Section 1.6
|
“Field of Use” shall mean exclusive use all of PATENT RIGHTS excluding human and animal therapeutics, animal health, medical devices and pharmaceutical uses and applications. Including but not limited to uses in cosmetics, uses in topical delivery of compounds which are not FDA-regulated therapeutic agents, reagents and platforms for in vitro cell and tissue culture, platforms and services for in vitro drug toxicology and efficacy testing, materials for preserving or extending the useful life of human organs and tissues, in vivo xenograft models using human tissues, and any other uses not specifically excluded. “Field of Use” shall also mean co-exclusive use of PATENT RIGHTS to products and methods in which living tissue or cells are incorporated outside the body into a polymer platform at a facility other than the point-of-care facility, and the resulting hybrid device is then subsequently implanted in humans for therapeutic use (“TISSUE ENGINEERED PRODUCTS”). These co-exclusive rights shall be shared with no more that one other licensee and include Sublicensing rights consistent with the AGREEMENT.
|
Section 5.2
|
Milestones and Fees.
|
|
(a)
|
Licensee shall pay a patent issue fee of five thousand dollars upon issuance of each U.S. patent COVERED BY this AGREEMENTgr. Such patent issue fee shall only be required for the first five (5) U.S. patents issued. If three (3) or more licensees have rights for distinct and separate fields of use for the same issued patent, at the time the patent issues, the patent issue fee shall be two thousand five hundred dollars ($2,500). Each required payment will be paid to Licensor within thirty (30) days of completion of each milestone listed above.
|
|
(b)
|
Licensee shall pay a milestone fee of $225,000 for the first sale of TISSUE ENGINEERED PRODUCTS for Human use. This payment will be paid to Licensor within six (6) months of completion of this milestone.
|
Glycosan BioSystems
|
University of Utah Research Foundation | ||||
By:
|
/s/ William P. Tew
|
By:
|
/s/ Ray F. Gesteland
|
||
Name:
|
William P. Tew, Ph.D
|
Name:
|
Ray F. Gesteland
|
||
Title:
|
President & CEO
|
Title:
|
President
|
||
Date:
|
May 9, 2006
|
|
Date:
|
May 9, 2006
|
1.
|
Article 6 of the Agreement is hereby deleted in its entirety and replaced with the following;
|
|
2.
|
Ratification of Agreement. Except as provided herein or as may be required to effectuate the intent of the parties with respect to the amendments described in paragraph 1 hereof, the parties hereby reaffirm and ratify the terms of the Agreement in their entirety.
|
3.
|
Further Assurances. Each of Licensee and Licensor hereby agrees to execute, deliver, verify, acknowledge, and file any and all documents, instruments, or agreements as shall be necessary or appropriate to reflect the intent of the parties with respect to the amendments of the Agreement described herein.
|
|
4.
|
Entire Understanding. This Amendment constitutes the entire understanding between the parties hereto with respect to the subject matter hereof, and any modification of this Amendment shall be in writing and shall be signed by a duly authorized representative of each party.
|
“LICENSEE” | “LICENSOR” | ||||
GLYCOSAN BIOSYSTEMS, INC. | UNIVERSITY OF UTAH RESEARCH FOUNDATION | ||||
By: |
/s/ William P. Tew
|
By: |
/s/ John K. Morris
|
||
(Signature) | (Signature) | ||||
Name: |
William P. Tew, Ph.D.
|
Name: |
John K. Morris Esq.
|
||
(Please Print) | (Please Print) | ||||
Title: |
President & CEO
|
Title: |
Secretary
|
||
Date: |
February 4, 2008
|
Date: |
February 4, 2008
|
1.
|
WITNESSETH section of the Agreement is hereby deleted in its entirety and replaced with the following:
|
2.
|
EXHIBIT “A” of the Agreement is hereby deleted in its entirety and replaced with the following:
|
U No.
|
Matter
|
Application No.
Date of Filing
|
Title
|
Inventor(s)
|
U-3405
|
21101.0036U1
Provisional
|
60/390,504
6/21/2002
|
Disulfide Crosslinked
Hyaluronan Hydrogels
|
Glenn Preswich,
Xiao Shu, Yi Luo,
Kelly Kirker
|
U-3405
|
21101.0036P1
PCT
|
PCT/US03/15519
5/15/03
|
Crosslinked
Compounds and
Methods of Making
and Using Thereof
|
Glenn Preswich,
Xiao Shu, Yi Luo,
Kelly Kirker
|
U-3405
|
21101.0036U2
Nationalized, United States
|
10/519,173
12/20/04
|
Crosslinked
Compounds and
Methods of Making
and Using Thereof
|
Glenn Preswich, X
iao Shu, Yi Luo,
Kelly Kirker
|
U-3405
|
21101.0036CA1
Nationalized, Canada
|
2,489,712
5/15/03
|
Crosslinked
Compounds and
Methods of Making
and Using Thereof
|
Glenn Preswich,
Xiao Shu, Yi Luo,
Kelly Kirker
|
U-3405
|
21101.0036EP1
Nationalized, Europe
|
03799796.2
5/15/03
|
Crosslinked
Compounds and
Methods of Making and
Using Thereof
|
Glenn Preswich,
Xiao Shu, Yi Luo,
Kelly Kirker
|
U-3656
|
21101.0051P1
Provisional
|
60/526,797
12/4/2003
|
Modified
Macromolecules and
Methods of Making and
Using Thereof
|
Glenn Prestwich,
Xiao Shu
|
U-3656
|
21101.0051U1
PCT
|
PCT/US04/040726
12/6/2004
|
Modified Macromolecules
and Methods of Making
and Using Thereof
|
Glenn Prestwich,
Xiao Shu
|
U-4406
|
24U03.1-140
Provisional
|
61/051,698
05/09/2008
|
Fall-Apart Composites
and Methods of Use
Thereof
|
Glenn Prestwich,
Jianxing Zhang,
Aleksander Skardal
|
3.
