Purchase and Sale of Products (a) Pursuant to Purchase Orders issued by MLNA/MLMX, Supplier shall sell and deliver to MLNA/MLMX, and MLNA/MLMX shall purchase from Supplier, Products specified in Purchase Orders. Such purchases and sales shall be for Products and Prices set forth on Schedule A. Any Affiliate of MLNA/MLMX shall also be entitled to issue Purchase Orders and purchase Products from Supplier under the terms of this Agreement. Only the specific MLNA/MLMX Party issuing a Purchase Order will be liable to Supplier for obligations in connection with a Purchase Order. Neither MLNA or MLMX or any Affiliate of either of them will be liable to Supplier for any obligations of any other MLNA/MLMX Party or Affiliate.
(b) During the term hereof, MLNA/MLMX may, but shall not be required to, provide Supplier with estimates or forecasts of MLNA/MLMX´s requirements for Products from Supplier. Any forecasts or estimates are for information purposes only and may be modified by MLNA/MLMX at any time and in its sole discretion. Any product quantities cited in or pursuant to this Agreement, except for quantities cited in a Purchase Order as firm, are preliminary and non-binding only. MLNA/MLMX makes no representation, warranty or agreement as to the quantity of products that it will purchase from Supplier, if any, or that MLNA/MLMX will buy Products exclusively from Supplier.
(c) MLNA/MLMX shall issue Purchase Orders to Supplier and Supplier shall confirm to MLNA/MLMX the receipt of each Purchase Order issued hereunder (each, a "Confirmation") within [NUMBER] Business Days following Supplier's receipt thereof. Each Confirmation must reference MLNA/MLMX's Purchase Order number and confirm acceptance of the Purchase Order unless Supplier timely advises MLNA/MLMX that Supplier is unwilling to accept any terms or conditions in the applicable Purchase Order that conflict with the terms and conditions of this Agreement. If Supplier fails to issue a Confirmation within the time set forth above or otherwise commences performance under such Purchase Order, Supplier will be deemed to have accepted the Purchase Order. MLNA/MLMX may withdraw any Purchase Order prior to Supplier's acceptance (or deemed acceptance) thereof.
(d) MLNA/MLMX may, in its sole discretion, on notice to Supplier, without liability or penalty, terminate all or any part of a Purchase Order with or without cause effective immediately or otherwise as specified in such notice. Upon any such termination, Supplier shall immediately cease work and purchasing materials relating to fulfilling the Purchase Order, and deliver to MLNA/MLMX on request all or any portion of Products under the relevant Purchase Order at the Prices.
(e) MLNA/MLMX may, on notice to Supplier, request changes to a Purchase Order. On or before the second Business Day after receiving the request, Supplier shall submit to MLNA/MLMX its good faith description of the impact of such changes on the Basic Purchase Order Terms. MLNA/MLMX may then submit an amended Purchase Order reflecting all MLNA/MLMX-accepted changes.
Sale of Products (a) All shipments, services, sales and quotations between Axitec, LLC. (“Seller”) and the purchaser (“Purchaser”) of Products set forth herein (“Products”) shall be subject to these Terms and Conditions of Sale (these “Terms” or this “Agreement”). Purchaser acknowledges receipt hereof and accepts these Terms. ANY ADDITIONAL OR DIFFERENT TERMS OR CONDITIONS CONTAINED IN ANY RESPONSE HERETO BY PURCHASER OR IN PURCHASER’S INITIAL ORDER AND ANY ASSERTIONS BY THE SALES REPRESENTATIVE THAT ARE NOT EXPRESSLY DESCRIBED IN THESE TERMS AND CONDITIONS OF SALE OUTSIDE OF THESE EXPRESSED TERMS AND CONDITIONS ARE HEREBY REJECTED BY SELLER AND SHALL BE OF NO EFFECT NOR IN ANY CIRCUMSTANCES BINDING ON SELLER. Seller’s acceptance of any order offered by Purchaser is EXPRESSLY MADE CONDITIONAL on Purchaser’s assent to these Terms, and under no circumstances will any terms other than these Terms apply to Seller’s sale of the Products.
(b) Seller’s quotations are not binding on Seller after 10 business days of submission of quotation. Each order of Products shall be in writing and no order of Purchaser shall be binding on Seller until the earlier of (i) payment of products has occurred or payment terms have been established and shipping arrangements have been made (ii) shipment to Purchaser of Products or (iii) transmittal of a written acceptance by Seller. Seller’s failure to respond to Purchaser’s order within two (2) weeks after receipt of the order shall be considered a rejection of the order.
