(1) NATINCO N.V.
(2) ALPHARMA INC.
(3) BISA HOLDINGS B.V.
"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; |
"Alpharma Mark" | shall mean any mark used by Alpharma for the Licensed Product, subject to Clause 12.6; |
"Asset Purchase Agreement" | shall mean the asset purchase agreement between Alpharma and SCB; |
"AUD" | shall mean Australian dollars; |
"best endeavours" | shall mean taking all actions which, having regard to the cost and degree of difficulty, are commercially practicable; |
"Bunge Agreement" | shall mean the letter of offer dated 12 October 1993 from the South African Breweries Beer Division to Bunge (Australia) Pty Ltd; |
"Closing" | shall mean the consummation of this transaction which, subject to Clauses 18, 19 and 20 hereof, shall take place at the office of Alpharma in Fort Lee, New Jersey, USA at 10:00 am (local time) on [Aug 6, 1999] or on such other date and time agreed upon by the Licensor and Alpharma ; |
"Confidential Information" | shall mean all information (including, but not limited to, Registration Dossiers and Know-How) which any Participant discloses to any other Participant 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 Participant owes obligations of confidence; |
"CSL Agreement" | shall mean the sub-lease and agreement dated 22 July 1988 between Bunge (Australia) Pty Ltd and the Commonwealth Serum Laboratories Commission relating to the premises situated in the West Wing of Block 5 at 45 Poplar Road, Parkville, Victoria., as varied by a deed of renewal and variation of lease made on 18 March 1993 between CSL Limited and Bunge (Australia) Pty Ltd, a deed of assignment and variation made on 18 March 1993 between Bunge (Australia) Pty Ltd, Fidelity Food Technologies Pty Ltd and CSL Limited and a sublease dated 13 July 1994 between Fidelity Food Technologies Pty Ltd, the Seller and Bunge (Australia) Pty Ltd; |
"Effective Date" | shall mean the date of Closing; |
"FDA" | shall mean the Center for Veterinary Medicine of the Food and Drug Administration of the US Department of Health and Human Services; |
"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 circumstance, 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, lock-out 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 Licensed Territory or Intended Licensed 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; |
"Improvement" | shall mean any improvement, enhancement, material alteration or modification to or of the Licensed Product; |
"Intellectual Property" | shall mean the Know-How, the Licensed Patents and the Trade Mark; |
"Intellectual Property Transfer Date" | shall mean 31 December 2003 (unless extended pursuant to the provisions of Schedule C) or such earlier date on which the Intellectual Property may be transferred and the Third Party Licences assigned to Alpharma under the provisions of this Agreement; |
"Intended Licensed Territory" | shall mean those countries listed in Schedule C as to which from time to time Licensee does not possess a Product Licence; |
"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, 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 applying to any Regulatory Authority and in the development, manufacture, use or sale of the Licensed Products; |
"Licence Fee" | shall mean, the amount payable on the Effective Date under Clause 5.1 and, in respect of each country listed in Schedule C, the sum of money set out in that Schedule as being due on the granting of a Product Licence in that country, or the equivalent sum in any other currency specified in writing by the Licensor within ten (10) business days of the date that the relevant Product Licence is granted (based on the average buying rate for the latter currency at Chase Manhattan Bank, New York, for the period between the date that the relevant Product Licence is granted and five (5) business days prior to the date of payment provided under Clause 5.2), and, in respect of any country not listed in Schedule C, such sum as the Parties may agree in accordance with Clause 5.4; |
"Licence Period" | shall mean, subject to Clause 15.4, the period from the Effective Date until the Intellectual Property Transfer Date; |
"Licensed Patents" | shall mean: |
| (a) 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; |
| (b) all patent applications that may hereafter be filed 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 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 anywhere in the world in respect of the Licensed Products; |
"Licensed Product" | shall mean and include: |
| (a) recombinant porcine somatotrophin; |
