Commercial Supply After the Option Termination Date:
(a) if requested by Kolltan, the Parties shall undertake good faith negotiations regarding a commercial supply agreement pursuant to which MedImmune would supply to Kolltan, and Kolltan would purchase from MedImmune, quantities of the Licensed Antibody or Licensed Product, in any of its forms, for use by Kolltan, for commercial sale (“Commercial Supply Agreement”); and
(b) if (i) for any reason the Parties have not entered into the Commercial Supply Agreement (including if Kolltan has not requested that the Parties undertake negotiations with respect to thereto pursuant to Section 3.6.4(a)) or (ii) the Commercial Supply Agreement is entered into by the Parties but expires or is terminated for any reason other than breach by Kolltan, without limitation of any other rights that may be available to Kolltan, upon Kolltan’s written request and subject to MedImmune’s good faith consent as described below, MedImmune shall (x) transfer and/or disclose to Kolltan or any Qualified Contract Manufacturer designated in good faith by Kolltan such MedImmune Manufacturing Know-How and (y) provide to Kolltan or such Qualified Contract Manufacturer such technical assistance, in each case ((x) and (y)) as reasonably required for Kolltan or such Qualified Contract Manufacturer to Manufacture the Licensed Antibody and Licensed Products for use in Kolltan’s Commercialization activities hereunder. The foregoing sentence notwithstanding, except as set forth in Section 3.6.5 below, MedImmune has no obligation to disclose to Kolltan or any Qualified Contract Manufacturer the MedImmune Manufacturing Know How related to MedImmune proprietary cell culture media and nutrient feeds used in the Manufacturing process. Kolltan acknowledges and agrees that any transfer and/or disclosure by Kolltan of any MedImmune Manufacturing Know-How described in the immediately preceding sentence to a Third Party shall require the prior written consent of MedImmune; provided, however, that (A) MedImmune shall not unreasonably withhold such consent and (B) MedImmune’s determination as to whether to provide such consent shall be made in good faith. The transfers and disclosures described in clause (x) above shall be made (1) in any manner or form reasonably requested by Kolltan and (2) at MedImmune’s expense; provided, however, if at Kolltan’s request any such transfer or disclosure is made in any manner or form that is not reasonably standard in the biopharmaceutical industry for transfers or disclosures of a similar kind, such transfer or disclosure shall be made at Kolltan’s expense. The assistance described in clause (y) above shall be provided at MedImmune’s expense, provided, however, that the scope of such assistance will be limited to reasonable and customary assistance related to technology transfer under similar circumstances in the biologics industry.
Payment for Forest Products Delivered Purchaser agrees to pay the State for delivered forest products at the following rate: $0.00/MBF $250.00/MBF for incorrect species delivery* $20/mbf for Utility logs (Adjusted Gross). Purchaser agrees to increase the above delivered payment rate as approved by the State in the event the location of delivery is changed per the G-026.2 clause. Purchaser will not be billed for any delivered logs that are scaled as containing metal. *When two or more log sorts from this project are delivered to the same destination, the species contained in them are not eligible for the species price reduction. Forest Products delivered that do not meet the sorting specifications in G-022.2 are considered mis-sorts. Purchaser receiving mis-sort Forest Products is required to pay the State at the bid price under this contract. However, when mis-sorted Forest Products amount to more than 5% of the total delivered sort volume, Purchaser may request approval for payment reduction for delivered volume exceeding the mis-sort threshold. Requests for payment reduction must be submitted to the State in writing prior to contract expiration. Eligibility for mis-sort payment reduction is subject to State approval and shall be determined by the State’s delivered product analysis. Forest Products determined by the State eligible for mis-sort price reduction are not eligible for any other price adjustments. Payment reduction for Forest Products deemed mis-sorted will be calculated as follows: Payment Reduction = (B x M) x R M = Mis-sorted volume exceeding threshold excluding utility R = Reduction factor* 0.2 for diameter mis-sort 0.3 for high quality mis-sort *Logs eligible for payment reduction based on multiple reduction factors will be calculated at the higher payment reduction factor. Third-party scaling organization information is required to determine Xxxxxxxx mbf for payment reduction purposes. Value will be derived from the applicable sort value as described in this contract. Scale information for determining mis-sort payment reduction eligibility must be obtained from roll-out scale. Truck-ramp, sample scaling, and/or bundle scaling information is not acceptable for determining eligibility. Purchaser’s exclusive remedy for mis-sorts shall be the payment reduction described in this clause, notwithstanding other provisions in the Uniform Commercial Code Forest Products delivered that do not meet preferred log length specifications or multiples or combinations of preferred lengths and Forest Products delivered not meeting manufacturing standards as described in clause G-024.2 are considered mis- manufactured. Purchaser receiving mis-manufactured Forest Products