ManufacturingandSupplyAgreement制造与供给合.docx

1、ManufacturingandSupplyAgreement制造与供给合Manufacturing and Supply Agreement制造与供给合同 - The following capitalized terms shall have the following meanings when used in this Agreement.1.1 Affiliate means, with respect to a particular Party, a person, corporation or other entity that, directly or indirectly,

2、through one or more intermediaries, controls, is controlled by or is under common control with such Party. For the purposes of this definition, control means the direct or indirect ownership by a Party of at least fifty percent (50%) of the outstanding voting securities of the controlled entity; pro

3、vided, that in any country where the law does not permit foreign equity ownership of at least fifty percent (50%), then with respect to corporations organized under such countrys laws, control shall mean the direct or indirect ownership by a Party of outstanding voting securities of such corporation

4、 at the maximum amount permitted by the law of such country.1.2 Back-Up License shall have the meaning set forth in Section 3.7(c).1.3 Business Day means any day that is not a Saturday, Sunday or other day on which (a) banks in the State of Washington are authorized or required to close for the purp

5、oses of any action to be taken by or any notice to be provided to AAA, or (b) the banks in _(COUNTRY) are authorized or required to close for the purposes of any action to be taken by or any notice to be provided to BBB.1.4 Collaborative License Agreement mean the Agreement by and between the Partie

6、s dated _,_,_(M/D/Y).1.5 Component or Components shall mean either a BBB Component or a AAA Component, depending upon the context of the applicable Section and the Party to which such section then applies.1.6 Controlled means, with respect to a particular item, material, or intellectual property rig

7、ht, that a Party owns or has a license under such item, material or intellectual property right and has the ability to grant to the other Party access to and/or a license or sublicense under such item, material or intellectual property right without violating the terms of any agreement or other arra

8、ngement with, or the rights of, any Third Party.1.7 AAA Antigen means an antigen that is claimed by a patent or is otherwise covered by intellectual property rights that are Controlled by AAA.1.8 AAA Component or AAA Components mean a Separation Device, Reagent or AAA Antigen, or any combination the

9、reof, other than a combination which comprises a AAA Product.1.9 AAA Product means: (a) any therapeutic product comprising Dendritic Cells that have been activated or loaded with a specific antigen, engineered antigen or antigen gene, (including without limitation AAA Antigen), for use in human ther

10、apy by infusion into a patient, which product has been developed by AAA based on the AAA Technology; or (b) any service provided by or on behalf of AAA to a patient that utilizes the AAA Technology and involves isolation or preparation of Dendritic Cells, activation or loading with specific antigen,

11、 engineered antigen or antigen gene, (including without limitation AAA Antigen), and infusion of such activated or antigen loaded Dendritic Cells into a patient. Further, the Parties may agree in writing to amend and extend the definition of AAA Product as provided in Section 5.8 of the Collaborativ

12、e License Agreement.1.10 AAA Technology means the AAA Know-How, the AAA Improvements and the AAA Patents, (as such terms are defined in the Collaborative License Agreement) either collectively or any part thereof.1.11 Dendritic Cell means a human dendritic cell or other antigen- presenting cell or o

13、ther cells from which dendritic cells can be derived.1.12 Fully-Burdened Manufacturing Costs means the actual fully burdened costs and expenses of manufacturing a particular Component, including without limitation the costs of all raw materials and labor (including all allocable benefits) used or co

14、nsumed in such manufacture, Third Party contract manufacturing costs, packaging costs and expenses, all quality assurance and quality control related expenses, all overhead amounts allocable to such manufacturing (including without limitation appropriately amortized capital equipment costs), all roy

15、alty amounts payable by Supplier to any Third Party based upon the manufacture of such Component, and all amounts related to failed production units or yield losses, all the foregoing as calculated in accordance with (i) U.S. generally accepted accounting principles consistently applied for manufact

16、ure of Components by AAA and (ii) _(COUNTRY)s generally accepted accounting principles consistently applied for manufacture of Components by BBB.1.13 Information means any and all information and data of any kind, including without limitation techniques, inventions, practices, methods, knowledge, kn