|
Fees. Licensee shall pay to Licensor a non-refundable amendment/license fee of three thousand dollars ($3,000) and back patent costs of three thousand dollars ($3,000), for a total of six thousand dollars ($6,000), three thousand dollars ($3,000) of which is deemed earned and immediately payable upon execution of this Amendment and the remaining three thousand dollars ($3,000) is due six months following the final signature and execution of this Amendment.
|
4.
|
Ratification of Agreement. Except as provided herein or as may be required to effectuate the intent of the parties with respect to the amendments described in paragraph 1 hereof, the parties hereby reaffirm and ratify the terms of the Agreement in their entirety.
|
5.
|
Further Assurances. Each of Licensee and Licensor hereby agrees to execute, deliver, verify, acknowledge, and file any and all documents, instruments, or agreements as shall be necessary or appropriate to reflect the intent of the parties with respect to the amendments of the Agreement described herein.
|
6.
|
Entire Understanding. This Amendment constitutes the entire understanding between the parties hereto with respect to the subject matter hereof, and any modification of this Amendment shall be in writing and shall be signed by a duly authorized representative of each party.
|
“LICENSEE”
|
“LICENSOR”
|
|||
GLYCOSAN BIOSYSTEMS, INC.
|
UNIVERSITY OF UTAH RESEARCH FOUNDATION
|
|||
By:
|
/s/ William P. Tew
|
By:
|
/s/ John K. Morris
|
|
(Signature)
|
(Signature)
|
|||
Name:
|
William P. Tew, Ph.D.
|
Name:
|
John K. Morris Esq.
|
|
(Please Print)
|
(Please Print)
|
|||
Title:
|
President & CEO
|
Title:
|
Secretary
|
|
Date:
|
June 25, 2008
|
Date:
|
July 3, 2008
|
1.
|
Section 4.4 of the Agreement is hereby deleted in its entirety and replaced with the following:
|
YEAR 2
|
$ | 7,500 | ||
YEAR 3
|
$ | 0 | ||
YEAR 4
|
$ | 0 | ||
YEAR 5
|
$ | 15,000 | ||
YEAR 6
|
$ | 22,500 | ||
YEAR 7 | $ |
30,000 (and Beyond)
|
2.
|
Issue Fee. Licensee shall pay to Licensor a non-refundable amendment/license fee of seven thousand five hundred ($7,500) and payable as;
|
|
$2,500 deemed earned and payable upon execution of this Amendment, $2,500 due January 31, 2010, and $2,500 due January 31, 2011.
|
3.
|
Ratification of Agreement. Except as provided herein or as may be required to effectuate the intent of the parties with respect to the amendments described in paragraph 1 hereof, the parties hereby reaffirm and ratify the terms of the Agreement in their entirety.
|
4.
|
Further Assurances. Each of Licensee and Licensor hereby agrees to execute, deliver, verify, acknowledge, and file any and all documents, instruments, or agreements as shall be necessary or appropriate to reflect the intent of the parties with respect to the amendments of the Agreement described herein.
|
5.
|
Entire Understanding. This Amendment constitutes the entire understanding between the parties hereto with respect to the subject matter hereof, and any modification of this Amendment shall be in writing and shall be signed by a duly authorized representative of each party.
|
“LICENSEE”
|
“LICENSOR”
|
|||
GLYCOSAN BIOSYSTEMS
|
UNIVERSITY OF UTAH RESEARCH FOUNDATION
|
|||
By:
|
/s/ William P. Tew
|
By:
|
/s/ Thomas N. Parks
|
|
(Signature)
|
(Signature)
|
|||
Name:
|
William P. Tew, PhD
|
Name:
|
Thomas N. Parks
|
|
Title:
|
President & CEO
|
Title:
|
President
|
|
Date:
|
March 19, 2009
|
Date:
|
March 4, 2009
|
1.
|
Issue Fee. Licensee shall pay to Licensor a non-refundable amendment/license fee of Ten Thousand Dollars ($10,000) deemed payable in two payments of five thousand dollars ($5,000), six (6) months and twelve (12) months following execution of this Amendment.
|
2. |
Due Diligence. Licensee shall perform the following due diligence:
|
a.
|
Licensee shall secure additional funding which shall be no less than two million dollars ($2,000,000) on or before the first anniversary of this Amendment.
|
b.
|
Licensee shall initiate safety and toxicology studies of a Licensed Product on or before the first anniversary of this Amendment.
|
|
c.
|
Licensee shall engage a Notified Body for a CE Mark in the European Union or submit an IND to the FDA on or before the second anniversary of this Amendment.
