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ITEM 10.3
LICENSING AGREEMENT
This Agreement is entered into as of the 3rd November 1995, by and between
Pharma Maehle, Xxxxx Xxxxx Street 23,30196 Isernhagen, Germany, a privately
held company organized under the laws of Germany (hereafter "LICENSEE") and
Bio-sphere Technology, 0000 Xxx Xxxxx Xxxxx, Xxx Xxxxx, Xxxxxx 00000, XXX, a
U.S. corporation (hereafter "LICENSOR").
LICENSOR is a research and development company which has expended considerable
resources to develop certain manufacturing process, including Licensor
technology and Licensor process and product patents. This Agreement pertains
specifically to the technologies referred to within LICENSOR as the proprietary
technologies and proprietary process and product patents, which are defined
below.
LICENSEE is a company which, among other things, manufactures through third
parties, products as well as markets and distributes products. LICENSOR and
LICENSEE mutually desire to enter into an Agreement whereby LICENSOR permits
LICENSEE to utilize LICENSOR technology and patents to manufacture, market and
sell products developed by LICENSOR under LICENSEE'S label. LICENSEE
compensates LICENSOR therefore, all upon the terms and conditions of this
Agreement.
Now therefore in consideration of the mutual covenants and undertakings set
forth herein the parties agree:
1.0 DEFINITION
1.1 "LICENSOR technology" means and includes LICENSOR design
technology and LICENSOR process technology for the PGE1 male erectile
dysfunction product, which includes all technical information and know-how,
including product manufacture and clinical date which is available. This
information is specific to a particular technology, which, in this Agreement
includes proprietary process and product technology.
1.2 "LICENSOR process and product patents" means any U.S., European of
International patent or patent applications now owned or controlled by
LICENSOR.
1.3 Execution date" is the date this Agreement is signed.
1.4 "Documentation date" is the date of the delivery of each category
of documents is completed.
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1.5 "Payment" shall mean receipt by Licensor of the agree-upon sum for
the delivery of the technology as per this Agreement.
1.6 "Territory" shall mean Western and Eastern Europe.
2.0 Grant of License
2.1 LICENSOR grants to LICENSEE for the life of this Agreement the
following rights.
2.1.1 An exclusive to the Licensor's technology for use only
in Licensee designed facilities in the Territory according to the conditions of
this Agreement, for the purpose of manufacturing the components of and the
completed product for distribution and sales in the Territory.
3.0 Transfer of Technology
LICENSOR shall furnish to LICENSEE all the required Licensor
technology in its possession, including documentation, software, training and
consultation initiated upon signing this Agreement.
4.0 Options
LICENSOR may develop and second generation product, or subsequent
trade secrets, additional internal technology, patents or trademarks, which are
proprietary to the LICENSOR. LICENSEE has the right to a non-exclusive option
to negotiate for such technology or subsequent trade secrets during the term of
this agreement with LICENSOR.
5.0 New Developments
5.1 LICENSOR and LICENSEE agree to keep each other regularly and fully
informed about new improvement, modification, applications and other
developments relating to LICENSOR TECHNOLOGY, whether patentable or
unpatentable. Any developments that are jointly developed by LICENSOR and
LICENSEE shall be owned by both Parties, unless negotiated and agreed
otherwise, to only include the same license rights as this agreement in the
Territory described in Section 1.6 above.
6.0 Representations, Warrants & Covenants
6.1 in order to induce LICENSEE to enter into the Agreement and to
consummate the transaction contemplated hereunder, LICENSOR makes the following
representations:
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6.1.1 Organization: Licensor is a corporation duly organized,
validly existing, and in good standing order under the law of the state of
Nevada, USA.
6.1.2 Authorization. The execution and delivery of the Agreement
and consummation of the transaction contemplated hereby have been
duly authorized by the Board of Directors of LICENSOR.
