Supply and Purchase Obligations. (1) MiniFAB shall manufacture the Product exclusively for TearLab; and MiniFAB shall sell the Product exclusively to TearLab or its designee; and unless the Parties otherwise agree MiniFAB shall not otherwise manufacture, sell, or distribute the Product to any third party. (2) TearLab must exclusively order the Product from MiniFAB unless there are Exceptional Circumstances or clause 3.4 (6) applies. For the purposes of this Agreement, Exceptional Circumstances mean: (a) an inability by MiniFAB to provide the Product for 60 days; or (b) a 3 month period in which each delivery of Product has at least 10% of the Product failing to meet the Supply Requirements, and MiniFAB being unable to supply conforming replacement Product such that MiniFAB would have to exceed the Monthly Manufacturing Limit in the following two months in order to ensure that it was able to supply the forecast requirements of Product in those two months. In the case that there are Exceptional Circumstances, MiniFAB may notify TearLab when the Exceptional Circumstances have been overcome and TearLab will be required, from 60 days after such notification, to be supplied exclusively with Product from MiniFAB; provided that TearLab shall have the right to fully honour any supply commitments incurred by TearLab resulting from the Exceptional Circumstances, to the extent that such commitment are not inconsistent with this Agreement. (3) Without limiting clause 3.4(2) and for the avoidance of doubt, TearLab may not assign or licence any of the TearLab IP (as defined in clause 10.4(1)) to anyone else with the intention or effect of allowing someone else to manufacture the Product except as expressly permitted under this Agreement (including without limitation if there are Exceptional Circumstances or clause 3.4(6) applies). [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. (4) MiniFAB hereby acknowledges that TearLab needs to obtain a reliable supply of the Product that meet certain quality, quantity and timing requirements, and agrees to comply with the following Supply Requirements: (a) ensure that each batch of Product is in full compliance with the Specifications (allowing for any failure rates specified in the Specifications); and (b) ensure that it does not for 3 successive months deliver to TearLab less than 95% of quantity of Product ordered by TearLab for delivery in those months in accordance with this agreement, after taking account of replacement Product. (5) If MiniFAB fails to comply with the Supply Requirements then: (a) MiniFAB must provide TearLab with the reasons for the non-compliance; (b) the parties must meet and discuss the reasons given by MiniFAB; (c) the parties must, acting reasonably, negotiate a mutually agreed remedy plan to address the reasons for the non-compliance; and (d) MiniFAB must implement the agreed remedy plan. (6) If MiniFAB: (a) gives notice to TearLab of Exceptional Circumstances or TearLab reasonably determines that the Exceptional Circumstances have occurred; or (b) fails to meet Supply Requirements more than 3 times in any 18 month period and is unable to satisfy TearLab (acting reasonably) that it will be able to maintain a reliable supply of the Product that meet the Specification, quantity and timing requirements, then TearLab may order the Product from an alternative supplier. (7) MiniFAB acknowledges and agrees that in consideration for Customer’s agreement to purchase the Product exclusively from MiniFAB, TearLab shall be entitled to all remedies (which remedies shall be cumulative) available under this Agreement and under applicable law, including without limitation the reasonable cover remedy, subject to TearLab duty to reasonably mitigate any losses it may incur.
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Supply and Purchase Obligations. (1) MiniFAB shall manufacture the Product exclusively for TearLab; and MiniFAB shall sell the Product exclusively to TearLab or its designee; and unless the Parties otherwise agree MiniFAB shall not otherwise manufacture, sell, or distribute the Product to any third party.
(2) TearLab must exclusively order the Product from MiniFAB unless there are Exceptional Circumstances or clause 3.4
(63.3(5) appliesapplies . For the purposes of this Agreement, Exceptional Circumstances mean:
(a) an inability by MiniFAB to provide the Product for 60 days; or
(b) a 3 month period in which each delivery of Product has at least 10% of the Product failing to meet the Supply Requirements, and MiniFAB being unable to supply conforming replacement Product such that MiniFAB would have to exceed the Monthly Manufacturing Limit in the following two months in order to ensure that it was able to supply the forecast requirements of Product in those two months. In the case that there are Exceptional Circumstances, MiniFAB may notify TearLab when the Exceptional Circumstances have been overcome and TearLab will be required, from 60 days after such notification, to be supplied exclusively with Product from MiniFAB; provided that TearLab shall have the right to fully honour honor any supply commitments incurred by TearLab resulting from the Exceptional Circumstances, to the extent that such commitment are not inconsistent with this Agreement.
