Exhibit 10.37
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY AN
ASTERISK, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
AGREEMENT FOR SERVICES
This AGREEMENT is made this 14 day of March, 2002 by and between Avid
Bioservices, Inc., a Delaware corporation (hereinafter referred to as "AVID"),
having its principal office at 00000 Xxxxxxxx Xxxxxx, Xxxxx 000, Xxxxxx,
Xxxxxxxxxx 00000, and INHIBITEX, INC., a Delaware corporation (hereinafter
referred to as "Inhibitex"), having its principal office at 0000 Xxxxxxxx
Xxxxxxx, Xxxxx 000, Xxxxxxxxxx, Xxxxxxx 00000.
1. DEFINITIONS
In this Agreement:
(a) "Act" means The Federal Food, Drug, and Cosmetic Act of the United
States of America as the same may be amended from time to time.
(b) "Affiliate" means, with respect to either Party, any corporation or
other business entity controlled by, controlling, or under common control with,
such Party. For this purpose, "control" shall mean direct or indirect beneficial
ownership of at least fifty percent (50%) of the voting stock or income interest
in such corporation or other business entity, or such other relationship as, in
fact, constitutes actual control.
(c) "Agreement" means this agreement together with the Proposal for
Development as the same may be amended as provided herein from time to time.
(d) "Avid Invention" means an Invention made solely by employees of
Avid.
(e) "AVID Property" means any tangible or intangible property owned or
possessed by AVID as of the date hereof or later made, acquired or developed by
AVID during the term of this Agreement, including but not limited to its
Confidential Information.
(f) "AVID SOPs" means AVID's Standard Operating Procedures.
(g) "Batch Production Record" means the detailed process steps for the
production of the Product, including quality control testing as agreed by AVID
and Inhibitex.
(h) "Cell Line" means a genetically engineered mammalian cell line
created by Inhibitex for the expression of a specific monoclonal antibody.
(i) "cGMP" means current Good Manufacturing Practices as established by
the FDA as the same may be amended from time to time.
(j) "Confidential Information" with respect to any Party means
know-how, technology, data (including, without limitation, Project Data),
inventions, expertise, trade secrets or information either proprietary to that
Party as of the date hereof or later made, learned, acquired, conceived or
developed by or on behalf of that Party during the term of this Agreement
(including any Inventions, applications for licensing, patenting or copyrighting
any of the foregoing), which is disclosed to the other party and identified in
writing or verbally as Confidential Information of the disclosing party. Any
information transmitted in unwritten form
and identified at the time as being confidential shall be considered as
Confidential Information if it is summarized in written form, clearly identified
in writing, marked "Confidential" (or with a similar designation), and
transmitted to the receiving party within thirty (30) days after the initial
disclosure.
Confidential Information shall not include any information
which (a) at the time of disclosure or thereafter is available or known to the
public other than as a result of a disclosure by the receiving party in
violation of this Agreement, (b) was known to the receiving party prior to
disclosure by the disclosing Party, as evidenced by written records, (c) is, at
any time, disclosed to the receiving Party by any third party having the right
to disclose same, or (d) is developed by the receiving Party independent of any
Confidential Information disclosed by the disclosing Party pursuant to this
Agreement, as evidenced by written records.
(k) "FDA" means the United States Food and Drug Administration.
(l) "Inhibitex Invention" means an Invention made solely by employees
of Inhibitex.
(m) "Inhibitex Property" means any tangible or intangible property
owned or possessed by Inhibitex as of the date hereof or later made, acquired or
developed by Inhibitex during the term of this Agreement, including, but not
limited to, its Confidential Information, Project Data, cell banks, cell lines,
raw materials, in-process and finished Product, retention samples, batch
records, and dedicated capital equipment and supplies purchased by Inhibitex or
by AVID on behalf of Inhibitex.
(n) "Invention" means any invention, improvement, or discovery, whether
patentable or not, which is made by either Party in executing the Project.
(o) "Joint Invention" means an Invention made jointly by one or more
employees of Inhibitex and one or more employees of AVID.
(p) "Party" means individually AVID or Inhibitex and "Parties" means
AVID and Inhibitex together.
(q) "Product" means Staphylococcus aureus monoclonal antibodies
generated from the Cell Line by AVID in the course of the Project in accordance
with the parameters and procedures set forth in the Proposal for Development.
(r) "Project" shall have the meaning set forth in the Proposal for
Development.
(s) "Project Authorization" means an addendum to the Proposal for
Development listing specific Project objectives, deliverables, milestones,
estimated costs and payment terms, schedules and any special
conditions/requirements that might apply to such Project.
(t) "Project Data" means documentation, records, raw data, specimens,
and other work product generated during execution of the Project and relating to
the process development, manufacture or testing of the Product.
(u) "Proposal for Development" means the Proposal for Development,
which may consist of one or more Project Authorizations, attached hereto as
Exhibit A as the same may be
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amended from time to time and which shall constitute an integral part of this
Agreement and is incorporated herein by reference.
2. THE PROJECT
(a) Engagement of AVID. Inhibitex hereby engages AVID, and AVID hereby
agrees, to process, develop, produce and test the Product on behalf of Inhibitex
in accordance with the terms and subject to the conditions set forth herein.
(b) Conduct of the Project. AVID's responsibilities hereunder with
respect to the Product shall consist of the performance of the services
specified in the Proposal for Development. AVID agrees to use its best efforts
to perform its obligations with respect to the Project in accordance with the
scope and within the estimated schedule and budget set forth in the Proposal for
Development. If AVID anticipates that it will be unable to complete or perform
any of its obligations under this Agreement for seven or more days after the
date scheduled for the performance of such obligation or will exceed any amount
budgeted for the Project by 10% or more, AVID will submit a revised Project
Authorization to Inhibitex for its approval prior to continuing work on the
Project. The Parties acknowledge that, as the Project progresses, the Parties
may wish to optimize, augment, delete, or otherwise amend parameters and
procedures currently set forth in the Proposal for Development. Such amendments
shall be effective only if adopted in the manner set forth in Section 12(e) of
this Agreement or by the Parties signing a revised "Project Authorization". Each
Party hereby agrees not to unreasonably withhold its consent to any proposed
amendment which does not have the effect of materially increasing the costs
incurred in connection with the Project and to negotiate in good faith any
amendment which would have such an effect.
(c) Compensation. In consideration of the performance of AVID's
obligations with respect to the Project, Inhibitex shall pay AVID in accordance
with the terms set forth in the Proposal for Development.
