Purchase and Supply Obligations. Norgine shall: manufacture or have manufactured and supply CMS such amounts of the Product for CMS’s Commercialisation of the Product in the Territory, as CMS may order from time to time in accordance with GMP, the Specifications and the Quality Agreement as well as the instructions of CMS which may vary from time to time, provided that CMS shall give Norgine reasonable written notice in advance (for the avoidance of doubt, any changes to the packaging of the Product requested by CMS shall be made at CMS’ sole cost); procure the package of the Product firm and complete in order to: i. prevent packing breakage, internal leakage and losing; ii.prevent the damage or deterioration of the Products due to stacking, collision, shock , pressure or temperature changes; iii. meet the needs for international long-distance transport and transport safety. procure that CMS, or its duly appointed agent (subject to the prior execution and delivery of a confidentiality agreement, in form and substance satisfactory to Norgine or Norgine’s contract manufacturer(s), as the case may be), shall have the right to inspect the premises of Norgine or Norgine’s contract manufacturer(s) where the Product are manufactured, Packaged and/or Labelled, which inspections may take place no more often than once per Year upon advance notice at any reasonable time and conducted in a manner designed to minimise inconvenience; cooperate with CMS for any inspection by a Regulatory Authority for the Territory, provided that CMS shall promptly notify Norgine of such inspection and provide reasonable assistance after CMS obtain the China IDL in the name of CMS or CMS’ designated party. Following delivery to CMS of a quantity of any Product (as specified in Section 9.6) CMS shall be responsible for all further activities, including all testing, shipping, transportation and certification of the relevant Product, necessary to import such quantity of the relevant Product into the Territory and otherwise distribute, store, handle, offer for sale and sell such quantity of the relevant Product in the Territory (or any part thereof). CMS shall pay all freight, insurance charges, taxes, import and export duties, inspection fees and other charges applicable to the sale and transport of the quantities of any Product purchased by CMS hereunder and Norgine shall assist and cooperate with CMS. Within ninety (90) calendar days of the Effective Date the Parties shall enter into a quality agreement covering manufact...
Purchase and Supply Obligations. (a) Any purchase of Product by Salix from Novel, and supply of Product by Novel to Salix, prior to the Supply Term Commencement Date shall be made only pursuant to mutual agreement of Salix and Novel as to quantities of Product to be so purchased and supplied.
(b) Subject to Section 2.8, from and after the Supply Term Commencement Date, Salix shall order from Novel, and Novel shall supply to Salix, all of Salix’s requirements of the Product.
(c) For each Calendar Year (or part thereof) in which Salix is required pursuant to Section 2.2(b) to order all of its requirements of Product from Novel, Salix shall provide, within thirty (30) days after the end of that Calendar Year, a certification that it has ordered all its requirements of Product for that Calendar Year (or part thereof) from Novel. Novel shall have the right to audit Salix’s financial records, pursuant to and in accordance with Section 8.8, to confirm that Salix has, from time to time, ordered such requirements pursuant to Section 2.2(b).
(d) The Parties acknowledge and agree that the provisions of this Agreement relating to manufacturing and supply of Product are not intended to apply in respect of any rights to Exploit Product outside of the Territory and that manufacturing and supply arrangements that may apply to any such rights that may be granted to or acquired by Salix will be governed by a separate supply agreement, any such separate supply agreement to be entirely at the discretion of the Parties, provided such agreement does not adversely affect Novel’s ability to supply Product for the Territory, and orders for Product in the Territory are given priority over such other orders.
(e) In the event that Salix desires to obtain supply of any pharmaceutical product (other than the Product) that constitutes a Covered Product in respect of rights to Exploit Product in the Territory, Novel shall have the option to act as Salix’s sole supplier for such product on terms substantially the same as those set forth in this Agreement. Novel shall exercise such option by notice to Salix given within thirty (30) days following notice given by Salix to Novel of its desire to obtain supply of a pharmaceutical product (other than the Product) that constitutes a Covered Product and providing information in reasonable detail regarding the nature of the contemplated Covered Product, anticipated quantities, timing considerations and other such matters as are reasonably necessary in order to permit Novel to ma...
