Strategic Alliances 11

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    OPTEON

    Philip Mendes Level 3, 33 Queen St

    Brisbane QLD, Australia

    Ph + 61 7 3211 9033

    Fax + 61 7 3211 9025

    [email protected]

    Topic 22

    Strategic Alliances

    WIPO-KIPO-KIPA IP Panorama Business School Investment Summit10 October 2008

    Geneva

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    Outline

    Commercialisation of IP

    License Strategic Alliance

    Co-Development Co-Marketing

    Passive Partnership

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    Outline

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    Commercialisation of IP

    License Strategic Alliance

    Co-Development Co-Marketing

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    $ $

    IP

    Sk

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    Passive features of a license

    Licensor grants exploitation rightsto a licensee

    Licensee pays royalties and other

    remuneration to the Licensor

    Licensor is passive

    Has no further exploitation rights

    Licensor has no need to actively do

    anything Licensor passively sits by and

    collects royalties

    Licensor

    Licensee

    IP

    $

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    Strategic Alliance

    In a strategic alliance both parties contribute to their joint venture theirrespective resources and capability

    Aim is to add greater value to their respective positions By doing so, to

    Increase their financial return

    To access the capability of their partner which they themselves lack

    To acquire skills that they themselves may lack

    Strategic PartnerStrategic Partner

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    Co-Development Agreements

    Co-Marketing Agreements

    Co-Development Agreement

    Partners collaborate scientifically to further develop the IP

    Take the IP further along the development path

    Licensor increase the value of the IP as a result of the collaboration

    Co-Marketing Agreement

    Partners co-market the products of their alliance

    One may manufacture only, and the other may sell products only

    They may sell products competitively in the same territory

    Or, they may sell in different territories

    Licensor retains some marketing rights, achieving greater financial upside

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    Strategic Alliance Financial Terms

    Payment of research monies

    Licensee pays an agreed amount for research and development to be continuedby Licensor

    Licensor owns the New IP that results of that further R&D

    New IP may be jointly owned

    Different categories of New IP may be solely owned by the Licensor andLicensee

    Licensee may pay research monies at an FTE rate that the Licensee isaccustomed to pay

    Licensor may do the research more cost effectively, and profits from thecontract research

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    Strategic Alliance Financial Terms

    Provision of assets and expertise

    To assist the further R&D:

    Licensor may purchase an asset (lab equipment) and give it to the Licensor

    Licensee may lend an asset, which is returned to the Licensee at thecompletion of the research

    Licensee may provide expertise, giving the Licensor access to thatexpertise

    All of these have a monetary value to the Licensor Licensor receives something of value which is required, without having to

    pay for it

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    Strategic Alliance Financial Terms

    Collaborative research

    Licensor and Licensee collaborate in the further R&D

    Each pays its own expenses in the collaboration

    New IP:

    Licensor owns the New IP that results of that further R&D

    New IP may be jointly owned

    Different categories of New IP may be solely owned by the Licensor andLicensee

    Again, the Licensor receives something of value

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    Strategic Alliance Financial Terms

    Equity Payments

    Licensee subscribes for shares in the Licensor

    Share subscription monies used to

    Fund further R&D

    Pay for its marketing and promotion expenses in a co-marketing alliance

    Not repayable

    Licensee acquires an equity stake in the Licensor, and therefore has an equitystake in the Licensors financial benefits under the terms of the license

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    Strategic Alliance Financial Terms

    Convertible Notes

    A Convertible Note is a loan, which either

    Is repaid by money, or

    Is repaid by the issue of shares in the receiver of the loan (the Licensor)

    Election as to repayment or satisfaction with equity is made by:

    Licensor only, or

    Licensee only, or

    Either licensor or licensee

    Loan monies used by Licensor to:

    Fund further R&D

    Pay for its marketing and promotion expenses in a co-marketing alliance

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    Strategic Alliance Financial Terms

    Genentech and Xoma Raptiva License

    Xoma licensed Genentech 1996 compound (FDA approved Oct 2003, now marketed asRaptiva, for psoriasis (skin condition)

    1999 deal amendment:

    Future development costs to be shared 25% Xoma and 75% Genentech

    Future co-marketing costs to be shared 25% Xoma and 75% Genentech

    Future profits on sales shared 25% Xoma and 75% Genentech

    Genentech providesXoma loan facility up to $80m to fund future development (that is,clinical studies)

    Genentech providesXoma loan facility up to $15m to fund future marketing

    Xoma can elect to Repay loan

    Issue equity instead of repaying loan

    Defer payment of up to $40m of loan against future profit share

    Xoma mortgages its future profit share to Genentech as security for repayment

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    Strategic Alliance Financial Terms