|
d.
|
Licensee shall initiate a clinical trial utilizing a Licensed Product on or before the third anniversary of this Amendment.
|
3.
|
Section 1.6 of the Agreement is hereby deleted in its entirety and replaced with the following:
|
4. |
Exhibit A of the Agreement is hereby deleted in its entirety and replaced with the new Exhibit
|
5.
|
Ratification of Agreement. Except as provided herein or as may be required to effectuate the intent of the parties with respect to the amendments described in paragraph 1 hereof, the parties hereby reaffirm and ratify the terms of the Agreement in their entirety.
|
6.
|
Further Assurances. Each of Licensee and Licensor hereby agrees to execute, deliver, verify, acknowledge, and file any and all documents, instruments, or agreements as shall be necessary or appropriate to reflect the intent of the parties with respect to the amendments of the Agreement described herein.
|
7.
|
Entire Understanding. This Amendment constitutes the entire understanding between the parties hereto with respect to the subject matter hereof, and any modification of this Amendment shall be in writing and shall be signed by a duly authorized representative of each party.
|
“LICENSEE”
|
“LICENSOR”
|
|||
GLYCOSAN BIOSYSTEMS, INC.
|
UNIVERSITY OF UTAH RESEARCH FOUNDATION
|
|||
By:
|
/s/ William P. Tew
|
By:
|
/s/ Thomas N. Parks
|
|
(Signature)
|
(Signature)
|
|||
Name:
|
William P. Tew, PhD
|
Name:
|
Thomas N. Parks
|
|
Title:
|
President & CEO
|
Title:
|
President
|
|
Date:
|
December 22, 2009
|
Date:
|
December 18, 2009
|
University No.
|
Country/Territory
|
Application No.
|
Title
|
Inventor(s)
|
Crosslinked
|
Glenn Preswich,
|
|||
U-3405
|
United States
|
12/234,445
|
Compounds and
|
Xiao Shu, Yi
|
12/244,135
|
Methods of Making
|
Luo, Kelly
|
||
and Using Thereof
|
Kirker
|
|||
Crosslinked
|
Glenn Preswich,
|
|||
U-3405
|
European Union
|
3799796.2
|
Compounds and
|
Xiao Shu, Yi
|
Methods of Making
|
Luo, Kelly
|
|||
and Using Thereof
|
Kirker
|
|||
Crosslinked
|
Glenn Preswich,
|
|||
U-3405
|
Canada
|
2,489,712
|
Compounds and
|
Xiao Shu, Yi
|
Methods of Making
|
Luo, Kelly
|
|||
and Using Thereof
|
Kirker
|
|||
Modified
|
Glenn Preswich,
|
|||
U-3656
|
United States
|
10/581,571
|
Macromolecules and
|
Xiao Shu,
|
Methods of Making
|
||||
and Using Thereof
|
||||
Modified
|
Glenn Preswich,
|
|||
U-3656
|
European Union
|
4813101.5
|
Macromolecules and
|
Xiao Shu,
|
Methods of Making
|
||||
and Using Thereof
|
||||
Modified
|
Glenn Prestwich,
|
|||
U-3656
|
Canada
|
2,549,295
|
Macromolecules and
|
Xiao Shu
|
Methods of Making
|
||||
and Using Thereof
|
||||
Modified
|
Glenn Prestwich,
|
|||
U-3656
|
Australia
|
2004297231
|
Macromolecules and
|
Xiao Shu
|
Methods of Making
|
||||
and Using Thereof
|
||||
U-3656 | Japan | 2006542843 | Modified
Macromolecules and
Methods of Making
and Using Thereof
|
Glenn Prestwich,
Xiao Shu
|
1.
|
Due Diligence. Due Diligence section in amendment 5 is hereby deleted in its entirety and replaced with the following:
|
a.
|
Licensee shall secure funding consisting of investment and grants which shall be no less than two million dollars ($2,000,000) on or before January 1, 2011.
|
b.
|
Licensee shall initiate safety and toxicology studies of a Licensed Product on or before the first anniversary of this Amendment.
|
c.
|
Licensee shall engage a Notified Body for a CE Mark in the European Union or submit an IND to the FDA on or before the second anniversary of this Amendment.
|
d.
|
Licensee shall initiate a clinical trial utilizing Licensed Product or obtain regulatory approval for commercial sale on or before January 1, 2014.
|
2. |
Section 1.6 of the Agreement is hereby deleted in its entirety and replaced with the following:
|
|
Field of Use” shall mean exclusive use all of PATENT RIGHTS, excluding animal therapeutics and animal health, in all countries and territories identified in Exhibit A except that:
|
|
within the United States only, “Field of Use” shall mean exclusive of use all of Patent Rights, excluding human and animal therapeutics, animal health, in vivo medical devices and pharmaceutical uses and applications. Including but not limited to in vitro medical devices, uses in cosmetics, uses in topical delivery of compounds which are not FDA-regulated therapeutic agents, reagents and platforms for in vitro cell and tissue culture, including such reagents and platforms that are medical devices, excluding in vivo medical devices, platforms and services for in vitro drug toxicology and efficacy testing, materials for preserving or extending the useful life of human organs and tissues, including such materials that are medical devices, excluding in vivo medical devices, in vivo xenograft models using human tissues, and any other uses not specifically excluded and,
|
|
within the United States only, “Field of Use” shall also mean co-exclusive use of PATENT RIGHTS to products and methods in which living tissue or cells are incorporated outside the body into a polymer platform at a facility other than the point-of-care facility, and the resulting hybrid device is then subsequently implanted in humans for therapeutic use (“TISSUE ENGINEERED PRODUCTS”). These co-exclusive rights shall be shared with no more that one other licensee and include Sublicensing rights consistent with the AGREEMENT.
