EXHIBIT 10.16
AGREEMENT
This agreement is made and entered into this 1st day of November, 1996, by and
between GalaGen Inc. (hereinafter referred to as "GalaGen") a Delaware
corporation having a place of business at 0000 Xxxxxxxxx Xxxxxx Xxxxx,
Xxxxx Xxxxx, Xxxxxxxxx 00000-0000, and Colorado Animal Research Enterprises,
Inc., a Colorado corporation having a place of business at 0000 Xxxx Xxxxxx
Xxxx 00, Xxxx Xxxxxxx, Xxxxxxxx 00000 (hereinafter referred to as "CARE").
WHEREAS, GalaGen desires to have CARE undertake routine manufacturing of
[***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] relating to
GalaGen's proprietary use of the [***CONFIDENTIAL TREATMENT REQUESTED;
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] as antigens; and
WHEREAS, CARE possesses the facilities and expertise to perform the
manufacturing.
NOW, THEREFORE, in consideration of the promises and mutual covenants herein
contained, the parties hereto agree to the following:
1. DEFINITIONS
1.1 [***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] shall mean [***CONFIDENTIAL TREATMENT
REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***].
1.2 "Manufacture" shall mean the Propagation, Initial Purification,
Sterilization, Inactivation and Distribution of [***CONFIDENTIAL
TREATMENT REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***] by CARE.
1.3 "Lot" shall mean the quantity of [***CONFIDENTIAL TREATMENT
REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***] manufactured from a set
of [***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] by CARE. Lots shall be manufactured using a minimum of
two (2) [***CONFIDENTIAL TREATMENT REQUESTED; PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***] to a maximum of sixteen (16)
[***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***].
1.4 "Propagation" shall mean the continuous in vivo propagation of
[***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***],
from original [***CONFIDENTIAL TREATMENT REQUESTED; PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] "seed stock", in [***CONFIDENTIAL TREATMENT
REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION***] and the retrieval of [***CONFIDENTIAL
TREATMENT REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***] in the [***CONFIDENTIAL
TREATMENT REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***] of said [***CONFIDENTIAL
TREATMENT REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***].
1.5 "Initial Purification" shall mean primary [***CONFIDENTIAL TREATMENT
REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***] purification, secondary [***CONFIDENTIAL
TREATMENT REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***] purification and
[***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION***] purification.
1.6 "Sterilization" shall mean treatment of [***CONFIDENTIAL TREATMENT
REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***] with [***CONFIDENTIAL TREATMENT REQUESTED;
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***], and standardization to a specified concentration
range, resulting in a preparation that passes current USP sterility
method.
1.7 "Inactivation" shall mean treatment of the sterile [***CONFIDENTIAL
TREATMENT REQUESTED; PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION***] preparation
resulting in the loss of [***CONFIDENTIAL TREATMENT REQUESTED;
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***].
1.8 "Distribution" shall mean the shipment of manufactured
[***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION***], that have
been released by GalaGen, to a destination of GalaGen's choice.
1.9 "Validation" shall mean the program undertaken by CARE and GalaGen to
demonstrate that CARE's facility, equipment and procedures will
reliably and consistently result in acceptable Manufacture of
[***CONFIDENTIAL
2
TREATMENT REQUESTED; PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION***].
2. PERFORMANCE
2.1 CARE shall complete Validation before commencing with Sterilization
of [***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] and
subsequent steps in the Manufacture of [***CONFIDENTIAL TREATMENT
REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***].
2.2 For each Lot scheduled by GalaGen under this Agreement, CARE shall
complete the Manufacture of [***CONFIDENTIAL TREATMENT REQUESTED;
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] in accordance with the terms and conditions of this
Agreement. Each Lot shall be Manufactured in accordance with standard
operating procedures (SOPs); CARE is responsible for SOP development;
each SOP will be mutually agreed upon, in writing, by CARE and GalaGen
prior to the commencement of Manufacturing.
