Common use of Delivery Terms Clause in Contracts

Delivery Terms. BII shall (a) deliver to XENCOR or, (b) at the request of XENCOR, store, the agreed amounts of the Product produced according to the Project Plan in accordance with agreed upon schedule, at the price set forth in the Project Plan. Delivery of Product by BII shall be made [...***...] BII Facility (Incoterms 2010). BII shall package and arrange for shipment of Product to the delivery address specified by XENCOR, all in accordance with the instructions of XENCOR provided that BII shall not be responsible for any damages with respect to Product or third party claims arising out of such arrangements for shipment of Product after delivery of such Product to the shipper in accordance with such instructions in accordance with XENCOR’s instructions. Each shipment of cGMP Product will include a Certificate of Analysis, a Confirmation of Compliance and such other documentation as reasonably required to meet all applicable statutory and regulatory requirements. Delivery of the Product shall be subject to quality and other provisions set forth in the QAA. The Parties shall cooperate reasonably to obtain all customs licenses or permits necessary to ship the Product (the evaluation of which customs licenses or permits required shall be performed by XENCOR), and no shipment shall be made until such licenses or permits, if any, have been obtained. XENCOR shall diligently examine all Product delivered under this Agreement as soon as practicable after receipt. Notice of all claims arising out of or relating to Obvious Defects shall be given in writing to BII within [...***...] after the date of XENCOR’s receipt of Product, otherwise, such Product shall be considered free of any Obvious Defects as between BII and XENCOR. XENCOR shall make a damaged Product available for inspection and shall comply with the requirements of any insurance policy covering the Product, and BII shall offer XENCOR all reasonable assistance, at the cost and expense of XENCOR, in pursuing any claims arising out of the transportation of the Product. Except as otherwise provided herein and as set forth in Section 2.5, XENCOR shall have [...***...] after the date of XENCOR’s receipt of Product, for all claims arising out of or relating to any Latent Defects and to reject such delivered Product for Latent Defects; provided, however that XENCOR shall only be permitted to reject the Product if the Acceptance Criteria are not met. If XENCOR determines after reviewing the relevant documentation and performing reasonable testing that any Batch does not meet the Acceptance Criteria, or if Product is determined by BII to be unsuitable for release, then the Parties will mutually agree, as promptly as reasonably possible, whether (a) to produce a new Batch at BII’s cost and expense, including the costs of materials used in the manufacture of such Batch, or (b) to rework or reprocess the Batch, at BII’s cost and expense, so that the Batch can be deemed to have been manufactured in compliance with cGMP and the agreed Process Description, and to conform to the Acceptance Criteria (provided that the Parties have mutually agreed in writing on any procedures for reworking or reprocessing a Batch). If the remedy set forth in either (a) or (b) is agreed to be performed by BII, then BII shall start the applicable work as soon as reasonably practicable, such that the next reasonably available (taking into consideration BII’s entire contract manufacturing business) manufacturing slot shall be used by BII to produce Product, and BII will use commercially reasonable efforts to resupply within [...***...] but in any event no later than [...***...] from time of rejection by XENCOR. For the avoidance of doubt, if Product is not accepted by XENCOR as provided above, then BII’s obligations set forth above shall apply both to the drug product and the bulk drug substance contained therein. In the event XENCOR rejects the Product for Obvious Defects or Latent Defects as provided above, BII shall have the right to sample and retest the Product, which shall be done as soon as practicable, provided that, if BII does not notify XENCOR in writing of its election to retest the Product within [...***...] after notice of rejection from XENCOR, BII shall be deemed to agree with XENCOR’s rejection of the Product. In the event of a discrepancy between XENCOR’s and BII’ s test results such that one Party’s results fall within the Acceptance Criteria and the other Party’s test results fall outside the Acceptance Criteria, or there exists a dispute over whether such failure is due (in whole or in part) to acts or omissions of XENCOR or any third party after delivery, the Parties shall cause a testing laboratory agreeable to both Parties to perform comparative tests and/or analyses on samples of the alleged defective Product. The testing laboratory’s results shall be in writing and shall be final and binding save for manifest error on the face of its report. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the testing laboratory result finally rules. The testing laboratory shall be required to enter into written undertakings of confidentiality no less burdensome than set forth or referred to by this Agreement.

Appears in 3 contracts

Sources: Collaboration Agreement (Xencor Inc), Collaboration Agreement (Xencor Inc), Collaboration Agreement (Xencor Inc)

Delivery Terms. BII shall (a) deliver to XENCOR or, (b) at the request of XENCOR, store, the agreed amounts of the Product produced according to the Project Plan in accordance with agreed upon schedule, at the price set forth in the Project Plan. Delivery of Product by BII shall be made [...***...] BII Facility (Incoterms 2010). BII shall package and arrange for shipment of Product to the delivery address specified by XENCOR, all in accordance with the instructions of XENCOR provided that BII shall not be responsible for any damages with respect to Product or third party claims arising out of such arrangements for shipment of Product after delivery of such Product to the shipper in accordance with such instructions in accordance with XENCOR’s instructions. 6.1 Each shipment of cGMP Product will include a Certificate Gold Bars shall be shipped to the Nominated International Airport and, upon Customs clearance by the Import Country Customs Authorities shall be delivered by the Seller to the Security Company, to be transferred and kept by the Security Company in their Bonded Warehouse for the purposes of Analysis, a Confirmation of Compliance and such other documentation as reasonably required this Agreement. The Security Company shall deliver the Gold bars to meet all applicable statutory and regulatory requirements. Delivery the Buyer’s Refinery or Smelting Company or Assayer in the presence of the Product Seller (or their authorized representatives in this agreement), in case they are present, as per Clause 7. 6.2 All Gold Bars shall be subject insured by the Seller against all risks until delivery to quality the Buyer pursuant to the terms of this Agreement on the Seller’s expense. 6.3 The export document processing, taxes, duties, freight & insurance costs and other provisions set forth in the QAA. The Parties shall cooperate reasonably expenses imposed on or required up to obtain all customs licenses or permits necessary to ship the Product (the evaluation of which customs licenses or permits required shall be performed by XENCOR), and no shipment shall be made until such licenses or permits, if any, have been obtained. XENCOR shall diligently examine all Product delivered under this Agreement as soon as practicable after receipt. Notice of all claims arising out of or relating to Obvious Defects shall be given in writing to BII within [...***...] after the date of XENCOR’s receipt of Product, otherwise, such Product shall be considered free of any Obvious Defects as between BII and XENCOR. XENCOR shall make a damaged Product available for inspection and shall comply with the requirements of any insurance policy covering the Product, and BII shall offer XENCOR all reasonable assistance, at the cost and expense of XENCOR, in pursuing any claims arising out delivery of the transportation of the Product. Except as otherwise provided herein and as set forth in Section 2.5, XENCOR shall have [...***...] after the date of XENCOR’s receipt of Product, for all claims arising out of or relating to any Latent Defects and to reject such delivered Product for Latent Defects; provided, however that XENCOR shall only be permitted to reject the Product if the Acceptance Criteria are not met. If XENCOR determines after reviewing the relevant documentation and performing reasonable testing that any Batch does not meet the Acceptance Criteria, or if Product is determined by BII to be unsuitable for release, then the Parties will mutually agree, as promptly as reasonably possible, whether (a) to produce a new Batch at BII’s cost and expense, including the costs of materials used in the manufacture of such Batch, or (b) to rework or reprocess the Batch, at BII’s cost and expense, so that the Batch can be deemed to have been manufactured in compliance with cGMP and the agreed Process Description, and to conform Gold Bars to the Acceptance Criteria (provided that the Parties have mutually agreed in writing on any procedures for reworking or reprocessing a Batch). If the remedy set forth in either (a) or (b) is agreed to be performed by BIINominated International Airport, then BII shall start the applicable work as soon as reasonably practicable, such that the next reasonably available (taking into consideration BII’s entire contract manufacturing business) manufacturing slot shall be used by BII to produce Product, and BII will use commercially reasonable efforts to resupply within [...***...] but in any event no later than [...***...] from time of rejection by XENCOR. For the avoidance of doubt, if Product is not accepted by XENCOR as provided above, then BII’s obligations set forth above shall apply both to the drug product and the bulk drug substance contained therein. In the event XENCOR rejects the Product for Obvious Defects or Latent Defects as provided above, BII shall have the right to sample and retest the Product, which shall be done as soon as practicable, provided that, if BII does not notify XENCOR in writing of its election to retest the Product within [...***...] after notice of rejection from XENCOR, BII shall be deemed to agree with XENCOR’s rejection of the Product. In the event of a discrepancy between XENCOR’s and BII’ s test results such that one Party’s results fall within the Acceptance Criteria and the other Party’s test results fall outside the Acceptance Criteria, or there exists a dispute over whether such failure is due (in whole or in part) to acts or omissions of XENCOR or any third party after delivery, the Parties shall cause a testing laboratory agreeable to both Parties to perform comparative tests and/or analyses on samples of the alleged defective Product. The testing laboratory’s results shall be in writing and shall be final and binding save for manifest error on the face of its report. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom Seller. 6.4 The import procedure (including clearance by the testing laboratory result finally rules. The testing laboratory Import Country customs authorities) shall be required the responsibility of the Seller, provided however that all associated fees taxes and levies, as well as, all security transport and associated costs from the Nominated International Airport to enter into written undertakings the Bonded Warehouse, including cost of confidentiality assaying, etc. and until the moment of transfer of ownership or termination of the Agreement pursuant to Clause 12 herein shall be borne and paid directly by the Seller, including the expenses of re-smelting or refined in case the Gold Bars sent by the Seller are not homogeneous which, if paid by the Buyer, will be deducted from the Final Commercial Invoice; 6.5 The Seller is obligated to notify the Buyer at least three (3) days prior to shipment all details of the airline, date of loading at the export country, flight number, date and time of arrival at the Import Country. Failure to do so may result in delays in Customs Clearance, and/or Assaying, and/or refining, and the Buyer shall be held harmless and blameless. 6.6 The Buyer undertakes to use its reasonable endeavours, subject always to applicable law, to facilitate the Seller in order to obtain clearance of the Gold Bars by the Import Country customs authorities; to this end the Buyer shall, should the Seller requires so, designate to the Seller any licensed customs clearance third parties or shall make available to the Seller any ▇▇▇▇▇’s licensed customs clearance personnel. 6.7 All delivery dates mentioned in this agreement assume that the Seller notifies the Buyer at least four (4) days in advance and the Customs Clearance Agents, the Assayer and especially the Refinery or Smelting Company that the gold bars will be taken for re-smelting or refined if they are not homogeneous agree to do it on the estimated time as planned in this agreement if everything runs smoothly, otherwise there may be delays beyond the Buyer’s control, since all the service providers (Security Company, Customs Brokers, Assayers, Refineries, Smelting Companies) are in no less burdensome than set forth or referred to way controlled by this Agreementthe Buyer and they will quote their own delivery times.