is required to pay the State at the bid price under this contract. However, when mis-manufactured Forest Products amount to more than 8% of the total delivered sort volume, Purchaser may request approval for payment reduction for delivered volume exceeding the mis-manufacture threshold. Requests for payment reduction must be submitted to the State in writing prior to contract expiration. Eligibility for mis-manufacture payment reduction is subject to State approval and shall be determined by the State’s delivered product analysis. Forest Products determined by the State eligible for mis-manufacture price reductions are not eligible for any other price adjustments. Payment reduction for Forest Products deemed mis-manufactured will be calculated as follows: Payment Reduction = (B x M) x (0.2) Where: B = Bid rate from P-028.2 clause M = Mis-manufactured volume exceeding threshold excluding utility Third-party scaling organization information is required to determine Xxxxxxxx mbf for payment reduction purposes. Value will be derived from the applicable sort value as described in this contract. Scale information for determining mis-manufacture payment reduction eligibility must be obtained from roll-out scale. Truck-ramp, sample scaling, and/or bundle scaling information is not acceptable for determining eligibility. Purchaser’s exclusive remedy for mis-manufacture shall be the payment reduction described in this clause, notwithstanding other provisions in the Uniform Commercial Code.
Third Party Components The Products and Services may contain third party components (including open source software) subject to separate license agreements. To the limited extent a third party license expressly supersedes this XXXX, such third party license governs Customer’s use of that third party component.
Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.
Manufacturing Technology Transfer Upon AbbVie’s written request with respect to a given Collaboration CAR-T Product and Licensed Product, Caribou shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party Provider) of all Materials and Know-How Controlled by Caribou relating to the then-current process for the Manufacture of such Collaboration CAR-T Product and any corresponding Licensed Products (each, a “Manufacturing Process”). Caribou shall provide, shall cause its Affiliates to provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to provide, all reasonable assistance requested by AbbVie to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to implement each Manufacturing Process at the facilities designated by AbbVie. If requested by AbbVie, such assistance shall include facilitating the entering into of agreements with applicable Third Party suppliers relating to such Collaboration CAR-T Product and any corresponding Licensed Products. Without limitation of the foregoing, in connection with the Manufacturing Process and related transfer:
(a) Caribou shall, and shall cause its Affiliates to, make available to AbbVie (or its Affiliate or designated Third Party Provider, as applicable), and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to make available to AbbVie, from time to time as AbbVie may request, all Materials and Manufacturing-related Know-How Controlled by Caribou relating to each Manufacturing Process, including methods, reagents and processes and testing/characterization Know-How, and all documentation constituting material support, performance advice, shop practice, standard operating procedures, specifications as to Materials to be used, and control methods, that are necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice such Manufacturing Process;
(b) Caribou shall cause all appropriate employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility at mutually convenient times to assist with the working up and use of each Manufacturing Process and with the training of the personnel of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to the extent necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice such Manufacturing Process;
(c) Without limiting the generality of this Section 4.4.2, Caribou shall cause all appropriate analytical and quality control laboratory employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate analytical and quality control laboratory employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility and make available all necessary equipment, at mutually convenient times, to support and execute the provision of all applicable analytical methods and the validation thereof (including all applicable Know-How, Information and Materials Controlled by Caribou, and sufficient supplies of all primary and other reference standards);
(d) Caribou shall, and shall cause its Affiliates to, take such steps, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers take such steps, as are necessary or reasonably useful to assist AbbVie (or its Affiliate or designated Third Party Provider, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities with respect to the Manufacture of the applicable Collaboration CAR-T Products and corresponding Licensed Products at the applicable facilities; and
(e) Caribou shall, and shall cause its Affiliates to, provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers to provide, such other assistance as AbbVie (or its Affiliate or designated Third Party Provider, as applicable) may reasonably request to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice each Manufacturing Process and otherwise to Manufacture the applicable Collaboration CAR-T Products and corresponding Licensed Products.