2.3 CARE shall provide, at its expense, all animals, supplies, reagents,
ingredients and other materials used in the Manufacture of
[***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***].
2.4 Propagation and Initial Purification will be conducted and the data
collected, reported and retained in a manner and form consistent with
applicable current Good Laboratory Practices. Subsequent steps in
the Manufacture of [***CONFIDENTIAL TREATMENT REQUESTED; PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] will be conducted and the data collected, reported and
retained in a manner and form consistent with applicable current Good
Manufacturing Practices.
2.5 CARE shall notify GalaGen, in writing, of any proposed change(s) to
SOPs prior to implementation of the change. Implementation of any
such change shall require the written consent of GalaGen.
2.6 After the Initial Purification and prior to Sterilization, CARE shall
collect a small quantity of [***CONFIDENTIAL TREATMENT REQUESTED;
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***], as specified by GalaGen, and provide this to GalaGen
for use as an assay reagent. After completing Sterilization and prior
to beginning Inactivation, CARE shall submit a sample, as specified by
GalaGen, from each container of [***CONFIDENTIAL TREATMENT REQUESTED;
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***], to GalaGen. GalaGen shall test each sample taken
after Sterilization for sterility, concentration, quantity and
identity according
3
to the following. CARE shall not proceed with Inactivation until
receiving notice from GalaGen that testing confirms sterility,
concentration, quantity and identification specifications.
2.6.1 Sterility - The sample shall be tested for sterility according
to current USP test methods and must pass. If the testing does
not confirm sterility, then CARE shall repeat Sterilization and
resubmit samples to GalaGen for testing. If required, repeat
Sterilization will be performed within five working days of
GalaGen's notification to CARE to repeat Sterilization.
2.6.2 Concentration of [***CONFIDENTIAL TREATMENT REQUESTED;
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***] shall be determined by direct count
(hemocytometer) and shall be [***CONFIDENTIAL TREATMENT
REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION***]/ml. If the testing does not
confirm this concentration, then CARE shall adjust the
[***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
concentration and resubmit samples to GalaGen for testing.
If required, concentration adjustment will be performed within
5 working days of GalaGen's notification to CARE to adjust
concentration.
2.6.3 Quantity shall be determined by multiplying the concentration
of [***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
determined in Section 2.6.2 by the total volume of
[***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
and dividing the result by the number of [***CONFIDENTIAL
TREATMENT REQUESTED; PORTION OMITTED FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION***] used for
Manufacturing of the Lot. The quantity of [***CONFIDENTIAL
TREATMENT REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***] shall be at least
[***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]
after Sterilization.
2.6.4 Identity of [***CONFIDENTIAL TREATMENT REQUESTED; PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] shall be determined by [***CONFIDENTIAL
TREATMENT REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***] and shall have the
following characteristics:
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2.6.4.1 [***CONFIDENTIAL TREATMENT REQUESTED;
PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***]
2.6.4.2 [***CONFIDENTIAL TREATMENT REQUESTED;
PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***]
2.6.4.3 [***CONFIDENTIAL TREATMENT REQUESTED;
PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***]
If testing fails to confirm [***CONFIDENTIAL TREATMENT
REQUESTED; PORTION OMITTED FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION***] identity,
GalaGen shall communicate to CARE final disposition of
the Lot.
GalaGen shall initiate testing of the sample(s) within 3 days of receipt.
GalaGen shall notify CARE of the results of testing within 21 days of test
initiation. If the testing confirms compliance with all specifications,
then CARE shall proceed with Inactivation and complete Inactivation within
10 working days of receiving notice to proceed. In the event of
reprocessing of [***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] according to
2.6.1 or 2.6.2, the resubmitted samples must meet all specifications before
proceeding to Inactivation.
2.7 CARE shall complete a quality review of each Lot that includes a
review of all Manufacturing documentation for accuracy, completeness
and consistency and to determine compliance with approved procedures
prior to submitting Lot documentation to GalaGen.