    Pluristem Life Systems and Stem Cell Innovations deal

    Deal announced 22 February 2007

    Pluristem licenses STI PLX-I product - stems cells obtained from the placenta and

    expanded by using Pluristem bioreactor that mimics physiological environments Cells are immune privileged reduction or absence of rejection of the cells in a patient

    first application in bone marrow transplantation

    Deal terms:

    Up front not cash - but instead 23 million fully paid shares Plurstem receives inSTI

    Additionally, STI issues 28 million shares to Pluristem, and Pluristem issues 66million shares to STI

    Undisclosed royalties

    Undisclosed milestone payments

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    Strategic Alliance Financial Terms

    Pluristem Life Systems and Stem Cell Innovations deal

    What is achieved by:

    Up front shares instead of cash

    Share swap where Licensor and Licensee each obtain shares in the other ?

    Licensors perspective: If technology fails and there are no sales

    Licensor has shares in licensee and shares in Licensees profit across the wholeof its business other than the failed technology

    If technology succeeds and there are sales

    Licensor gets the usual royalties and milestones

    Additionally, licensees shareholders are diluted from those benefits asLicensee now holds shares, but licensors shareholders now share in licenseesprofits across the successful technology, as well as the Licensees otherbusiness

    Win Win for licensor in both cases

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    Acquiring new skills

    In a co-development agreement the alliance partners may work collaboratively

    Opportunity therefore for skills transfer

    That is, the staff of one alliance partner sharing their skills with the staff of theother alliance partner, and in that way to upskill the staff of the other

    May be technical skills

    Skill in generating transgenic animals

    Skills extracting, isolating, or synthesizing the active chemical frombiodiverse resources

    May be management skills managing pre-clinical studies such as animal studies, toxicology studies etc

    Managing the regulatory pathway to product registration

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    Acquiring new skills

    Skills transfer can occur by

    Collaborative teams working side by side and learning from each other

    Internships where one alliance partner trains another at its own facilities

    Observation, participation, and experiencing

    Skills transfer benefits both alliance partners by

    Increasing the skill and capability of each others staff for the purposes of

    the alliance

    Skills transfer benefits one partner separately Increasing the skill and capability of one partners staff that can be used in

    other projects unconnected with the alliance

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    Acquiring new technology

    In a Co-Development Agreement one partner may make its IP available to theother

    For the purposes of the collaboration

    For purposes outside the collaboration

    Collaboration benefits by the access to the IP of the strategic partner for the co-development program

    Strategic partners benefit independently by access to the IP of the other forother research programs outside the collaboration

    Access to research tools Animal models, vectors, cell lines, other biological material

    Access to IP to pursue areas of investigation outside the collaboration

    There may be preferential rights to access New IP given to the provider ofthe technology

    Eg, option to negotiate a license

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    Creating new technology

    Purpose of the Alliance is to create New IP

    Builds on the licensor partners IP

    May create new unrelated independent IP

    Purpose of the collaboration is to build on the existing IP to further develop itand to bring a product to market

    That is the ultimate aim of the collaboration by the alliance partners

    Side benefit is the creation of IP that may be beneficial to one alliance partner

    only That partners IP position is enhanced, and its IP capability is strengthened

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    Ownership of new technology

    Who should own that new IP ?

    Common Model #1

    1. Partner A owns new IP that improves its own existing IP

    2. Partner B owns new IP that improves its own existing IP

    3. Partners A and B jointly own new IP outside categories 1 & 2

    Common Model #2

    No new IP is separately owned

    All new IP is jointly owned by both Partners A & B

    What are the implications ?

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    Ownership of new technology

    More complex models:

    Partner A has a platform technology for producing vaccines against viruses Partner B has patents in the gene sequence and function of particular virus and

    its interest is producing therapeutic drugs

    Categories of new IP1. New IP that solely relates to vaccine technology2. New IP that solely relates to therapeutic drug against Partner Bs virus of

    interest3. New IP that solely relates to therapeutic drug against viruses broadly

    4. New IP that relates to 1 and 2 but not 35. New IP that relates to 1 and 3 but not 26. New IP that relates to 2 and 3 but not 1

    How is ownership of these various categories of New IP dealt with ? How does each partner ensure that it shares with the other what is intended to

    be shared, but does not prejudice its own core business by having to share newIP affecting its own core business ?

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    Conclusion

    Benefits of licensing

    1. Financial payments

    Benefits of strategic alliance

    1. Upside financial payments

    2. Increased financial resources Cash

    Transfer assets

    Equity

    Loans

    3. Skills Transfer

    Technical Management

    4. IP Acquisition

    Platforms

    Research Tools

    5. IP Creation

    In field of collaboration

    Outside field ofcollaboration

    6. Co-marketing

    Manufacturing

    Selling