(3) Without limiting clause 3.4(2) and for the avoidance of doubt, TearLab may not assign or licence any of the TearLab IP (as defined in clause 10.4(1)) to anyone else with the intention or effect of allowing someone else to manufacture the Product except as expressly permitted under this Agreement (including without limitation if there are Exceptional Circumstances or clause 3.4(6) applies). [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(4) MiniFAB hereby acknowledges that TearLab needs to obtain a reliable supply of the Product that meet certain quality, quantity and timing requirements, and agrees to comply with the following Supply Requirements:
(a) ensure that each batch of Product is in full compliance with the Specifications (allowing for any failure rates specified in the Specifications); and
(b) ensure that it does not for 3 successive months deliver to TearLab less than 95% of quantity of Product ordered by TearLab for delivery in those months in accordance with this agreement, after taking account of replacement Product.
(54) If MiniFAB fails to comply with the Supply Requirements then:
(a) MiniFAB must provide TearLab with the reasons for the non-compliance;
(b) the parties must meet and discuss the reasons given by MiniFAB;
(c) the parties must, acting reasonably, negotiate a mutually agreed remedy plan to address the reasons for the non-compliance; and
(d) MiniFAB must implement the agreed remedy plan. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(65) If MiniFAB:
(a) gives notice to TearLab of Exceptional Circumstances or TearLab reasonably determines that the Exceptional Circumstances have occurred; or
(b) fails to meet Supply Requirements more than 3 times in any 18 month period and is unable to satisfy TearLab (acting reasonably) that it will be able to maintain a reliable supply of the Product that meet the Specificationquality, quantity and timing requirements, then TearLab may order the Product from an alternative supplier.
(76) MiniFAB acknowledges and agrees that in consideration for Customer’s agreement to purchase the Product exclusively from MiniFAB, TearLab shall be entitled to all remedies (which remedies shall be cumulative) available under this Agreement and under applicable law, including without limitation the reasonable cover remedy, subject to TearLab duty to reasonably mitigate any losses it may incurthe damages.
Appears in 1 contract
Supply and Purchase Obligations. (1) Subject to MiniFAB’s rights under clause 15.4, MiniFAB shall manufacture the Product Products exclusively for TearLab; and MiniFAB shall sell the Product Products exclusively to TearLab or its designee; and unless the Parties otherwise agree MiniFAB shall not otherwise manufacture, sell, or distribute the Product Products to any third party. MiniFAB acknowledges that TearLab may manufacture Products itself and/or engage one or more third parties in addition to MiniFAB to supply the Products to TearLab.
(2) If the Manufacturing and Ordering Schedule for a Product provides for any exclusivity arrangement, then TearLab must exclusively order the Product from MiniFAB unless there are Exceptional Circumstances or clause 3.4
during the relevant exclusivity period until the exclusive volume (6if any) appliesspecified in Manufacturing and Ordering Schedule is met, subject to MiniFAB meeting the conditions (if any) for the exclusivity, as set out in the Manufacturing and Ordering Schedule. For clarity, if TearLab orders sufficient units of the purposes of Product to satisfy the exclusivity obligations set forth in this clause 3.3(2), but MiniFAB does not accept such orders and/or MiniFAB does not supply such ordered quantities in accordance with this Agreement, Exceptional Circumstances mean:
(afailure by TearLab to purchase such quantities shall not be a breach of TearLab’s exclusivity obligations hereunder. This clause 3.3(2) an inability by MiniFAB shall not be construed to provide the Product for 60 days; or
(b) a 3 month period require TearLab to place orders in which each delivery of Product has at least 10% excess of the Product failing to meet the Supply Requirements, and MiniFAB being unable to supply conforming replacement Product such that MiniFAB would have to exceed the Monthly Manufacturing Limit in the following two months in order to ensure that it was able to supply the forecast requirements of Product in those two months. In the case that there are Exceptional Circumstances, MiniFAB may notify TearLab when the Exceptional Circumstances have been overcome and TearLab will be required, from 60 days after such notification, to be supplied exclusively with Product from MiniFAB; provided that TearLab shall have the right to fully honour any supply commitments incurred by TearLab resulting from the Exceptional Circumstances, to the extent that such commitment are not inconsistent with this AgreementAnnual Production Capacity.