Appears in 2 contracts

Sources: Sale and Purchase Agreement, Sale and Purchase Agreement

Delivery Terms. BII shall (a) deliver to XENCOR or, (b) at the request of XENCOR, store, the agreed amounts of the Product produced according to the Project Plan in accordance with agreed upon schedule, at the price set forth in the Project Plan. Delivery of Product by BII shall be made [...***...] BII Facility (Incoterms 2010). BII shall package and arrange for shipment of Product to the delivery address specified by XENCOR, all in accordance with the instructions of XENCOR provided that BII shall not be responsible for any damages with respect to Product or third party claims arising out of such arrangements for shipment of Product after delivery of such Product to the shipper in accordance with such instructions in accordance with XENCOR’s instructions. 6.1 Each shipment of cGMP Product will include a Certificate Gold Bars shall be shipped to the Nominated International Airport and, upon Customs clearance by the Import Country Customs Authorities shall be delivered by the Seller to the Security Company, to be transferred and kept by the Security Company in their Bonded Warehouse for the purposes of Analysis, a Confirmation of Compliance and such other documentation as reasonably required this Agreement. The Security Company shall deliver the Gold bars to meet all applicable statutory and regulatory requirements. Delivery the Buyer’s Refinery or Smelting Company or Assayer in the presence of the Product Seller (or their authorized representatives in this agreement), in case they are present, as per Clause 7. 6.2 All Gold Bars shall be subject insured by the Seller against all risks until delivery to quality the Buyer pursuant to the terms of this Agreement on the Seller’s expense. 6.3 The export document processing, taxes, duties, freight & insurance costs and other provisions set forth in the QAA. The Parties shall cooperate reasonably expenses imposed on or required up to obtain all customs licenses or permits necessary to ship the Product (the evaluation of which customs licenses or permits required shall be performed by XENCOR), and no shipment shall be made until such licenses or permits, if any, have been obtained. XENCOR shall diligently examine all Product delivered under this Agreement as soon as practicable after receipt. Notice of all claims arising out of or relating to Obvious Defects shall be given in writing to BII within [...***...] after the date of XENCOR’s receipt of Product, otherwise, such Product shall be considered free of any Obvious Defects as between BII and XENCOR. XENCOR shall make a damaged Product available for inspection and shall comply with the requirements of any insurance policy covering the Product, and BII shall offer XENCOR all reasonable assistance, at the cost and expense of XENCOR, in pursuing any claims arising out delivery of the transportation of the Product. Except as otherwise provided herein and as set forth in Section 2.5, XENCOR shall have [...***...] after the date of XENCOR’s receipt of Product, for all claims arising out of or relating to any Latent Defects and to reject such delivered Product for Latent Defects; provided, however that XENCOR shall only be permitted to reject the Product if the Acceptance Criteria are not met. If XENCOR determines after reviewing the relevant documentation and performing reasonable testing that any Batch does not meet the Acceptance Criteria, or if Product is determined by BII to be unsuitable for release, then the Parties will mutually agree, as promptly as reasonably possible, whether (a) to produce a new Batch at BII’s cost and expense, including the costs of materials used in the manufacture of such Batch, or (b) to rework or reprocess the Batch, at BII’s cost and expense, so that the Batch can be deemed to have been manufactured in compliance with cGMP and the agreed Process Description, and to conform Gold Bars to the Acceptance Criteria (provided that the Parties have mutually agreed in writing on any procedures for reworking or reprocessing a Batch). If the remedy set forth in either (a) or (b) is agreed to be performed by BIINominated International Airport, then BII shall start the applicable work as soon as reasonably practicable, such that the next reasonably available (taking into consideration BII’s entire contract manufacturing business) manufacturing slot shall be used by BII to produce Product, and BII will use commercially reasonable efforts to resupply within [...***...] but in any event no later than [...***...] from time of rejection by XENCOR. For the avoidance of doubt, if Product is not accepted by XENCOR as provided above, then BII’s obligations set forth above shall apply both to the drug product and the bulk drug substance contained therein. In the event XENCOR rejects the Product for Obvious Defects or Latent Defects as provided above, BII shall have the right to sample and retest the Product, which shall be done as soon as practicable, provided that, if BII does not notify XENCOR in writing of its election to retest the Product within [...***...] after notice of rejection from XENCOR, BII shall be deemed to agree with XENCOR’s rejection of the Product. In the event of a discrepancy between XENCOR’s and BII’ s test results such that one Party’s results fall within the Acceptance Criteria and the other Party’s test results fall outside the Acceptance Criteria, or there exists a dispute over whether such failure is due (in whole or in part) to acts or omissions of XENCOR or any third party after delivery, the Parties shall cause a testing laboratory agreeable to both Parties to perform comparative tests and/or analyses on samples of the alleged defective Product. The testing laboratory’s results shall be in writing and shall be final and binding save for manifest error on the face of its report. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom Seller. 6.4 The import procedure (including clearance by the testing laboratory result finally rules. The testing laboratory Import Country customs authorities) shall be required the responsibility of the Seller, provided however that all associated fees taxes and levies, as well as, all security transport and associated costs from the Nominated International Airport to enter into written undertakings the Bonded Warehouse, including cost of confidentiality assaying, etc. and until the moment of transfer of ownership or termination of the Agreement pursuant to Clause 12 herein shall be borne and paid directly by the Seller, including the expenses of re-smelting or refined in case the Gold Bars sent by the Seller are not homogeneous which, if paid by the Buyer, will be deducted from the Final Commercial Invoice; 6.5 The Seller is obligated to notify the Buyer at least three (3) days prior to shipment all details of the airline, date of loading at the export country, flight number, date and time of arrival at the Import Country. Failure to do so may result in delays in Customs Clearance, and/or Assaying, and/or refining, and the Buyer shall be held harmless and blameless. 6.6 The Buyer undertakes to use its reasonable endeavours, subject always to applicable law, to facilitate the Seller in order to obtain clearance of the Gold Bars by the Import Country customs authorities; to this end the Buyer shall, should the Seller requires so, designate to the Seller any licensed customs clearance third parties or shall make available to the Seller any Buyer’s licensed customs clearance personnel. 6.7 All delivery dates mentioned in this agreement assume that the Seller notifies the Buyer at least four (4) days in advance and the Customs Clearance Agents, the Assayer and especially the Refinery or Smelting Company that the gold bars will be taken for re-smelting or refined if they are not homogeneous agree to do it on the estimated time as planned in this agreement if everything runs smoothly, otherwise there may be delays beyond the Buyer’s control, since all the service providers (Security Company, Customs Brokers, Assayers, Refineries, Smelting Companies) are in no less burdensome than set forth or referred to way controlled by this Agreementthe Buyer and they will quote their own delivery times.