(d) Project Managers. AVID and Inhibitex will each assign a dedicated
Project Manager to the Project as set forth in the Proposal for Development.
AVID's Project Manager will be responsible for the overall timeliness and
integrity of the Project and will communicate with, and provide a written status
report to, Inhibitex's Project Manager, or his designee, on at least a bi-weekly
basis, or more frequently if necessary, on all matters pertinent to the Project.
Additional AVID personnel responsible for different components of the Project
shall be identified in the Proposal for Development. Any dispute regarding
AVID's performance with respect to the Project shall be resolved jointly by each
Party's head of quality control and, failing the resolution of any dispute by
such parties, by the Chief Executive Officer of each Party.
(e) Waiver of In-Process Quality Control Holds. Project scheduling
includes certain FDA "Points to Consider" (PTC) and in-process tests and assays.
Project-specific PTC and in-process tests and assays will be detailed in the
Proposal for Development. In general, PTC and in-process tests and assays
required in "quality control (QC) holds" and the Project do not progress to
subsequent scheduled events until the results of said PTC and in-process tests
and assays are completed, documented and audited by the appropriate QC group. In
the event that Inhibitex wishes to expedite the Project by eliminating said QC
holds and proceeding to subsequent Project events without PTC and/or assay
results, AVID's liability for the Project shall
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be limited to the point where said PTC or in-process tests or assays were waived
by Inhibitex. Any such waiver must be mutually agreed upon by the Parties and
documented in writing. The Parties agree hereby that Inhibitex bears the entire
liability for waiver of QC holds.
(f) Custody of Inhibitex Property. All Inhibitex Property shall be the
sole and exclusive property of Inhibitex. In connection with this Agreement, the
Parties agree that AVID will have custody over certain tangible Inhibitex
Property. It is understood that such Inhibitex Property is held in trust by AVID
for Inhibitex, that all such materials will be clearly labeled by AVID, unless
so labeled by Inhibitex prior to delivery, as belonging to Inhibitex, and that
AVID shall bear the risk of loss for any Inhibitex Property during the time that
such property is in the possession of AVID. Risk of loss for the Inhibitex
Property shall pass to Inhibitex upon delivery of such property to a carrier on
behalf of Inhibitex or Inhibitex's designee. Title to tangible Inhibitex
Property shall at all times remain in Inhibitex or its assigns and AVID shall
not pledge to any party a security or other interest in the Inhibitex Property,
nor shall AVID allow the Inhibitex Property to be otherwise encumbered. If
necessary, AVID will retain and store Inhibitex Property after the Project is
completed for no longer than three months from completion of the Project for
equipment, materials and cell banks, and twelve (12) months for retained samples
at no cost. AVID shall maintain required retention samples on hand at no cost to
Inhibitex in accordance with the rules and regulations of the FDA. All Property
shipped from AVID to Inhibitex shall be shipped at the sole cost and expense of
Inhibitex and Inhibitex shall inform AVID in advance of the dollar value of any
insurance to be added to the shipment. Thereafter, Inhibitex may request
contracted storage arrangements at Inhibitex's sole cost and expense. Except as
is specifically permitted under Section 7, AVID shall not use any Inhibitex
Property for any purpose other than performing its obligations under this
Agreement.
(g) AVID Property. All AVID Property shall be the sole and exclusive
property of AVID.
3. REPRESENTATIONS AND WARRANTIES
(a) AVID Representations and Warranties. AVID represents and warrants:
(i) that it has the full power, right and authority to execute, deliver and
perform this Agreement;(ii) that it will assign to the Project professional
personnel, qualified to perform the process procedures consistent with the
technical requirements of the Project; (iii) that none of the AVID personnel to
be assigned to the Project have or shall have been subject to debarment under
the Generic Drug Enforcement Act or any other penalty or sanction by the FDA
(iv) that it will conduct the Project in conformity with AVID SOPs, cGMP, all
applicable FDA regulatory requirements and the procedures and parameters set
forth in the Proposal for Development and generally accepted professional
standards (except as otherwise specifically provided in any Project
Authorization as mutually agreed to by the Parties); (v) that the Project Data
will be prepared in accordance with AVID SOPs, cGMP, all applicable FDA
regulatory requirements and the procedures and parameters set forth in the
Proposal for Development and in the AVID Batch Production Records or reports;
(vi) that, upon delivery of Product to a carrier on behalf of Inhibitex or
Inhibitex's designee and during such time as Product is under AVID's control,
Product will be in conformity with the Act and shall not be adulterated or
misbranded or otherwise of a nature which may not be introduced into United
States interstate commerce, or misused, contaminated, tampered with or otherwise
altered, mishandled, or subjected to negligence; and (vii) that AVID's
performance of its obligations under this Agreement will not, to its knowledge,
violate or infringe on the
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patents, trademarks, trade names, service marks, copyrights or any other
intellectual property rights of any other party.
Due to the developmental characteristics of the Product, the nature of
the manufacture of biological products, and the fact that AVID neither owns nor
developed the Cell Line, AVID makes no representations or warranties with
regards to characterization, potency and/or expression levels set forth in the
Proposal for Development.
(b) Inhibitex Representations and Warranties. Inhibitex represents and
warrants (i) that it has the full power, right and authority to execute and
deliver this Agreement; (ii) that it has legal title and/or a valid license to
the cell banks, cell lines, raw materials, data and any other Inhibitex
Property, and that it has the right to transfer and/or provide such property to
AVID in connection with this Agreement and (iii) that AVID's use of such
Inhibitex Property will not, to the knowledge of Inhibitex, violate or infringe
on the patents, trademarks, trade names, service marks, copyrights or any other
intellectual property rights of any other party.
4. IND; BLA
(a) AVID will provide Inhibitex the batch production records for all
clinical batches manufactured by AVID for Inhibitex. AVID shall provide to the
FDA any other information requested by the FDA and otherwise cooperate as
reasonably requested by Inhibitex, at Inhibitex's sole cost and expense, in
support of Inhibitex's Investigational New Drug Application ("IND") and
Biologics License Application ("BLA") related to the Product, both of which
shall be filed by Inhibitex at its sole cost and expense. Any IND or BLA related
to the Product shall be the sole and exclusive property of Inhibitex.
