SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of
1934
Date
of
Report (date of earliest event reported): March 24, 2006.
BioTime,
Inc.
(Exact
name of registrant as specified in its charter)
|
California
|
1-12830
|
94-3127919
|
|
(State
or other jurisdiction
of
incorporation)
|
(Commission
File Number)
|
(IRS
Employer
Identification
No.)
|
6121
Hollis Street
Emeryville,
California 94608
(Address
of principal executive offices)
(510)
350-2940
(Registrant's
telephone number, including area code)
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
[
] Written communications pursuant to Rule 425 under the Securities Act (17
CFR
230.425)
[
] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
[
] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange
Act (17 CFR 240.14d-2(b))
[
] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange
Act (17 CFR 240.13e-4(c))
Statements
made in this Report that are not historical facts may constitute forward-looking
statements that are subject to risks and uncertainties that could cause actual
results to differ materially from those discussed. Such risks and uncertainties
include but are not limited to those discussed in this report and in BioTime's
Annual Report on Form 10-K filed with the Securities and Exchange Commission.
Words such as “expects,” “may,” “will,” “anticipates,” “intends,” “plans,”
“believes,” “seeks,” “estimates,” and similar expressions identify
forward-looking statements.
Section
1-Registrant’s Business Operations
Item
1.01 Entry Into a Material Definitive Agreement
On
March
24, 2006, we entered into a license agreement with Summit Pharmaceuticals
International Corporation (“Summit”) to develop Hextend and PentaLyte in the
People’s Republic of China, and Taiwan. Summit will seek to sublicense to a
pharmaceutical company the right to use our patents, trademarks and other
proprietary information to manufacture and market .Hextend and PentaLyte in
those countries. Summit or a sublicensee must obtain regulatory approval before
Hextend and PentaLyte can be brought to the market in China and
Taiwan.
Summit
has agreed to pay BioTime $500,000 by May 8, 2006 as the initial consideration
for the China and Taiwan license. BioTime also will be entitled to receive
50%
of any royalties and milestone payments payable to Summit by its sublicensee.
BioTime
may terminate the license if Summit fails to enter into a sublicense agreement
with a pharmaceutical company acceptable to BioTime by March 24, 2008, or if
certain other events occur.
The
preceding discussion of the license agreement between BioTime and Summit is
a
summary only, does not purport to describe in full all provisions of the license
agreement as a whole, and is qualified in all respects by the full text of
the
license agreement a copy of which has been filed as an exhibit to this report
and which is incorporated by reference herein.
Hextend®
and PentaLyte® are registered trademarks of BioTime, Inc.
2
Section
9-Financial Statements and Exhibits
Item
9.01 Financial Statements and Exhibits.
| Exhibit Number | Description | |
| 99.1 | Hextend and PentaLyte China License Agreement Between BioTime Inc. and Summit Pharmaceuticals International Corporation |
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SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
| BIOTIME, INC. | ||
| |
|
|
| Date: March 30, 2006 | By: | /s/ Steven Seinberg |
|
Chief Financial Officer |
||
|
|
||
4
|
Exhibit Number
|
Description | |
| 99.1 | Hextend and PentaLyte China License Agreement Between BioTime Inc. and Summit Pharmaceuticals International Corporation |
5
HEXTEND
AND PENTALYTE CHINA LICENSE AGREEMENT BETWEEN
BIOTIME,
INC. AND SUMMIT PHARMACEUTICALS INTERNATIONAL CORPORATION
This
License Agreement, dated as of March 24,
2006,
sets forth the terms under which BioTime Inc. (“BioTime”) grants Summit
Pharmaceuticals International Corporation (“Summit”) the rights to develop and
commercialize Hextend
and PentaLyte in China and Taiwan.