Appears in 2 contracts

Sources: Sale and Purchase Agreement, Sale and Purchase Agreement

Delivery Terms. BII 3.1 Product destined for Lantheus shall (a) deliver be delivered by NTP and its Subcontractor to XENCOR or, (b) the airfreight carrier at the request airport of XENCORdeparture on a **** basis, store, the agreed amounts of the Product produced according to the Project Plan in accordance with agreed upon schedule, at the price which carrier and airport will be set forth in the Project Plansupply schedule provided pursuant to Section 2.2. Delivery of Product by BII shall be made [...***...] BII Facility (Incoterms 2010)*” in this Agreement shall be interpreted in accordance with INCOTERMS 2000 as amended. BII All export permits and licenses shall package be obtained by NTP or its Subcontractor, as necessary to meet the shipping requirements set forth herein. NTP and arrange its Subcontractor shall use their best efforts to ensure that all Product destined for Lantheus is loaded onboard a commercial airfreight carrier accepting radioactive shipments and that such carrier actually departs the departure airport with such Product. Upon execution of this Agreement, NTP shall commence negotiations and use best efforts to obtain a firm, written commitment from the relevant air carriers for delivery of at least the **** volume of Product required to be purchased by and destined for Lantheus hereunder. 3.2 NTP and its Subcontractor shall procure and manage transportation on Lantheus’ behalf by air or on land and in accordance with Lantheus’ instructions for delivery to JFK. Lantheus shall make all shipping arrangements to ship Product from JFK to the final destination. NTP and its Subcontractor agree to assist Lantheus with making the arrangements for the transshipment, including, without limitation, providing shipping documentation such as air waybills. If the information provided by NTP in the documentation provided by NTP is incorrect or incomplete and this incorrect or incomplete information delays the delivery of Product to Lantheus to such an extent that Lantheus cannot use Product at its scheduled production time then Lantheus will be relieved of it’s obligation to purchase the delayed Product and NTP shall grant Lantheus a purchase credit for the full amount of the price of the Product. 3.3 All costs in respect of transporting any shipment of Product on a **** basis from the airport of departure as set forth above, shall be for the account of ****. NTP and its Subcontractor shall pre-pay such shipping costs and invoice Lantheus accordingly for actual out-of-pocket costs incurred. 3.4 Risk of loss and title to Product shall transfer from NTP or its Subcontractor to Lantheus on **** (“****”) of such shipment from the delivery address specified **** after acceptance of a Product shipment by XENCOR, all in accordance the ****. For clarity if Product is not on the **** at **** then title for Product shall remain with the instructions of XENCOR provided that BII shall NTP and Lantheus will not be responsible for any damages obligated to purchase the Product. Lantheus will work with respect NTP in good faith and at Lantheus’ sole discretion to accept the Product or third party claims arising out of such arrangements for shipment of Product after at a later time. If a later delivery of such Product is agreed to NTP will adjust the shipper in accordance with such instructions in accordance with XENCOR’s instructions. Each shipment of cGMP Product will include a Certificate of Analysis, a Confirmation of Compliance and such other documentation as reasonably required to meet all applicable statutory and regulatory requirements. Delivery volume of the Product delivered to reflect decay over the time of the delay. 3.5 Subject to the foregoing obligations of this Section 3, shipping arrangements shall be subject to quality and other provisions the availability of commercial airfreight services accepting radioactive shipments on the days necessary to meet the shipping requirements set forth in the QAA. The Parties shall cooperate reasonably to obtain all customs licenses or permits necessary to ship the Product (the evaluation of which customs licenses or permits required shall be performed by XENCOR), and no shipment shall be made until such licenses or permits, if any, have been obtained. XENCOR shall diligently examine all Product delivered under this Agreement as soon as practicable after receipt. Notice of all claims arising out of or relating to Obvious Defects shall be given in writing to BII within [...***...] after the date of XENCOR’s receipt of Product, otherwise, such Product shall be considered free of any Obvious Defects as between BII and XENCOR. XENCOR shall make a damaged Product available for inspection and shall comply with the requirements of any insurance policy covering the Product, and BII shall offer XENCOR all reasonable assistance, at the cost and expense of XENCOR, in pursuing any claims arising out of the transportation of the Product. Except as otherwise provided herein and as set forth in Section 2.5, XENCOR shall have [...***...] after the date of XENCOR’s receipt of Product, for all claims arising out of or relating to any Latent Defects and to reject such delivered Product for Latent Defects; provided, however that XENCOR shall only be permitted to reject the Product if the Acceptance Criteria are not met. If XENCOR determines after reviewing the relevant documentation and performing reasonable testing that any Batch does not meet the Acceptance Criteria, or if Product is determined by BII to be unsuitable for release, then the Parties will mutually agree, as promptly as reasonably possible, whether (a) to produce a new Batch at BII’s cost and expense, including the costs of materials used in the manufacture of such Batch, or (b) to rework or reprocess the Batch, at BII’s cost and expense, so that the Batch can be deemed to have been manufactured in compliance with cGMP and the agreed Process Description, and to conform to the Acceptance Criteria (provided that the Parties have mutually agreed in writing on any procedures for reworking or reprocessing a Batch). If the remedy set forth in either (a) or (b) is agreed to be performed by BII, then BII shall start the applicable work as soon as reasonably practicable, such that the next reasonably available (taking into consideration BII’s entire contract manufacturing business) manufacturing slot shall be used by BII to produce Product, and BII will use commercially reasonable efforts to resupply within [...***...] but in any event no later than [...***...] from time of rejection by XENCOR. For the avoidance of doubt, if Product is not accepted by XENCOR as provided above, then BII’s obligations set forth above shall apply both to the drug product and the bulk drug substance contained therein. In the event XENCOR rejects the Product for Obvious Defects or Latent Defects as provided above, BII shall have the right to sample and retest the Product, which shall be done as soon as practicable, provided that, if BII does not notify XENCOR in writing of its election to retest the Product within [...***...] after notice of rejection from XENCOR, BII shall be deemed to agree with XENCOR’s rejection of the Productherein. In the event of a discrepancy between XENCOR’s changes in the availability of existing airfreight services on such days, NTP or its Subcontractor shall promptly notify Lantheus and, upon such notification, NTP and BII’ s test results such that one Party’s results fall within the Acceptance Criteria its Subcontractor and Lantheus shall work together to find mutually acceptable alternatives. 3.6 All air waybill numbers of NTP or its Subcontractor and the other Partyidentification number of each container to be used for each month’s test results fall outside scheduled shipments, shall be forwarded to Lantheus as mutually agreed. 3.7 Promptly upon its receipt at Lantheus’ facility, Lantheus shall inspect Product and if Product does not conform to the Acceptance Criteriaspecifications set out in Exhibit A (including, without limitation, calibration as provided in Section 2.1), Lantheus shall promptly notify NTP of any such non-compliance with specification. Immediately upon NTP’s receipt of such notice, NTP and its Subcontractor shall make arrangements, at Lantheus’ sole discretion, either to replace such nonconforming Product at no extra cost or there exists to grant Lantheus a dispute over whether purchase credit in the amount of the price to Lantheus of such failure is due (in whole or in part) to acts or omissions nonconforming Product. Lantheus and NTP shall immediately consult on the disposition of XENCOR or any third party after deliverysuch nonconforming Product. Unless NTP and Lantheus agree otherwise, Lantheus shall discard such nonconforming Product, and NTP shall indemnify Lantheus for the cost of disposal. Alternatively, the Parties shall cause a testing laboratory agreeable parties may agree that nonconforming Product may be returned to both Parties to perform comparative tests and/or analyses on samples of the alleged defective Product. The testing laboratoryNTP for disposal at NTP’s results shall be in writing and shall be final and binding save for manifest error on the face of its report. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the testing laboratory result finally rules. The testing laboratory shall be required to enter into written undertakings of confidentiality no less burdensome than set forth or referred to by this Agreementcost.