(b) If requested by Inhibitex, AVID will file any required amendments
to the BLA to allow manufacturing of the Product in its facility; provided,
however, that (i) if any such amendment is required solely in order to allow
manufacturing of the Product in the AVID facility, then Inhibitex shall
reimburse AVID for all costs and expenses incurred in connection with such
amendment and (ii) in all other cases, such costs and expenses shall be divided
evenly between AVID, Inhibitex and each other customer of AVID that would
benefit from such amendment; provided, however, that Inhibitex shall not
reimburse AVID for more than 20% of such costs and expenses.
5. RIGHT OF ACCESS
AVID agrees that all Project Data, equipment, and facilities relating
to the Project shall be made available upon Inhibitex's request with seven days
advance written notice for inspection by Inhibitex, its representatives,
including authorized third party consultants, or the FDA, at any time during,
and for up to six months after completion of, the Project, as long as (i) the
Product is in use or under IND, providing Inhibitex notifies AVID on a yearly
basis that the Product is still in trials and (ii) such inspection does not
compromise normal GMP operations as reasonably determined by AVID's Quality
Systems Department. Inhibitex or its authorized representative shall be allowed
to perform an audit or review of any AVID facility related to the Project up to
three days per GMP run at no charge to Inhibitex. Additional days will be
charged on an hourly basis at $[ *** ] per hour for each member of AVID's
personnel participating or otherwise assigned to such audit. AVID will, within
24 hours of notification to AVID, inform Inhibitex in
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the event of any FDA or other regulatory inspection, notice or communication
relating to the Project and will immediately notify Inhibitex of any adverse
event relating to the Project or any change in either (i) AVID's SOPs that
pertain directly to the manufacturing process performed under the Project or
(ii) AVID's manufacturing process pertaining to the Project.
6. SUBCONTRACTORS
AVID shall not assign, subcontract, or delegate any of its
responsibilities under this Agreement without prior written consent of
Inhibitex. Inhibitex shall have the right to audit and inspect, at Inhibitex's
sole cost and expense, all subcontractors, including all vendors and testing
contractors, subject to the approval by such vendors and testing contractors,
with whom AVID may enter into agreements in the performance of its obligations
with respect to the Project. AVID shall coordinate the vendor audits for
Inhibitex and shall have the right to accompany Inhibitex personnel on such
audits. Inhibitex shall provide to AVID, in writing, a list of approved vendors
for raw materials and testing contractors. All vendors and subcontractors not on
such list, and any change in vendors or subcontractors, shall be subject to the
approval of Inhibitex. AVID will use its best efforts to ensure that all
agreements with vendors and subcontractors include provisions to maintain the
confidentiality of Confidential Information and provide Inhibitex rights with
respect to such vendors and subcontractors substantially similar to the rights
with respect to AVID granted to Inhibitex under Section 5.
7. INTELLECTUAL PROPERTY
(a) Ownership of Inventions. Ownership of Inventions shall be
determined by inventorship, which shall in turn be determined in accordance with
U.S. patent law. The entire right and title in all Inhibitex Inventions, and any
patent applications or patents based thereon, shall be owned solely by
Inhibitex. The entire right and title in all AVID Inventions, and any patent
applications or patents based thereon, shall be owned solely by AVID. The entire
right and title in all Joint Inventions, and any patent applications or patents
based thereon, shall be owned jointly by Inhibitex and AVID.
(b) Disclosure of Inventions. Each party promptly shall disclose to the
other party the making, conception or reduction to practice of Inventions by
employees or others acting on behalf of such party in the performance of its
obligations under this Agreement. Inhibitex and AVID each represent that all
employees and others acting on its behalf in performing its obligations under
this Agreement shall be obligated under a binding written agreement to assign to
it, or as it shall direct, all Inventions made or developed by such employees or
others.
(c) Inhibitex License. For Inhibitex Inventions (including any
unpatented Inventions or Project Data), Inhibitex hereby grants to AVID, solely
for the field of contract manufacture of monoclonal antibodies (other than
antibodies against cell surface adhesions) for third parties, a royalty free,
non-exclusive, transferable, worldwide, paid up license, with the right to
assign and sublicense; provided, however that each transferee, assignee or
sublicensee shall be obligated in writing to maintain the confidentiality of any
Inhibitex Confidential Information provided to it by AVID, on terms at least as
restrictive as those required of AVID hereunder; and further provided that any
sublicensee of AVID shall not be granted the right to grant sublicenses.
Inhibitex shall have the right but no obligation to file and prosecute patent
applications at its own expense for Inhibitex Inventions.
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(d) Avid License. For AVID Inventions (including any unpatented
Inventions and Project Data), AVID hereby grants to Inhibitex, solely for the
field of use required for Inhibitex to develop and commercialize its products
using antibodies against cell surface adhesions, a royalty free, non-exclusive,
transferable, worldwide, paid up license, with the right to assign and
sublicense; provided, however that each transferee, assignee or sublicensee
shall be obligated in writing to maintain the confidentiality of any Avid
Confidential Information provided to it by Inhibitex ,on terms at least as
restrictive as those required of Inhibitex hereunder; and further provided that
any sublicensee of Inhibitex shall not be granted the right to grant
sublicenses. AVID shall have the right but no obligation to file and prosecute
patent applications at its own expense for AVID Inventions.
(e) Joint Inventions. The Parties agree to cooperate in determining
whether patent protection is desirable for any given Joint Invention, and if it
is agreed that a patent application should be filed, the Parties shall cooperate
and share the expenses incurred in the filing and prosecution of any patent
application relating to a Joint Invention. If any Party elects not to file and
prosecute a patent application relating to a Joint Invention, such Party shall
immediately notify the other Party in writing within a reasonable period of time
of such decision and the other Party shall have the right but no obligation to
file and prosecute the patent application, at its sole expense, for such Joint
Invention. The non-filing Party will have not input into the prosecution of the
patent application for such Joint Invention(s), except as required to assist the
filing Party with the prosecution of the patent application(s). The ownership
rights of a non-filing Party with respect to a Joint Invention and the right to
practice same shall not be affected by such Party's election to not file and
prosecute a patent application therefor.
Notwithstanding the foregoing, (i) Inhibitex shall have the
exclusive, worldwide, fully paid, royalty free right to practice Joint
Inventions to make and have made those of its produces that use antibodies
against cell surface adhesins (the "Inhibitex Field") and (ii) AVID shall have
the exclusive, worldwide, fully paid, royalty free right to practice Joint
Inventions to make and have made monoclonal antibodies (other than antibodies
against cell surface adhesion) (the "AVID Field"). Inhibitex agrees that it
shall not license, exclusively or non-exclusivity, or assign or transfer, any of
its rights in the Inhibitex Field with respect to any Joint Invention to any
third party, (a) except that Inhibitex may assign or license such rights only as
necessary to have manufactured its products that use antibodies against cell
surface adhesins and (b) except in the context of an assignment of this
Agreement.
