- In this Agreement, unless the context otherwise expressly requires, the following terms shall have the following meanings:
"Affiliate" shall mean any entity in whatever country organised, which directly or indirectly owns, is owned by or is under common ownership with a Party to this Agreement or any entity actually controlled by, controlling or under common control of a Party to this Agreement. For the purpose of this definition, "ownership" or "control" shall mean where such entity owns or controls fifty per cent (50%) or more of the equity conferring voting rights and/or otherwise has the ability or power to control and direct the business affairs of another entity;
"AU$" shall mean Australian dollars;
"Business" shall mean the business presently carried on by Alpharma in the Territory pursuant to the Technology Licence and Option Agreement in respect of the manufacturing, use, marketing and selling of the Licensed Products in the Territory;
"Business Assets" shall mean those assets, agreements and rights relating to the Business required by a Purchaser to enable such Purchaser to continue the Business in the Territory, including (without limitation) intangibles, stocks (including finished stocks) of Licensed Products, raw materials, manufacturing equipment, machinery, agreements relating to the lease and/or usage of laboratory and production premises and all other assets required to facilitate the carrying on of the Business but excluding (i) any licences or rights granted under Clause 3 and (ii) any property, plant and equipment located in Terre Haute, Indiana, USA;
"Confidential Information"shall mean all information (including, but not limited to, Registration Dossiers and Know-How) which any Party discloses to any other Party either prior to and in contemplation of, or during the course of, this Agreement, whether commercial, financial or otherwise, whether in electronic, documentary or any other form and howsoever disclosed, whether marked or otherwise designated confidential or proprietary, and all matters arising during or in connection with the performance of the Agreement including, but not limited to, details of customers and employees and all materials and information in respect of which any Party owes obligations of confidence;
"Effective Date" shall mean the date of this Agreement;
"Extended Licence Period" shall mean the period commencing the date immediately following the expiration of the Licence Period if no Purchaser is found until the earlier of: (1) the date of assignment by the Licensor of the Licensed Patents, Trade Mark and Know-How in the Territory to Alpharma pursuant to Clause 9.7.3; or (2) the date of discontinuance by Alpharma of the manufacturing, use, marketing or sale of Licensed Products in the Territory pursuant to Clause 6.1; or (3) the date of expiration or abandonment of all of the relevant Licensed Patents in the Territory;
"Force Majeure Event"shall mean any event preventing or restricting a Party from performing any or all of its obligations under this Agreement which arises from or is attributable to any circumstances, acts, omissions or causes beyond the reasonable control of the Party so prevented including without limitation:
(a) act of God, flood, fire, storm, explosion or other destruction of property by natural causes;
(b) war, invasion, revolution, riot, civil commotion or other acts of armed force;
(c) strike, lockout or other industrial dispute involving the workforce of the Party so prevented;
(d) blockade, embargo or other economic sanction having general effect; or
(e) law, government order, regulation, rule or other official directive, policy demand or request having the force of law, including any directive, restriction or other condition of a legal nature imposed in the Territory by a relevant Regulatory Authority, which is of general application to animal health companies and in particular to products having the general characteristics of the Licensed Product;
"Intellectual Property Rights"shall mean the know-how, patent and trade mark rights originally licensed to Alpharma in the Technology and LicenceAgreement including (but without limitation) the Know-How, the Licensed Patents and the Trade Mark licensed hereunder in the Territory;
"Know-How"shall mean and include all present and future techniques, inventions, practices, knowledge, know-how, skill, experience, test data, engineered cell lines, samples, analytical data, field trial protocols, field trial data, reports, information in any application to any Regulatory Authority including without limitation Registration Dossiers, marketing and sales data, toxicological and safety data, INAD's, NADA's or equivalent protocols and all supplements thereto, descriptions and the like (whether in electronic, documentary, eye readable or any other form and howsoever stored and communicated) with regard to the Licensed Product or Licensed Patents, owned by the Licensor at the Effective Date or at any time in the course of this Agreement and which might reasonably be necessary, required or useful to Alpharma in the manufacture, use, marketing or sale of the Licensed Products in the Territory;
"Licence Period" shall mean (i) the period of **** from the Effective Date, or (ii) if a potential Purchaser has been identified during such period by the Licensor, such other period commencing from the date of such Purchaser being identified until the date of the Licensor entering into a binding contract to sell the Intellectual Property Rights to such Purchaser; (provided that the period under this subparagraph (ii) shall not exceed **** from the Effective Date); or (iii) such other period as the Parties may mutually agree in writing;
"Licensed Patents"shall mean:
- all patents, including all pending applications whether filed with a complete specification or an incomplete specification, short particulars of which are set out in Schedule A;
_____________________________
**** Indicates that material has been omitted pursuant to a request for confidential treatment and has been filed separately with the Securities and Exchange Commission.