2.8 CARE shall submit documentation for each Lot to GalaGen within
10 working days of completing Inactivation. Documentation shall
include a batch record and copies of certain raw data as requested
by GalaGen.
2.9 There will be no guarantee by CARE of the quality and/or number of
[***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION***] submitted to GalaGen
from each Lot; provided, however, that only [***CONFIDENTIAL TREATMENT
REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***] that have been Propagated and undergone
Initial Purification, Sterilization and Inactivation according to
approved SOPs, have been confirmed as sterile and in compliance with
and meeting the specifications contained in Section 2.6 will be
accepted by GalaGen. GalaGen shall conduct a review of documentation
submitted by CARE after Inactivation and shall be responsible for
determining whether [***CONFIDENTIAL TREATMENT REQUESTED; PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] from a Lot meet such specifications and whether
documentation is acceptable. GalaGen shall notify CARE, in
writing within 30 days of receipt of documentation, if the Lot
5
passes or fails GalaGen's review. CARE will not perform Distribution
of a Lot until the Lot is released by GalaGen.
2.10 Between the Manufacture of Lots, CARE shall be responsible for
maintaining a minimum of two separate stock solutions of
[***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] according
to agreed upon procedures and shall use its best efforts to prevent
loss or destruction of such "seed stocks". GalaGen shall be notified
immediately, in writing, if there is any actual or suspected loss,
contamination, destruction, etc. of such stocks between Manufacture
of Lots.
3. VALIDATION
3.1 GalaGen and CARE shall be jointly responsible for developing a
Validation Master Plan (the "Plan") that identifies what is to be
validated and the acceptance criteria for each validation to be
executed.
3.2 The Plan shall be executed by GalaGen and CARE personnel as identified
in the Plan.
3.3 GalaGen shall be responsible for supplying analytical testing used in
execution of the Plan and selecting and reimbursing any consultants
retained for Validation.
3.4 CARE shall be responsible for providing the facility, personnel and
equipment, at its expense, in the execution of the Plan; however
GalaGen shall reimburse CARE for personnel time in the execution of
the Plan. Such time shall be documented by CARE and submitted to
GalaGen. GalaGen shall reimburse CARE at the rate of $60/hour in 1996
and $63/hr in 1997. Compensation for Validation or re-Validation
required in later years shall be negotiated as needed.
3.5 Once the Manufacture has been Validated according to the Plan any
subsequent validation required pursuant to Section 2.5, made at the
request of CARE, shall be executed and paid for by CARE. If changes
are made not at the request of CARE then GalaGen shall compensate CARE
for personnel time expended to implement the change in accordance with
Section 3.4.
4. REPRESENTATIONS AND WARRANTIES
4.1 CARE warrants and represents to GalaGen that it has the capability to
perform the Manufacture in an expert and professional manner.
4.2 CARE warrants and represents to GalaGen that Manufacturing will be
performed in accordance with the specifications and instructions
provided by GalaGen.
4.3 CARE warrants and represents to GalaGen that it has no obligations,
contractual or otherwise, that would conflict with its entering into
this Agreement.
6
4.4 CARE warrants and represents to GalaGen that all Manufacturing shall
be performed in accordance with applicable current Good Laboratory
Practices or current Good Manufacturing practices according to
Section 2.4.
4.5 CARE warrants and represents to GalaGen that it will comply with all
laws, ordinances, rules, regulations and actions of the United States
and of any state, county, township or municipal subdivision or other
governmental agency which may now or hereafter be applicable to this
Agreement, and that it has obtained and will maintain in effect all
permits, licenses and other documentation now or hereafter necessary
in order to comply with such governmental laws, ordinances, orders,
rules, regulations and actions, and that it shall furnish copies of
same to GalaGen upon request.