| (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 any country of the world to the extent that such Licensed Patents cover the product in the actual country of such manufacture, use or sale; and |
| (c) any product (including products used in connection with other species) which utilizes any of the Know-How or the Third Party Know-How; |
"Licensed Territory" | shall mean Australia, Malaysia and Indonesia and shall be expanded from time to time to include any other country in respect of which Alpharma has paid the appropriate Licence Fee pursuant to Clause 5; |
"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; |
"Option Price" | Shall mean, depending on the Intellectual Property Transfer Date, the price for the Intellectual Property set out in Schedule D; |
"Participants" | shall mean the Licensor, Alpharma, Bisa and BIL and "Participant" means any of them; |
"Personnel" | shall mean Richard Levitt, David Hughes, and Ian Walker; |
"Pig Dose" | shall mean that amount of recombinant porcine somatotrophin required to give one pig one course of treatment (150 mg of recombinant porcine somatotrophin per pig, or such other quantity as may be agreed by the Parties from time to time or as shall be mandated by a Regulatory Agency); |
"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, which enables the legal marketing and sale of the Licensed Product in that country; |
"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; |
"Registration Programme" | Shall mean the programme for filing applications to register Product Licences set out in Schedule C; |
"Regulatory Authority" | shall mean the duly constituted authority in a relevant country charged with approving veterinary products for manufacture and/or sale, and regulating and controlling the use of such products; |
"SCB" | shall mean Southern Cross Biotech Pty Ltd, a company registered in Australia, whose registered office is at Level 10, Trak Centre, 443-449 Toorak Road, Toorak, Victoria; |
"Serious Breach" | shall mean (a) a failure of Alpharma to make a payment of monies validly due hereunder or (b) a failure by Alpharma to secure the grant of at least five (5) new Product Licences under the Registration Programme by 31 December 2002 under circumstances which would entitle the Licensor to liquidated damages under Clause 8.8 for four (4) or more Product Licences; |
"Sold" | shall mean invoiced, (irrespective of delivery or payment terms, on Alpharma's terms and conditions of sale) to a purchaser or user and "sell" and "sale" and cognate expressions shall be construed accordingly, and shall extend to all sales made by any sub-licensee, sub-licensed Affiliate of Alpharma or any other person on behalf of Alpharma; |
"Target Grant Date" | shall mean, with respect to any Product Licence, the last day of the calendar quarter in which that Product Licence would be expected to have been granted, as set out in the Registration Programme; |
"Target Submission Date" | shall mean, with respect to the application for any Product Licence, the last day of the calendar quarter in which it is required to be filed., as set out in the Registration Programme; |
"Third Party 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, descriptions and the like (whether in electronic, documentary, eye readable or any other form and howsoever stored and communicated) which the Licensor has obtained from the Third Party Licensors pursuant to the Third Party Licences and has in its possession at the Effective Date; |
"Third party Licences" | shall mean the licences listed in Schedule B; |
"Third Party Licensors" | shall mean those parties listed in Schedule B ; |
"Third Party Patents" | shall mean the patents referred to in the Third Party Licences; |
"Trade Mark" | shall mean REPORCIN; |
"Trade Mark Licence" | shall mean the licence to use the Trade Mark described in Clause 12; |
"Warrantors" | shall mean Bisa and BIL; |
1.2 references to Clauses and Schedules are to the clauses and schedules of this Agreement;
1.4 references to persons and entities include, without limitation, bodies corporate, firms or unincorporated associations;
1.6 Clause headings are included for convenience only and shall not affect the interpretation of this Agreement; and
1.7 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.
solely for the purposes in either case of developing and manufacturing the Licensed Products.
3.1 Alpharma, the Licensor and each of the Warrantors warrants that it is a company duly incorporated under the laws of the country or state referred to above, and that it has the corporate power and authority to accept the terms of this Agreement and to perform its obligations under it.