1. Definitions.
(a) “Confidential
Information” means any information including, but not limited to, ideas,
proposals, plans, know-how, reports, drawings, designs, data, discoveries,
inventions, improvements, suggestions, specifications, products, samples,
components and materials relating to a Product, and all information relating
to
the manufacture, formulation, analysis, stability, pharmacology, toxicology,
pathology, clinical data, results of clinical efficacy studies, clinical effects
and indications for use of a Product which a party discloses to the other party,
except any portion thereof which:
(i) is
known
to the receiving party at the time of disclosure and documented by written
records made prior to the date of this Agreement;
(ii) is
disclosed to the receiving party by a Third Person who has a right to make
such
disclosure;
(iii) is
patented, published or otherwise part of the public domain as a result of acts
by a third party through no fault of the receiving party or any subsidiary
or
other affiliate of the receiving party; or
(iv) is
independently developed by the receiving party without the use of Confidential
Information, as evidenced by its written records.
(b) “Field”
means the use of Hextend and PentaLyte in the treatment of hypovolemia when
plasma volume expansion is desired in surgical, trauma care, or therapeutic
procedures and other related or suitable diseases or conditions, but only for
use at body temperatures above 12 Centigrade.
(c) “Hextend”
means 6% hetastarch in lactated electrolyte injection, in the formulation shown
on Exhibit A, developed by BioTime as a proprietary plasma volume expander
for
the treatment of hypovolemia.
(d) “Know-How”
means that proprietary technology developed by BioTime for manufacturing or
formulating Hextend or PentaLyte, including, but not limited to: manufacturing
data; formulation or production technology; methods of synthesis, isolation
and
purification methods and other manufacturing information required to manufacture
Hextend or PentaLyte; and that proprietary data developed by BioTime related
to
pharmacology, toxicology, pathology, clinical data, results of clinical efficacy
studies, clinical effects and indications for use of Hextend or
PentaLyte.
1
(e) “Licensed
Patents” means any and all patents and patent applications in the Territory
which during the term of this Agreement are owned by or licensed to BioTime
and
which claim, cover, or relate to a Product, including but not limited to (i)
the
patents and patent applications listed in Exhibit B; (ii) all patents arising
from applications identified in (i) and any divisions, continuations and
continuations-in-part defined in (i); (iii) any extension, renewal or reissue
of
a patent identified in (i) or (ii); and (iv) any continuation or divisional
of
any licensed patent application and any reissue or reexamination of any patent
identified in (i) through (iii); but excluding any and all patents pertaining
to
the use of a Product outside the Field.
(f) “Licensed
Trademarks” means Hextend® and PentaLyte®, and any other trademark developed,
acquired or licensed by BioTime for use in connection with the sale of Hextend
and PentaLyte in the Territory.
(g) “PentaLyte”
means 6% pentastarch in lactated electrolyte injection, in the formulation
shown
on Exhibit A, developed by BioTime as a proprietary plasma volume expander
for
the treatment of hypovolemia especially for use when a faster elimination of
the
starch component is desired and acceptable.
(h) “Product(s)”
means Hextend and PentaLyte.
(i) “Proprietary
Rights” means all of BioTime's property rights (except Licensed Patents and
Licensed Trademarks) and interests in, to, or covering Hextend and PentaLyte,
or
the manufacture or use of Hextend and PentaLyte, to the extent that such
property rights and interests are of such legal status and nature as to permit
the same to be lawfully licensed and, without limiting the generality thereof,
specifically include unpatented inventions, ideas, data, Know-How, technology,
trade secrets and Confidential Information.
(j) “Regulatory
Approval” means, with respect to each Product, any and all government approvals
required to market and use that Product in the Territory.
(k) “Territory”
means the People’s Republic of China and Taiwan.
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2. License
For Manufacturing and Marketing.
(a) BioTime
hereby grants to Summit an exclusive license, with the right to sublicense
the
use of Licensed Patents, Licensed Trademarks, and Proprietary Rights to develop,
manufacture and sell Hextend and PentaLyte in the Territory only for human
therapeutic use in the Field. As used in this Agreement, “develop” and
“development” means conducting laboratory and clinical studies and obtaining
Regulatory Approval of the Product.
(b) Summit
shall have the right to sublicense its rights under this Agreement only to
a
Third Person approved by BioTime (the “Sublicensee”) and only on such terms and
conditions as BioTime may approve (the “Sublicense Agreement”).