5. EXCLUSIVITY
5.1 During the term of this Agreement, CARE will not Manufacture
[***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] for
purposes of provision of retrieved [***CONFIDENTIAL TREATMENT
REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION***] to any other individual or entity
except GalaGen.
5.2 CARE has the right, as this is the usual type of business in which
they are engaged, to perform research projects, unrelated to GalaGen,
in which pharmaceutical or biological products are tested for efficacy
against [***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] in
[***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***]. CARE
will not conduct other testing in [***CONFIDENTIAL TREATMENT
REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***] used for Manufacturing of GalaGen's Lots
during the period in which a Lot is being Manufactured.
6. SCHEDULING
6.1 Lots will be Manufactured at least approximately every three
(3) months and at most twice per month.
6.2 Both parties recognize that [***CONFIDENTIAL TREATMENT REQUESTED;
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] viability must be maintained via in vivo Propagation
minimally every three (3) months, thus scheduling will accommodate
said requirement. Each Lot will be Manufactured using a minimum of
two (2) [***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] and a
maximum of sixteen (16) [***CONFIDENTIAL
7
TREATMENT REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***].
If GalaGen places an order, in writing, for a Lot at least six
(6) months prior to the desired completion of Manufacturing then
CARE shall guarantee the availiability of facilities for the
Manufacture of that Lot. Shorter advance notice will be accommodated
by CARE if possible dependent upon prior commitments, but in any
case CARE will complete Manufacturing of an order for any Lot no
later than six (6) months from the time the order is received by
CARE.
7. COMPENSATION
7.1 Compensation to CARE for Manufacturing of a Lot will be dependent
upon the number of [***CONFIDENTIAL TREATMENT REQUESTED; PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] included in the Lot as follows:
COMPENSATION PER [***
CONFIDENTIAL TREATMENT
REQUESTED; PORTION OMITTED
FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE
COMMISSION***]
1996 1997 1998
Two (2) [***CONFIDENTIAL TREATMENT REQUESTED; [***CONFIDENTIAL
PORTION OMITTED FILED SEPARATELY WITH THE TREATMENT REQUESTED;
SECURITIES AND EXCHANGE COMMISSION***] Lot: PORTION OMITTED FILED
SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION***]
Three to four (3-4) [***CONFIDENTIAL TREATMENT [***CONFIDENTIAL
REQUESTED; PORTION OMITTED FILED SEPARATELY TREATMENT REQUESTED;
WITH THE SECURITIES AND EXCHANGE PORTION OMITTED FILED
COMMISSION***] Lot: SEPARATELY WITH THE
SECURITIES AND EXCHANGE
COMMISSION***]
Five to seven (5-7) [***CONFIDENTIAL TREATMENT [***CONFIDENTIAL
REQUESTED; PORTION OMITTED FILED SEPARATELY TREATMENT REQUESTED;
WITH THE SECURITIES AND EXCHANGE PORTION OMITTED FILED
COMMISSION***] Lot: SEPARATELY WITH THE
SECURITIES AND EXCHANGE
COMMISSION***]
8
eight to ten (8-10) [***CONFIDENTIAL TREATMENT [***CONFIDENTIAL
REQUESTED; PORTION OMITTED FILED SEPARATELY TREATMENT REQUESTED;
WITH THE SECURITIES AND EXCHANGE PORTION OMITTED FILED
COMMISSION***] Lot: SEPARATELY WITH THE
SECURITIES AND EXCHANGE
COMMISSION***]
eleven to sixteen (11-16) [***CONFIDENTIAL [***CONFIDENTIAL
TREATMENT REQUESTED; PORTION OMITTED FILED TREATMENT REQUESTED;
SEPARATELY WITH THE SECURITIES AND EXCHANGE PORTION OMITTED FILED
COMMISSION***] Lot: SEPARATELY WITH THE
SECURITIES AND EXCHANGE
COMMISSION***]
In addition to the per [***CONFIDENTIAL TREATMENT REQUESTED;
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***] cost, compensation shall include the following
per Lot for Sterilization, Inactivation and Distribution.