3.2 The Licensor warrants and represents that, at the Effective Date, (a) the Licensor is the sole beneficial owner of the Licensed Patents and the Know-How and a licensee of the Third Party Patents and the Third Party Know-How under the Third Party Licences and the Licensor has full right and power to grant licences set out in Clauses 2.1, 2.2 and 2.3, and (b) so far as it is aware, no other party has any rights or claims in respect of the Licensed Patents and the Know-How, and (c) there are no outstanding agreements, assignments or encumbrances in existence inconsistent with the provisions of the Agreement with respect to or relating to the Licensed Patents or Know-How, except for the obligations to pay royalties under the CSL Agreement and Bunge Agreement, and (d) the Third Party Licences are in full force and effect and the Licensor is not in default with respect to any of the Third Party Licences, and (e) so far as it is aware, no other party (except the Third Party L icensors) has any rights or claims in respect to the Third Party Patents or Third Party Know-How and there are no outstanding agreements inconsistent with the provisions of this Agreement created or allowed to exist by or on behalf of any Third Party Licensor, and (f) the Licensor has full power and right to grant the sub-licences under the Third Party Licences and, upon the Intellectual Property Transfer Date, the transfer of the Third Party Licences, and (g) the Licensor has not created or, with its knowledge, allowed to exist any outstanding agreement, assignment, or encumbrance with respect to the Third Party Licences inconsistent with the provisions of this Agreement. As the phrase "agreement, assignment or encumbrance" is used in the Clause it includes without limitation, any obligations to governmental agencies, private foundations, companies, corporations, individuals or the like resulting from acceptance of research grant or other monies, or otherwise.
3.3 The Licensor warrants that, at the Effective Date, Schedule A contains a full list of the Licensor's patents and pending patent applications worldwide, and that the Licensor has acquired all of the Intellectual Property owned by SCB prior to the transfer of the Intellectual Property to the Licensor and all of SCB's rights under Third Party Licenses.
3.4 The Licensor warrants that, at the Effective Date, so far as it is aware:
3.4.1 no person is infringing (nor is there any claim that any person is infringing) any of the Licensed Patents or Third Party Patents in any part of the Licensed Territory or the Intended Licensed Territory;
3.4.2 the manufacture, use, sale or other dealing or disposition of the Licensed Products does not infringe (nor is there any claim of infringement of) the intellectual property rights of any other person in any part of the Licensed Territory or the Intended Licensed Territory; and
3.4.3 the granted patents within the Licensed Patents and the Third Party Patents are valid and enforceable and no facts or information exist which render any of Know-How or Third Party Know-How invalid, unusable or unenforceable in the Licensed Territory or the Intended Licensed Territory.
3.5 The Licensor warrants that, at the Effective Date, no material part of the Licensor's Confidential Information (other than information set out in the specifications of the Licensed Patents, or that would reasonably be expected to have been disclosed to a Regulatory Authority, or that would not have been kept confidential by a reasonably prudent animal health company) has been disclosed to any third party (other than the Third Party Licensors) except on a confidential basis and pursuant to a confidentiality agreement nor, so far as it is aware, has any third party disclosed any of the Licensor's Confidential Information to any person in material breach of .such confidentiality agreement
3.6 The Warrantors hereby separately warrant in the terms of Clauses 3.2 to 3.5 (inclusive) but solely on the basis that such warranties are given by them to the best of their knowledge.
3.7 For the purposes of this Clause 3, the expression "so far as it is aware" in relation to the Licensor shall be construed as being the actual knowledge of the Licensor having made reasonable prior enquiry of SCB and relying on, and being responsible to Alpharma hereunder for any fraudulent misrepresentation by any of the Personnel during the course of such prior enquiry. In respect of warranties given in this Clause 3 relating to the Third Party Patents and Third Party Know-How, Alpharma acknowledges that the expression "so far as it is aware" also means that no independent investigation or enquiry has been carried out by the Licensor of any of the Third Party Licensors or any other person other than the Personnel. For the purposes of this Clause 3, the expression "to the best of their knowledge" in relation to the Warrantors shall be construed as being in the actual knowledge of Bisa or BIL, as the case may be, relying exclusively on, and solely restricted to, the ac tual knowledge of their respective officers and management, their having made no investigation or prior enquiry of SCB, the Third Party Licensors or any other person.