(3) Without limiting clause 3.4(2) and for the avoidance of doubt, TearLab may not assign or licence any of the TearLab IP (as defined in clause 10.4(1)) to anyone else with the intention or effect of allowing someone else to manufacture the Product except as expressly permitted under this Agreement (including without limitation if there are Exceptional Circumstances or clause 3.4(6) applies). [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(4) MiniFAB hereby acknowledges that TearLab needs to obtain a reliable supply of the Product Products that meet meets certain quality, quantity and timing requirements, and agrees to comply with the following Supply Requirements:
(a) ensure that the Supply Start Date for the Second Product occurs on or prior to the applicable cut-off date as specified in the Development Order for the Second Product;
(b) ensure that each batch of Product is are in full compliance with the Specifications (allowing for including without limitation any failure rates specified in therein), the Specifications)Technical Agreement, and the Regulatory Requirements; and
(bc) ensure that it does not that, for each 3 successive months deliver to TearLab less than month period, at least 95% of quantity shipments of Product ordered Products are delivered by TearLab for the delivery in those months in accordance with this agreement, after taking account of replacement Productdate required under clause 3.6.
(54) If MiniFAB fails to comply with the Supply Requirements then:
(a) MiniFAB must provide TearLab with the reasons for the non-compliance;
(b) the parties must meet and discuss the reasons given by MiniFAB;
(c) the parties must, acting reasonably, negotiate a mutually agreed remedy plan to address the reasons for the non-compliance; and;
(d) MiniFAB must implement the agreed remedy plan; and
(e) in respect of the Product in respect of which MiniFAB has failed to comply with the Supply Requirements, TearLab is not obligated for such Product ordered, but not delivered in accordance with Schedule 4, Invoicing and Reporting, Sections 1 and 2.
(5) TearLab must meet the minimum ordering obligations for each Product (if any) as set out in the Manufacturing and Ordering Schedule of that Product by placing orders to purchase (and, to the extent such orders are accepted and filled in accordance with this Agreement, purchase from MiniFAB) the Product.
(6) If MiniFAB:
(a) gives notice to TearLab of Exceptional Circumstances or TearLab reasonably determines that the Exceptional Circumstances have occurred; or
(b) fails to meet Supply Requirements more the minimum orders requirement set forth in clause 3.3(5) during the relevant period (other than 3 times in any 18 month period and is unable to satisfy TearLab (acting reasonably) that it will be able to maintain as a reliable supply result of the Product that meet the Specification, quantity and timing requirementsinability or failure of MiniFAB to timely supply conforming Products in quantities ordered by TearLab), then TearLab may must pay to MiniFAB the minimum order liquidated damages (as applicable) as specified in the Product from an alternative supplierManufacturing and Ordering Schedule for that Product.
(7) MiniFAB acknowledges TearLab shall have no purchase obligations under this Agreement, except as expressly set forth in this clause 3.3. For the avoidance of doubt, subject to clauses 3.3(2), 3.3(5) and agrees that in consideration for Customer’s agreement to purchase the Product exclusively from MiniFAB3.3(6), TearLab shall be entitled have the right to all remedies (which remedies shall be cumulative) available under this Agreement engage any third party to manufacture and under applicable law, including without limitation the reasonable cover remedy, subject to TearLab duty to reasonably mitigate supply any losses it may incurProducts.
Appears in 1 contract
Samples: Manufacturing and Development Agreement (TearLab Corp)
Supply and Purchase Obligations. (1) MiniFAB shall manufacture the Product Products exclusively for TearLabOcuSense; and MiniFAB shall sell the Product Products exclusively to TearLab OcuSense or its designee; and unless the Parties otherwise agree MiniFAB shall not otherwise manufacture, sell, or distribute the Product Products to any third party.