COMPENSATION PER LOT
1996 1997 1998
Two to four (2-4) [***CONFIDENTIAL TREATMENT NA [***CONFIDENTIAL
REQUESTED; PORTION OMITTED FILED SEPARATELY TREATMENT REQUESTED;
WITH THE SECURITIES AND EXCHANGE PORTION OMITTED
COMMISSION***] Lot: FILED SEPARATELY
WITH THE
SECURITIES AND
EXCHANGE
COMMISSION**]
Five to seven (5-7) [***CONFIDENTIAL TREATMENT NA [***CONFIDENTIAL
REQUESTED; PORTION OMITTED FILED SEPARATELY TREATMENT
WITH THE SECURITIES AND EXCHANGE REQUESTED; PORTION
COMMISSION***] Lot: OMITTED FILED
SEPARATELY WITH THE
9
SECURITIES AND
EXCHANGE
COMMISSION***]
Eight to ten (8-10) [***CONFIDENTIAL TREATMENT NA [***CONFIDENTIAL
REQUESTED; PORTION OMITTED FILED SEPARATELYC TREATMENT
WITH THE SECURITIES AND EXCHANGE REQUESTED; PORTION
COMMISSION***] Lot: OMITTED FILED
SEPARATELY WITH THE
SECURITIES AND
EXCHANGE
COMMISSION***]
Eleven to thirteen (11-13) [***CONFIDENTIAL NA [***CONFIDENTIAL
TREATMENT REQUESTED; PORTION OMITTED FILED TREATMENT
SEPARATELY WITH THE SECURITIES AND EXCHANGE REQUESTED; PORTION
COMMISSION***] Lot OMITTED FILED
SEPARATELY WITH THE
SECURITIES AND
EXCHANGE
COMMISSION***]
Fourteen to sixteen (14-16) [***CONFIDENTIAL NA [***CONFIDENTIAL
TREATMENT REQUESTED; PORTION OMITTED FILED TREATMENT
SEPARATELY WITH THE SECURITIES AND EXCHANGE REQUESTED; PORTION
COMMISSION***] Lot: OMITTED FILED
SEPARATELY WITH THE
SECURITIES AND
EXCHANGE
COMMISSION***]
If more than one shipment of each Lot is required for Distribution
then GalaGen shall pay for the additional shipping costs.
7.2 Payments shall be made to CARE by GalaGen according to the following
schedule per Lot:
- 40 % of total Lot compensation prior to [***CONFIDENTIAL
TREATMENT REQUESTED; PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION***] procurement
- 30 % of total Lot compensation within 30 days of submitting
sample from Sterilization step provided sterility,
concentration, quantity and identification specifications as
set forth in Section 2 have been met.
10
- 30 % of total Lot compensation within 30 days of receiving Lot
documentation from CARE provided that documentation is found
acceptable by GalaGen.
8. OWNERSHIP
8.1 CARE shall retain title to and shall be responsible for all
calibration, certification and maintenance for any equipment used in
the execution of this Agreement. Equipment purchased with funds
provided by GalaGen shall be maintained and certified at CARE's
expense. Use of equipment purchased with funds provided by GalaGen
shall be prioritized to performance of this Agreement. All rights
to procedures provided by GalaGen and the content and results of the
Plan shall be owned exclusively by GalaGen and shall be considered
its confidential, proprietary information.
8.2 Ownership of all Lots, whether or not possessed by CARE, shall vest
in GalaGen.
9. CONFIDENTIALITY
9.1 CARE agrees to maintain confidentiality of GalaGen's proprietary
information disclosed by GalaGen in writing or verbally to CARE.
After termination of this Agreement, CARE shall not use or disclose
such information, including procedures supplied by GalaGen or the
Plan.