(c) Summit
agrees not to use or permit Sublicensee to use any Licensed Patents, Licensed
Trademark, and Proprietary Rights for any use other than the development,
manufacture, and sale of Hextend and PentaLyte in the Territory. Summit will
not
sell and will not permit Sublicensee to sell Hextend and PentaLyte outside
the
Territory. If Hextend or PentaLyte is sold by Sublicensee or any of its
sublicensees to a Third Person that intends to resell the Product, that Third
Person will be required by Sublicensee to agree not to resell the Product
outside the Territory. If Summit or Sublicensees becomes informed of a violation
of that agreement by the Third Person, Summit will notify BioTime of such
violation, and Summit will take reasonable means to enforce the Third Person's
agreement, including by requiring Sublicensee to discontinue sales to such
Third
Person if the sales outside the Territory compete with sales made by BioTime
or
any of BioTime's licensees.
(d) Summit
shall not have the right, directly or through any Affiliate or Subsidiary,
to
market or sell any Product in the Territory. Summit’s rights under this
Agreement are limited to the right to develop the Products and to enter into
a
Sublicense Agreement with a Sublicensee for the development, manufacture and
sale of the Products in the Territory.
(e) Summit
agrees that it, it’s Subsidiaries, and other Affiliates will not challenge or
contest the validity of any Licensed Patent or any claim under any Licensed
Patent, or BioTime's ownership of Proprietary Rights, or BioTime's ownership
or
registration of any Licensed Trademark.
(f) BioTime
retains all rights to Licensed Patents, Proprietary Rights, Licensed Trademarks,
and the Products for any purpose not expressly licensed to Summit under this
Agreement or sublicensed to Sublicensee under the Sublicense
Agreement.
(g) Summit
shall not amend, modify, terminate, or supplement its Sublicense Agreement
with
Sublicensee, or waive any material right thereunder, without the prior written
approval of BioTime.
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3. Regulatory
Approval For Human Therapeutic Use.
(a) Summit
or
Sublicensee will apply for Regulatory Approval of the Products for use in the
Field. All applications and all laboratory and clinical studies required to
obtain Regulatory Approval of each Product will be conducted by Summit or
Sublicensee in accordance with the laws of the countries comprising the
Territory. These trials will include adequate numbers of patients to gain
Regulatory Approval for the indications in the Field chosen. Summit or
Sublicensee will bear all costs associated with these trials.
(b) Summit
or
Sublicensee will fund all laboratory, preclinical and clinical testing and
developmental activities regarding the Products, and will pay all application
filing and similar fees for purposes of obtaining and maintaining Regulatory
Approvals in the Territory.
(c) If
BioTime has information concerning the Products that is required by regulatory
agencies in the Territory for Regulatory Approval of the Products in the Field,
BioTime will share that information with Summit and Sublicensee free of charge.
BioTime will only provide Summit and Sublicensee with information that BioTime
owns and has access to, or that BioTime has access to and permission from any
third party owners to disclose to Summit and Sublicensee.
(d) Although
BioTime plans to conduct additional clinical studies of PentaLyte in the United
States, and may conduct additional clinical and laboratory studies of Hextend
for markets other than the Territory, BioTime will not be under any obligation
to conduct any further clinical trials or laboratory studies of the Products
for
Regulatory Approval in the Territory.
(e) BioTime
will have non-exclusive access to, and use of, all clinical and laboratory
study
data and other data and information generated by Summit and Sublicensee or
others from the clinical testing, laboratory testing, and Regulatory Approval
of
the Products in the Territory.
(f) After
this Agreement is executed, BioTime will provide or make available to Summit
and
Sublicensee at BioTime’s offices, BioTime’s information concerning Hextend that
BioTime has agreed to share with Summit and Sublicensee in paragraph 3(c),
to
the extent that Summit or Sublicensee requests such information.
(g) Summit
or
Sublicensee will commence seeking Regulatory Approval of the Products (including
designing, arranging, and conducting any and all clinical and laboratory
studies) within the time required under the Sublicense Agreement. Summit or
Sublicensee shall use commercially reasonable and diligent efforts to complete
all clinical and laboratory studies and to file all applications, reports,
and
documents, and shall pay all filing fees and other fees required to obtain
Regulatory Approval of the Products in the Territory within the time required
under the Sublicense Agreement.