(f) Project Data. Upon either the request of Inhibitex or completion of
the Project, AVID shall send to Inhibitex copies of all Project Data. The
Project Data shall be prepared, documented and communicated in a manner
consistent with the specifications described in the Proposal for Development.
(g) No Implied Right or License. Nothing contained in this Agreement
shall be implied to grant AVID any implied right or license with respect to any
Inhibitex Property, Project Data, Inhibitex Invention or any other Confidential
Information of Inhibitex disclosed to AVID by Inhibitex or conceived or
developed in executing the Project, other than as specifically provided herein.
Nothing contained in this Agreement shall be implied as granting to Inhibitex
any implied right or license with respect to any AVID Property, Project Data,
AVID Invention or other Confidential Information of AVID disclosed to Inhibitex
by AVID or conceived or developed in executing the Project, other than as
specifically provided herein.
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8. CONFIDENTIALITY
(a) Confidential Information: Each Party agrees that the other has and
shall retain sole and exclusive rights of ownership in all Confidential
Information of such other Party, including without limitation, inventions
(including Inventions), information, knowledge or trade secrets whether or not
such Party discloses such information to the other during the course of the
Project and whether or not relevant to the Project. Each Party agrees that it
will not use any Confidential Information received from the other Party except
for the purposes of this Agreement and as otherwise set forth herein. Except as
specifically authorized herein, each Party agrees not to disclose any
Confidential Information to any third parties, and to maintain and follow
reasonable procedures to prevent unauthorized disclosure or use of the
Confidential Information and to prevent it from becoming disclosed or being
accessed by unauthorized persons unless such disclosure is required by law or by
regulatory agencies, including, but not limited to the FDA and the Securities
and Exchange Commission. Each Party agrees to disclose to its employees only
such Confidential Information as is necessary to each employee's
responsibilities in performing the acts allowed by this Agreement. Each Party
shall promptly advise the other Party of any disclosure, loss, or use of
Confidential Information in violation of this Agreement. The Parties agree that,
upon written request at the termination of this Agreement, any intermediate or
finished Product produced by AVID pursuant to this Agreement shall be returned
to Inhibitex (subject to Section 10 of this Agreement), and all Confidential
Information of a Party, whether in written, graphic, or other tangible form,
shall be returned to that Party upon written request of that Party at the
termination of this Agreement. In addition, each Party agrees not to disclose
any information pertaining to this Agreement, including costs and, Project
Authorizations, unless such disclosure is required by law or regulatory
agencies, including, but not limited to the FDA and the Securities and Exchange
Commission.
(b) Remedies. Because of the unique nature of the Confidential
Information, each Party acknowledges and agrees that the other Party would
suffer irreparable injury if the first Party fails to comply with the
obligations set forth in Section 8(a) and that monetary damages would be
inadequate to compensate the other Party for such breach. Accordingly, each
Party agrees that the other Party will, in addition to any other remedies
available to it at law, in equity or, without limitation, otherwise, be entitled
to injunctive relief and/or specific performance to enforce the terms, or
prevent or remedy the violation, of Section 8(a). This provision shall not
constitute a waiver by either Party of any rights to damages or other remedies
which it may have pursuant to this Agreement or otherwise.
9. INDEMNIFICATION AND INSURANCE
(a) Inhibitex Indemnification. Inhibitex hereby agrees to defend,
indemnify, and hold harmless AVID, its Affiliates, officers, employees, or
agents, from and against all costs, claims, suits, expenses (including
reasonable attorneys' fees) and damages arising out of or resulting from (i)
Inhibitex's negligent or willful misuse of any Project Data or Product or (ii)
any claim that any cell line, raw material, or process provided by Inhibitex
pursuant to this Agreement infringes a valid patent or is a violation of trade
secret or other proprietary rights of a third party and (iii) any Product
Liability claim arising out of or resulting from the storage, use or
administration of the Product, provided such claim does not arise out of or
result from any injury to or death of any person or damage to property which
arises out of or in connection with any negligent or willful misconduct or
omission by AVID relating to the performance of this
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Agreement.
(b) AVID Indemnification. AVID shall indemnify, defend and hold
harmless Inhibitex, its Affiliates, officers, employees, or agents, from and
against all costs, claims, suits, expenses (including reasonable attorneys'
fees) and damages arising out of or resulting from (i) any injury to or death of
any person or damage to property which arises out of or in connection with any
negligent or willful misconduct or omission by AVID relating to the performance
of this Agreement or (ii) any claim that any material or service provided by
AVID in the course of the Project infringes a valid patent or is a violation of
trade secret or other proprietary rights of a third party.
(c) Indemnification Procedure. As a condition to the indemnified
Party's right to indemnification under this Section, the indemnified Party shall
give prompt notice to the indemnifying Party of any suits, claims or demands by
third parties which may give rise to any loss for which indemnification may be
required under this Section, but the indemnified Party's failure to do so shall
not affect the indemnifying Party's obligation hereunder except to the extent of
its actual damages as a result of such failure. The indemnifying Party shall be
entitled to assume the defense and control of any suit, claim or demand of any
third party at its own cost and expense. If the indemnifying Party shall assume
the defense of such action, it shall not settle such action without the prior
written consent of the indemnified Party, which consent shall not be
unreasonably withheld or delayed; provided, however, that an indemnified Party
shall not be required to consent to any settlement that (i) does not include as
an unconditional term thereof the giving by the claimant or the plaintiff of an
unconditional release of the indemnified Party from all liability with respect
to such action or (ii) involves the imposition of equitable remedies or the
imposition of any material obligations on such indemnified Party other than
financial obligations for which such indemnified Party will be indemnified
hereunder. As long as the indemnifying Party is contesting any such action in
good faith and on a timely basis, the indemnified Party shall not pay or settle
any claims brought in such action without the prior written consent of the
indemnifying Party. Notwithstanding the assumption by the indemnifying Party of
the defense of any action as provided herein, the indemnified Party shall be
permitted to participate in the defense of such action and to employ counsel at
its own expense; provided, however, that if the defendants in any action shall
include both an indemnifying Party and any indemnified Party and such
indemnified Party shall have reasonably concluded that counsel selected by
indemnifying Party has a potential conflict of interest because of the
availability of different or additional defenses to such indemnified Party, such
indemnified Party shall have the right to select separate counsel to participate
in the defense of such action on its behalf, at the expense of the indemnifying
Party, it being understood, however, that the indemnifying Party shall not be
liable for the reasonable fees and expenses of more than one separate firm of
attorneys at any time for all indemnified parties (in addition to local counsel)
in such action or group of related actions.