|
3.
|
Ratification of Agreement. Except as provided herein or as may be required to effectuate the intent of the parties with respect to the amendments described in paragraph 1 hereof, the parties hereby reaffirm and ratify the terms of the Agreement in their entirety.
|
4.
|
Further Assurances. Each of Licensee and Licensor hereby agrees to execute, deliver, verify, acknowledge, and file any and all documents, instruments, or agreements as shall be necessary or appropriate to reflect the intent of the parties with respect to the amendments of the Agreement described herein.
|
5.
|
Entire Understanding. This Amendment constitutes the entire understanding between the parties hereto with respect to the subject matter hereof, and any modification of this Amendment shall be in writing and shall be signed by a duly authorized representative of each party.
|
“LICENSEE”
|
“LICENSOR”
|
|||
GLYCOSAN BIOSYSTEMS, INC.
|
UNIVERSITY OF UTAH RESEARCH FOUNDATION
|
|||
By:
|
/s/ William P. Tew
|
By: |
/s/ Thomas N. Parks
|
|
(Signature)
|
(Signature)
|
|||
Name:
|
William P. Tew, PhD
|
Name: |
Thomas N. Parks
|
|
Title:
|
President & CEO
|
Title: |
President
|
|
Date:
|
September 23, 2010
|
Date: |
September 22, 2010
|
1.
|
Due Diligence. Due diligence section in the 6th Amendment dated September 22, 2010 is hereby deleted in its entirety and replaced with the following:
|
a.
|
Within 90 days of completing the merger between Glycosan and Orthocyte, Licensee shall submit to the University’s Technology Commercialization Office a licensed product development plan and shall use commercially reasonable efforts to execute such plan.
|
2.
|
Section 1 of the 4th Amendment dated March 6, 2009 is hereby deleted in its entirety and replaced with the following:
|
YEAR 2
|
$ | 7,500 | ||
YEAR 3
|
$ | 0 | ||
YEAR 4
|
$ | 0 | ||
YEAR 5
|
$ | 0 | ||
YEAR 6
|
$ | 0 | ||
YEAR 7
|
$ | 15,000 | ||
YEAR 8
|
$ | 22,500 | ||
YEAR 9 | $ | 30,000 (and Beyond) |
3.
|
Assignability. For the merger between Glycosan and Orthocyte only, the Licensor hereby waives the payment of a non-refundable assignment fee as set forth in Article 19, Assignability of the License Agreement, and assigns the License Agreement to BioTime. Further, Article 19 or the License Agreement is replaced in its entirety with the following:
|
4.
|
Fees. Within 90 days of the closing of the merger between Glycosan and Orthocyte, the Licensee shall deliver to Licensor a non-refundable amendment/assignment fee consisting of $30,000 in the merger consideration received by Glycosan (BioTime shares and warrants) as se t forth in the Merger Agreement between Glycosan and OrthoCyte. Pursuant to the terms of the Merger Agreement, the value of the BioTime stock will be the 10 day trailing average of the BioTime stock price as listed on Nasdaq on the day preceding the execution of the Merger Agreement and the value of the BioTime warrants will be determined by Black-Scholes calculation of the warrant value on the day preceding execution of the Merger Agreement. Licensee shall also submit, with the assignment fee, a certified capitalization table for Glycosan at the time of the merger indicating BioTime shares and warrants received for Glycosan shares.
|
5.
|
Ratification of Agreement. Except as provided herein or as may be required to effectuate the intent of the parties with respect to the amendments described in paragraphs 1, 2, and 3 hereof, the parties hereby reaffirm and ratify the terms of the Agreement in their entirety.
|
6.
|
Further Assurances. Each of Licensee and Licensor hereby agrees to execute, deliver, verify, acknowledge, and file any and all documents, instruments, or agreements as shall be necessary or appropriate to reflect the intent of the parties with respect to the amendments of the Agreement described herein.
|
7.
|
Entire Understanding. This Amendment constitutes the entire understanding between the parties hereto with respect to the subject matter hereof, and any modification of this Amendment shall be in writing and shall be signed by a duly authorized representative of each party.
|
“LICENSEE”
|
“LICENSOR”
|
|||
GLYCOSAN BIOSYSTEMS, INC.
|
UNIVERSITY OF UTAH RESEARCH FOUNDATION
|
|||
By:
|
/s/ William P. Tew
|
By:
|
/s/ Thomas N. Parks
|
|
(Signature)
|
(Signature)
|
|||
Name:
|
William P. Tew, PhD
|
Name:
|
Thomas N. Parks
|
|
Title:
|
President & CEO
|
Title:
|
President
|
|
Date:
|
February 10, 2011
|
Date:
|
February 8, 2011
|
1.
