definiens: means this Supply Agreement for the P roduct, including all Exhibits attached hereto ; c ) means any applicable law, statut e, rule, regulation, order, judgment or ordinance o f any governmental or regulatory authority or agency ; d ) means FDA, EMEA and/or other equivalent governmental or regulatory authorities or agencies and any successors thereto ; e ) means any day on which banking ins titutions in Boston, Massachusetts and Bubendorf, Switzerland are open for business ; f ) means a schedule of one or more discre te batches of Product Manufactured in sequence by S upplier without pausing to change over to manufacture of an y other product ; g ) means the current Good Manufa cturing Practices standards required under ICH Q7A guideline and/or any similar standards of applicabl e governmental and/or regulatory authorities as def ined in the Quality Agreement ; h ) means any transaction or seri es of transactions wherein ( a ) the voting securitie s of Supplier outstanding immediately prior thereto cease to repr esent at least fifty percent ( 50 % ) of the combined voting power of the surviving entity immediately after such tran saction or transactions ; ( b ) the stockholders or eq uity holders of Supplier approve a plan of complete liquidation of Supplier, or an agreement for the sale or dispositi on by Supplier of all or substantially all of Supplier ’s assets, o ther than to an Affiliate ; ( c ) a Third Party become s the beneficial owner of fifty percent ( 50 % ) or more of the combine d voting power of the outstanding securities of Sup plier ; or ( d ) substantially all of Supplier ’s business or ass ets which relate to this Agreement are sold or othe rwise transferred to a Third Party ; i ) means established and reliab le execution of chemical reactions in order to prod uce the by applying chemical and physical manipul ations usually involving one or more reactions ; j ) means all written info rmation and data provided by the Parties to each ot her hereunder and identified as being an d provided to the recipient, except that the term shall not apply to any information or any portion thereof which : ( i ) was known to the recipient or any of its Affili ates, as evidenced by its written records, before r eceipt thereof under this Agreement ; ( ii ) is disclosed to the recipient or any of its Af filiates, without obligations of confidentiality, d uring the Term by a Third Party who has the right to make suc h disclosure ; ( iii ) is or becomes part of the public domain throu gh no breach of this Agreement by the recipient ; or CONFIDENTIAL Page 7 of 47 THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT O F A CONFIDENTIAL TREATMENT REQUEST