Exhibit 10.14
AMENDMENT TO LICENSE AND SPONSORED RESEARCH AGREEMENT
WHEREAS, Duke University, a North Carolina not-for-profit corporation,
(hereinafter called the "LICENSOR"), having its principal office at Xxxxxx,
Xxxxx Xxxxxxxx 00000, and Microlslet Pharmaceutical, Inc. a corporation
organized under the laws of California (hereinafter called the "LICENSEE"),
having its principal office at 00000 Xxxxxxx Xxxxxx Xxxxx, Xxxxx X, Xxx Xxxxx,
XX 00000 entered into a License and Sponsored Research Agreement dated 15
September 1998 [Duke University Office of Science & Technology Agreement # 495,
herein after the "LICENSE"]; and
WHEREAS, Article 3.05 of the LICENSE called for LICENSEE to inform
LICENSOR within thirty (30) days of receipt of certain information if LICENSEE
wished to initiate the RESEARCH PROGRAM described In Article 3 and Exhibit B of
the LICENSE; and
WHEREAS, Article 3.05 of the LICENSE also called for LICENSEE to
reimburse LICENSOR for expenses incurred by LICENSOR in obtaining the
information specified in said Article 3.05; and
WHEREAS, LICENSOR has provided LICENSEE with the information specified
in said Article 3.05 and has also invoiced LICENSEE for said expenses; and
WHEREAS, LICENSEE has now informed LICENSOR that it wishes to proceed
with a modified research program that differs substantially from the RESEARCH
PROGRAM specified in the LICENSE; and
WHEREAS, the LICENSEE will reimburse LICENSOR for the expenses incurred
by LICENSOR in providing the information specified in Article 3.05 of the
LICENSE; and
WHEREAS, LICENSOR and LICENSEE now wish to amend the LICENSE to provide
for the modified RESEARCH PROGRAM, including the delay in starting the RESEARCH
PROGRAM, and to activate the LICENSE by initiating the RESEARCH PROGRAM; and
WHEREAS, LICENSEE now wishes to be bound by the terms and conditions of
the LICENSE;
THEREFORE, LICENSEE and LICENSOR agree as follows:
1. The parties agree that LICENSOR has provided the information required under
Article 3.05.a of the LICENSE and also that, in executing this Amendment,
the LICENSEE is notifying LICENSOR that LICENSEE shall proceed to sponsor
the RESEARCH PROGRAM.
2. The parties agree that Article 1.01.c of the LICENSE shall be amended to
read:
1.01.c "EFFECTIVE DATE" shall mean the date that LICENSOR receives from
LICENSEE the last of the following payments: (a) a check in an amount of
eight thousand six hundred three dollars and eighty four cents [$8603.44]
as reimbursement for expenses specified in invoices #3860 and # 3748
previously sent to LICENSEE by LICENSOR; and (b) the stock specified in
Article 4.01.c herein; and (c) the first payment for the RESEARCH PROGRAM
specified in Article 3.04 herein.
3. The parties agree that Article 3.04 of the LICENSE shall be amended to
read:
3.04 - Budget. In consideration of the foregoing, and as more specifically
provided in the budget included as Exhibit B, LICENSEE will pay LICENSOR
for all direct and indirect costs incurred in the performance of the
research as set forth in the STATEMENT, a total not to exceed one hundred
eighty nine thousand four hundred and eight dollars [$189,408]. An initial
payment of forty-one thousand six hundred sixty eight dollars [$41,668]
shall be made to LICENSEE to initiate the RESEARCH PROGRAM. The remaining
balance of funds due, one hundred forty-seven thousand seven hundred and
forty dollars [$147,740] shall be paid to LICENSEE in five payments of
twenty-nine thousand five hundred forty eight dollars ($29,548) each. Such
payments shall be made to LICENSOR on 1 April, 1 June, 1 August, 1 October,
and 1 December of 1999. The parties agree that this budget may be revised
by mutual written agreement between the parties based upon the reasonable
requirements of the research project including the availability of funding
from other sources.