Appears in 2 contracts

Sources: Sales Agreement (Lantheus MI Intermediate, Inc.), Sales Agreement (Lantheus MI Intermediate, Inc.)

Delivery Terms. BII shall a. Seller will furnish and pay for all labor, work, supervision, materials, tools, apparatuses, utilities and other items necessary to provide the Goods and Services, except as otherwise specified in writing by Buyer. If Seller Group uses any materials, equipment, tool, apparatus or utility owned or leased by Buyer (aor Buyer’s other contractors) deliver to XENCOR orprovide Goods and Services, whether authorized by Buyer (bor Buyer’s other contractors, as applicable) or not, such use will be entirely at Seller’s risk. All Goods and Services provided to Buyer under this Agreement will meet the applicable Specifications, if any. It is understood that, notwithstanding any Specifications or other expressed descriptions of Goods and Services to be provided hereunder, Buyer is relying on Seller's skill and judgment to provide such Goods and Services. b. All Services will be performed so as to minimize interference with the operations at the request Site. In the course of XENCORperforming Services, storeSeller will keep the Site free from accumulation of waste materials and rubbish. Upon completion of Services, Seller will remove all waste materials, rubbish, tools, scaffolding, equipment, surplus materials and all other items belonging to Seller Group from the agreed amounts Site and leave the Site "broom clean.” As between the Parties, Seller will bear the full risk of, and will make good, damages or losses to Goods and Services being provided prior to completion of the Product produced according applicable project (except to the Project Plan extent damage is caused by the fault of Buyer) and will deliver Services complete and in accordance with agreed upon schedulethe Agreement. c. No Change Order will be made unless pursuant to a written order issued in advance by Buyer and accepted by Seller, at and no claim for an addition to or reduction of the price Contract Price or for an extension or reduction of any time(s) of performance caused thereby will be valid unless pursuant to a Change Order. Upon Seller’s acceptance of a Change Order, Seller will promptly commence performance of such Change Order in accordance with the applicable provisions of the Agreement. As to Goods and Services required because of such Change Order, for which no unit prices are set forth in the Project Plan. Delivery of Product Agreement, Seller will proceed on a fixed price or cost reimbursable basis, as agreed to by BII shall be made [...***...] BII Facility (Incoterms 2010). BII shall package and arrange for shipment of Product both Parties; provided however, to the extent performance of the Change Order does not result in net additional cost or require net additional effort or resources, the Change Order will not result in any increase in the Contract Price. d. To the extent particular Goods and Services require the preparation and delivery address specified of new or modified plans, drawings, designs, or other documents by XENCORSeller Group, and at the time(s) agreed to by the Parties (or, if no such time is so agreed to, at the time of delivery of the Goods and Services), Seller will deliver to Buyer the following: (i) Seller’s detailed operational and maintenance manual(s) applicable to the Goods and Services; (ii) a full final set of “as-built” drawings and all in accordance with other drawings, designs, diagrams or plans necessary for the installation, operation, maintenance, modification, repair, and or training relating to the applicable equipment; (iii) a writing of all critical instructions of XENCOR provided that BII shall not be responsible for any damages and recommendations with respect to Product the installation, operation, maintenance, modification and/or repair of the applicable equipment that are given by Seller to Buyer verbally or third party claims arising out in other intangible format; (iv) a list of recommended consumable parts typically replaced within the first 90 days of such arrangements equipment’s first use; (v) a complete list of recommended spare parts suitable for shipment of Product after delivery the overhaul and preventative maintenance of such Product equipment; and (vi) all other documents, photographs, reports, presentations, analyses, electronic recordings or other Deliverables to be provided by Seller relating to the shipper in accordance particular equipment. Any list provided pursuant to (iv) and (v) will be consistent with such instructions in accordance with XENCORSpecifications and will show unit price and original manufacturer’s instructionsname and part number. Each shipment of cGMP Product will include a Certificate of Analysis, a Confirmation of Compliance and such other documentation as reasonably required to meet all applicable statutory and regulatory requirements. Delivery of the Product shall be subject to quality and other provisions set forth in the QAA. The Parties shall cooperate reasonably to obtain all customs licenses or permits necessary to ship the Product (the evaluation of which customs licenses or permits required shall be performed by XENCOR), and no shipment shall be made until such licenses or permits, if any, have been obtained. XENCOR shall diligently examine all Product delivered under this Agreement as soon as practicable after receipt. Notice of all claims arising out of or relating to Obvious Defects shall be given in writing to BII within [...***...] after the date of XENCOR’s receipt of Product, otherwise, such Product shall be considered free of any Obvious Defects as between BII and XENCOR. XENCOR shall make a damaged Product available for inspection and shall comply with the requirements of any insurance policy covering the Product, and BII shall offer XENCOR all reasonable assistance, at the cost and expense of XENCOR, in pursuing any claims arising out of the transportation of the Product. Except as otherwise provided herein and as set forth in Section 2.5, XENCOR shall have [...***...] after the date of XENCOR’s receipt of Product, for all claims arising out of or relating to any Latent Defects and to reject such delivered Product for Latent Defects; provided, however that XENCOR shall only be permitted to reject the Product if the Acceptance Criteria are not met. If XENCOR determines after reviewing the relevant documentation and performing reasonable testing that any Batch does not meet the Acceptance Criteria, or if Product is determined by BII to be unsuitable for release, then the Parties will mutually agree, as promptly as reasonably possible, whether (a) to produce a new Batch at BII’s cost and expense, including the costs of materials used in the manufacture of such Batch, or (b) to rework or reprocess the Batch, at BII’s cost and expense, so that the Batch can be deemed to have been manufactured in compliance with cGMP and the agreed Process Description, and to conform to the Acceptance Criteria (provided that the Parties have mutually agreed in writing on any procedures for reworking or reprocessing a Batch). If the remedy set forth in either (a) or (b) is agreed to be performed by BII, then BII shall start the applicable work as soon as reasonably practicable, such that the next reasonably available (taking into consideration BII’s entire contract manufacturing business) manufacturing slot shall be used by BII to produce Product, and BII will use commercially reasonable efforts to resupply within [...***...] but in any event no later than [...***...] from time of rejection by XENCOR. For the avoidance of doubt, if Product is not accepted by XENCOR as provided above, then BII’s obligations set forth above shall apply both to the drug product and the bulk drug substance contained therein. In the event XENCOR rejects the Product for Obvious Defects or Latent Defects as provided above, BII shall have Buyer has the right to sample copy and retest the Product, which shall be done distribute such documentation as soon as practicable, provided that, if BII does not notify XENCOR in writing of needed for its election to retest the Product within [...***...] after notice of rejection from XENCOR, BII shall be deemed to agree with XENCOR’s rejection of the Product. In the event of a discrepancy between XENCOR’s and BII’ s test results such that one Party’s results fall within the Acceptance Criteria and the other Party’s test results fall outside the Acceptance Criteria, or there exists a dispute over whether such failure is due (in whole or in part) to acts or omissions of XENCOR or any third party after delivery, the Parties shall cause a testing laboratory agreeable to both Parties to perform comparative tests and/or analyses on samples of the alleged defective Product. The testing laboratory’s results shall be in writing and shall be final and binding save for manifest error on the face of its report. Affiliates internal purposes. e. Unless otherwise agreed to by the Parties in writingParties, (i) any Goods will be delivered by Seller to Buyer DDP the costs associated with such testing and review shall be borne by the Party against whom the testing laboratory result finally rules. The testing laboratory shall be required to enter into written undertakings of confidentiality no less burdensome than set forth or referred to by this Agreement.Site (Incoterms 2020),