|
Issue Fee. Licensee shall pay to Licensor a non-refundable, non-creditable amendment/license fee of One Hundred Twenty Thousand Dollars ($120,000) deemed payable in 4 quarterly payments of Thirty Thousand Dollars ($30,000). The first payment is due within ten days of the execution date of this Amendment and the 3 remaining payments of Thirty Thousand Dollars ($30,000) each are due within 10 days of the 3 calendar quarters following the Execution Date. For purposes of this Paragraph 1, “execution date” shall mean the date under Licensor’s signature below.
|
2.
|
Section 2 of the 7th Amendment dated February 7, 2011 (control number 1038.G/1535) is deleted in its entirety and replaced with the following:
|
YEAR 2 (2008)
|
$ | 7,500 | ||
YEAR 3 (2009)
|
$ | 0 | ||
YEAR 4 (2010)
|
$ | 0 | ||
YEAR 5 (2011)
|
$ | 0 | ||
YEAR 6 (2012)
|
$ | 0 | ||
YEAR 7 (2013)
|
$ | 0 | ||
YEAR 8 (2014)
|
$ | 22,500 | ||
YEAR 9 (2015 and beyond)
|
$ | 30,000 |
3.
|
Section 2 of the 6th Amendment dated September 23, 2010 (control number 1038.F/1495) is hereby deleted in its entirety and replaced with the following:
|
4.
|
“Future Patent Expenses”. Section 10.1 of the License Agreement is hereby deleted in its entirety and replaced with the following:
|
5.
|
License to Prospective Licensee for Proposed Product. From and after the fifth anniversary of the Effective Date of this amendment, Licensor shall provide written notice to Licensee of any request Licensor receives for an exclusive or non-exclusive license relating to any method or process, composition, product or component part thereof for which rights to the Technology Rights are necessary for manufacture, sale, use, distribution, or as applicable the reproduction, preparation of derivatives of, public performance of, public display of, or other practice of a proposed product or service (a “Proposed Product”) from any third party that desires to make, use, and sell such Proposed Product (a “Prospective Licensee”) within fifteen (15) business days of receiving such request. If Licensor fails to provide Licensee with written notice within 15 business days of receipt of a request from a third party the provisions provided below will not apply.
|
|
I.
|
In the event neither Licensee nor any Affiliate or Sublicensee is then developing or commercializing or has plans to develop or commercialize a Licensed Product or Licensed Service for use or sale in the same general industry as proposed by the Prospective Licensee for the Proposed Product, as identified in a report provided to Licensor hereunder, then within sixty (60) days of receipt of the notice by Licensee from Licensor that it desires Licensee to negotiate with the Prospective Licensee for the purpose of granting a sublicense under the Technology Rights to develop and commercialize the Proposed Product within the relevant portion of the Field of Use, Licensee shall elect one of the following options:
|
|
a.
|
Provide Licensor with documentation demonstrating to Licensor’s reasonable satisfaction that Licensee, an Affiliate or Sublicensee has initiated commercially reasonable efforts to develop, make, use, sell, distribute, and as applicable reproduce, prepare derivatives of, publicly perform, or publicly display a Licensed Product for use or sale that would commercially compete with the Proposed Product in the same general industry; or
|
|
b.
|
Provide Licensor with written notice that Licensee, an Affiliate or Sublicensee has plans to or will develop plans to initiate commercially reasonable efforts to develop or commercialize a Licensed Product or Licensed Service for use or sale in the same general industry that would commercially compete with the Proposed Product; or
|
|
c.
|
Begin good faith negotiations with the Prospective Licensee to sublicense Licensee’s rights in the Technology Rights to the extent necessary for such Prospective Licensee to develop, make, use, sell, distribute, use, and as applicable reproduce, prepare derivatives of, publicly perform, or publicly display such Proposed Product or other Licensed Product in the relevant portion of the Field of Use; or
|
|
d.
|
Grant back to Licensor limited rights in the Technology Rights for the sole purpose of allowing Licensor to license the Technology Rights to the extent necessary for such Prospective Licensee to develop, make, use, sell, distribute, and as applicable reproduce, prepare derivatives of, publicly perform, or publicly display such Proposed Product in the relevant portion of the Field of Use; or
|
|
e.
|
Provide Licensor with written notice demonstrating to Licensor’s reasonable satisfaction that the development or commercialization of such Proposed Product would have a reasonable likelihood of materially and adversely affecting the development or commercialization of any Licensed Product or Licensed Service then being developed or commercialized by Licensee, an Affiliate or Sublicensee.
|
|
II.
|
If Licensee elects to negotiate with a Prospective Licensee for a sublicense to develop, make, use, sell, distribute, and as applicable reproduce, prepare derivatives of, publicly perform, or publicly display a Proposed Product (or other Licensed Product) as provided for in Section I.(c)., Licensee shall make a good faith effort to complete negotiations with the Prospective Licensee within six (6) months from the date on which it begins negotiations. Upon Licensor’s written approval, this six (6) month period shall be extended to the extent Licensee reasonably demonstrates that such extension is reasonable in view of the circumstances. For the purpose of this Section II, Licensee shall have made a good faith effort to complete negotiations if it has offered a sublicense to the Prospective Licensee the terms of which include:
|
|
a.
