Sigma. Xxxxxxx pty. Ltd. (Australia) purchased equity in Benitec, Ltd., an Australian company
Sigma out of responsibility and consideration for the Company's employees, shareholders, creditors, and for the sake of allowing the Company to complete its rehabilitation process, has agreed to implement the following changes to the terms of the Agreement: · Postponement of all mature debt amounts (due December 31st, 2010) in the amount of $4,265,300 until January 1st, 2012. · The 2011 accrued interest, pursuant to the terms of the Agreement, to be paid to Sigma, as follows:
Sigma. Tau's Obligations
Sigma. Tau and its Affiliates shall keep SCLN informed of the progress of the Trial and shall provide SCLN with quarterly summary reports of the results of the Trial. Sigma-Tau and its Affiliates shall give SCLN access to the clinical reports and patient histories concerning the Trial. Sigma-Tau will provide to SCLN and to SPIL, for regulatory and marketing purposes and with the intention of assisting SCLN and SPIL in the submission of such regulatory filings as SCLN and SPIL deem appropriate, the data resulting from the Trial when and as it is available.
Sigma. TAU shall be responsible for conducting pre-clinical, clinical and other trials necessary or advisable to process encochleated COMPOUNDS in order to register and commercialize the PRODUCTS in the FIELD in the TERRITORY. As soon as possible after signature hereof (the parties envisage within sixty (60) days from EFFECTIVE DATE), and provided that BDSI fulfils its obligations under Sections 3.1 and 3.2 above, SIGMA-TAU and BDSI shall mutually agree upon a plan setting forth the respective duties and responsibilities for, among other matters as may be agreed to, the encochleation of the COMPOUNDS and the development and registration of the PRODUCTS in the FIELD (hereinafter referred to as “DEVELOPMENT PLAN”). Such DEVELOPMENT PLAN may be amended from time to time during the term of this Agreement with the agreement of SIGMA-TAU and BDSI. BDSI agrees to use its commercially reasonable efforts to provide to SIGMA-TAU two (2) cochleate formulations with respect to two (2) COMPOUNDS (to be mutually agreed upon by SIGMA-TAU and BDSI) by March 31, 2005. SIGMA-TAU shall use its commercially reasonable efforts to: (i) begin the testing of COMPOUNDS formulated with and incorporating the PATENTS and KNOW-HOW within thirty (30) days of receipt of same from BDSI and (ii) inform BDSI of the results of such testing and SIGMA-TAU’s view of subsequent next development and/or marketing and commercialization steps with respect to such COMPOUNDS within one hundred twenty (120) days of initial receipt of such COMPOUNDS from BDSI. In addition, SIGMA-TAU shall use its commercially reasonable efforts to complete all pre-clinical and clinical studies necessary to file the MARKETING AUTHORIZATION for the PRODUCTS in the FIELD in the TERRITORY within the timeframes contemplated in the DEVELOPMENT PLAN. Other cochleate formulations with respect to the COMPOUNDS will be provided by BDSI to SIGMA-TAU within the timeframes contemplated in the DEVELOPMENT PLAN.
Sigma. TAU shall own all the data of any kind generated by any clinical study conducted by SIGMA-TAU and SIGMA-TAU will own the new drug application or submission filed by SIGMA-TAU with any AGENCY to obtain the MARKETING AUTHORIZATION in any country of the TERRITORY. SIGMA-TAU will also own all MARKETING AUTHORIZATIONS. BDSI shall have the right, however, to use such data for purposes of demonstrating the safety and efficacy of encochleation to potential licensees of rights under the PATENTS for products not related to the PRODUCTS or COMPOUNDS. Prior to any such demonstration, BDSI shall remove from such data any information related to the identity of the COMPOUNDS, and the identity of SIGMA-TAU and any AFFILIATED COMPANIES.
Sigma. TAU undertakes to exercise commercially reasonable efforts to commence sales of the PRODUCTS as soon as possible after the date of the obtaining of the first MARKETING AUTHORIZATIONS (including pricing approvals, if applicable). SIGMA-TAU agrees to keep BDSI informed about the progress made in the preparation of the launching of the PRODUCTS in the TERRITORY and of the date of such launching. The appropriate timing for launching and whether or not to launch the PRODUCTS in a particular country of the TERRITORY will be decided by SIGMA-TAU only.
Sigma. TAU hereby agrees to save, defend, indemnify and hold BDSI and its respective officers, directors, employees, independent contractors, agents, and assigns, harmless from and against any and all suits, claims, actions, demands, liabilities, expenses or loss (including attorneys’ fees) resulting directly or indirectly from:
Sigma. Tau shall use its commercially reasonable efforts to (i) maintain in effect the Commitment Letter; (ii) negotiate definitive agreements with respect to the Financing on the terms and conditions contained in the Commitment Letter (or on terms no less favorable to Sigma-Tau (including with respect to the conditionality thereof) than the terms and conditions in the Commitment Letter); (iii) satisfy on a timely basis all conditions applicable to it and its Affiliates, if any, in such definitive agreements that are within its or its Affiliates, if applicable, control; (iv) upon satisfaction of such conditions (and all of the other conditions contained in Section 9.1 and Section 9.2 (other than Section 9.2(d)), consummate the Financing at or prior to the Closing, accept the funds comprising the Financing and transfer such funds (whether by contribution or loan or otherwise) to the Purchasing Parties; and (v) comply with its obligations set forth in the Commitment Letter. Sigma-Tau shall keep the Seller informed on a reasonably current basis and in reasonable detail of the status of the Financing and shall promptly provide to the Seller appropriate notice when the definitive binding documents related to the Financing have been executed (which notice will include reasonable detail regarding any terms to the Financing that are inconsistent with those contained in the Commitment Letter). Sigma-Tau shall have the right from time to time to enter into any amendment, replacement, supplement or other modification of, waive any of its rights under, or terminate, the Commitment Letter (other than with respect to the conditions thereto), substitute other debt or equity financing for all or any portion of the Financing from the same and/or alternate funding sources (on terms no less favorable to Sigma-Tau with respect to the conditionality thereof), or reduce the amount of the Financing, in any case in its reasonable discretion, but only if such amendment, replacement, supplement or other modification of, waiver of any provision contained in, or termination of, the Commitment Letter, substitution of other financing or reduction of the Financing does not, and would not reasonably be expected to, prevent or delay the Closing or add any additional or greater conditionality to the funding of the Financing. Sigma-Tau shall keep the Seller informed on a prompt basis and in reasonable detail if it takes any of the actions referred to in the preceding sentence. Sigma-Tau shall give...
Sigma. Tau shall retain a perpetual, royalty-free exclusive license to use for any purposes, within the Territory, except in Italy, where such license shall be non-exclusive subject to Section 2.4, any such Improvements or Inventions made by or on behalf of Sigma-Tau or SPIL arising out of the clinical trials referenced in this Article 5 or otherwise developed by Sigma-Tau or SPIL under this Agreement, unless this Agreement is terminated pursuant to Section 10.3 (a) hereof.