Appears in 1 contract

Sources: Master Purchase Agreement

Delivery Terms. BII shall (a) deliver The Buyer provides the Seller with full and timely information about the Place of Destination and the Carrier, including any special location access instructions and all contact information of the Carrier. The named information is to XENCOR orbe provided to the Seller via facsimile or by other means agreed upon by the Parties, at least 5 (five) Business Days prior to each scheduled date of shipment of the Goods by the Seller. Such information can be changed by the Buyer with written notification to the Seller and no later than 1 (one) Business Day before each scheduled shipment. The information must include: i. The name of the Carrier (person or entity). ii. Documentation testifying ▇▇▇▇▇▇▇’s rights to accept and carry the Goods (should be presented by the Carrier at delivery). iii. The identity, location and address of Place of Destination, with instructions for access to the Place of Destination. iv. Any other information requested by the Seller. b) at the request of XENCOR, storeIf applicable, the agreed amounts of the Product produced according to the Project Plan in accordance with agreed upon schedule, at the price set forth in the Project Plan. Delivery of Product by BII Nomination shall be made [...***...] BII Facility (Incoterms 2010). BII shall package and arrange for shipment of Product to the delivery address specified by XENCOR, all in accordance with the PTC. c) Immediately upon the receipt of Seller’s Nomination, but not later than one day from the receipt of Seller’s Nomination, the Buyer shall provide the Seller with full written instructions regarding the particulars for the Bills of XENCOR provided that BII shall not be responsible Lading including consignee, contact details and address of the authorized person of the consignee, other information necessary for any damages with respect to Product or third party claims arising out the delivery and reasonably required by the Seller, number of such arrangements for shipment of Product after delivery of such Product to the shipper in accordance with such instructions in accordance with XENCOR’s instructionscopies, addresses, etc. Each shipment of cGMP Product will include a Certificate of Analysis, a Confirmation of Compliance and such other documentation as reasonably information which may be required to meet all applicable statutory and regulatory requirements. Delivery by the Place of Shipment, Place of Destination and/or the Product shall be subject to quality and other provisions set forth in the QAASeller. The Parties shall cooperate reasonably to obtain all customs licenses or permits necessary to ship the Product (the evaluation of which customs licenses or permits required shall be performed by XENCOR), and no shipment shall be made until such licenses or permits, if any, have been obtained. XENCOR shall diligently examine all Product delivered under this Agreement as soon as practicable after receipt. Notice of all claims arising out of or relating to Obvious Defects shall be given in writing to BII within [...***...] after the date of XENCOR’s receipt of Product, otherwise, such Product shall be considered free of any Obvious Defects as between BII and XENCOR. XENCOR shall make a damaged Product available for inspection and shall comply with the requirements of any insurance policy covering the Product, and BII shall offer XENCOR all reasonable assistance, at the cost and expense of XENCOR, in pursuing any claims arising out of the transportation of the Product. Except as otherwise provided herein and as set forth in Section 2.5, XENCOR shall have [...***...] after the date of XENCOR’s receipt of Product, for all claims arising out of or relating to any Latent Defects and to reject such delivered Product for Latent Defects; provided, however that XENCOR shall only be permitted to reject the Product if the Acceptance Criteria are not met. If XENCOR determines after reviewing the relevant documentation and performing reasonable testing that any Batch does not meet the Acceptance Criteria, or if Product is determined by BII to be unsuitable for release, then the Parties will mutually agree, as promptly as reasonably possible, whether (a) to produce a new Batch at BII’s cost and expense, including the costs of materials used in the manufacture of such Batch, or (b) to rework or reprocess the Batch, at BII’s cost and expense, so that the Batch can be deemed to have been manufactured in compliance with cGMP and the agreed Process Description, and to conform to the Acceptance Criteria (provided that the Parties have mutually agreed in writing on any procedures for reworking or reprocessing a Batch). If the remedy set forth in either (a) or (b) is agreed to be performed by BII, then BII shall start the applicable work as soon as reasonably practicable, such that the next reasonably available (taking into consideration BII’s entire contract manufacturing business) manufacturing slot shall be used by BII to produce Product, and BII will use commercially reasonable efforts to resupply within [...***...] but in any event no later than [...***...] from time of rejection by XENCOR. For the avoidance of doubt, if Product is not accepted by XENCOR as provided above, then BII’s obligations set forth above shall apply both to the drug product and the bulk drug substance contained therein. In the event XENCOR rejects the Product for Obvious Defects or Latent Defects as provided above, BII Seller shall have the right to sample issue its own instructions if the Buyer fails to provide such instructions and/or information required by this Clause. d) The Parties shall obtain any licenses, permits and retest documents which are necessary for successful import and export clearance of the Product, which Goods. (i) Export permits shall be done as soon as practicable, provided that, if BII does not notify XENCOR in writing of its election to retest timely obtained by the Product within [...***...] after notice of rejection from XENCOR, BII Seller. STRICTLY PRIVATE AND CONFIDENTIAL PTC_V_13.11 (ii) Import permits shall be deemed to agree with XENCOR’s rejection timely obtained by the Buyer. e) All delays for the reason of absence of custom clearance shall be at the expense of the Product. In the event of a discrepancy between XENCOR’s and BII’ s test results such that one liable Party’s results fall within the Acceptance Criteria and the other Party’s test results fall outside the Acceptance Criteria, or there exists a dispute over whether such failure is due (in whole or in part) to acts or omissions of XENCOR or any third party after delivery, the Parties shall cause a testing laboratory agreeable to both Parties to perform comparative tests and/or analyses on samples of the alleged defective Product. The testing laboratory’s results shall be in writing and shall be final and binding save for manifest error on the face of its report. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the testing laboratory result finally rules. The testing laboratory shall be required to enter into written undertakings of confidentiality no less burdensome than set forth or referred to by this Agreement.