(iii) Summit
shall send BioTime written progress reports no less frequently than every six
months after clinical trials begin. The progress reports will summarize in
reasonable detail the work performed by Summit and Sublicensee to obtain
Regulatory Approval. Each progress report shall include in reasonable detail
any
proposed changes to the plan or schedule for conducting clinical trials and
obtaining Regulatory Approval. Summit’s progress reports will include copies of
correspondence with regulatory authorities and, to the extent available, data
obtained from clinical studies. If BioTime requests additional information
concerning any progress report or the actions taken by Summit or Sublicensee,
Summit will provide such information within two weeks.
4
(iv) Summit
shall promptly notify BioTime of (A) any communication from any government
authority concerning clinical trials or Regulatory Approval, and (B) any adverse
outcomes in clinical trials or other developments that could reasonably warrant
a change in the plans for obtaining Regulatory Approval or could result in
a
material delay in implementing or completing any aspect of clinical trials
or
obtaining Regulatory Approval.
4. Patents.
Summit
shall cooperate with BioTime in filing patent applications in the Territory.
Any
patent rights to any modification of any Product or any other product or
technology developed by BioTime shall belong to BioTime. Summit shall cooperate
with BioTime in filing and prosecuting patent applications in BioTime's name
covering such modifications or technology. Summit shall not use any Product,
any
of BioTime’s technology (patented or unpatented) or any of BioTime’s
Confidential Information to develop and patent (including filing for any patent
protection or registration) any technology other than in the name of
BioTime.
5. Patent
and Trademark Marking.
(a) Summit
shall require Sublicensee to label or mark the Product container or package
made
by or on behalf of Sublicensee with the patent number or numbers of any issued
or pending Licensed Patents. The content, form, location and language used
for
such marking shall be in accordance with the laws and practices (including
customary practices) of the Territory and in accordance with Sublicensee’s
marketing preferences.
(b) If
Sublicensee uses a Licensed Trademark, Summit shall require Sublicensee to
include such symbols or indications of trademark registration or
non-registration as may be comparable under laws of the Territory and a
statement that the trademark is licensed from BioTime. Nothing in this paragraph
requires Sublicensee to use the Licensed Trademarks in marketing the Products
in
the Territory.
(c) Summit
shall use good faith efforts to obtain Sublicensee’s compliance with paragraphs
(a) and (b) of this Section in connection with Sublicensee’s use of Licensed
Patents and Licensed Trademarks:
6. Consideration
and Revenue Sharing
(a) In
consideration of licenses granted under this Agreement, Summit shall pay BioTime
Five Hundred Thousand Dollars (US$500,000) within forty-five (45) days from
the
execution of this Agreement.
5
(b) Excluding
the first payment to be made by Sublicensee upon the execution of the Sublicense
Agreement, any and all payments, including without limitation milestone payments
and royalties, to be made by Sublicensee to Summit pursuant to the Sublicense
Agreement shall be shared between BioTime and Summit as additional consideration
for the grant of the licenses pursuant to this Agreement, as follows: 50% to
BioTime and 50% to Summit.
(c) The
Sublicense Agreement shall require the Sublicensee to send Summit written
reports containing (i) the amount of net sales during each accounting period
(which shall be no longer than six months) shown in both yen and unit amounts.
Summit shall deliver to BioTime a copy of each report from Sublicensee showing
the computation of the royalty paid by Sublicensee. Summit shall deliver the
report to BioTime within ten (10) business days after Summit receives the report
from Sublicensee.
(d) BioTime
and its accountants may audit the accounting documents of Summit related to
milestones, royalties, and any other consideration from the Sublicense
Agreement. The audit may be conducted at any time within 2 years from the time
the relevant calculation was made. BioTime shall bear the expense of such audit,
in principle, but Summit shall bear the expense of the audit if the audit
discloses that Summit has underpaid any payment by an amount of 5% or more.