(c) Purchaser may cancel any order before it has become binding pursuant to subsection (b) above. Seller may cancel all accepted orders and deliveries of Products if (i) Purchaser makes an assignment for the benefit of creditors, (ii) becomes party to a voluntary or involuntary proceeding of insolvency, bankruptcy or reorganization, (iii) generally becomes unable to pay its debts as they become due, (iv) fails to remit payment to Seller in accordance with the terms hereof or under any other agreement between Seller and Purchaser, or (v) breaches any other term, provision or condition contained in these Terms.
(vi) in cases where fraud and deceit is evident in the payment of products
(d) All references in sales brochures, data sheets and offers as to specifications, price and other details of the Products are approximate and shall not be binding on the Seller unless expressly agreed to in writing. Seller may, from time to time, update and replace Products in its line. Seller reserves the right to substitute updated Products, provided that such updated Products meet the specifications of the ordered Products in all material respects and are sold for the same price as the ordered Products.
(e) Purchaser acknowledges that Seller’s acceptance of any purchase order is dependent on Seller’s prior approval of Purchaser’s business credit and personal credit with personal guarantee where warranted. Purchaser acknowledges that Seller may demand assurances of Purchaser’s ability to pay by requesting such trade or banking references or a letter of credit or such other information as deemed adequate by Seller.
Manufacturing and Supply (a) Depomed shall supply Product for use in conducting Depomed’s development activities for Product in the Field and in the Territory as set forth in Exhibit D.
(b) During the four-year period beginning on the Effective Date (the “Supply Period”), Depomed shall supply and package (or have supplied and packaged) Product pursuant to this Section 4.8. Depomed will use commercially reasonable efforts to enter into a long-term Product supply agreement with [***] days after the Effective Date (the “Depomed Supply Agreement”) that will be freely assignable to Solvay or its Affiliates, successors or assigns at any time. In addition, Depomed and Solvay will negotiate and enter into a Product supply agreement with business terms substantially similar to the Depomed Supply Agreement concurrently with the execution and delivery by Depomed and [***] of the Depomed Supply Agreement (the “Solvay Supply Agreement”, and, together with the Depomed Supply Agreement, the “Supply Agreements”). The Supply Agreements will, together, contain the following provisions (among others mutually agreeable to the Parties):
(i) Under the Solvay Supply Agreement, Depomed will agree to supply Solvay with its requirements of finished, packaged Product during the Supply Period;
(ii) All manufacturing and records will be performed and maintained in accordance with specifications, cGMP and Applicable Law;
(iii) Depomed will provide reasonable assistance to Solvay in the event Solvay wishes to qualify a backup Product manufacturer;
(iv) Depomed shall [***];
(v) Solvay will pay Depomed the following amounts in connection with all activities performed by or on behalf of Depomed associated with Product manufacture and supply (other than activities specified on Exhibit D) (A) [***]% of Depomed’s out-of-pocket costs incurred in connection with such manufacture and supply of Product to Solvay, and (B) a labor charge equal to the FTE Charges for all Depomed employees allocated to the manufacture and supply of Product to Solvay, not to exceed FTE Charges for an aggregate of [***] during any given calendar quarter (and Depomed shall provide to Solvay periodic reports detailing the FTE Charges for which Solvay must pay Depomed hereunder);
Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.
Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.
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.
Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.
New Products You agree to comply with NASD Notice to Members 5-26 recommending best practices for reviewing new products.
Licensed Product The term “Licensed Product” shall mean any product (a) the manufacture, use, importation, sale or offer for sale of which would, in the absence of the license granted by this Agreement, infringe a Valid Claim of any of the Licensed Patent Rights, or (b) that is comprised of, utilizes or incorporates Licensed Biological Materials, or (c) that is discovered, developed or made using a Licensed Process.
Manufacture of Products All Products marketed through Grantor's Web ------------------------- Site shall be manufactured, packaged, prepared, and shipped in accordance with the specifications and requirements described on Exhibit A hereto as it may be modified from time to time. Quality control standards relating to the Product's weight, color, consistency, micro-biological content, labeling and packaging are also set forth on Exhibit A. In the event that Exhibit A is incomplete, Products shall be manufactured and shipped in accordance with industry standards.