|
Reasonable financial terms taking into account the field in which the sublicense is being offered and Licensee’s obligations to Licensor pursuant to this Agreement;
|
|
b.
|
Commercially reasonable minimum performance requirements;
|
|
c.
|
Non-financial terms which are commercially reasonable;
|
|
d.
|
The Licensor and Licensee agree that commercially reasonable terms offered to the Prospective Licensee means terms that cannot be more favorable to the Prospective Licensee than those obtained by Licensee from Licensor.
|
|
III.
|
Within thirty (30) days of the end of the six (6) month negotiation period (or as it may be extended under this Section 1 (the “Negotiation Period”), Licensee shall:
|
|
a.
|
Provide Licensor a copy of the fully executed sublicense with such Prospective Licensee; or
|
|
b.
|
Meet with Licensor representatives and provide documentation of reasons that (A) Licensee and or the Prospective Licensee chose not to proceed with good faith negotiations, or (B) negotiations between Licensee and such Prospective Licensee failed.
|
|
IV.
|
In the event that (a) Licensee elects to pursue the option set forth in Section I.(c), and Licensee fails to demonstrate to Licensor’s reasonable satisfaction that Licensee has made a good faith effort as required by Section II, or (2) Licensee fails to submit to Licensor a plan to develop a product or service that is essentially equivalent to the product or service of the Prospective Licensee and (b) the Prospective Licensee notifies the Licensor, following the end of the negotiation period, that the Prospective Licensee is willing to license the Technology Rights directly from the Licensor on substantially the same terms previously offered to the Licensee, at the Licensor’s election, then this Agreement shall be deemed automatically amended to the extent reasonably necessary to enable the Licensor, and Licensor shall have the right, to negotiate a co-exclusive license to the Technology Rights for the Prospective Licensee, provided however, that the Field of Use for the Technology Rights will not extend beyond that which is necessary for the Prospective Licensee to make, sell, offer to sell, or use its product or services which are not commercially competing with any Licensed Product or Licensed Service of the Licensee.
|
|
V.
|
The Licensor and Licensee agree that the dispute resolution terms in the original license agreement will apply to this amendment.
|
6.
|
Exhibit A in Amendment 6 dated December 10, 2009 (control number 1038.E/1405) is hereby deleted in its entirety and replaced with the new Exhibit A attached hereto.
|
7.
|
Ratification of Agreement. Except as provided herein or as may be required to effectuate the intent of the parties with respect to the amendments described in paragraph 1 hereof, the parties hereby reaffirm and ratify the terms of the Agreement in their entirety.
|
8.
|
Further Assurances. Each of Licensee and Licensor hereby agrees to execute, deliver, verify, acknowledge, and file any and all documents, instruments, or agreements as shall be necessary or appropriate to reflect the intent of the parties with respect to the amendments of the Agreement described herein.
|
9.
|
Entire Understanding. This Amendment constitutes the entire understanding between the parties hereto with respect to the subject matter hereof, and any modification of this Amendment shall be in writing and shall be signed by a duly authorized representative of each party.
|
“LICENSEE”
|
“LICENSOR”
|
|||
BioTime, Inc.
|
University of Utah Research Foundation
|
|||
By:
|
/s/ William P. Tew
|
By:
|
/s/ Thomas N. Parks
|
|
(Signature)
|
(Signature)
|
|||
Name:
|
William P. Tew, PhD
|
Name:
|
Thomas N. Parks
|
|
(Please Print)
|
(Please Print)
|
|||
Title:
|
Chief Commercial Officer
|
Title:
|
President
|
|
Date:
|
August 13, 2012
|
Date:
|
August 20, 2012
|
University
No.
|
Country/
Territory
|
Application/
Patent No.
