Manufacture by LONZA Sample Clauses

Manufacture by LONZA. During the time period specified in the relevant Statement of Work, LONZA will Manufacture, package, ship, handle quality assurance and quality control for the Product exclusively at the applicable Facility, all as set forth in such Statement of Work, and will deliver to MODERNA the Product requested by MODERNA in such Statement of Work in accordance with the estimated timelines set forth in such Statement of Work, all in accordance with the terms set forth in Section 7.6 below. LONZA shall, at its own cost and expense, ensure that at all times the applicable Facility is in a qualified and validated state appropriate for inclusion as a Manufacturing site for the Products, as required by the applicable Regulatory Authorities, Applicable Laws and the Specifications for the Products. Any costs or expenses related to bringing a Facility or any LONZA Equipment needed to Manufacture Products or to perform the Services into compliance with any applicable regulatory requirements of a Regulatory Authority at any time shall be borne exclusively by LONZA subject however to changes required solely based on the Products as well as change of Applicable Laws or cGMP requirements. Notwithstanding the foregoing, a Statement of Work may include terms and conditions relating to delays of the Commencement Date for a Product or other delays, including discounts, cancellation rights and other terms and conditions relating to any such delay.
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Manufacture by LONZA. LONZA will use commercially reasonable efforts to manufacture, package, ship, handle quality assurance and quality control for the Product, all as set forth in the Statement of Work, and to deliver to CLIENT the quantities of Product requested by CLIENT in the Statement of Work, all in accordance with the terms set forth in Section 4.5 below. Notwithstanding the foregoing, [***] revise the production schedule with respect to a Statement of Work provided that such schedule does not advance or delay the Commencement Date of any Batch by more than [***] days.
Sample 1
Manufacture by LONZA. LONZA shall manufacture, package, store, ship, handle quality assurance and quality control for the Product, all as set forth in the Statement of Work and the Quality Agreements, and to deliver to CLIENT the Product stated in the Statement of Work, all in accordance with the terms set forth in Section 4.7 below. Lonza and CLIENT agree to adhere to production schedules mutually agreed upon in the relevant Statement of Work. LONZA will use commercially reasonable efforts to deliver according to such production schedules and will consult in advance and in good faith with CLIENT regarding any amendment or change to the production schedule or the Commencement Date with respect to a Statement of Work.
Sample 1
Manufacture by LONZA. 4.2.1 Subject to Section 4.7.3(a), up to and including First Commercial Launch, and thereafter during the Term of this Agreement except with respect to amounts for which Sections 4.2.3 and 4.2.4 apply, LONZA shall use its Best Efforts to manufacture and supply to CLIENT each Product to support CLIENT’s clinical development and commercialization of such Product in accordance with the terms and conditions of this Agreement as further set forth in one or more Statements of Work and/or Binding Purchase Orders accepted by LONZA. Each such Statement of Work shall set forth, among other information, the Specifications and requirements for the formulation, packaging, shipment and quality control with respect to such Product, the time period during which such Product will be manufactured (the “Production Term”), and the Commencement Date(s) for the production of each Batch of such Product based on the applicable Draft Plan for such Product.
Sample 1
Manufacture by LONZA. During the fime period specified in the relevant Statement of Work, LONZA will Manufacture, package, ship, handle quality assurance and quality control for the Product exclusively at the applicable Facility, all as set forth in such Statement of Work, and will deliver to MODERNA the Product requested by MODERNA in such Statement of Work in accordance with the esfimated fimelines set forth in such Statement of Work, all in accordance with the terms set forth in Secfion 7.6 below. LONZA shall, at its own cost and expense, ensure that at all fimes the applicable Facility is in a qualified and validated state appropriate for inclusion as a Manufacturing site for the Products, as required by the applicable Regulatory Authorifies, Applicable Laws and the Specificafions for the Products. Any costs or expenses related to bringing a Facility or any LONZA Equipment needed to Manufacture Products or to perform the Services into compliance with any applicable regulatory requirements of a Regulatory Authority at any fime shall be borne exclusively by LONZA subject however to changes required solely based on the Products as well as change of Applicable Laws or cGMP requirements. Notwithstanding the foregoing, a Statement of Work may include terms and condifions relafing to delays of the Commencement Date for a Product or other delays, including discounts, cancellafion rights and other terms and condifions relafing to any such delay.
Sample 1
Manufacture by LONZA. LONZA will [***] manufacture, package, ship, handle quality assurance and quality control for the Product all as set forth in the Statement of Work, and to deliver to CLIENT the Product requested by CLIENT in the Statement of Work, all in accordance with the terms set forth in Section 4.6 below. [***], LONZA shall [***].
Sample 1
Manufacture by LONZA. LONZA will use commercially reasonable efforts to Manufacture Product, all as set forth in the Statement of Work, and to deliver to CLIENT the quantities of Product requested by CLIENT in the Statement of Work, all in accordance with the terms set forth in Section 3.4 below, the Specifications, the Master Production Record, and Applicable Law; provided, however, LONZA shall not be obligated to use facilities other than the Designated Suites in the production of Product hereunder. CLIENT shall use commercially reasonable efforts to provide LONZA at least (i) [***] lead time prior to the Commencement Date of any Batch of Drug Product requested by CLIENT, and (ii) [***] days' lead time prior to the Commencement Date of any Batch of Vector Product requested by CLIENT. Subject to CLIENT's continued compliance with its payment obligations hereunder, LONZA will reserve the capacity of the Designated Suites, [***] for CLIENT for the production of Products hereunder; provided, however, that if CLIENT does not utilize such reserved suites by January 1, 2019 then (i) such unutilized suites will be released by LONZA, or (ii) CLIENT may continue to reserve such unutilized suites after January 1, 2019 at a cost of (a) $[***] per suite until January 1, 2021, (b) $[***] per suite per year from January 1, 2021 until January 1, 2023 and (b) $[***] per suite per year from January 1, 2023 until January 1, 2026.
Sample 1
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Manufacture by LONZA. 4.2.1 Subject to Section 4.7.3(a), up to and including First Commercial Launch, and thereafter during the Term of this Agreement except with respect to amounts for which Sections 4.2.3 and 4.2.4 apply, LONZA shall use its Best Efforts to manufacture and supply to CLIENT each Product to support CLIENT’s clinical development and commercialization of such Product in accordance with the terms and conditions of this Agreement as further set forth in one or more Statements of Work and/or Binding Purchase Orders accepted by LONZA. Each such Statement of Work shall set forth, among other information, the Specifications and requirements for the formulation, packaging, shipment and quality control with respect to such Product, the time period during which such Product will be manufactured (the “Production Term”), and the Commencement Date(s) for the production of each Batch of such Product based on the applicable Draft Plan for such Product. THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Sample 1
Manufacture by LONZA. LONZA will (a) manufacture, package, ship, handle quality assurance and quality control for the Product, all as set forth in the Statement of Work, and (b) deliver to CLIENT the Product requested by CLIENT in the Statement of Work, all in accordance with the terms set forth in Section 4.6 below, and provided that the failure to achieve any of the deliverables set forth in a Statement of Work will not be deemed as a breach of LONZA’s obligation under this Section or under the Statement of Work if LONZA has used Commercially Reasonable Efforts to achieve such deliverables.
Sample 1

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