7. Confidentiality.
Neither
party shall disclose any Confidential Information received from the other party
pursuant this Agreement. This obligation will continue for a period of ten
(10)
years after expiration or prior termination of this Agreement. Summit shall
obtain Sublicensee’s agreement to protect the secrecy of BioTime’s Confidential
Information on the terms set forth in this Section. Nothing contained in this
Section shall be construed to restrict the parties from disclosing Confidential
Information as required:
(a) For
regulatory, tax or customs reasons;
(b) For
audit
purposes;
(c) By
court
order or other government order or request as long as reasonable efforts have
been made to assure its confidentiality or BioTime is timely notified to make
such efforts; or
(d) For
using
such Confidential Information as is reasonably necessary to perform acts
permitted by this Agreement.
8. Indemnification.
Summit
shall defend, indemnify and hold BioTime harmless against any liability, damage,
loss, cost or expense, including legal fees, arising out of or resulting from
any claims or lawsuits made or brought against BioTime to the extent such
damage, loss, cost or expense arises out of or relates to negligence or willful
misconduct of Summit or any subsidiary or third party with regard to the use,
testing, storage of, or other action or omission with respect to, a Product,
including the injury or death of any patient during any clinical trial conducted
by or for Summit in the Territory.
6
9. Termination.
(a) This
Agreement and the licenses granted in this Agreement shall terminate as
follows:
(i) Upon
the
breach of, or default in the performance of, any material provision of the
Sublicense Agreement by Summit or Sublicensee, if the breach or default is
not
cured within sixty (60) days after written notice thereof to
Summit;
(ii) Upon
the
breach of any material provision of this Agreement by a party if the breach
is
not cured within sixty (60) days after written notice thereof to the party
in
default;
(iii) On
March
24, 2008 if Summit has not executed a Sublicense Agreement with a Sublicensee
in
accordance with Section 2(b) by such date;
(iv) On
the
fourth anniversary date of the expiration of the Sublicense Agreement or
termination of the Sublicense Agreement for any reason other than a breach
or
default by Summit or Sublicensee, unless prior to such fourth anniversary date
Summit enters into a new sublicense agreement with a new sublicensee on terms
acceptable to BioTime;
(v) By
either
party giving to the other party sixty (60) days prior written notice following
the bankruptcy or the insolvency of the other party; or
(vi) Summit
may terminate this Agreement at any time upon ninety (90) days prior written
notice to BioTime if the Sublicense Agreement is not in effect and Summit
determines that it no longer wishes to pursue obtaining Regulatory Approval
of
at least one Product in the Territory.
(b) If
the
Sublicense Agreement is terminated and this Agreement remains in effect, Summit
shall endeavor to find a new sublicensee to manufacture and market the Product
in the Territory in place of the original Sublicensee on terms acceptable to
BioTime. Although Summit expects that it would seek a new sublicensee on terms
comparable to the terms of the Sublicense Agreement, the parties recognize
that
a new sublicensee may require different terms. If such a new sublicensee is
found, this Agreement shall be amended as appropriate and agreed by the parties
to reflect the terms of the new sublicense.
(c) Upon
the
expiration or termination of the sublicense permitted under this Agreement,
(i)
Sublicensee, and its Subsidiaries, Affiliates, and any sublicensees shall
immediately cease all use of Licensed Patents, Licensed Trademarks, Proprietary
Rights and Confidential Information, and shall discontinue the manufacture
and
sale of the Products, except that the Licensed Trademarks may be used for a
period of 180 days, exclusively
for the purpose of selling inventory of Products on hand on the date the
Sublicense terminated, and (ii) Sublicensee shall execute or cause its
Subsidiaries and Affiliates to execute, all documents necessary to assign to
BioTime all rights with respect to Regulatory Approval, including but not
limited to all applications, approvals, and permits.
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(d) Termination,
expiration, cancellation or abandonment of this Agreement through any means
and
for any reason shall not relieve the parties of any obligation accruing prior
thereto and shall be without prejudice to the rights and remedies of either
party with respect to any antecedent breach of any of the provisions of this
Agreement, and provisions of Section 8 of this Agreement shall survive
termination of this Agreement.
