Supply Obligations. 3.1. HOKU shall deliver each Year pursuant to this Agreement starting on the First Shipment Date at least the Minimum Annual Quantity of Product in approximately equal monthly shipments pursuant to Section 4.1 below; provided however, that if HOKU fails to deliver a monthly shipment, then HOKU may deliver any deficiency within [*] days without breaching this section or incurring any purchase price adjustment (pursuant to Section 3.3 below). At any time during the term of this Agreement, HOKU may ship to SOLARFUN up to the full cumulative balance of Minimum Annual Quantity of Product to be shipped through the end of this Contract (an “Excess Shipment”) with SOLARFUN’s written consent. This shipment will be credited against each subsequent Minimum Annual Quantity of Product. For example, if the Minimum Annual Quantity of Product for a given Year is [*] metric tons, and if HOKU delivers [*] metric tons in January, then the next shipment of [*] metric tons is not required until the following Year.
3.2. HOKU intends to manufacture the Products at its Facility; however, notwithstanding anything to the contrary herein, HOKU may deliver to SOLARFUN Products that are manufactured by a third party other than HOKU, where HOKU is acting only as a reseller or distributor of such Products; and provided that the Products meet the Product Specifications and price set forth in this Agreement.
3.3. Except in the case of a force majeure pursuant to Section 12 below, if at any time after [*], HOKU does not supply any Products pursuant to Section 3.1 or 3.2 within [*] days of the scheduled delivery date, HOKU will provide SOLARFUN with a purchase price adjustment. Such purchase price adjustment shall be [*] percent ([*]%) of the value of the respective delayed Products for each week or part thereof that the Product shipment (or part thereof) is delayed beyond the [*] day grace period. Any purchase price adjustment as a result of this Section 3.3 will be paid by HOKU at the end of the term of the applicable calendar quarter. In lieu of making a cash payment to SOLARFUN pursuant to this Section 3.3, HOKU may, at its option, pay for such purchase price adjustment in the form of a credit issued for future shipments of Products. Notwithstanding anything to the contrary, the maximum amount of such purchase price adjustment shall not exceed [*] percent ([*]%) of the value of the respective delayed Products. Monthly shipments which are delayed beyond one hundred fifty (150) days shall...
Supply Obligations. Subject to the terms of this Agreement, Arbutus, by itself or through an Affiliate or one or more Third Parties, shall be responsible for Manufacturing and supplying to Qilu all quantities of the Licensed Compound and Licensed Products necessary for Qilu to Develop and Commercialize the Licensed Compound and Licensed Products in the Field in the Territory until Qilu has received all Approvals required for Qilu or its designated CMO to Manufacture the Licensed Compound and Licensed Products in the Territory (the “Supply End Date”). Qilu shall use Commercially Reasonable Efforts to obtain all Approvals required for Qilu or its designated CMO to Manufacture the Licensed Products in the Territory as soon as reasonably practicable following the License Effective Date. After the Supply End Date, Qilu shall be responsible at its sole cost for Manufacturing all quantities of the Licensed Products necessary for Qilu and its Affiliates and Sublicensees to Develop and Commercialize Licensed Products in the Field in the Territory, and Arbutus’ obligation to Manufacture and supply quantities of the Licensed Products for Qilu shall terminate. Qilu acknowledges and agrees that Arbutus has engaged certain CMOs to Manufacture the Licensed Products on behalf of Arbutus and that Arbutus’ ability to conduct the Manufacturing Technology Transfer and to supply quantities of the Licensed Products to Qilu are subject to, and limited by, the terms of Arbutus’ agreements with such CMOs. Arbutus shall use Commercially Reasonable Efforts to, or to cause its CMOs to, complete the Manufacturing Technology Transfer and supply the Licensed Products in a timely manner. Notwithstanding the foregoing, Arbutus will remain directly responsible for its obligations under this Agreement that have been subcontracted to its CMO. Arbutus hereby represents and warrants to Qilu that, as of the Execution Date, the terms of Arbutus’ agreements with its CMOs (i) do not conflict in any material respect with its supply obligations for the Licensed Compound and Licensed Products as contemplated hereunder; and (ii) do not limit its ability or otherwise conflict with its obligations to conduct the Manufacturing Technology Transfer as contemplated hereunder.
Supply Obligations. During the Term Auxilium is entitled to and shall be responsible for arranging, including, but not limited to, through the Back-Up Suppliers, for the supply of all Product for use by Auxilium in Clinical Trials. After the Effective Date, Auxilium shall purchase or Manufacture, at its own cost and expense, sufficient quantities of the Product to conduct all of its requisite Clinical Trials from the Back-Up Suppliers.