4. The parties agree that Article 4.01.a of the LICENSE shall be amended to
read: 4.01.a. LICENSEE shall sponsor the RESEARCH PROGRAM specified in
Article 3 herein.
5. The parties agree that the budget in Exhibit B of the LICENSE shall be
amended to read:
EXHIBIT B: STATEMENT OF WORK
BUDGET
PRECLINICAL TRIALS WITH MICROENCAPSULATED ISLETS IN FIVE BABOONS
*EQUIPMENT $ 12,000
Itemized costs
1. 1 Stereomicroscope $ 2,500
2. Isolation Chamber and accessories $ 2,500
3. Automatic Freezer $ 2,000
4. Equipment and Service Contracts $ 5,000
* For this phase, we may be able to rent the COBE cell separator as
suggested by Xxxx Xxxxx. We could also use most of the existing
equipment whose maintenance costs and distilled water supply contract
Microislet would pay for, as indicated on line item #4. Under these
circumstances, only the three items of equipment requested would still
be required.
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SUPPLIES $ 23,750
Itemized costs
1. Ficoll (5 kg) $ 7,000
2. Organ Preservation (UW-solution) $ 1,500
3. Cell Isolation and Culture Media $ 1,500
4. Preservatives (antioxidants, anticytokines, etc.) $ 1,000
5. Collagenase and DNase $ 2,500
6. Purified Alginate $ 3,500
7. Poly-L-Lysine and sodium citrate $ 1,500
8. Accessories for encapsulation $ 1,000
(tubings, syringes, needles, test-tubes
centrifuge tubes, etc)
9. Streptozotocin $ 750
10. Chemicals for analytical buffers $ 2,000
11. Assay kits for glucose, insulin and C-peptide $ 1,500
ANIMALS $ 17,500
Itemized costs
1. 5 Diabetic Baboons (Transplant recipients) $ 15,500
(cost and shipping)
2. 20 Pigs (Pancreatic donors) $ 2,000
(cost and shipping)
ANIMAL CARE $ 4,200
Itemized costs
1. Daily Care for 5 Baboons for 6 months $ 1,000
2. Quarantine for 5 Baboons $ 3,000
3. Per diem for 20 Pigs prior to sacrifice $ 200
SURGERY COSTS $ 17,250
(Breakdown of Surgery Costs per animal)
1. Operating room charges $ 1,500
2. Medications $ 500
3. Sterile syringes and needles $ 250
4. Tru cut needle for biopsy $ 200
5. Sutures $ 150
6. IVfluids $ 100
7. Pump, head, tubing, adapters $ 250
8. Sterile Supplies $ 500
Total Surgery cost/animal $ 3,450
PERSONNEL $ 52,500
Itemized costs
1. Principal Investigator (50% effort) $ 50,000
2. Co-Investigator (Transplant Surgeon) $ 2,500
(@ $250/procedure and 2 procedures/animal)
DIRECT COSTS $ 127,200
INDIRECT COST $ 62,208
(Institutional @ 54% direct cost, except on equipment)
TOTAL COSTS $ 189,408
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6. The address for notices sent to LICENSOR specified in Article 15 shall be
amended to read:
Mr. Xxxx Xxxxx
President
Microlslet Pharmaceuticals, Inc.
00000 Xxxxxxx Xxxxxx Xxxxx, Xxxxx X
Xxx Xxxxx, XX 00000
All other terms and conditions of the LICENSE remain in force and unchanged by
this Amendment.
IN WITNESS WHEREOF, the parties have caused this Amendment to be executed in
duplicate as of the dates inscribed below.
LICENSOR
By: /s/ Xxxxxx Xxxxx
------------------------------
Xxxxxx Xxxxx
Director, Office of Science and Technology
Duke University
Date: 2/5/99
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[LICENSEE]
By: /s/ Xxxx X. Steel
------------------------------
Name: Xxxx Xxxxx
Title: President/CEO
Date: 2/9
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