Appears in 1 contract

Sources: Purchase Terms and Conditions

Delivery Terms. BII 7.1 The Products shall be delivered by Suisse SA or Quotient as the case may be to OCD FCA (aIncoterms 2010) deliver to XENCOR or, (b) at the request place of XENCOR, storemanufacture. At the time so delivered, the agreed amounts Consumables and Ancillary Products shall have a remaining minimum shelf life of the Product produced according to the Project Plan in accordance with agreed upon schedule, at the price set forth in the Project Plan. Delivery of Product by BII shall be made least [...***...]. Suisse SA shall use its best efforts to extend the shelf life of Consumables so that after the first anniversary of the first to occur of FDA Approval or CE Marking for a Product (excluding a Screening Consumable), such Consumables and Ancillary Products shall have a remaining shelf life of either [***] BII Facility (Incoterms 2010)or at least [***] of the shelf life dictated by the Regulatory Approval when delivered to OCD, whichever is longer. BII Notwithstanding this obligation, the Parties agree to reasonably cooperate and to discuss in good faith prior to shipping the acceptability of non-material deviations from the minimum shelf life. All deliveries of the Products in this manner shall package constitute sales made directly to OCD. OCD shall pay all freight, insurance charges, import duties, inspection fees and arrange for shipment of Product other charges applicable to the delivery address specified transport and receipt by XENCOROCD or its Affiliates, all in accordance with the instructions Sub-Licensees or Sub-Distributors of XENCOR provided that BII Products purchased by OCD hereunder. Title and risk of loss and damage to Products purchased by OCD hereunder shall not be responsible for any damages with respect pass to Product or third party claims arising out of such arrangements for shipment of Product after delivery of such Product to the shipper in accordance with such instructions in accordance with XENCOR’s instructions. Each shipment of cGMP Product will include a Certificate of Analysis, a Confirmation of Compliance and such other documentation as reasonably required to meet all applicable statutory and regulatory requirements. Delivery OCD upon loading of the Product shall Products onto the carrier appointed by OCD. 7.2 OCD acknowledges that the supply of Products and Know-how by Suisse SA and/or Quotient, as applicable, to OCD under this Agreement may be subject to quality export control and other provisions set forth trade sanctions laws and regulations in the QAA. The Parties shall cooperate reasonably to obtain all customs licenses or permits necessary to ship the Product Territory (the evaluation of which customs licenses or permits required shall be performed by XENCOR), “Trade Restrictions”) and no shipment shall be made until such licenses or permits, if any, have been obtained. XENCOR shall diligently examine all Product delivered under this Agreement as soon as practicable after receipt. Notice of all claims arising out of or relating to Obvious Defects shall be given in writing to BII within [...***...] after the date of XENCOR’s receipt of Product, otherwise, such Product shall be considered free of any Obvious Defects as between BII and XENCOR. XENCOR shall make a damaged Product available for inspection and shall comply with the requirements of any insurance policy covering the Product, and BII shall offer XENCOR all reasonable assistance, at the cost and expense of XENCOR, in pursuing any claims arising out of the transportation of the Product. Except as otherwise provided herein and as set forth in Section 2.5, XENCOR shall have [...***...] after the date of XENCOR’s receipt of Product, for all claims arising out of or relating to any Latent Defects and to reject such delivered Product for Latent Defects; provided, however that XENCOR shall only be permitted to reject the Product if the Acceptance Criteria are not met. If XENCOR determines after reviewing the relevant documentation and performing reasonable testing that any Batch does not meet the Acceptance Criteria, or if Product is determined by BII to be unsuitable for release, then the Parties will mutually agree, as promptly as reasonably possible, whether (a) to produce a new Batch at BII’s cost and expense, including the costs of materials used in the manufacture of such Batch, or (b) to rework or reprocess the Batch, at BII’s cost and expense, so that the Batch can be deemed to have been manufactured in compliance with cGMP and the agreed Process Description, and to conform to the Acceptance Criteria (provided that the Parties have mutually agreed in writing on any procedures for reworking or reprocessing a Batch). If the remedy set forth in either (a) or (b) is agreed to be performed by BII, then BII shall start the applicable work as soon as reasonably practicable, such that the next reasonably available (taking into consideration BII’s entire contract manufacturing business) manufacturing slot shall be used by BII to produce Product, and BII will use commercially reasonable efforts to resupply within [...***...] but in any event no later than [...***...] from time of rejection by XENCOR. For the avoidance of doubt, if Product is not accepted by XENCOR as provided above, then BII’s obligations set forth above shall apply both to the drug product and the bulk drug substance contained therein. In the event XENCOR rejects the Product for Obvious Defects or Latent Defects as provided above, BII shall have the right to sample and retest the Product, which shall be done as soon as practicable, provided that, if BII does not notify XENCOR in writing of its election to retest the Product within [...***...] after notice of rejection from XENCOR, BII shall be deemed to agree with XENCOR’s rejection of the Product. In the event of a discrepancy between XENCOR’s and BII’ s test results such that one Party’s results fall within the Acceptance Criteria and the other Party’s test results fall outside the Acceptance Criteria, or there exists a dispute over whether such failure is due (in whole or in part) to acts or omissions of XENCOR or any third party after delivery, the Parties shall cause a testing laboratory agreeable to both Parties to perform comparative tests and/or analyses on samples of the alleged defective Product. The testing laboratory’s results shall be in writing and shall be final and binding save for manifest error on the face of its report. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the testing laboratory result finally rules. The testing laboratory neither Quotient nor Suisse SA shall be required to enter into written undertakings supply any Products or Know-how to OCD where such supply would constitute a breach of confidentiality no less burdensome than set forth or referred applicable Trade Restrictions. OCD shall comply, and shall use All Reasonable Endeavours to by procure that its customers shall comply with, all applicable Trade Restrictions relating to the performance of its obligations under this AgreementAgreement and the Commercialization of the Products in the Territory, as applicable.

Appears in 1 contract

Sources: Distribution and Supply Agreement (Quotient LTD)