(2) TearLab must exclusively order the Product from . MiniFAB unless there are Exceptional Circumstances acknowledges that OcuSense may manufacture Products itself and/or engage one or clause 3.4
(6) applies. For the purposes of this Agreement, Exceptional Circumstances mean:
(a) an inability by more third parties in addition to MiniFAB to provide the Product for 60 days; or
(b) a 3 month period in which each delivery of Product has at least 10% of the Product failing to meet the Supply Requirements, and MiniFAB being unable to supply conforming replacement Product such that MiniFAB would have to exceed the Monthly Manufacturing Limit in the following two months in order to ensure that it was able to supply the forecast requirements of Product in those two months. In the case that there are Exceptional Circumstances, MiniFAB may notify TearLab when the Exceptional Circumstances have been overcome and TearLab will be required, from 60 days after such notification, Products to be supplied exclusively with Product from MiniFAB; provided that TearLab shall have the right to fully honour any supply commitments incurred by TearLab resulting from the Exceptional Circumstances, to the extent that such commitment are not inconsistent with this Agreement.
(3) Without limiting clause 3.4(2) and for the avoidance of doubt, TearLab may not assign or licence any of the TearLab IP (as defined in clause 10.4(1)) to anyone else with the intention or effect of allowing someone else to manufacture the Product except as expressly permitted under this Agreement (including without limitation if there are Exceptional Circumstances or clause 3.4(6) applies). [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portionsOcuSense.
(4) MiniFAB hereby acknowledges that TearLab OcuSense needs to obtain a reliable supply of the Product Products that meet meets certain quality, quantity and timing requirements, and agrees to comply with the following Supply Requirements:
(a) subject to clause 3.2(3), ensure that the Supply Start Date for the First Product occurs on or prior to the Cut-Off Date;
(b) ensure that the Supply Start Date for the Second Product occurs on or prior to the applicable cut-off date as specified in the Development Order for the Second Product;
(c) ensure that each batch of Product is are in full compliance with the Specifications (allowing for including without limitation any failure rates specified in therein), the Specifications)Technical Agreement, and the Regulatory Requirements; and
(bd) ensure that it does not that, for each 3 successive months deliver to TearLab less than month period, at least 95% of quantity shipments of Product ordered Products are delivered by TearLab for the delivery in those months in accordance with this agreement, after taking account of replacement Productdate required under clause 3.6.
(5) If MiniFAB fails to comply with the Supply Requirements then:, subject to clause 3.3(6):
(a) MiniFAB must provide TearLab OcuSense with the reasons for the non-compliance;
(b) the parties must meet and discuss the reasons given by MiniFAB;
(c) the parties must, acting reasonably, negotiate a mutually agreed remedy plan to address the reasons for the non-compliance; and
(d) MiniFAB must implement the agreed remedy plan.
(6) If MiniFAB:
(a) gives notice to TearLab of Exceptional Circumstances or TearLab reasonably determines that the Exceptional Circumstances have occurred; or
(b) MiniFAB fails to meet comply with the same Supply Requirements more than Requirement again within a period of 3 times in any 18 month period and is unable to satisfy TearLab (acting reasonably) that it will be able to maintain a reliable supply of months after the Product that meet the Specification, quantity and timing requirementsfirst non-compliance, then TearLab may order MiniFAB is deemed to have committed a material breach of this Agreement for the Product from an alternative supplierpurposes of clause 15.2(1).
(79) MiniFAB acknowledges and agrees that in consideration for Customer’s agreement to OcuSense shall have no purchase the Product exclusively from MiniFAB, TearLab shall be entitled to all remedies (which remedies shall be cumulative) available obligations under this Agreement and under applicable lawAgreement, including without limitation except as expressly set forth in this clause 3.3. For the reasonable cover remedyavoidance of doubt, subject to TearLab duty clauses 3.3(2), 3.3(7) and 3.3(8), OcuSense shall have the right to reasonably mitigate engage any losses it may incurthird party to manufacture and supply any Products.
Appears in 1 contract
Samples: Manufacturing and Development Agreement (OccuLogix, Inc.)