definiens: H " means the form of KLH manufactured by BIOS':t'j'\ corresponding to and ha,-ing specifications detailed on the Data Sheet attached hereto as Schedule 1 and incorporated by reference herein ; shall ha\-e the meaI11ng set forth 1I1 clause 2.3 ; Information " means all materials, knmv - how, trade secrets or other information, 1l1cluding, without limitation, proprietary information and materials ( whether or not pmentable ) regarding a Party 's technology, Vaccines or business, which is designated as confidential in \\Titing by such Party, whether by letter or by the use of an appropriate stamp or legend, prior to or at the time any such information is disclosed by such Party to the other Party _ Not\vithstanding the foregoing, mformation that is orally, electronically or visually disclosed by a Party, or is disclosed in writing without an appropriate letter, stamp or legend, shall constitute Confidential Information of the disclosing Party if the disclosing Party, within 30 days after such disclosure, to the other Party a written communication describing the information and referencing the place and date of such oral, visual, electronic or written disclosure and the names of the persons to whom such disclosure was made . Notwithstanding the foregoing, Confidential Information of a . disclosing Party shall not include information which the receiving Party can demonstrate by competent written proof : ( i ) is now, or hereafter becomes, through no act or failure to act on the part of the receiving Party, generally known or available ; ( ii ) is known by the receiving Party at the time of receiving such information, as evidenced by its written records ; ( iii ) is hereafter furnished to the receiving Party by a Third Party, as a matter of right and without restriction on disclosure ; or ( iv ) is independently developed by the receiving Party without the use of or reference to the disclosing Party 's Confidential Information ; means the Drug Master File for biosyn IQH a copy of which has been flied with the FDA ; shall have the meal11ng set forth l!1 means the United States Food and Drug Administration ; means the United States Food, Drug and Cosmetic Act, as amended, and regulations and guidelines promulgated thereunder ; of the relevant bears the meaning set out in Incoterms 2000, a copy of which is included as Schedule 3 hereto ; means current Good ~fanufacturing Practices promulgated by the Division of I\fanufacturing and Product Quality of the FDA ; fully defined 111 21 with the Favrillc II 1204r means an Invesngational 1\:e\\7 Drug Application ( as more .R. 312 ) and all amendments and supplements thereto filed 2 means Kevhole Limpet Hemocyanin, a protein the giant limpet 1\legathura crenulata ; means, collecti\~cly, all raw materials, ingredients and packaging components required to produce biosyn KLH in accordance with the Specifications ; means a New Drug Application ( as more fully defined in 21 C.F.R. 314.5 d j'cq . ) or Biologics Licensing Application ( as more fully defined in 21 c.r . R. 6(1 ) and all amendments and supplements to any of the foregoing filed with the FDA ; means approval by the FDA of applicable filing and satisfaction of any related applicable FDA registration and notification requirements, if any, required to market and sell a Vaccine in the U means the characteristics, processing, formulae, labeling and packaging recp.lirements and standards pertaining to the manufacture or supply of biosyn KLH that are set ford1 in Data Sheet attached as Schedule 1 hereto, as it may be amended or supplemented from time to pursuant to clause means the first ninen ' ( 96 ) months of this Agreement running from the Dare for a period of six ( 96 ) months . Thereafter, the Agreement will automatically extend for successive additional twelve ( 12 ) month periods unless, by notice given at least thm ) ' ( 30 ) days prior to the expiration of any such period, either elects to cause the Agreement to tenninate at the of the rhen current period ; means in tellectual property righ ts and technology necessary for the manufacture, use or sale of Vaccines ; VaccineYear " means calendar year, flrst month being J anuaty and the last month being December