Delivery Terms. BII 7.1 The Products shall be delivered by Suisse SA or Quotient as the case may be to OCD FCA (aIncoterms 2010) deliver to XENCOR or, (b) at the request place of XENCOR, storemanufacture. At the time so delivered, the agreed amounts Consumables and Ancillary Products shall have a remaining minimum shelf life of the Product produced according to the Project Plan in accordance with agreed upon schedule, at the price set forth in the Project Plan. Delivery of Product by BII shall be made least [...***...]. Suisse SA shall use its best efforts to extend the shelf life of Consumables so that after the first anniversary of the first to occur of FDA Approval or CE Marking for a Product (excluding a Screening Consumable), such Consumables and Ancillary Products shall have a remaining shelf life of either [***] BII Facility (Incoterms 2010)or at least [***] of the shelf life dictated by the Regulatory Approval when delivered to OCD, whichever is longer. BII Notwithstanding this obligation, the Parties agree to reasonably cooperate and to discuss in good faith prior to shipping the acceptability of non-material deviations from the minimum shelf life. All deliveries of the [***] CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION 44 Products in this manner shall package constitute sales made directly to OCD. OCD shall pay all freight, insurance charges, import duties, inspection fees and arrange for shipment of Product other charges applicable to the delivery address specified transport and receipt by XENCOROCD or its Affiliates, all in accordance with the instructions Sub-Licensees or Sub-Distributors of XENCOR provided that BII Products purchased by OCD hereunder. Title and risk of loss and damage to Products purchased by OCD hereunder shall not be responsible for any damages with respect pass to Product or third party claims arising out of such arrangements for shipment of Product after delivery of such Product to the shipper in accordance with such instructions in accordance with XENCOR’s instructions. Each shipment of cGMP Product will include a Certificate of Analysis, a Confirmation of Compliance and such other documentation as reasonably required to meet all applicable statutory and regulatory requirements. Delivery OCD upon loading of the Product shall Products onto the carrier appointed by OCD. 7.2 OCD acknowledges that the supply of Products and Know-how by Suisse SA and/or Quotient, as applicable, to OCD under this Agreement may be subject to quality export control and other provisions set forth trade sanctions laws and regulations in the QAA. The Parties shall cooperate reasonably to obtain all customs licenses or permits necessary to ship the Product Territory (the evaluation of which customs licenses or permits required shall be performed by XENCOR), “Trade Restrictions”) and no shipment shall be made until such licenses or permits, if any, have been obtained. XENCOR shall diligently examine all Product delivered under this Agreement as soon as practicable after receipt. Notice of all claims arising out of or relating to Obvious Defects shall be given in writing to BII within [...***...] after the date of XENCOR’s receipt of Product, otherwise, such Product shall be considered free of any Obvious Defects as between BII and XENCOR. XENCOR shall make a damaged Product available for inspection and shall comply with the requirements of any insurance policy covering the Product, and BII shall offer XENCOR all reasonable assistance, at the cost and expense of XENCOR, in pursuing any claims arising out of the transportation of the Product. Except as otherwise provided herein and as set forth in Section 2.5, XENCOR shall have [...***...] after the date of XENCOR’s receipt of Product, for all claims arising out of or relating to any Latent Defects and to reject such delivered Product for Latent Defects; provided, however that XENCOR shall only be permitted to reject the Product if the Acceptance Criteria are not met. If XENCOR determines after reviewing the relevant documentation and performing reasonable testing that any Batch does not meet the Acceptance Criteria, or if Product is determined by BII to be unsuitable for release, then the Parties will mutually agree, as promptly as reasonably possible, whether (a) to produce a new Batch at BII’s cost and expense, including the costs of materials used in the manufacture of such Batch, or (b) to rework or reprocess the Batch, at BII’s cost and expense, so that the Batch can be deemed to have been manufactured in compliance with cGMP and the agreed Process Description, and to conform to the Acceptance Criteria (provided that the Parties have mutually agreed in writing on any procedures for reworking or reprocessing a Batch). If the remedy set forth in either (a) or (b) is agreed to be performed by BII, then BII shall start the applicable work as soon as reasonably practicable, such that the next reasonably available (taking into consideration BII’s entire contract manufacturing business) manufacturing slot shall be used by BII to produce Product, and BII will use commercially reasonable efforts to resupply within [...***...] but in any event no later than [...***...] from time of rejection by XENCOR. For the avoidance of doubt, if Product is not accepted by XENCOR as provided above, then BII’s obligations set forth above shall apply both to the drug product and the bulk drug substance contained therein. In the event XENCOR rejects the Product for Obvious Defects or Latent Defects as provided above, BII shall have the right to sample and retest the Product, which shall be done as soon as practicable, provided that, if BII does not notify XENCOR in writing of its election to retest the Product within [...***...] after notice of rejection from XENCOR, BII shall be deemed to agree with XENCOR’s rejection of the Product. In the event of a discrepancy between XENCOR’s and BII’ s test results such that one Party’s results fall within the Acceptance Criteria and the other Party’s test results fall outside the Acceptance Criteria, or there exists a dispute over whether such failure is due (in whole or in part) to acts or omissions of XENCOR or any third party after delivery, the Parties shall cause a testing laboratory agreeable to both Parties to perform comparative tests and/or analyses on samples of the alleged defective Product. The testing laboratory’s results shall be in writing and shall be final and binding save for manifest error on the face of its report. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the testing laboratory result finally rules. The testing laboratory neither Quotient nor Suisse SA shall be required to enter into written undertakings supply any Products or Know-how to OCD where such supply would constitute a breach of confidentiality no less burdensome than set forth or referred applicable Trade Restrictions. OCD shall comply, and shall use All Reasonable Endeavours to by procure that its customers shall comply with, all applicable Trade Restrictions relating to the performance of its obligations under this AgreementAgreement and the Commercialization of the Products in the Territory, as applicable.

Appears in 1 contract

Sources: Distribution and Supply Agreement

Delivery Terms. BII shall (a) CyDex agrees to deliver Captisol to XENCOR orHospira’s carrier at a continental United States factory or warehouse designated by CyDex, (b) at the request of XENCOR, store, the agreed amounts of the Product produced according to the Project Plan in accordance with agreed upon schedule, at the price set forth in the Project Plan. Delivery of Product by BII shall be made [...***...] BII Facility (Incoterms 2010). BII shall package and arrange for shipment of Product to the delivery address specified by XENCOR, all in accordance with the instructions of XENCOR provided that BII shall not be responsible for any damages with respect to Product or third party claims arising out of such arrangements for shipment of Product after delivery of such Product to the shipper purchase orders submitted by Hospira in accordance with Section 3.2 (each such instructions delivery to be accompanied by a copy of the purchase order submitted by Hospira that corresponds to such delivery). All Captisol shall be delivered to Hospira using the carrier and in accordance with XENCOR’s instructionsthe delivery schedule specified by Hospira in its purchase orders. Each shipment of cGMP Product will include a Certificate of Analysis, a Confirmation of Compliance and such other documentation as reasonably required to meet all applicable statutory and regulatory requirements. Delivery of the Product Captisol shall be subject delivered by CyDex to quality Hospira [***]. CyDex will provide the carrier with proper instructions regarding how to transport the Captisol in conditions which will not adversely affect the Captisol, including ensuring that the shipment is temperature monitored and other provisions set forth in the QAA. The Parties Captisol is kept at an appropriate temperature throughout shipment. (b) If CyDex is unable to deliver the Captisol on the date specified by Hospira, CyDex shall cooperate reasonably to obtain all customs licenses or permits necessary to ship the Product (the evaluation of which customs licenses or permits required shall be performed by XENCOR), and no shipment shall be made until such licenses or permits, if any, have been obtained. XENCOR shall diligently examine all Product delivered under this Agreement notify Hospira as soon as practicable after receipt. Notice of all claims arising out of or relating to Obvious Defects shall be given in writing to BII within [...***...] after the date of XENCOR’s receipt of Product, otherwise, such Product shall be considered free of any Obvious Defects as between BII and XENCOR. XENCOR shall make a damaged Product available for inspection and shall comply with the requirements of any insurance policy covering the Product, and BII shall offer XENCOR all reasonable assistance, at the cost and expense of XENCOR, in pursuing any claims arising out of the transportation of the Product. Except as otherwise provided herein and as set forth in Section 2.5, XENCOR shall have [...***...] after the date of XENCOR’s receipt of Product, for all claims arising out of or relating to any Latent Defects and to reject such delivered Product for Latent Defects; provided, however that XENCOR shall only be permitted to reject the Product if the Acceptance Criteria are not met. If XENCOR determines after reviewing the relevant documentation and performing reasonable testing that any Batch does not meet the Acceptance Criteria, or if Product is determined by BII to be unsuitable for release, then the Parties will mutually agree, as promptly as reasonably possible, whether (a) to produce a new Batch at BII’s cost and expense, including the costs of materials used in the manufacture of such Batch, or (b) to rework or reprocess the Batch, at BII’s cost and expense, so that the Batch can be deemed to have been manufactured in compliance with cGMP and the agreed Process Description, and to conform to the Acceptance Criteria (provided that the Parties have mutually agreed in writing on any procedures for reworking or reprocessing a Batch). If the remedy set forth in either (a) or (b) is agreed to be performed by BII, then BII shall start the applicable work as soon as reasonably practicable, such that the next reasonably available (taking into consideration BII’s entire contract manufacturing business) manufacturing slot shall be used by BII to produce Product, and BII will use commercially reasonable efforts to resupply within [...***...] but in any event no later than within [...***...] of receipt of the purchase order. CyDex’s providing of such notification shall not be interpreted in any manner as relieving CyDex of its obligations under this Agreement, nor shall it prevent Hospira from pursuing any and all rights and remedies Hospira may have based on CyDex’s failure to deliver the Captisol in accordance with the terms of this Agreement. *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. (c) With each shipment of Captisol, CyDex shall, if so requested, provide by reference or otherwise all documentation as is reasonably required by any [***] from time to time in connection with Hospira’s research, development, modification, manufacture, importation, exportation, use, promotion, marketing, distribution, packaging, offering for sale, selling, and otherwise commercially exploitation, as applicable, of rejection by XENCORCaptisol or the Finished Product. For the avoidance of doubt, if Product If such documentation is not accepted by XENCOR as provided above, then BII’s obligations set forth above shall apply both to supplied Hospira may reject the drug product and the bulk drug substance contained therein. In the event XENCOR rejects the Product for Obvious Defects or Latent Defects as provided above, BII shall have the right to sample and retest the Product, which shall be done as soon as practicable, provided that, if BII does not notify XENCOR in writing of its election to retest the Product within [...***...] after notice of rejection from XENCOR, BII shall be deemed to agree with XENCOR’s rejection of the Product. In the event of a discrepancy between XENCOR’s and BII’ s test results such that one Party’s results fall within the Acceptance Criteria and the other Party’s test results fall outside the Acceptance Criteria, or there exists a dispute over whether such failure is due (in whole or in part) to acts or omissions of XENCOR or any third party after delivery, the Parties shall cause a testing laboratory agreeable to both Parties to perform comparative tests and/or analyses on samples of the alleged defective Product. The testing laboratory’s results shall be in writing and shall be final and binding save for manifest error on the face of its report. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the testing laboratory result finally rules. The testing laboratory shall be required to enter into written undertakings of confidentiality no less burdensome than set forth or referred to by this AgreementCaptisol.