Supply Obligations. SBS shall supply Voyager with, and Voyager shall purchase from SBS, (a) all of Voyager’s clinical requirements of the Product and placebos necessary in connection with Clinical Trials and (b) all of Voyager’s commercial requirements of the Product; provided that SBS shall not be required to supply a number of units of Product in any calendar quarter that exceeds the reasonable maximum quarterly manufacturing capacity of SBS’s manufacturing facility in Birmingham, Alabama on the date of this Agreement unless SBS otherwise agrees. These supply and purchase obligations shall continue until the earlier to occur of (i) the effective date of SBS’s election to discontinue supply of Voyager’s commercial requirements of Product, which effective date shall be specified in a written notice delivered by SBS to Voyager not less than [**] prior to such effective date; provided that in no event may SBS elect to terminate its supply obligations prior to the second anniversary of the First Commercial Sale of the Product in the Territory, (ii) the termination of this Agreement and (iii) the termination of these supply and purchase obligations with respect to the Product in accordance with Sections 2.5, 3.8, 4.5 and 5.6. SBS may, in its sole discretion, subcontract with a qualified contract manufacturer in order to fulfill SBS’s supply obligations to Voyager hereunder; provided that in no event shall any such subcontract release SBS from any of its obligations under this Agreement, including its obligation to deliver Product that complies with the warranty set forth in Section 5.4.
Supply Obligations. Under the auspices of, and subject to review and approval by, the JMC, and except as mutually agreed by ERS and the Company, the Parties shall have the following responsibilities relating to the manufacture and supply of API and Finished Products:
(a) Commencing on the Effective Date, and thereafter during the term of this Agreement, the Company (or its Affiliates) shall be responsible for the manufacture or supply of all requirements of API for clinical and commercial use in the Territory pursuant to this Agreement.
(b) Prior to expiration, termination or assignment (pursuant to Section 8.9) of any existing agreement between the Company and a Third Party Manufacturer for the manufacture of Finished Products, the Company shall be the Party responsible for processing the API into Finished Products pursuant to such agreement. Commencing upon the expiration, termination or assignment (pursuant to Section 8.9) of any existing agreement between the Company and a Third Party Manufacturer for the manufacture of Finished Products, ERS shall become and thereafter shall remain the Party responsible for processing the API into Finished Products.
Supply Obligations. Subject to the terms and conditions of this Agreement, UCB (or its designee) shall supply, in a timely manner in quantities and timing as agreed by the JDT to satisfy the Development activities set forth in the Development Plan in the manner set forth in the Development Responsibility Matrix, with required quantities of the Product in final packaged form, and Comparator Drugs and Placebo, to be used in a Phase 3 Study, and any Post-Approval Study in the Development Indication. UCB represents and warrants that: (a) all Product and Product Placebo shall have been manufactured in accordance with Applicable Law, including GMP; and (b) any Product and Product Placebo supplied to an Investigator or Institution will, at the time of delivery to such Investigator or Institution, conform to the applicable specifications for the Product or Product Placebo, as applicable, in effect at the date of delivery and shall not be adulterated or misbranded within the meaning of the PHSA ((a) and (b) collectively, the “Product Warranty”). Dermira shall, in accordance with Section 10.13, pay the costs and expenses for the supply of Product and Comparator Drugs and Placebo, which shall be UCB’s Cost of Goods for the Product and Comparator Drugs and Placebo for activities undertaken by or on behalf of Dermira under the Development Plan (and including those activities undertaken by or on behalf of Dermira in relation to any Post-Approval Studies in the Development Indication to the extent and in the same ratio Dermira is responsible for the Development Costs for such Post-Approval Studies as set forth in Section 5.4) all in relation to the Development of the Product in the Development Indication in the Development Territory. Dermira shall be solely responsible for ensuring that all Investigators engaged by Dermira under the Development Plan meet all applicable requirements of 21 C.F.R. Part 312, including the record-keeping requirements specified in Section 5.12(b). UCB acknowledges that Institutions may require Dermira to include in Clinical Site Agreements representations and warranties regarding Product and/or Product Placebo supplied to Institutions or Investigators for use in a Phase 3 Study, or any Post-Approval Study in the Development Indication, and will require Dermira to include in such Clinical Site Agreements standard indemnities regarding the Product and/or Product Placebo. UCB further acknowledges and agrees that: (A) Dermira will be entitled to, and will, rely exclu...