|
Title
|
Inventor(s)
|
Third Party
Patent Rights
|
U-3405
|
United States
|
12/234,445
|
Crosslinked Compounds
and Methods of Making and Using Thereof
|
Glenn Preswich,
Xiao Shu, Yi
Luo, Kelly Kirker
|
Yes
|
U-3405
|
United States
|
12/244,135
|
Crosslinked Compounds and Methods of Making and
Using Thereof
|
Glenn Preswich,
Xiao Shu, Yi
Luo, Kelly Kirker
|
Yes
|
U-3405
|
European Union
|
03799796.2
|
Crosslinked Compounds and Methods of Making and
Using Thereof
|
Glenn Preswich,
Xiao Shu, Yi
Luo, Kelly Kirker
|
Yes
|
U-3405
|
Canada
|
2,489,712
|
Crosslinked Compounds and Methods of Making and
Using Thereof
|
Glenn Preswich,
Xiao Shu, Yi
Luo, Kelly Kirker
|
Yes
|
U-3656
|
United States
|
7,981,871
|
Modified Macromolecules and Methods of Making and
Using Thereof
|
Glenn Preswich,
Xiao Shu
|
Yes
|
U-3656
|
United States
|
13/184,401
|
MODIFIED MACROMOLESCULES
AND ASSOCIATED
METHODS OF
SYNTHESIS AND USE
|
Glenn Preswich,
Xiao Shu
|
Yes
|
U-3656
|
European Union
|
04813101.5
|
Modified Macromolecules
and Methods of Making and Using Thereof
|
Glenn Preswich,
Xiao Shu
|
Yes
|
U-3656
|
Canada
|
2,549,295
|
Modified Macromolecules
and Methods of Making and Using Thereof
|
Glenn Preswich,
Xiao Shu
|
Yes
|
U-3656
|
Australia
|
2004297231
|
Modified Macromolecules
and Methods of Making and Using Thereof
|
Glenn Preswich,
Xiao Shu
|
Yes
|
U-3656
|
Japan
|
2006542843
|
Modified Macromolecules
and Methods of Making and Using Thereof
|
Glenn Preswich,
Xiao Shu
|
Yes
|
ARTICLE l. DEFINITIONS
|
1
|
ARTICLE 2. LICENSE GRANT
|
3
|
ARTICLE 3. TERM OF AGREEMENT
|
4
|
ARTICLE 4. FEES & ROYALTIES
|
4
|
ARTICLE 5. COMMERCIAL DILIGENCE & MILESTONES
|
5
|
ARTICLE 6. EQUITY OWNERSHIP
|
6
|
ARTICLE 7. CONFIDENTIALITY
|
6
|
ARTICLE 8. QUARTERLY & ANNUAL REPORTS
|
6
|
ARTICLE 9. PAYMENTS, RECORDS AND AUDITS
|
8
|
ARTICLE 10. PATENT PROSECUTION AND MAINTENANCE
|
8
|
ARTICLE 11. PATENT MARKING
|
9
|
ARTICLE 12. TERMINATION BY LICENSOR
|
9
|
ARTICLE 13. TERMINATION BY LICENSEE
|
10
|
ARTICLE 14. DISPOSITION OF LICENSED PRODUCTS ON HAND
|
10
|
ARTICLE 15. WARRANTY BY LICENSOR
|
10
|
ARTICLE 16. INFRINGEMENT
|
11
|
ARTICLE 17. INSURANCE
|
11
|
ARTICLE 18. WAIVER
|
12
|
ARTICLE 19. ASSIGNABILITY
|
12
|
ARTICLE 20. INDEMNIFICATION BY LICENSEE
|
12
|
ARTICLE 21. INDEMNIFICATION BY LICENSOR
|
12
|
ARTICLE 22. NOTICES
|
13
|
ARTICLE 23. REGULATORY COMPLIANCE
|
13
|
ARTICLE 24. GOVERNING LAW
|
14
|
ARTICLE 25. RELATIONSHIP OF PARTIES
|
14
|
ARTICLE 26. USE OF NAMES
|
14
|
ARTICLE 27. DISPUTE RESOLUTION
|
14
|
ARTICLE 28. GENERAL PROVISIONS
|
15
|
EXHIBIT “A”
|
17
|
Patent Rights
|
17
|
EXHIBIT “B”
|
18
|
LICENSE TO THE UNITED STATES GOVERNMENT
|
18
|
EXHIBIT “C”
|
19
|
Quarterly Report
|
19
|
EXHIBIT “D
|
20
|
Due Diligence
|
20
|
|
a.
|
publish the general scientific findings from research conducted in whole or in part at the University related to Patent Rights; and
|
|
b.
|
manufacture, have manufactured, use, or transfer Patent Rights for research, teaching and other educationally-related purposes
|
|
a.
|
Any sublicense granted by Licensee to a Sublicensee shall incorporate all of the terms and conditions of this Agreement, which shall be binding upon each Sublicensee as if such Sublicensee were a party to this Agreement. Licensee shall collect and guarantee all payments due Licensor from Sublicensees. In each such sublicense, the Sublicensee will be prohibited from granting further sublicenses.
|
|
b.
|
If Licensee becomes Insolvent, Licensor’s proportionate share of all payments then or thereafter due and owing to Licensee from its Sublicensees for the sublicense of the Patent Rights will, upon notice from Licensor to any such Sublicensee, become payable directly to Licensor; provided however, that Licensor will remit to Licensee the amount by which such payments exceed the amounts owed by Licensee to Licensor.
|
|
c.
|
Licensee shall within thirty (30) days of: (a) execution, provide Licensor with a copy of each sublicense granted by Licensee hereunder and any amendments thereto or terminations thereof; and (b) upon receipt, summarize and deliver copies of all reports due to Licensee from Sublicensees.
|
|
d.
|
Upon any termination of this Agreement, Sublicensees rights shall at Licensor’s option, be (i) assigned to and assumed by Sublicensee, or (ii) terminated.
|
|
a.
|
If any patent or any claim thereof included within Licensor’s Patent Rights shall be found invalid by a court of competent jurisdiction and last resort, from which decision no appeal may be taken, Licensee’s obligation to pay Licensor royalties based on such patent or claim or any claim patentably indistinct therefrom shall cease as of the date of such decision. Licensee shall not, however, be relieved from paying Licensor any royalties, fees, expenses, or other liabilities that accrued prior to the date of such decision or that are based on any of Licensor’s Patent Rights not the subject of such decision.
|
YEAR 2
|
$ | 7,500 | ||
YEAR 3
|
$ | 15,000 | ||
YEAR 4
|
$ | 22,500 | ||
YEAR 5 | $ | 30,000 (and Beyond) |
|
(a)
|
Licensee shall deliver to Licensor within six (6) months from Effective Date, a complete and accurate commercialization plan detailing each phase of development, the target markets and time frames toward first sale of the Licensed Products and Licensed Methods.