9.2 CARE shall have no obligation of confidentiality with respect to
information disclosed to CARE by GalaGen if:
- such information is, at the time of disclosure by GalaGen, in
the public domain or such information thereafter becomes a part
of the public domain without a breach of this Agreement by
CARE; or
- such information is known to CARE at the time GalaGen discloses
it; or
- such information is independently developed by CARE personnel
who have not had access to the information; or
- such information is received by CARE from a third party who had
a lawful right to disclose such information; or
- such information is disclosed with the written approval of
GalaGen; or
- such information is obligated to be produced by CARE under
court order. In such event, CARE shall promptly notify GalaGen
so that GalaGen may file its own timely objections to said
court order.
9.3 If required by law, CARE may disclose proprietary Information received
hereunder to the United States Government provided that such
Information is requested to be treated as confidential in accordance
with appropriate federal regulations.
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10. RECALLS, INVESTIGATIONS AND CORRECTIVE ACTION
10.1 Without limiting the generality of the warranties made in Section 4,
CARE warrants that it shall observe at all times the laws and
regulations in the United States in order to maintain an effective
system for the recall from the market of GalaGen products
containing [***CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***].
10.2 In the event of a recall CARE shall cooperate with GalaGen in
identifying and locating any Lots included in the recall.
10.3 CARE will assist GalaGen, as necessary, in any investigations and/or
corrective actions as a result of any complaint or adverse experience
report including, but not limited to, evaluation and modification of
procedures used in the performance of Manufacturing. In the event
that a modification of procedures is implemented the Parties shall
mutually agree to a modification of compensation, if any.
11. TERM
This Agreement shall become effective upon the date first herein above
written and shall be effective for a period of five years unless extended
by mutual written consent of the parties hereto or terminated pursuant to
the terms of this Agreement.
12. TERMINATION
12.1 This Agreement may be terminated by GalaGen at any time with or
without cause by providing ninety (90) days prior written notice
of termination to CARE.
12.2 If this Agreement is terminated and CARE is not in default in its
performance of its obligations under this Agreement, then CARE shall
be entitled to receive full payment for all work performed under
this Agreement through the date of termination.
12.3 Any party hereto may terminate this Agreement upon a material breach
of this Agreement by such other party if such other party has failed
to cure or demonstrate the nonexistence of such breach within sixty
(60) days of receipt of a written notice describing the breach with
reasonable specificity and demanding cure of such breach.
12.4 Any party hereto may terminate this Agreement, effective immediately,
by written notice to the other party (i) if the other party shall
file in any court or agency pursuant to any statute or regulation
of the United States or any state a petition in bankruptcy or
insolvency or for reorganization or for an arrangement or for the
appointment of a receiver or trustee of such party or its assets,
or if the other party shall make an assignment for the benefit of
creditors, or (ii) if the other party is unable to perform its
obligations hereunder due to conditions within the scope of Section 17
(Force Majeure) and such inability continues for more than ninety
(90) days.
12
12.5 Upon expiration or early termination of this Agreement for any reason,
(i) neither party shall be relieved of any obligation which accrued
prior to the effective date of such expiration or early termination;
(ii) each party shall return to the other party any and all
confidential information originally disclosed by the other party,
and (ii) in the case of early termination, each party shall retain any
and all rights or remedies such party may have in law or in equity,
provided that neither party may claim compensation for lost
opportunity or consequential damages arising out of the fact of such
early termination.
12.6 Sections 9 and 14 shall survive the termination of this Agreement.
13. INDEPENDENT CONTRACTOR
13.1 CARE shall be deemed to be and shall be an independent contractor
with respect to GalaGen, and as such, shall not be entitled to any
benefits applicable to employees of GalaGen.
13.2 No party is empowered to act as an agent for the other for any
purpose and shall not on behalf of the other enter into any
contract, warranty, or representation as to any matter.