If the indemnifying Party shall fail to notify the indemnified Party of
its desire to assume the defense of any such action within the prescribed period
of time, or shall notify the indemnified Party that it will not assume the
defense of any such action, then the indemnified Party may assume the defense of
any such action, in which event it may do so acting in good faith in such manner
as it may deem appropriate, and the indemnifying Party shall be bound by any
determination made in such action.
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(d) Insurance. AVID shall obtain, at its expense, property insurance,
including boiler and machinery, and general commercial liability insurance,
including products liability, covering AVID's obligations hereunder, in each
case, in amounts and with carriers acceptable to Inhibitex and naming Inhibitex
as an additional insured, and require Inhibitex's subcontractors to obtain
similar such insurance coverage. Inhibitex shall obtain, at its expense, general
commercial insurance covering Inhibitex's obligations hereunder, in amounts and
with carriers acceptable to AVID and naming AVID as an additional insured. Each
Party will provide to the other certificates of insurance evidencing
satisfaction of their obligations under this Section 9(d) within 30 days of the
date hereof.
All insurance required under this Agreement shall be maintained during
the term of this Agreement, and each Party shall promptly notify the other of
any cancellation or notice of cancellation received in connection with such
insurance policies. Notwithstanding the preceding sentence, each Party shall be
obligated to maintain the claims-made products liability insurance (or
occurrence-based insurance, if available on commercially acceptable terms)
obtained by it on a continuous basis without interruption (or provide "tail"
coverage therefor) pursuant to this Section 9(d) during the term of this
Agreement and for six years following termination or expiration of this
Agreement, and the other Party shall be notified promptly of any cancellation or
notice of cancellation received in connection with such Party's insurance
policy. Either Party may terminate its insurance obligations herein with the
prior written consent of the other Party.
10. TERMINATION
This Agreement shall terminate upon completion of the Project unless
earlier terminated in accordance with the terms of this Section 10. This
Agreement may be terminated (a) by the mutual consent of the Parties or (b) by
either Party, upon written notice having immediate effect, if the other Party
(i) defaults in any material respect in the performance of any of its
obligations or any of its representations or warranties under this Agreement or
otherwise commits any material breach of this Agreement and such default is not
cured within twenty (20) days after written notice specifying in reasonable
detail the nature of such default; (ii) becomes bankrupt, insolvent, makes an
assignment for the benefit of creditors or proposes or makes any arrangements
for the liquidation of its debts or a receiver is appointed with respect to all
or any part of the assets of the other Party, or the other Party ceases or
threatens to cease to carry on business or to wind-up its business, and such
Party fails to provide within sixty (60) business days after notice by the other
Party such specified assurances of performance as are reasonably requested in
writing by the other Party; or (iii) fails to promptly secure or renew any
license, registration, permit, authorization or approval necessary for the
conduct of its business in the manner contemplated by this Agreement, or if any
such license, registration, permit, authorization or approval is revoked or
suspended and not reinstated within sixty (60) days or diligent efforts are
being made to effect such reinstatement.
In the event that AVID, despite its best efforts, is unable to perform
the Project or any part of it due to scientific or technical reasons, the
Parties shall enter into good faith discussions for a period of sixty (60) days
to attempt to resolve the relevant issues. If the matter has not been resolved
within this sixty (60) day period, either party may terminate this Agreement
immediately upon written notice to the other party.
If termination occurs prior to completion of the Project, work will be
suspended at the
10
earliest possible point. Upon termination of this Agreement, AVID agrees to
return to Inhibitex all Inhibitex Property once all compensation and incurred
charges owed to AVID up to the date of termination have been fully paid to AVID.
AVID will be permitted to retain such retention samples as are necessary to be
retained by manufacturers for regulatory reasons. Upon mutual agreement of AVID
and Inhibitex, AVID will also retain such other items of Inhibitex Property
which are necessary for future production, such as cell banks, purification
columns, and the like. There may be an additional fee, to be paid by Inhibitex,
associated with storage of Inhibitex Property subsequent to the termination of
this Agreement.
11. FORCE MAJEURE
Either Party shall be excused from performing its respective
obligations under this Agreement if its performance is delayed or prevented by
any event beyond such Party's reasonable control, including, but not limited to,
acts of God, fire, explosion, weather, disease, war, insurrection, civil strife,
riots, governmental action (except governmental action resulting from the
negligence or willful misconduct of AVID), earthquake or terrorism provided that
such performance shall be excused only to the extent of and during such
disability. Any time specified for completion of performance in the Proposal for
Development falling due during or subsequent to the occurrence of any or all
such events shall be automatically extended for a period of time to recover from
such disability. AVID shall promptly notify Inhibitex if, by reason of any of
the events referred to herein, AVID is unable to meet any such time for
performance specified in the Proposal for Development.
12. MISCELLANEOUS
(a) Governing Law. This agreement shall be governed by the laws of the
State of New York, without regard to the conflicts of laws or rules thereof.
(b) Dispute Resolution. In the event of a dispute arising from the
performance of this Agreement, including any dispute that has not been resolved
in accordance with Section 2(d) of this Agreement, each Party agrees to notify
the other Party of the specific complaints or points of disagreement and to use
its good faith efforts to resolve any conflicts without legal action. Any
controversy or claim arising out of or relating to this Agreement or any breach
thereof that is not resolved by the Parties in the manner set forth above shall
be settled by binding arbitration in New York under the then-current Commercial
Arbitration Rules (the "Rules") of the American Arbitration Association by one
arbitrator to be mutually agreed upon by the Parties. In the event that the
Parties cannot so agree, such arbitrator shall be elected in accordance with the
Rules. The Parties agree that, any provision of applicable law notwithstanding,
they will not request, and the arbitrators shall have no authority to award
punitive or exemplary damages against either Party. The costs of the
arbitration, including administration fees and fees of other arbitrators, shall
be shared by the Parties in proportion to their fault as determined by the
arbitrator. Notwithstanding the foregoing, the Parties agree that if any breach
or threatened breach of this Agreement would necessarily result in immediate,
irreparable injury to a Party, that Party, in addition to any other remedies
available under this Agreement, shall have the right to seek injunctive relief
in any court of competent jurisdiction in any court of competent jurisdiction.