(e) Upon
termination of this Agreement, Summit and or its Sublicensees and assignees,
if
any, shall promptly return to BioTime all copies of BioTime’s Confidential
Information, and BioTime shall return to Summit all copies of all of Summit’s
Confidential Information, except that (i) BioTime shall have a right to retain
and use outside the Territory all of Summit’s Confidential Information if this
Agreement is terminated for any reason other than a termination by Summit under
paragraph (a)(vi) above, and (ii) if Summit terminates this Agreement under
paragraph (a)(vi) above, BioTime may retain and use all Summit Confidential
Information inside or outside the Territory in connection with the development,
Regulatory Approval, manufacture, marketing, and sale of the
Products.
(f) Upon
the
expiration or termination of this Agreement, Summit shall immediately cease
all
use of all Products and BioTime Confidential Information, and shall discontinue
all laboratory and clinical testing of the Products. If Summit terminates this
Agreement under paragraph (a)(vi) above, Summit shall execute all documents
necessary to assign to BioTime all of Summit’s rights with respect to Regulatory
Approval, including but not limited to all applications, approvals, and
permits.
(g) Upon
the
occurrence of an event giving Summit the right to terminate this Agreement
in
accordance with paragraph (a)(ii), Summit may elect to keep this Agreement
in
effect, and in lieu of any other remedy that Summit might have the 50% share
of
revenue of BioTime described in Section 6(b) shall be reduced to
25%.
10. Governing
Law.
This
Agreement shall be construed under and governed by California law without regard
to conflicts of interest principles or the choice of law principles of
California or any other jurisdiction.
11. Dispute
Resolution.
(a) The
parties recognize that bona fide disputes may arise which relate to the parties’
rights and obligations under this Agreement. The parties agree that any such
dispute shall be resolved by arbitration. Arbitration shall be held in San
Francisco, California according to the commercial rules of the American
Arbitration Association (“AAA”) provided, however, that the parties shall be
entitled to take depositions and obtain discovery as provided in California
Code
of Civil Procedure Section 1283.05, and the arbitrator or arbitrators shall
have
the powers as set forth therein. In addition, the arbitrators shall have the
authority to impose sanctions for the failure or refusal of any party to permit
discovery as provided in California Code of Civil Procedure Section 1283.05
or
to comply with any discovery order of the arbitrators. Such sanctions against
a
party may include, without limitation, one or more of the following: (I)
inference that facts alleged by the adverse party are true and correct; (ii)
a
prohibition or limitation upon the evidence that may be presented by the party
being sanctioned; (iii) the entry of a default award in against the party being
sanctioned and in favor of the adverse party, and (iv) the imposition or
assessment of costs and attorneys’ fees against the party being sanctioned. The
arbitration will be conducted by a panel of three (3) arbitrators appointed
in
accordance with AAA rules; provided, however, that each party shall within
thirty (30) days after the institution of the arbitration proceedings appoint
an
arbitrator, and the two arbitrators so appointed shall select a neutral
arbitrator to be the chairman of the arbitration panel, within thirty (30)
days
thereafter. If the arbitrators appointed by the parties are unable to select
a
neutral arbitrator within such thirty (30) day period, the neutral arbitrator
shall be appointed in accordance with the AAA rules. All arbitrators eligible
to
conduct the arbitration must agree to render their opinion(s), determination(s)
and award(s) within thirty (30) days after the final arbitration hearing.
8
(b) Neither
any individual arbitrator nor the panel of arbitrators shall have the power
to
award punitive damages under this Agreement, and any award of punitive damages
is expressly prohibited. Decisions of the arbitrators shall be final and binding
upon the parties. Judgment on the arbitration award rendered by the arbitrators
may be entered in a court having jurisdiction. In any arbitration pursuant
to
this Agreement, the arbitrators shall apply the substantive laws of the state
of
California. Summit agrees to submit to the jurisdiction of the courts of the
state of California.
12. Counterparts;
Electronic Signatures.
This
Agreement may be executed in two or more counterparts, each of which shall
be an
original and together which shall constitute one and the same instrument. This
Agreement may be executed by facsimile or other electronic signature. If a
party
provides a facsimile or electronic signature, that party shall also promptly
send the other party a manually signed paper copy of this
Agreement.