6.1.3 Licensor is owner of the deliverables listed. In the
event Licensor is not prepared to maintain patents and provide protection to
Licensee. The Licensee should be so informed immediately. The Licensee then has
three (3) months in which time can assume all such responsibilities for the
patents pertaining to the product, as well as assuming full legal and
maintenance costs of such patents.
6.2 Representations to Licensee: In order to induce the Licensor to
enter into this Agreement and to consummate the transactions contemplated
hereunder License make the following representations:
6.2.1 Licensee is a corporation duly organized, validly
existing, and in good standing order under the laws of Germany.
6.2.2 Authorization: The execution and delivery of this
Agreement and the consummation of the transactions contemplated hereby have
been duly authorized by the Board of Directors of the Licensee, and this
Agreement constitutes Licensee's valid and binding obligations and is
enforceable in accordance with its terms.
6.3 Licensor and Licensee mutually covenant to comply with all the
time deadlines imposed by this Agreement.
7.0 Confidentiality and Non-Disclosure
7.1 Licensee hereby agrees to keep confidential from any third party
any and all information relating to Licensor's technology, other than those
parties who have a need to know to manufacture product for Licensee or those
parties to whom information must be disclosed according to local law.
7.2 Licensee agrees that information relating to Licensor's technology
provided by Licensor will be disclosed or made available only to those
employees or stockholders ro subcontractors who agree in writing to receive
information and to retain confidentiality thereof.
7.3 The term of confidentiality shall be three years from the date of
signing this Agreement, unless the information becomes public knowledge
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through no fault of action of either Licensee of Licensor. In the event of
breach of confidentiality, either party may seek compensatory damages through
the legal system as permitted by law. In the event information becomes
available to third parties to this Agreement shall make available to the other
its communications records in order to ensure that the
8.0 Infringements.
8.1 To the best of Licensor's knowledge, none of the Licensor patents
infringe the rights of any third party. In the event that such infringements
are alleged by third parties, Licensor agrees to use all best commercial
efforts to remedy the situation and to assume full liability for such
infringements.
8.2 Licensee agrees to exercise diligence in locating possible
infringements and shall immediately inform Licensor of any such situation which
may come to the attention of Licensee. In such event, Licensor shall initiate
any and all appropriate legal actions to stop such infringements. Licensee will
share Licensor's cost in dealing with such possible infringers in the Territory
described in Section 1.6. Any damages recovered from such action will be
divided between Licensor and Licensee shall be borne by Licensor.
9.0 Inspection to Verify Compliance
Licensee shall permit duly authorized representatives of Licensor,
upon reasonable notice, to enter into and upon any premises of Licensee for the
purpose of inspecting the same to ascertain that all of the provisions of this
Agreement are being complied with by Licensee..
10.0 Government Approvals
As a condition to the process transfer in whole or in part, Licensee
shall obtain or cause to be obtained at its expense all permits including legal
registration of the product for marketing and sale within the Territory. Such
permits and approvals will also include any necessary for importing components
of the product to be manufactured with Licensor's technology.
11.0 Indemnities for Malfeasance, Liability for Personal Injury on
Indemnification
11.1 The License herein granted to Licensee in primarily in the nature
of sharing information. Process operation, plant and equipment safety shall be
the sole responsibility of Licensee. Accordingly, Licensor shall not be liable
for any personal injury, property damage resulting from the design or
manufacture of products or product components used in connection with this
Agreement.
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11.2 When one party to this Agreement admits another party's
representative to his premises, the admitting party shall not be liable for any
claims, losses, damages, or expenses due to death or injury suffered in the said
premises by the said visiting personnel.
12.0 Term and Termination
12.1 This Agreement shall remain in force for the life of the patent
from the execution date, but this Agreement may be renewed thereafter, from
year to year, until expiration of the last to expire of Licensor patents.
12.2 Should this Agreement be terminated for any reason, Licensee
shall not be able to claim from Licensor any damages or compensation for losses
or expenses incurred, or for lost profits.