(c) Independent Contractors. For purposes of this Agreement, AVID shall
be deemed to be an independent contractor and not an agent or employee of
Inhibitex and nothing in this
12
Agreement shall be construed to create any other relationship between AVID and
Inhibitex. Neither Party shall have any right, power, or authority to assume,
create, or incur any expense, liability or obligation, expressed or implied, on
behalf of the other, except as expressly set forth in the Proposal for
Development. AVID shall be solely responsible for withholding and payment of all
appropriate state and federal taxes, including social security payments, with
respect to all of its employees.
(d) Severability/Enforceability. If any provision(s) of this Agreement
shall be held invalid, illegal, or unenforceable by a court of competent
jurisdiction, this Agreement shall continue in full force and effect without
said provision(s), consistent with the intent of the Parties at the time of its
execution. If deletion of such provision materially alters the basis of this
Agreement, then the Parties shall negotiate a good faith alternative.
(e) Modification/Waiver. This Agreement, including the Proposal for
Development, may not be altered, amended, or modified, nor shall any obligation
or breach be deemed waived, in any way, unless such alteration, amendment or
modification is in writing and signed by the Parties or such waiver is in
writing and signed by the waiving Party. The failure of a Party to enforce any
provision(s) of this Agreement shall not be construed to be a waiver of the
right of such Party to thereafter enforce that provision or any other provision
or right.
(f) Notices. All notices and demands required or permitted to be given
or made pursuant to this Agreement shall be in writing and shall be deemed given
if delivered personally or by facsimile transmission (receipt verified),
telexed, mailed by registered or certified mail (return receipt requested),
postage prepaid, or sent by express courier service, properly addressed to the
address of the Party to be notified as shown below:
12
If to AVID:
Avid Bioservices, Inc.
00000 Xxxxxxxx Xxx.
Xxxxxx, XX 00000
Attention: Xxxx Xxxxx
Telephone: 000-000-0000
Facsimile: 000-000-0000
with a copy to:
Xxxxxxx, Xxxxx & Xxxx, LLP
00000 Xxx Xxxxxx Xxxxxx, Xxxxx 0000
Xxxxxx, Xxxxxxxxxx 00000
Attn: Xxxx Xxxxxxx, Esq.
Telephone: 000-000-0000
Facsimile: 949-660-7799
If to Inhibitex:
Inhibitex, Inc.
0000 Xxxxxxxx Xxxxxxx, Xxxxx 000
Xxxxxxxxxx, XX 00000
Attention: Xxxxxx Xxxxxxxxx
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
with a copy to:
Xxxxxxx Berlin Shereff Xxxxxxxx, LLP
000 Xxxxxxxxx Xxxxxx
Xxx Xxxx, XX 00000
Attn: Xxxxx X. Xxxxxxxxx, Esq.
Telephone: 000-000-0000
Facsimile: 000-000-0000
or to such other address as to which either Party may notify the other. Any
notice sent by facsimile transmission or telex shall be followed within 24 hours
by a signed notice sent by first class mail, postage prepaid.
(g) Assignability: Neither AVID nor its Affiliates may assign its
rights and/or delegate its obligations under this Agreement to any party without
Inhibitex's prior written consent, however, that no such consent shall be
necessary for an assignment by AVID to an Affiliate or entity acquiring all or
substantially all of AVID's assets related to the subject matter of this
AGREEMENT, which Affiliate or acquiring entity has a net worth at least equal to
that of AVID's. Notwithstanding anything else in this Agreement to the contrary,
AVID may not assign its rights and/or delegate its obligations under this
Agreement if such action would in any way impair or jeopardize any regulatory
approval for the manufacture of the Product or affect the regulatory status of
Inhibitex or the Product. Inhibitex may assign its rights hereunder in whole or
part, or delegate any of its obligations hereunder to any third party, provided
such third party agrees to be bound by the terms of this Agreement and provided
that Inhibitex promptly notifies AVID of such assignment.
13
(h) Public Announcements. No public announcement relating to the
Product or this Agreement shall be made by either Party without the prior
written consent of the other Party, and neither Party shall use the name of the
other Party to this Agreement, any trademark or trade name, or the name of any
employee of the other Party in any advertising or news release without the prior
written consent of the other Party. Notwithstanding the foregoing, either Party
may at any time make any announcement which is required by applicable law,
agency regulation or administrative order.
(i) Binding Effect. This Agreement shall be binding upon and inure to
the benefit of the Parties hereto and their respective successors and permitted
assigns.
(j) Survival. The following paragraphs shall survive the termination or
expiration of this Agreement for any reason: 2(f), 7, 8 and 9.
(k) Integration. This Agreement, including the Proposal for
Development, constitutes the entire Agreement between Inhibitex and AVID and
supersedes all prior communications, understandings, and agreements (including
any prior confidentiality agreement) with respect thereto. The terms of this
Agreement shall prevail in the event of unclear or conflicting terms in the
Proposal for Development.
(l) Counterparts. This Agreement may be executed in two counterparts,
each of which shall be deemed an original and both of which together shall
constitute one instrument. This Agreement may be evidenced by facsimile
signatures.
14
IN WITNESS THEREOF: the Parties have caused this Agreement to be duly
executed as of the day and year first above written.
INHIBITEX, INC.
By: /s/ Xxxxxxx X. Xxxxxxxx
-------------------------------------
Xxxxxxx X. Xxxxxxxx, President & CEO
----------------------------------------
Print Name and Title
AVID BIOSERVICES, INC.
By: /s/ Xxxx Xxxxx
-------------------------------------
Xxxx Xxxxx, CFO
----------------------------------------
Print Name and Title
15
Exhibit A
Proposal for Development
A-1
[AVID LOGO]
Proposal for Development and GMP Production of
Monoclonal Antibodies
Prepared For:
Inhibitex, Inc.