DEVELOPMENT OR ASSISTANCE IN DEVELOPMENT OF SPECIFICATIONS REQUIREMENTS/ STATEMENTS OF WORK
Billing and Payment Procedure for Forest Products Delivered The State will compute and forward to Purchaser a billing statement of charges for forest products delivered during the billing period at the delivered rate shown in P- 028.2 clause. After receipt of the billing statement, Purchaser’s payment must be received by the Department of Natural Resources on or before the due date shown on the billing statement. Purchaser agrees to make payment, payable to the Department of Natural Resources. Failure to pay on time for forest products delivered is considered a breach of contract. Included with the billing statement will be a summary report for the billing period compiled by the State or their log and load reporting service. The State will adjust final xxxxxxxx to account for any State approved payment reductions. Advance payments made under P-045 or P-045.2 remaining on account above the value for the charges shall be returned to Purchaser within 30 days following the final report of charges. Refunds not made within the 30 day period will accrue interest at the interest rate, as established by WAC 000-000-000, computed on a daily basis until paid.
Selection of Subcontractors, Procurement of Materials and Leasing of Equipment The contractor shall not discriminate on the grounds of race, color, religion, sex, national origin, age or disability in the selection and retention of subcontractors, including procurement of materials and leases of equipment. The contractor shall take all necessary and reasonable steps to ensure nondiscrimination in the administration of this contract.
a. The contractor shall notify all potential subcontractors and suppliers and lessors of their EEO obligations under this contract.
b. The contractor will use good faith efforts to ensure subcontractor compliance with their EEO obligations.
Clinical Supply In connection with the Technology Transfer, Lexicon shall transfer to Sanofi any usable inventory of Licensed Compound or Licensed Product, subject to Lexicon’s retention of reasonable requirements of such Licensed Compound or Licensed Product for its T1DM Development activities no later than [**] (or such other date as is agreed by the Parties), and Lexicon’s Manufacturing Cost paid to Lexicon CMOs for such transferred quantities of inventory shall be treated as Development Costs and borne by the Parties in accordance with Section 7.6. Prior to the completion of the Technology Transfer in accordance with Section 6.2, Lexicon shall, to the extent requested by Sanofi and as mutually agreed by the Parties, supply clinical quantities of the Licensed Products and placebo for use by Sanofi in the Development of Licensed Products for T2DM in accordance with the Development Plan, and Lexicon’s Manufacturing Cost incurred in connection therewith shall be treated as Development Costs. After the Technology Transfer, Sanofi shall supply clinical quantities of the Licensed Products and placebo reasonably required by Lexicon for Lexicon’s use in the Development of Licensed Products for T1DM in accordance with the Development Plan and for its own use in the Development of Licensed Products. Lexicon shall Manufacture (or have Manufactured) all such Licensed Product in accordance with Applicable Law and the applicable specifications therefor, including, to the extent required by Applicable Law, cGMP; provided that Lexicon’s liability arising from a breach by the CMO of its agreement with Lexicon shall be limited to such recoveries as are obtained by Lexicon using Commercially Reasonable Efforts to obtain such recoveries and such other remedies as may be available to Lexicon for such breach under its agreement with such CMO. Otherwise, Sanofi’s sole and exclusive remedy and Lexicon’s sole and exclusive liability to Sanofi for any nonconformity shall be for Lexicon to replace such nonconforming Licensed Compound or Licensed Product with conforming Licensed Compound or Licensed Product within reasonable timelines to be mutually agreed by the Parties in writing, but nothing in this Section 6.1.1 shall limit Lexicon’s liability for Third Party Claims under ARTICLE 11. At either Party’s option, Lexicon and Sanofi shall enter into a clinical supply agreement and a reasonable and customary Quality Agreement that shall set forth the terms and conditions upon which Lexicon and any of its Affiliates will conduct their quality activities in connection with such supply, including (i) a right of Sanofi to audit Lexicon and the Lexicon CMOs, (ii) coordination regarding inspections by Regulatory Authorities and (iii) the exchange of information between the Parties regarding the foregoing and quality issues in general. Such agreements shall be negotiated and agreed by the Parties in good faith.
Technical Support Services 2.1 The technical support services (the "Services"): Party A agrees to provide to Party B the relevant services requested by Party B, which are specified in Exhibit 1 attached hereto ("Exhibit 1").