12.3 Termination of this Agreement for any reason, Licensee shall not
affect (a) obligations including the payment of any fees, which have accrued as
of the date of termination, and (b) those obligations which, from the context
hereof, are intended to survive termination of this Agreement.
12.4 Termination of intent to terminate this agreement requires
notification from the terminating party to the other in writing, 6 months prior
to the termination date, which shall be the date of expiration of the last of
the patents held by the Licensor.
12.5 Should either party declare bankruptcy, the surviving party has
the right of first refusal to acquire the patents and proprietary information
from the bankrupt party. In the event Bio-sphere declares bankruptcy, Pharma
Maehle has the right to continue the marketing of the product, use of and
access to the patents, with continuing royalty payments to the original patent
holder. In the event Pharma Maehle declares bankruptcy, Bio-sphere has the
right to assume control of distributors and continue product marketing and
distribution in the Territory.
12.6 Licensor can terminate this Agreement with three (3) months
written notice if Licensee is unable to initiate sales of the product in the
Territory within 2 months of receipt of Board of Health approval of the
marketing of the product in the countries within the Territory.
12.7 Licensee will submit to Licensor an annual business plan for each
country in the Territory which include projected product sales. Licensor and
Licensee shall mutually agree to these projected product sales as a monitoring
mechanism for Licensee performance, including annual growth of sales. Failure
of Licensee to perform according to agreed upon product sales levels could lead
to loss of exclusivity according to this agreement, however, Licensee and
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Licensor shall negotiate in good faith to reach agreement on remediation of any
such performance issues/s.
12.8 Licensee agrees to pay Licensor a royalty of 205 of the
Licensee's selling price to its distributors or subsidiaries. Once the amount
of $250,000 has been paid to Licensor from the royalty on product sales, the
royalty shall be reduced to 13% of the Licensee's selling price to its
distributors or subsidiaries. Royalties will be paid quarterly in US dollars in
a manner to be determined and agreed upon by the parties to this Agreement.
13.0 Waivers
If either party waives its right to xxx or terminate this Agreement
arising from a breach of any provision thereof, that waiver will not be
construed as a continuing waiver of other breaches of the same or other
provisions.
14.0 No Assignment
This Agreement and any of the rights and obligations hereunder cannot
be assigned or otherwise transferred by either party and will not inure to the
benefit of any successor of either party, whether by operation of law or
otherwise, without the written consent of the other party. The assignment or
transfer without such consent will be null and void, and will constitute breach
of this Agreement. Either party reserves the right to transfer information to a
wholly or majority owned subsidiary of the party, provided all other terms and
conditions of this Agreement are adhered to.
In the event of acquisition or merger of either party with another organization
this Agreement shall continue to remain in force.
15.0 Force Majeur
Neither party shall be in default hereunder by reason of its delay in
the performance of or its failure to perform any of its obligations hereunder
if such delay or failure is caused by strikes, acts of God or the public enemy,
riots, incendiaries, interference by civil or military authorities, compliance
with governmental laws, rules and regulations, delays in transit or delivery,
inability to secure necessary governmental priorities for materials, or any
fault beyond its control or without its fault of negligence.
16.0 Arbitration
16.1 This Agreement will be construed, in all respects, according to
the laws of the state of Nevada, USA, provided, however, that if any provisions
of this Agreement are in contravention of the laws of Germany, such provisions
shall either be ineffective to the extent that they are in conravention of such
laws without invalidating the remaining provisions hereof.
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16.2 Any controversy or claim arising out of or relating to this
Agreement, or the breach thereof, will be settled by binding arbitration to
take place in Nevada, USA.
17.0 Notices
17.1 All notices required herein shall be transmitted by first class
mail, or overnight courier delivery, if necessary.
17.2 Written notices may be delivered personally or may be transmitted
by facsimile to the president of the subject party or to the officer specified
in subparagraph 17.3.