Date:
March 14, 2002
Avid Bioservices, Inc. Contacts:
Xxxx Xxxxxxxx, Production Project Manager
(000) 000-0000
xxxxxxxxx@xxxxxxx.xxx
Xxxxxxx Xxxxxxxx, Vice President, Manufacturing and Process Development
(000) 000-0000
xxxxxxxxx@xxxxxxx.xxx
Xxxxxx Xxxx, President
(000) 000-0000
xxxxx@xxxxxxx.xxx
Xxxx Xxxxx, CFO
(000) 000-0000
xxxxxx@xxxxxxx.xxx
Page 1 of 15
INDEX
A. PROJECT OBJECTIVES, MILESTONES AND DELIVERABLES
- Part 1-Project Initiation and Establishing GMP Documentation
- Part 2-Technology Transfer and Process Development
- Part 3-Production Runs
- Part 4-Fill and Finish Activities
- Part 5-Regulatory Consulting
- Part 6-Stability Studies
B. GENERAL TERMS
- Project Authorization
- Project Communication
- Production Slot Reservation Payment Terms
- Emergency Back-up System
- Security
- Plans to implement 21 CFR, Chapter l1 regulations
- Confidentiality
- Contaminated Production Runs
C. EXHIBITS
Exhibit A-Project Authorization
Exhibit B-Available Production Slots
Page 2 of 15
A. PROJECT OBJECTIVES, MILESTONES AND DELIVERABLES
PART 1 - PROJECT INITIATION AND ESTABLISHING GMP DOCUMENTATION
OBJECTIVES:
The objectives of the Project initiation are as follows:
1. Inhibitex to transfer cell line documentation, process development
information and analytical test methods to Avid Bioservices, Inc. for
review and comment.
2. Finalize a project plan that will encompass all Avid and Inhibitex
activities related to SA-mAb development from Master Cell Bank
generation to the release of vialed material to Inhibitex for a phase 1
clinical trial. Project plan would be created through a series of
discussions, with the purpose of establishing a working and an initial
regulatory strategy (additional regulatory consulting will be performed
in accordance with Part 5 attached hereto) for GMP production of the
SA-mAb to support an IND filing. Topics to be discussed include:
- Cell line assessment
- MCB characterization to support IND filing
- Process development necessary to support process specifications
- Product characterization to support IND filing
- Viral clearance studies to support IND filing
- Strategy for stability studies
- Allocation of resources and timelines
- Assay development
- Facility and process improvements necessary for GMP production
The objectives for establishing GMP documentation are as follows
1. The SA-mAb cell line will be received, documentation associated with
cell line will be evaluated and a determination will be made as to
further testing or development that may be necessary prior to beginning
production of the master cell bank.
2. Review of raw materials necessary for the production of the SA-mAb and
generation of new raw material specifications as needed
3. Review of test methods necessary for in-process, bulk and final
material testing. Generation of test methods and test method forms for
all process and product specifications,
4. Once process development and downstream processing development is
complete, generation of all documents necessary for GMP production.
5. Agreement on specification documents for in-process, bulk and final
materials.
6. Assist Inhibitex with assembling CMC section for the SA-mAb.
The GMP documentation transfer/generation process will be a continuous process
that begins with the project initiation and continues through completion of the
CMC section for the SA-mAb and release of the final product. Activities include
all QA/Document control aspects involved in the generation of necessary
documentation including initiation of documents, routing and review of new
documents, approval of documents, issuing all production related documents,
review of batch record documents and storage of necessary documents.
PROJECT MILESTONES:
1. Assessment of incoming cell line and process documentation (INHX and
AVID)
2. Project initiation meetings to finalize project plan (INHX and AVID)
Page 3 of 15
3. Generation of an initial regulatory strategy for the development SA-mAb
(INHX and AVID)
4. Generation and approval of documentation relating to GMP production
a) Batch Production Records
b) Standard Operating Procedures
c) Raw Material Specifications and vendor qualifications
d) In-Process, Bulk and Final Material Specifications
e) Test methods
5. Completion of the CMC section for the SA-mAb
6. Implementation of facility and process improvements deemed necessary
for a quality process (see part B)
TARGET DATE FROM AGREEMENT
INHIBITEX DELIVERABLES: SIGNING
1. Inhibitex to provide copies of cell line documentation including technical 60 Days
reports, test results and process information
2. Inhibitex to provide available specifications/documentation for cell culture 60 Days
equipment
3. Inhibitex to provide available process related documentation for upstream and 60 Days
downstream processing steps
4. Inhibitex to provide available raw material specifications 60 Days
TARGET DATE FROM RECEIPT OF
AVID DELIVERABLES: CELL LINE
1. Avid to generate and rout for approval Batch Production Records for Inhibitex's 100 days
process
2. Avid to provide xxxx of materials (including quantities and type) for batch 80 days
production
3. Avid/INHX to generate raw material specifications and quality specifications for 45 days
SA-mAb
4. Avid/Inhibitex to generate a strategic plan for the GMP production of the SA-mAb 30 days
to support an IND filing
5. Avid to assist with generating the CMC section for an IND including facilities, 150 days.
process and testing sections.
COSTS:
Project initiation and establishing GMP documentation $[ *** ]
PAYMENT TERMS:
$[ *** ] due within 30 days of contract signing
$[ *** ] due within 60 days of contract signing
$[ *** ] due upon successful completion of clinical batch
Page 4 of 15
PART 2 - TECHNOLOGY TRANSFER AND PROCESS DEVELOPMENT
OBJECTIVE:
The overall objectives of the Technology Transfer and Process Development part
of the project is to establish all procedures and processes necessary to
manufacture the SA-mAb under GMP. Specific objectives include:
- Transfer the SA-mAb research cell line from Inhibitex to Avid
Bioservices, Inc.
- Once the research cell line meets minimum requirements for sterility
and mycoplasma, produce a Master Cell Bank (approximately 150 vials)
and initiate agreed-upon internal and external testing
- Transfer analytical methods from Inhibitex to Avid for testing the
SA-mAb.
- Transfer gold standard SA-mAb from Inhibitex to Avid Bioservices, Inc.
- Establish test methods and documentation at Avid Bioservices, Inc.
- Generate reports pertaining to the establishment of the test methods.
- Transfer upstream and downstream production methods from Inhibitex to
Avid for the production of the SA-mAb. This includes personnel time
associated with assay transfer, assay development and process
development. Reports will be generated that document the assay
qualification and upstream/downstream processing development.