Supply Obligations. BIT shall be required to supply the Committed Purchase Volume as forecasted by Client under this Section 4 in any calendar quarter up to [***] percent more (+[***]%) of the quantity forecasted for the quarterly period. If Client’s orders in any calendar quarter exceed [***] percent (+[***]%) of the quantity forecasted for the quarterly period, BIT shall use good faith efforts to supply such excess.
Supply Obligations. (a) Subject to the terms and conditions hereof and in consideration for the payments set forth in Schedule 2.1(a), Patheon shall provide the Manufacturing Services and shall supply the Product […***…] to Flexion. Flexion agrees to purchase from Patheon such quantities of Product as Flexion may order, in its discretion, in accordance with the terms herein during the Term.
(b) Pursuant to the Technical Transfer Agreement, Flexion will develop and Patheon will confirm Flexion’s Manufacturing Process. Flexion’s Manufacturing Process is the Proprietary Information of Flexion, as further clarified in Article V.
(c) Patheon shall Manufacture all Products delivered hereunder (i) in accordance with the Specifications, this Agreement, the Quality Agreement, and (ii) in compliance with GMP and all other Applicable Law.
(d) Patheon shall ensure that sufficient numbers of adequately educated and experienced staff are retained at the Facility in order to Manufacture evenly throughout the year the volumes of Product set out in the Forecast. Patheon shall perform all activities necessary to maintain a GMP compliant status of the manufacturing lines and areas of the Facility applicable to the Manufacture of the Product.
(e) Flexion reserves the right to request replacement of any personnel assigned by Patheon to perform the Services hereunder. If Patheon disagrees with such request and the Parties cannot reach resolution on Flexion’s request for replacement, such request will be discussed by the Steering Committee pursuant to the procedures set forth in Exhibit 2.7 of the Technology Transfer and Services Agreement.
(f) Patheon shall perform the Services under the direction of key personnel of Patheon to a project for the duration of the project (“Key Personnel”). Key Personnel include the Project Manager, Operational Manager, Quality Manager or other personnel reasonably agreed-to by the Parties. Patheon shall provide information on the qualifications and background of all proposed Key Personnel prior to such Key Personnel’s commencement of activities under this Agreement on Patheon’s behalf. Patheon will not remove Key Personnel without Flexion’s prior written consent (not to be unreasonably withheld, conditioned or delayed) except in the event of such Key Personnel’s promotion, resignation, incapacity or death, or termination for cause. Patheon will use commercially reasonable efforts to minimize turnover in Key Personnel, and will provide […***…] business days’ notice t...
Supply Obligations. Patheon shall manufacture and supply to Santarus, and Santarus agrees to purchase from Patheon, such quantities of Finished Product specified by Santarus in accordance with this Agreement at the Price. *** *** ***
Supply Obligations. Upon Licensor’s request, AbbVie shall either (a) to the extent allowable under such agreements, assign to Licensee or its Affiliates the portion of AbbVie’s agreement(s) with its Third Party manufacturing provider related to the Terminated Antibodies, Terminated Products and placebo used in connection therewith, or alternatively, use Commercially Reasonable Efforts to facilitate Licensor’s entering into a direct supply agreement with such Third Party manufacturing provider of the Terminated Antibodies, Terminated Products and placebo used in connection therewith on comparable terms to those between AbbVie and such Third Party manufacturing provider (in each case assuming AbbVie is then obtaining supply of Terminated Antibodies, Terminated Products or placebo used in connection therewith from a Third Party manufacturing provider) and (b) to the extent AbbVie or its Affiliate is producing its own supply of the Terminated Product, Terminated Antibody or placebo, use Commercially Reasonable Efforts to supply to Licensor the Terminated Antibodies and/or Terminated Products and placebo as requested by Licensor, to the extent reasonably necessary for Licensor’s continued Development and Commercialization of such Terminated Antibodies and/or Terminated Products, until the date on which Licensor notifies AbbVie in writing that Licensor has secured an alternative manufacturer for the Terminated Antibodies and/or Terminated Products, but in no event more for than [***] after the effective date of any expiration or termination of this Agreement. In the case of (b), Licensor shall pay to AbbVie a transfer price for the materials supplied equal to the Manufacturing Cost thereof. Without limiting the foregoing, in either case Licensor shall additionally have the right to immediately have AbbVie commence the transfer of the Manufacturing Process to Licensor or its designee, with such transfer to be carried out in accordance with the terms of Section 3.5.3, applied mutatis mutandis. *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