(b) all patent applications that may hereafter be filed in the Territory by or on behalf of the Licensor which are either based on or claim priority from any of the foregoing patents and applications (including any division, continuation, or continuation-in-part of any such application);
(c) all patents which may be granted in the Territory pursuant to any of the foregoing applications;
(d) any patent which is a re-issue or extension of, or patent of addition or any application maturing into a patent, any patent or patent application defined in (a), (b) or (c) above; and
(e) any patent or patent application corresponding to any patent or patent application defined in (a), (b), (c) or (d) above which is hereafter filed or issued by or on behalf of the Licensor in the Territory in respect of the Licensed Products;
"Licensed Product" shall mean:
(a) recombinant porcine somatotropin; or
(b) any product which is within the scope of, or whose manufacture, use or sale falls within, one or more valid claims of the Licensed Patents in the Territory to the extent that such Licensed Patents cover the product in the actual country of such manufacture, use or sale;
"****"shall mean ****;
"Net Invoiced Price"shall mean the total sale price as invoiced by or on behalf of Alpharma or any sub-licensee for Licensed Products without any deductions except for the following to the extent to which any of the same are allowed for or included in the invoice:
(a) transport charges (including carriage and insurance) and delivery expenses;
(b) costs to reflect special packaging costs required by a customer;
(c) credits on Licensed Products returned;
(d) usual trade discounts and discounts for prompt payment; and
(e) sales, value added tax, customs duties or other taxes based on the sales price and borne by Alpharma;
provided that, in the event that any Licensed Products are used by Alpharma or any sub-licensee for its own commercial purposes or are sold or transferred otherwise than on an arms length basis or are sold or transferred to any of Alpharma's Affiliates, the Net Invoiced Price of such Licensed Products shall be deemed to be equivalent to the Net Invoiced Price which would have been applicable hereunder had such Licensed Products been sold or transferred to an independent arms length customer at the date of first use, or, in the case of such a sale or transfer to an Affiliate, the price charged upon first sale or transfer to such customer by such Affiliate;
"Parties"shall mean the Licensor, Alpharma, BISA and BIL and"Party" means any of them;
"Product Licence"shall mean the licence, certificate or other written approval issued by the Regulatory Authority as provided for by the law of the relevant country in the Territory, which enables the legal marketing and sale of the Licensed Products in that country in the Territory;
"Purchaser"shall mean a third party who has indicated to the Licensor in writing during the Licence Period that it is prepared in principle to purchase any or all of the Intellectual Property Rights (but which shall include the Know-How, the Licensed Patents and the Trade Mark licensed hereunder in the Territory);
"Registration Dossier"shall mean all data and information (including, but not limited to, composition, method of manufacture, analytical procedures, cell lines and other genetic material, and field trial reports) required for an application for a Product Licence by the applicable Regulatory Authority;
"Regulatory Authority"shall mean the duly constituted authority in a relevant country in the Territory charged with approving veterinary products for manufacture and/or sale, and regulating and controlling the use of such products;
"Sales"shall mean invoiced, (irrespective of delivery or payment terms, on Alpharma's terms and conditions of sale) to a purchaser or user, and shall extend to all sales made by any sub-licensee, sub-licensed Affiliate of Alpharma or any other person on behalf of Alpharma;
"Technology Licence andshall mean the technology licence and optionOption Agreement"agreement entered into by the Parties on 5th
August 1999 regarding recombinant porcine somatotrophin;
"Territory" shall mean Australia, Indonesia, Malaysia, Peru, Guatemala, Mexico, South Africa, Brazil, Colombia, Costa Rica, Philippines, Viet Nam and New Zealand;
"Third Party Licences"shall mean the licences listed in Schedule B;
"Trade Mark"shall mean REPORCIN; and
"Trade Mark Licence"shall mean the licence to use the Trade Mark described in Clause 8;
- references to Clauses and Schedules are to the clauses and schedules of this Agreement;
- words importing gender include each gender;
- references to persons and entities include, without limitation, bodies corporate, firms or unincorporated associations;
- the singular includes the plural and vice versa;
- Clauses headings are included for convenience only and shall not affect the interpretation of this Agreement; and
- references to any statute or any clause of any statute include any statutory amendment, modification or re-enactment in force from time to time and references to any statute include any statutory instrument or regulations made under it.
4.7 Any examination conducted pursuant to Clause 4.6 shall be conducted at the expense of the Licensor unless, when conducting such inspection, the accountant discovers an error of more than three per cent (3%) in the returns made by Alpharma since the Effective Date, in which event Alpharma shall pay the cost of such inspection.
4.8 In the event that, in the course of any examination conducted pursuant to Clause 4.6, the accountant discovers any underpayment in the returns made by Alpharma since the Effective Date, Alpharma shall pay a sum equivalent to the amount of such underpayment forthwith and, in the case of any overpayment being established, the Licensor shall repay the amount of such overpayment forthwith.