Purchase and Supply Obligations. AeroGen shall purchase its and its Marketing Partners' requirements of BD Cartridges from BD, except as provided herein in the event of a supply default. BD shall manufacture and supply to AeroGen and its Marketing Partners their requirements for the BD Cartridge in accordance with binding purchase orders provided by AeroGen as described below.
Purchase and Supply Obligations. Subject to the provisions of this Agreement, during the Term Licensee shall, and Licensee shall cause its Sublicensees to, purchase one hundred percent (100%) of their requirements of Licensed Product in bulk capsule form according to the Specifications for sale in the Licensee Territory from GPC Biotech, and GPC Biotech shall Manufacture and supply such quantities of Licensed Product to Licensee. GPC Biotech shall not supply Licensed Products to any Third Party within the Licensee Territory. In the event that GPC Biotech, at any time during the Term, has reason to believe that it or any Subcontractor will be unable to perform the services hereunder or that there will be a material delay in performance thereof, GPC Biotech shall (without limiting any other obligations GPC Biotech may have or rights or remedies Licensee may have ) promptly notify Licensee thereof.
Purchase and Supply Obligations. (a) Subject to the terms and conditions hereof, including Section 2.23, Salix shall purchase from Cosmo all of Salix’s requirements of the Products, and Cosmo shall Manufacture and supply the Products for Salix, in the quantities ordered by Salix hereunder.
(b) Cosmo shall supply Products to Salix either in bulk form or in finished, packaged, and labeled form, as specified in Salix’s applicable Purchase Orders; provided that Cosmo shall be obligated to supply Products in finished, packaged, and labeled form only after the date on which Cosmo notifies Salix that Cosmo is capable of supplying Products in finished, packaged, and labeled form.
Purchase and Supply Obligations. (a) Subject to the terms and conditions hereof, Glenmark shall Manufacture or have Manufactured by its Affiliate, Glenmark Generics Ltd., and supply to Salix, and Salix shall purchase from Glenmark, such quantities of Compound as Salix may order pursuant to Purchase Orders in accordance with the terms hereof from time to time during the Term.
(b) During the [*] ([*]) years following the first installation of Agreed Scale-Up Equipment and the production of the first trial batch of Compound therefrom, Salix shall order from Glenmark, on an [*] basis, the lesser of (i) the then-current Augmented Capacity (pro rated and averaged (on the basis of number of days elapsed) as necessary in respect of any partial year) and (ii) [*] percent ([*]%) of Salix’s aggregate requirements of Compound. For each year in the aforesaid [*] ([*])-year period, Salix shall provide to Glenmark, within [*] ([*]) [*] after the end of such year, a certification that it has ordered the required portion of its requirements of Compound for that year from Glenmark.
Purchase and Supply Obligations. (a) Subject to the terms and conditions hereof, Lupin shall Manufacture and supply to Salix such quantities of Compound as Salix may order in accordance with the terms hereof from time to time during the Term.
(b) Salix hereby covenants and agrees that, during the Term, it shall purchase from Lupin the Salix Purchase Commitment. Salix shall provide, within thirty (30) days of the end of each Calendar Quarter, a certification that it has purchased its Salix Purchase Commitment for such Calendar Quarter, along with sufficient backup documentation of such fact. Lupin shall have the right to audit Salix’s records to confirm that Salix has purchased the Salix Purchase Commitment, pursuant to Section 8.8. In the event that as of the end of any Calendar Quarter during the Term commencing on or after January 1, 2010 (a “Covered Quarter”), Salix’s purchases of Compound pursuant to this Agreement during such Calendar Quarter are less than the Salix Purchase Commitment in such Calendar Quarter, then Salix shall, within thirty (30) days following the end of such Calendar Quarter, pay to Lupin an amount equal to the product obtained by multiplying (i) the difference between the Salix Purchase Commitment and Salix’s purchases of Compound pursuant to this Agreement during such Calendar Quarter by (ii) the Purchase Price. With respect to the Calendar Quarter ending December 31, 2009, Salix shall, within thirty (30) days following the end of such Calendar Quarter, pay to Lupin an amount equal to (a)(i) Salix’s requirements for Compound in 2009 for the manufacture of Products for sale in the Territory divided by (ii) eight (8) multiplied by (b) the Purchase Price; provided, that Salix may, at its election, make such payment prior to December 31, 2009 based on its reasonable estimate of its requirements for 2009, so long as within thirty (30) days following the end of such Calendar Quarter it makes Lupin whole for any difference between such estimated requirements and Salix’s actual requirements for 2009.