13.3 No party shall be bound by the acts or conduct of the other.
14. INDEMNIFICATION
14.1 GalaGen shall defend, indemnify, and hold CARE harmless from and
against all claims, demands, loss, liability, expenses (including
reasonable litigation expenses) or damage GalaGen and/or CARE may
incur arising from GalaGen's use of the [***CONFIDENTIAL TREATMENT
REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION***] manufactured under this Agreement.
14.2 CARE shall defend, indemnify, and hold GalaGen harmless from and
against all claims, demands, loss, liability, expenses (including
reasonable litigation expenses) or damage CARE and/or GalaGen may
incur arising from CARE's Manufacture.
15. AUDITS AND INSPECTIONS
15.1 GalaGen reserves the right to conduct audits of CARE's operations
applicable to the execution of this Agreement. Without limitation,
upon reasonable notice GalaGen may periodically visit CARE's
facilities and review CARE's manufacturing and quality control
procedures and records to ensure conformance with contractor's
obligations under this Agreement. GalaGen reserves the right
to have its representative present during all CARE's manufacturing
operations applicable to this Agreement. CARE agrees to cooperate
with GalaGen in the performance of any such audits and visits.
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15.2 In the event regulatory agencies conduct facility or product
inspections or audits which include a review of CARE's records
related to performance of this Agreement, CARE agrees to immediately
notify GalaGen of the arrival of such regulatory personnel so as to
enable GalaGen the opportunity to be present on the premises in such
inspections or audits. CARE agrees to notify GalaGen before any
release of CARE's records related to performance of this Agreement
to regulatory agencies. CARE agrees to provide GalaGen copies of
(a) portions of any inspection or audit reports provided by
regulatory agencies relevant to performance of this Agreement, and
(b) any responses by CARE to any such regulatory agency regarding
such an inspection or audit and relating to performance of this
Agreement.
16. GOVERNING LAW
This Agreement shall be governed and construed in accordance with
the laws of the State of Minnesota.
17. FORCE MAJEURE
Neither party to this Agreement shall be liable for delay or failure
in the performance of any of its obligations hereunder if such delay
or failure is due to causes beyond its reasonable control,
including, without limitation, acts of God, fires, earthquakes,
strikes and labor disputes, acts of war, civil unrest or
intervention of any governmental authority, and inability to obtain
raw materials, but any such delay or failure shall be remedied by
such party as soon as is reasonably possible.
18. ASSIGNMENT
This Agreement shall not be assigned by either party without the
prior written consent of the parties hereto except that GalaGen
may assign this Agreement to a successor of its entire interest.
19. ENTIRE AGREEMENT
This Agreement is the entire and complete understanding between the
parties in regard to the covered subject matter.
20. MODIFICATION
Any agreement to change the terms of this Agreement in any way shall
be valid only if the change is made in a written document, signed by
authorized representatives of both parties.
21. NOTICES
Notices and special communications hereunder shall be deemed made if
given by registered or certified envelope, postage prepaid, and
addressed to the party to receive such notice or communication at
the address given below, or such other address as may be hereafter
be designated by notice in writing:
If to GalaGen: If to CARE:
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Xxxxxxx X. Xxxx Xxxxx X. Xxxxxxxxx, Ph.D.
Vice President, Manufacturing President and General Manager
GalaGen Inc. Colorado Animal Research Enterprises, Inc.
0000 Xxxxxxxxx Xxxxxx North 0000 Xxxx Xxxxxx Xxxx 00
Xxxxx Xxxxx, XX 00000-0000 Xxxx Xxxxxxx, XX 00000
IN WITNESS WHEREOF, the parties have caused these presents to be executed in
duplicate as of the day and year first above written.
GALAGEN INC. COLORADO ANIMAL RESEARCH
ENTERPRISES, INC.
By: /s/ Xxxxxxx X. Xxxx By: /s/ Xxxxx X. Xxxxxxxxx
Name: Xxxxxxx X. Xxxx, Name: Xxxxx X. Xxxxxxxxx, Ph.D.,
Vice President President
Date: November 1, 1996 Date: November 11, 1996
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