details relating to Supported Equipment, including the location, serial numbers and any Third Party Vendor-designated system identifiers and labels for such Supported Equipment; • maintain all Supported Equipment at the latest specified configuration and revision levels; • ensure that where employees use the Supported Equipment, such employees are competently trained to do so; • promptly notify SCC of any faults in the operation of the Supported Equipment and give SCC a minimum of ten (10) Business Days' prior written notice of any Modification to the Supported Equipment prior to such Modification being carried out. SCC shall: • acknowledge the Modification in writing; and • notify the Customer if any proposed alteration to the Charges due to such Modification or if such Modification is accepted (such acceptance not being unreasonably withheld or delayed), and any stability studies performed onModification should be made in accordance with industry standards and the Customer shall only use products and parts approved by the relevant SCC or the relevant Third Party Vendor; • ensure the external surfaces of the Supported Equipment are kept clean and in good condition; • only use consumables recommended by SCC or the relevant Third Party Vendor; • not request, permit or authorise any third party other than SCC or the relevant Third Party Vendor to carry out any modifications, adjustments, repairs or maintenance to the Supported Equipment (or any part of it) without the prior consent of SCC or the relevant Third Party Vendor; and • save for mobile hardware, not move the Supported Equipment or any part of it to another site without providing SCC with a minimum of thirty (30) calendar days' prior written notification of any such move of Supported Equipment to another Customer Site. In such event, the Product LotsCustomer accepts movement of Supported Equipment to a new Customer Site may result in changes to the Service Levels and/or Charges for any Service relevant to that Supported Equipment and, in terms of a new location outside of the United Kingdom, shall also be subject to availability in the destination country. • Unless such Services are expressly stated as being the responsibility of SCC in the relevant Order, the Customer shall be solely responsible for the performance and management of its data back-up and data recovery and SCC shall have no liability whatsoever for the back-up or recovery of the Customer's data. If the Customer requests SCC to provide any assistance in respect of such Excluded Services following execution of an Order which does not include the same, such Excluded Services and the charges for the same shall be agreed by the Parties in accordance with the Change Control Procedure. • SCC maintains title and the Customer shall bear the risk of loss or damage (unless such loss or damage is caused by SCC or its personnel) to any: • equipment provided by SCC during the performance of the Services, unless otherwise agreed in writing between the Parties; or • loan units, if provided at SCC’s discretion as part of the Services or warranty services and such loan units will be returned to SCC without lien or encumbrance at the end of the loan period. • The Customer shall not charge, mortgage or otherwise deal with any of the equipment referred to in Clause and use all reasonable efforts to prevent third parties from asserting rights in relation to such equipment.
Appears in 1 contract
Samples: Framework Agreement
Product Supply. The Parties parties shall reasonably cooperate with respect to Product supply 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”) manufacture as set forth in the Transition Plan. In connection with the Transition Plan, each Seller Party will maintain in full force and effect and perform its obligations under the applicable agreements set forth on Exhibit A attached hereto 6.05 as promptly set forth on such Exhibit 6.05. To the extent Purchaser requests assignment of any applicable agreement set forth on Exhibit 6.05 after the Closing to Purchaser and the consent of a third party thereto is required for such assignment, each Seller Party and Purchaser will cooperate, in all reasonable respects, to seek to obtain such third party consent as reasonably practicable following the Effective Date; soon as practicable, provided, however, that neither no Seller Party shall be required to pay money make any payments, incur any liability or agree 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 undertakings in connection therewith. The Parties have entered into a Quality Agreement substantially If such third party consent is not obtained, or if an attempted assignment or transfer of such agreement would be ineffective or would affect the rights thereunder so that Purchaser would not receive all such rights, then, in each such case and until such consent is obtained, each Seller Party and Purchaser (i) will cooperate, in all reasonable respects, to provide to Purchaser the form attached hereto as Exhibit F, dated as of benefits under such agreement (with Purchaser entitled to all 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 gains 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 the costs, losses, Taxes, liabilities and expenses in connection with obligations thereunder) and (ii) will enter into such arrangements (including subcontracting if permitted) as may be reasonably necessary to provide to the storage parties hereto the economic and operational equivalent of obtaining such third party consent and assigning or transferring such agreement, including enforcement by each applicable Seller Party for the benefit of Purchaser of all claims or rights arising thereunder, and the performance by Purchaser of the obligations thereunder on a prompt and punctual basis. Purchaser agrees to indemnify and hold each Seller Party and its Affiliates, agents, successors and assigns harmless from and against any and all liabilities based upon, arising out of or relating to Purchaser’s performance of, and or failure to perform, such obligations under such agreement. Notwithstanding the foregoing, this Agreement shall not constitute an agreement to assign or transfer any stability studies performed onagreement, or any claim, right or benefit arising thereunder or resulting therefrom, if an attempted assignment or transfer thereof, without the Product Lotsconsent of a third party thereto would constitute a breach thereof.
Appears in 1 contract