3.8 The Licensor and the Warrantors agree that the warranty contained in Clause 3.2 shall be deemed to have been repeated by them on the Intellectual Property Transfer Date with the deletion of the words "sole beneficial owner" in Clause 3.2(3) and the substitution therefor by the words "sole legal and beneficial owner" subject to (i) the qualifications referred to in Clause 3.6 and 3.7; (ii) the existence of any licences which may have been granted by the Licensor during the Licence Period (in the event that the provisions of Clause 10.2 and/or Clause 10.3 have come into effect), and Alpharma hereby agrees that it shall be deemed to have had knowledge of such licences; and (iii) any other matters disclosed by any of the Licensor or the Warrantors to Alpharma, or which come to the attention of Alpharma at any time on or prior to the Intellectual Property Transfer Date. The Licensor and the Warrantors further agree that the warranties contained in Clauses 3.4 and 3.5 shall be deemed to have been repeated by them on the Intellectual Property Transfer Date subject to the qualifications referred to in Clause 3.6 and 3.7, but neither the Licensor nor the Warrantors shall be liable for the breach of , either such warranty at the Intellectual Property Transfer Date in respect of any matters disclosed by any of the Licensor or the Warrantors to Alpharma, or which come to the attention of Alpharma at any time on or prior to the Intellectual Property Transfer Date.
3.9 Save as expressly provided in this Agreement, nothing in the Agreement or any licence granted hereunder shall be construed as a representation or warranty that any of the Licensed Patents or the Third Party Patents are valid or enforceable or that the manufacture, use, sale or other dealing or disposition of the Licensed Products will not infringe the intellectual property rights of any other person anywhere in the world.
3.10 Without prejudice to Alpharma's duty to mitigate its loss, the total liability of the Licensor and the Warrantors in respect of any claim under this Clause 3 shall be limited as provided in Clauses 3.10 and 3,11 and Alpharma, the Licensor and the Warrantors agree that, notwithstanding anything to the contrary express or implied in this Agreement, the following provisions shall override any inconsistent provisions in this Agreement:
3.10.1 the total liability of the Licensor arising by reason of any claims under this Clause 3 shall not exceed the aggregate amount of Licence Fees actually paid by Alpharma prior to the date of the claim and during the calendar year of the claim;
3.10.2 the Licensor shall not be liable in respect of any claim under this Clause 3 unless it shall have received from Alpharma written notice giving full details of the relevant claim within a period of two years after the Intellectual Property Transfer Date;
3.10.3 the Warrantors shall not be liable in respect of any claim under this Clause 3 unless they shall have received from Alpharma written notice giving full details of the relevant claim within a period of two years after the Effective Date in relation to any alleged breach of Clause 3.6 and within a period of two years after the Intellectual Property Transfer Date in relation to any alleged breach of Clause 3.8; and
3.10.4 the Licensor and the Warrantors shall in no event be liable to Alpharma for any loss of future profits or any special, indirect, economic or consequential loss, damage, cost or expense of any kind whatsoever and howsoever caused, whether arising under contract, tort (including negligence) or otherwise, including (without limitation) loss of production, loss of contracts and loss of goodwill or anticipated savings.
3.11 Alpharma accepts and acknowledges that the total liability of each of Bisa and BIL arising by reason of any claim under this Clause 3 shall be limited as follows:
3.11.1 in respect of any claim relating to a breach of Clause 3.6, to the amount that it shall have received from the Licensor with respect to its share of Licence Fees paid by Alpharma to the Licensor within two years of the Effective Date, and
3.11.2 in respect of any claim relating to a breach of Clause 3.8, to the amount that it shall have received from the Licensor with respect to its share of the Option Price (less the sum of all Licence Fees already paid or payable to the Licensor under this Agreement prior to the Intellectual Property Transfer Date) paid by Alpharma to the Licensor.