17、ow-how, skill, experience, test data (including pharmacological, toxicological and clinical test data), analytical and quality control data, marketing, cost, sales and manufacturing data and descriptions, compositions, and assays.1.14 BBB Antigen means an antigen that is claimed by a patent or is ot

18、herwise covered by intellectual property rights that are Controlled by BBB.1.15 BBB Component or BBB Components shall mean any BBB Antigen or any other BBB proprietary component of a BBB Product, and any combination thereof, that AAA is either unable to prepare or generally does not prepare for BBB

19、or for itself.1.16 BBB Product means: (a) any therapeutic product developed by or on behalf of BBB based on, derived from or incorporating the AAA Technology that comprises Dendritic Cells that have been activated or loaded with a specific antigen, engineered antigen or antigen gene, (including with

20、out limitation a BBB Antigen), for use in human therapy by infusion into a patient; or (b) any service provided by or on behalf of BBB to a patient that involves isolation or preparation of Dendritic Cells, activation or loading of a specific antigen, engineered antigen or antigen gene, (including w

21、ithout limitation a BBB Antigen), and infusion of such activated or antigen loaded Dendritic Cells into a patient, wherein such service is based on, utilizes, comprises or is derived from the AAA Technology. The Parties may agree in writing to amend and extend the definition of BBB Product as provid

22、ed in Section 5.8 of the Collaborative License Agreement.1.17 Licensed AAA Product shall have the meaning set forth in Section 2.3(b) of the Collaborative License Agreement.1.18 Licensed BBB Product shall have the meaning set forth in Section 2.4(b) of the Collaborative License Agreement.1.19 Manufa

23、cturing Know-How means all Information other than Patents necessary for the manufacture of a BBB Antigen or AAA Antigen which is subject to the Back-Up License.1.20 Manufacturing Plan shall mean the plan prepared by the Supplier and delivered to the Purchaser for its review and approval, in good fai

24、th, which plan details the Suppliers manufacturing plan for achieving manufacture of the Components at levels at least equal to the Purchasers forecasted orders for the first year after commercial launch of the first BBB Product or AAA Product, as applicable.1.21 Net Revenue means the total revenue

25、received by a Party for sale or other disposition of a Product by such Party or an Affiliate or Sublicensee of such Party to a Third Party less the following to the extent actually incurred or allowed with respect to such sale or disposition: (i) reasonable costs paid, if any, by the Party to a Thir

26、d Party on account of apheresis performed as part of or in association with the Product; (ii) discounts, including cash discounts, or rebates, retroactive price reductions or allowances actually allowed or granted from the billed amount; (iii) credits or allowances actually granted upon claims, reje

27、ctions or returns of Products, including recalls, regardless of the Party requesting such; (iv) freight, postage, shipping and insurance charges paid for delivery of Product, to the extent billed; and (v) taxes, duties or other governmental charges levied on or measured by the billing amount when in

28、cluded in billing, as adjusted for rebates and refunds; provided, however, that with respect to sales of a particular BBB Product or Licensed AAA Product by BBB or its Affiliate or Sublicensee in _(COUNTRY), the total revenue received , as set forth above in the first line of this definition, shall

29、not in any event be less than the NHI Price established for insurance reimbursement of Single Treatment (as defined in the Collaborative License Agreement), less the average amount charged by the particular hospital purchaser of such Product for the same number of apheresis services and infusion ser

30、vices needed for and performed for Single Treatment (as defined in the Collaborative License Agreement) where such averages are calculated including all apheresis services or infusion services, as applicable, that were performed for any purpose during the applicable period.1.22 Patent means (i) a va

31、lid and enforceable patent, including any extension, registration, confirmation, reissue, re-examination or renewal thereof; and (ii) to the extent valid and enforceable rights are granted by a governmental authority thereunder, a patent application.1.23 Product means a BBB Product or a AAA Product.

32、1.24 Purchaser shall mean the Party purchasing Components from the other Party to the Agreement, as applicable, in the applicable section.1.25 Reagent means, with respect to a particular Licensed AAA Product, any proprietary reagent of AAA (excluding any reagents contained in a Separation Device) that is required for commercial manufacture and/or use of such Licensed AAA Product.1.26 Reasonable Efforts shall mean efforts and resources commonly used in the research-based pharmaceutical industry for the researc