13. Notices.
All
notices given under this Agreement shall be in writing and shall be delivered
personally, by facsimile confirmed by postage prepaid first-class mail, by
over-night or next business day air courier, or by postage prepaid certified
mail to the following addresses of the respective parties:
Summit
Pharmaceuticals International Corporation
Harumi
Island Triton Square Office Tower Z, 1-8-12
Harumi,
Chuo-ku, Tokyo 104-6233
Facsimile:
81 (03) 3536-8630
Attention:
President
9
BioTime,
Inc.
6121
Hollis Street
Emeryville,
California 94608
Facsimile:
(510) 350-2948
Attention:
Hal Sternberg, Vice President
With
copies to: Chief Financial Officer
Notices
shall be effective upon receipt if personally delivered or delivered by
facsimile or air courier, or on the fifth business day following the date of
mailing. A party may change its address listed above by notice to the other
party.
14. Assignment.
This
Agreement may not be assigned or otherwise transferred, nor may any rights
or
obligations hereunder be assigned or transferred, by either party without the
prior written consent of the other party; provided, however, that either party
may, without such consent of the other party, assign this Agreement and its
rights and obligations hereunder to its Affiliate (provided that each party
shall assure performance by its Affiliate) or in connection with the transfer
or
sale of all or substantially all of its assets related to this Agreement or
the
business relating thereto, or in the event of its merger or consolidation or
change in control or similar transaction.
15. Entire
Agreement.
This
Agreement and the Exhibits constitute the entire agreement between the parties
concerning the subject matter hereof and supersede all written or oral prior
agreements or understandings with respect thereto. No course of dealing or
usage
of trade shall be used to modify the terms and conditions hereof.
16. Severability.
This
Agreement is subject to the restrictions, limitations, terms and conditions
of
all applicable laws, governmental regulations, approvals and clearances. If
any
term or provision of this Agreement shall for any reason be held invalid,
illegal or unenforceable in any respect, such invalid, illegal or unenforceable
provision shall be modified so as to conform to the applicable requirements,
and
this Agreement shall be modified by the parties so as to accomplish as nearly
as
possible the original intention of the parties consistent with applicable laws
and regulations.
17. Waiver
- Modification of Agreement.
No
waiver or modification of any of the terms of this Agreement shall be valid
unless in writing and signed by authorized representatives of the party to
be
charged. Failure or delay by either party to enforce any rights under this
Agreement shall not be construed as a waiver of such rights nor shall a waiver
by either party in one or more instances be construed as constituting a
continuing waiver or as a waiver in other instances.
18. Press
Release. BioTime
and Summit each agrees that the other party may issue a press release concerning
the entering into of this Agreement, with the content of such press releases
to
be approved by the non-issuing party (which consent shall not be unreasonably
withheld or delayed).
10
|
SUMMIT PHARMACEUTICALS
INTERNATIONAL CORPORATION
|
BIOTIME, INC. | |
| By: __________________________ | By: __________________________ | |
| Name:________________________ | Name: ________________________ | |
| Title:_________________________ | Title:_________________________ | |
| Date: | Date: |
11
BIOTIME,
INC.
AND
SUMMIT
PHARMACEUTICALS INTERNATIONAL CORPORATION
EXHIBIT
A
Product
Formulation
Hextend
and PentaLyte Formulation
Hydroxyethyl
Starch 6%
Sodium
Chloride 115 millimoles/liter
Magnesium
Chloride Hexahydrate 0.45 millimoles/liter
Calcium
Chloride Dihydrate 2.5 millimoles/liter
Potassium
Chloride 3 millimoles/liter
Glucose
5
millimoles/liter
Sodium
Lactate 28 millimoles/liter
12
BIOTIME,
INC.
AND
SUMMIT
PHARMACEUTICALS INTERNATIONAL CORPORATION
EXHIBIT
B
Patents
and Patent Applications
Chinese
Patent
| * |
ZL94192801.2
Title
: Plasma-like solution.
|
| * |
ZL00806029.0
Title
: System and compositions for use in perfusion
applications.
|
Taiwanese
Patent
| * |
No.191436
Title
: Physiologically acceptable aqueous solutions and methods for their
use.
|
| * |
No.
183193
Title
: Kits and systems for use in perfusion
application.
|
13