(c) Lupin shall have the right, pursuant to and in accordance with Section 8.8, to audit Salix’s records to confirm that Salix has made all payments required to be made by it by the provisions of clause (b).
(d) Notwithstanding anything in this Section 2.1 to the contrary, during the [*] ([*])[*] prior to the Launch Date, Salix may at any time submit Purchase Orders for Compound solely for the purpose of qualifying then-existing Salix Products and Lupin shall use its commer...
Purchase and Supply Obligations. From the Restated Effective Date subject to the provisions set forth in Sections 2.2, 3.1, 3.3, 10.1, 10.2.1 and Section 10.3.2, Elan shall have no further obligation to purchase Adjuvant from Antigenics (or its Affiliates or Third Party designee), and Antigenics (or its Affiliates or Third Party designee) shall have no further obligation to supply Adjuvant to Elan and its Sublicensees and, subject to the remaining provisions of this Agreement, Elan, its Sublicensees and/or selected Third Party Manufacturer shall have the right to manufacture its Adjuvant Requirements. Except as otherwise expressly set forth herein, including Section 10.3.1, the Parties hereby mutually agree that this Agreement will entirely supersede the Supply Agreement as of the Restated Effective Date.
10.3.1 The Parties hereby mutually agree to cancel, and hereby cancel [**] pursuant to the [**] and agree that neither Party shall have any obligations under Sections 2.4 or 2.5 of the Supply Agreement as of the Restated Effective Date. For the avoidance of doubt, the Parties agree that Elan’s [**] of [**] for [**] of [**] for [**] (the “[**]”) remains in effect and that the terms of the Supply Agreement applicable to [**] shall survive.
10.3.2 In the event Antigenics shall fail to meet any of the Technology Transfer Events by the corresponding due dates set forth above in Section 10.2.1, except to the extent due to the [**] or [**] on the part of [**] or [**], and fails to remedy such failure within [**] of receiving notice of such failure from Elan, then unless Antigenics shall demonstrate that Antigenics is willing and able to [**] of [**] of [**] by [**]:
a) Notwithstanding the Parties [**] with respect to [**] to [**], Elan may either [**] its [**] from a [**] or [**] or [**] for its [**] its [**];
b) Elan shall have no obligation to [**] any [**] to Antigenics under Section [**]; and
c) Antigenics shall [**] Elan [**] and [**] cooperate with [**] to [**] as a [**] of the [**].
Purchase and Supply Obligations. (a) During the term of this Agreement, Seller agrees to sell and Buyer agrees to buy the saliva collection kit (the "Product") which conforms to the descriptions and specifications in Appendix A ("Product Specifications") according to the terms and conditions set forth in this Agreement. Seller agrees to meet Buyer's requirements for the Product.
(b) Buyer will supply to Seller the components of the Product listed on Appendix B ("Buyer-Supplied Components"). Seller will incorporate the Buyer-Supplied Components into the Product. Seller will use the Buyer-Supplied Components solely for production of the Products under this Agreement.
(c) Seller will manufacture, perform quality control and deliver the Product in accordance with Buyer's manufacturing processes and Seller's standard operating procedures listed on Appendix C. Seller shall manufacture in accordance with U.S. FDA Quality System regulations and EN46001. Seller shall not modify applicable SOP's in a fashion which will affect Buyer's product.
(d) Seller understands that the current Product is an interim configuration and that the final Product configuration will differ. When Buyer provides specifications for the final Product configuration, the parties will negotiate in good faith a new price list (Appendix D) for the final Product configuration. Such new price list will provide approximately the same gross margin to Seller as the prices set forth on Appendix B, except as the parties may otherwise agree in writing.
Purchase and Supply Obligations. 2.1 Establishment of Capacity and Volume Commitments
(a) Forecast. Within [...***...] prior to the [...***...] during the term of this Supply Agreement, RFMD shall submit in writing or electronically to JAZZ a rolling [...***...] forecast setting forth the number of Wafers for which the Company shall commence a specified fabrication process [...***...] during each month of the forecast (a "Forecast").