Appears in 1 contract

Sources: License and Supply Agreement (Ligand Pharmaceuticals Inc)

Delivery Terms. BII shall (a) deliver The Buyer provides the Seller with full and timely information about the Place of Destination and the Carrier, including any special location access instructions and all contact information of the Carrier. The named information is to XENCOR orbe provided to the Seller via facsimile or by other means agreed upon by the Parties, at least 5 (five) Business Days prior to each scheduled date of shipment of the Goods by the Seller. Such information can be changed by the Buyer with written notification to the Seller and no later than 1 (one) Business Day before each scheduled shipment. The information must include: i. The name of the Carrier (person or entity). ii. Documentation testifying ▇▇▇▇▇▇▇’s rights to accept and carry the Goods (should be presented by the Carrier at delivery). iii. The identity, location and address of Place of Destination, with instructions for access to the Place of Destination. iv. Any other information requested by the Seller. b) at the request of XENCOR, storeIf applicable, the agreed amounts of the Product produced according to the Project Plan in accordance with agreed upon schedule, at the price set forth in the Project Plan. Delivery of Product by BII Nomination shall be made [...***...] BII Facility (Incoterms 2010). BII shall package and arrange for shipment of Product to the delivery address specified by XENCOR, all in accordance with the PTC. c) Immediately upon the receipt of Seller’s Nomination, but not later than one day from the receipt of Seller’s Nomination, the Buyer shall provide the Seller with full written instructions regarding the particulars for the Bills of XENCOR provided that BII shall not be responsible Lading including consignee, contact details and address of the authorized person of the consignee, other information necessary for any damages with respect to Product or third party claims arising out the delivery and reasonably required by the Seller, number of such arrangements for shipment of Product after delivery of such Product to the shipper in accordance with such instructions in accordance with XENCOR’s instructionscopies, addresses, etc. Each shipment of cGMP Product will include a Certificate of Analysis, a Confirmation of Compliance and such other documentation as reasonably information which may be required to meet all applicable statutory and regulatory requirements. Delivery by the Place of Shipment, Place of Destination and/or the Product shall be subject to quality and other provisions set forth in the QAASeller. The Parties shall cooperate reasonably to obtain all customs licenses or permits necessary to ship the Product (the evaluation of which customs licenses or permits required shall be performed by XENCOR), and no shipment shall be made until such licenses or permits, if any, have been obtained. XENCOR shall diligently examine all Product delivered under this Agreement as soon as practicable after receipt. Notice of all claims arising out of or relating to Obvious Defects shall be given in writing to BII within [...***...] after the date of XENCOR’s receipt of Product, otherwise, such Product shall be considered free of any Obvious Defects as between BII and XENCOR. XENCOR shall make a damaged Product available for inspection and shall comply with the requirements of any insurance policy covering the Product, and BII shall offer XENCOR all reasonable assistance, at the cost and expense of XENCOR, in pursuing any claims arising out of the transportation of the Product. Except as otherwise provided herein and as set forth in Section 2.5, XENCOR shall have [...***...] after the date of XENCOR’s receipt of Product, for all claims arising out of or relating to any Latent Defects and to reject such delivered Product for Latent Defects; provided, however that XENCOR shall only be permitted to reject the Product if the Acceptance Criteria are not met. If XENCOR determines after reviewing the relevant documentation and performing reasonable testing that any Batch does not meet the Acceptance Criteria, or if Product is determined by BII to be unsuitable for release, then the Parties will mutually agree, as promptly as reasonably possible, whether (a) to produce a new Batch at BII’s cost and expense, including the costs of materials used in the manufacture of such Batch, or (b) to rework or reprocess the Batch, at BII’s cost and expense, so that the Batch can be deemed to have been manufactured in compliance with cGMP and the agreed Process Description, and to conform to the Acceptance Criteria (provided that the Parties have mutually agreed in writing on any procedures for reworking or reprocessing a Batch). If the remedy set forth in either (a) or (b) is agreed to be performed by BII, then BII shall start the applicable work as soon as reasonably practicable, such that the next reasonably available (taking into consideration BII’s entire contract manufacturing business) manufacturing slot shall be used by BII to produce Product, and BII will use commercially reasonable efforts to resupply within [...***...] but in any event no later than [...***...] from time of rejection by XENCOR. For the avoidance of doubt, if Product is not accepted by XENCOR as provided above, then BII’s obligations set forth above shall apply both to the drug product and the bulk drug substance contained therein. In the event XENCOR rejects the Product for Obvious Defects or Latent Defects as provided above, BII Seller shall have the right to sample issue its own instructions if the Buyer fails to provide such instructions and/or information required by this Clause. d) The Parties shall obtain any licenses, permits and retest documents which are necessary for successful import and export clearance of the Product, which Goods. (i) Export permits shall be done as soon as practicable, provided that, if BII does not notify XENCOR in writing of its election to retest timely obtained by the Product within [...***...] after notice of rejection from XENCOR, BII Seller. STRICTLY PRIVATE AND CONFIDENTIAL PTC_V_18.01 (ii) Import permits shall be deemed to agree with XENCOR’s rejection timely obtained by the Buyer. e) All delays for the reason of absence of custom clearance shall be at the expense of the Product. In the event of a discrepancy between XENCOR’s and BII’ s test results such that one liable Party’s results fall within the Acceptance Criteria and the other Party’s test results fall outside the Acceptance Criteria, or there exists a dispute over whether such failure is due (in whole or in part) to acts or omissions of XENCOR or any third party after delivery, the Parties shall cause a testing laboratory agreeable to both Parties to perform comparative tests and/or analyses on samples of the alleged defective Product. The testing laboratory’s results shall be in writing and shall be final and binding save for manifest error on the face of its report. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the testing laboratory result finally rules. The testing laboratory shall be required to enter into written undertakings of confidentiality no less burdensome than set forth or referred to by this Agreement.

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Sources: Purchase Terms and Conditions