17.3 Mailed notices shall be deemed to have been effective seven days
following the date of mailing by certified mail, postage prepaid, return
receipt requested addressed as follows:
Bio-sphere Technology, Inc., 0000 Xxx Xxxxx Xxxxx, Xxx Xxxxx, Xxxxxx 00000, XXX.
Pharma Maehle, Xxxxx Xxxxx Xxxxxx 00, 00000 Xxxxxxxxxx, Xxxxxxx.
18.0 English Language
This Agreement is prepared in the English language only. Any other
summary or documentation prepared in the German language shall be translated
into English.
19.0 Entire Agreement
This Agreement constitutes the entire and only agreement between the
parties relating to the subject matter hereof and supersedes and cancels all
previous Agreements, negotiations, commitments, and representations in respect
thereto, and cannot be released, discharged, abandoned, changed or modified in
any manner except by an instrument in writing of concurrent or subsequent date
and signed by duly authorized officers or representatives or each of the
parties hereto.
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Agreed to on this third day of November by:
Pharma Maehle: Bio-Sphere Technology:
Name: /s/ X. XXXXXX Name: /s/ XXXXXX X. SEE, M.D.
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Signature: X. XXXXXX Signature: Xxxxxx X. See
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Title: President Title: President
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Date: November 3, 1995 Date: November 3, 1995
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This Modification to Agreement dated December 29, 1995 by and between:
Bio-sphere Technology, Inc. (A Nevada Corporation)
herein referred to as "Bio-sphere".
Harvard Scientific Corp. (A Nevada Corporation),
formerly named The Male Edge, Inc., a subsidiary company of Bio-sphere,
herein referred to as "HSC"; and
Pharma Maehle, Xxxxx Xxxxx Xx. 00, 00000 Xxxxxxxxxx, Xxxxxxx
herein referred to as "Licensee".
WHEREAS, Bio-sphere developed a Frosiaglandin based treatment for male proctile
dysfunction, herein referred to as "product", and;
WHEREAS, Bio-sphere entered into licensing Agreement ("Agreement") with
Licensee dated November 3, 1995 to register, manufacture, market and sell its
product within the Territory of Eastern and Western Europe;
AND WHEREAS, HSC holds all rights to the product and Bio-sphere has assigned
Agreement to HSC;
IT IS THEREFORE AGREED on this date set forth below that:
1) HSC shall assume the responsibilities of Bio-sphere under the same
terms and conditions in the Agreement.
2) Licensee and Bio-sphere acknowledges this assignment is the only
modification to the original Agreement as of this date and that all other terms
and conditions remain in full force and effect as of the signing of this
Modification to Agreement.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date set
forth below.
Harvard Scientific Corp. Bio-Sphere Technology, Inc. Pharma Maehle
/s/ Xxxx Xxxxxxxxx /s/ Xxxxxx Xxxxxxxx /s/ X. XXXXXX
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By: Xxxx Xxxxxxxxx By: Xxxxxx Xxxxxxxx By: X. Xxxxxx
Chief Financial Officer Vice President President
Date: February 27, 1996 Date: February 20, 1996 Date: February 26, 1996
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Amendment
Ref: Licensing Agreement dated 3 November 1995, Section 19.0. Entire Agreement,
page 7
19.0 Entire Agreement
This agreement constitutes the entire and only Agreement between Bio-sphere
Technology, Inc. And Pharma Maehle (or its predecessor company, innoteo Pharma
and Consulting), or any of its progeny, relating to the subject matter hereof
and supersedes and cancels all previous Agreements, negotiations, commitments,
and representations in respect thereto, and cannot be released, discharged,
abandoned, changed or modified in any manner except by an instrument in writing
of concurrent or subsequent date and signed by duly authorized officers or
representatives or each of the parties hereto.
Pharma Maehle: Bio-Sphere Technology:
Name: /s/ XXXXX XXXXXX Name: /s/ XXX XXXXX
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Signature: /s/ Xxxxx Xxxxxx Signature: /s/ Xxx Xxxxx
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Date: March 20, 1996 Date: March 20, 1996
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