|
|
(b)
|
Licensee shall submit within eight (8) months from Effective Date, at least one grant application regarding development of technology licensed in this Agreement.
|
|
(c)
|
Licensee shall secure within one year from Effective Date office and laboratory space to conduct its business.
|
|
(d)
|
Licensee shall spend at least three hundred thousand dollars ($300,000) on research, development and commercialization of Licensed Products and/or Licensed Methods during the two-year period following the date of this Agreement. Included in such expense shall be normal corporate start-up costs including, but not limited to, corporate overhead such as rent, salaries and benefits, insurance, legal, and laboratory and equipment acquisition
|
|
(e)
|
Net Sales shall have occurred on or before the second anniversary of the Effective Date.
|
|
a.
|
number of Licensed Products manufactured, leased and sold by and/or for Licensee, Affiliates and all Sublicensees;
|
|
b.
|
accounting for all Licensed Methods used or sold by and/or for Licensee, Affiliates and all Sublicensees;
|
|
c.
|
accounting for Net Sales, noting the deductions applicable as provided in Section 1.10;
|
|
d.
|
royalties due under Section 4.4;
|
|
e.
|
running royalties due under Section 4.3 and 4.6;
|
|
f.
|
royalties due on other payments from Sublicensees and assignees under Section 4.5;
|
|
g.
|
total royalties due;
|
|
h.
|
names and addresses of all Sublicensees of Licensee;
|
|
i.
|
the amount spent on product development; and
|
|
j.
|
the number of full-time equivalent employees working on the Licensed Products and/or Licensed Methods.
|
|
a.
|
a warranty or representation by Licensor as to the validity or scope of any Patent Rights.
|
|
b.
|
a warranty or representation by Licensor that anything made, used, sold or otherwise disposed of pursuant to any license granted under this Agreement is or will be free from infringement of intellectual property rights of third parties.
|
|
c.
|
an obligation by Licensor to bring or prosecute actions or suits against third parties for patent infringement, except as expressly provided in Article 16 hereof.
|
|
d.
|
conferring by implication, estoppel or otherwise any license or rights under any patents of Licensor other than Patent Rights.
|
“Licensee” |
“Licensor”
|
|||
GLYCOSAN BIOSYSTEMS, Inc.
|
UNIVERSITY OF UTAH RESEARCH FOUNDATION
|
|||
By
|
/s/ William P. Tew |
By
|
/s/ Raymont F. Gesteland | |
(Signature) |
(Signature)
|
|||
Name
|
William P. Tew, Ph.D. | Name | Raymond F. Gesteland | |
(Please Print)
|
(Please Print)
|
|||
Title
|
President & CEO | Title | President | |
Date
|
February 18, 2006 | Date | February 14, 2006 |
U No.
|
Matter
|
Application No.
Date of Filing
|
Title
|
Inventor(s)
|
U-3405
|
21101.0036U1
Provisional
|
60/390,504
6/21/2002
|
Disulfide Crosslinked
Hyaluronan Hydrogels
|
Glenn Preswich, Xiao
Shu, Yi Luo, Kelly
Kirker
|
U-3405
|
21101.0036P1
PCT
|
PCT/US03/15519
5/15/03
|
Crosslinked
Compounds and
Methods of Making and
Using Thereof
|
Glenn Preswich, Xiao
Shu, Yi Luo, Kelly
Kirker
|
U-3405
|
21101.0036U2
Nationalized, United States
|
10/519,173
12/20/04
|
Crosslinked
Compounds and
Methods of Making and
Using Thereof
|
Glenn Preswich, Xiao
Shu, Yi Luo, Kelly
Kirker
|
U-3405
|
21101.0036CA1
Nationalized, Canada
|
2,489,712
5/15/03
|
Crosslinked
Compounds and
Methods of Making and
Using Thereof
|
Glenn Preswich, Xiao
Shu, Yi Luo, Kelly
Kirker
|
U-3405
|
21101.0036EP1
Nationalized, Europe
|
03799796.2
5/15/03
|
Crosslinked
Compounds and
Methods of Making and
Using Thereof
|
Glenn Preswich, Xiao
Shu, Yi Luo, Kelly
Kirker
|
U-3656
|
21101.0051P1
Provisional
|
60/526,797
12/4/2003
|
Modified
Macromolecules and
Methods of Making and
Using Thereof
|
Glenn Prestwich,
Xiao Shu
|
U-3656
|
21101.0051U1
PCT
|
PCT/US04/040726
12/6/2004
|
Modified
Macromolecules and
Methods of Making and
Using Thereof
|
Glenn Prestwich,
Xiao Shu
|
Signed:
|
|
Date:
|
|||
Name:
|
Raymond F. Gesteland
|
Title:
|
President
|
(title) | , | U- |
(title) | , | U- |
___Yes ___No
|
In the designated reporting period, did your company or any Sublicensee of the above referenced technology have 500 or more mployees? This information is required to determine and report large or small entity status in the United States.
|
___Yes ___No
|
In the designated reporting period, did your company or any Sublicensee of the above referenced technology have more than 50 mployees? This information is required to determine and report large or small entity status in Canada.
|