Inhibitex Deliverables (the timing of the below deliverables will be determined
in accordance with the Project Plan in Part 1 above)
- Provide available specifications/documentation for purification
equipment and materials
- Provide available process related documentation for all purification
steps
- Provide copies of Test Methods associated with in-process and bulk
product testing
- Provide reference material for testing in Avid's labs
- Purchase purification columns and matrices
- Transfer SA-mAb cell line from Inhibitex to Avid
- Assist with transfer analytical methods and reference materials from
Inhibitex to Avid
Deliverables (the timing of the below deliverables will be determined in
accordance with the Project Plan in Part 1 above):
1. Preparation of Master Cell Bank (150+ vials)]
2. Outside testing of the MCB
3. Assay Transfer and setup
a) In-process, bulk and final testing assays transferred from
Inhibitex
b) Immunoreactivity/Potency assay transferred from Inhibitex
c) Establishment and documentation of QC test methods at Avid
d) Qualification of the QC assays per agreed-upon protocols
e) Validation of the Endotoxin assay
4. Establish upstream process.
a) Media selection as agreed upon
b) Growth and productivity experiments
c) Pilot scale stirred tank production (20-30 liter) (If needed)
5. Establish downstream process up to completion of the manufacturing work
order.
a) Clarification
b) Protein A loading/elution conditions
c) Low Ph hold step
d) SP Sepharose
Page 5 of 15
e) Q Sepharose
f) Viral filter (DV20/DV50)
g) Concentration/buffer exchange via Ultra Filtration
h) Report preparation
6. GMP Documentation
a) Assay Test Methods
b) Development report for cell culture process.
c) Development report for purification process
d) Establish Standard Operating Procedures for cell culture
process
e) Establish Standard Operating Procedures for purification
process
f) Generation of Manufacturing Work Orders and associated
documentation
7. Viral Clearance (scale down and study support)
a) Scale Columns and Gel Matrices
b) Run full scale process intermediates over small-scale version
to validate scaled process
c) Prepare validation report
8. Outside testing and viral clearance studies as agreed upon
a) Transfer small scale process to vendor lab
b) Directly assist vendor during validation study
ESTIMATED COSTS AND TIME
Preparation of Master Cell Bank (150+ vials) $ [ *** ]
Outside testing of the MCB (estimated $[ *** ]) billed at [ *** ]
Assay transfer and set-up $ [ *** ]
Establish upstream process (may be adjusted based on Avid's required involvement $ [ *** ]
Establish downstream process up to the completion of the manufacturing work order $ [ *** ]
GMP documentation $ [ *** ]
Viral clearance (scale-down and study support) $ [ *** ]
Travel expenses billed at [ *** ]
Outside testing and viral clearance studies as agreed upon billed at [ *** ]
Dedicated equipment and supplies (estimated at <$[ *** ]) billed at [ *** ]
PAYMENT TERMS:
All amounts due under Part 2 are due within 30 days of invoicing. Invoice will
be generated at the completion of the each task identified above.
Page 6 of 15
PART 3 - PRODUCTION RUNS
OBJECTIVE:
- Procure Raw Materials
- Testing and release of Raw Materials
- Shakedown run at 300L scale (tox study material) to be filled at Avid
- Manufacture product at the 300L scale
- Test and release raw materials used in production
- Test in-process and sterile bulk material
- Provide customer with GMP manufactured and tested product meeting
specifications for filling.
DELIVERABLES (THE TIMING OF THE BELOW DELIVERABLES WILL BE DETERMINED ITS
ACCORDANCE WITH THE PROJECT PLAN IN PART 1 ABOVE):
1. Raw materials
a) Purchase raw materials
b) Testing of raw materials
c) Release raw materials
2. Cell Culture
a) Thaw vial and grow cells to inoculate 300L liter reactor
b) Grow cells in reactor according to agreed-upon protocols
3. Purification
a) Protein A
b) Viral Inactivation
c) Q-Sepharose
d) SP-Sepharose
e) Viral Filtration
4. Formulation
a) Buffer Exchange
b) Concentration Adjustment
5. Sterile Filtration
6. Quality Testing
a) In-process testing (internal and external as agreed upon)
b) Bulk testing (internal and external as agreed upon)
7. Quality Assurance
a) Review of all test results from outside vendors
b) Review and approval of Batch Production Records
c) Review and approval of environmental testing results
8. Generate C of A for the purified bulk
Page 7 of 15
ESTIMATED COSTS AND TIME:
300 Liter clinical batch runs (composite price for the entire process (excluding $ [ *** ] per run
raw material cost), from inoculum prep to issuing C of A).
Includes deliverables detailed above in numbers 1 through 8.
300 Liter non-clinical batch runs, including the fill of the tox material up to 100 $ [ *** ] per run
vials. (composite price for the entire process (excluding raw material cost),
detailed above in numbers 1 through 6
20-30 liter non-clinical batches (includes downstream processing and standard $ [ *** ] per day of
in-house testing). bioreactor time
Raw Materials & Outside Testing. billed at [ *** ]%
PAYMENT TERMS:
Production Runs
- 25% non-refundable deposit is due in advance to reserve any production
slot and at the latest must be received prior to ordering raw materials
for the production run.
- 25% is due upon the completion of fermentation.
- 50% is due upon completion of the batch.
Upon written notice from Inhibitex, Avid shall reserve any available production
slot for up to two weeks without payment. If the non-refundable deposit has not
been received by Avid within two weeks of notification, Avid shall have no
obligation to hold and reserve such production slot.
Page 8 of 15
PART 4 - FILL AND FINISH ACTIVITIES
Avid shall be responsible for production of bulk antibody product (drug
substance) and for filing and release of final product vials (drug product).
Avid shall either identify an outside vendor for contract fill/finish activities
or perform the filling at its facilities.
OUTSIDE CONTRACTED FILL/FINISH
Activities and estimated costing associated with establishing fill/finish at a
sub-contractor's site shall include:
1. Identifying the sub-contractor (No charge)
2. Qualifying the vendor through an on-site audit ($[ *** ] per day +
travel time (i.e. one travel day (if necessary) and one audit day = $[
*** ])
3. Negotiating contract with outside contractor (subject to approval from
Inhibitex) ($[ *** ])
4. Overseeing pre-filling qualification activities (TBD)
- Generation of falling batch record
- Approval of vial labels
- Water and media fills
- Cleaning validation as necessary
5. Product Filling (estimated at $[ *** ] to $[ *** ] billed at [ *** ]
- Vial filling underclass 100 conditions
- Inspection, labeling and packaging of filled product
- Avid review of documentation associated with filled product.
6. In-house and external testing for release of drug product (TBD)
7. Generating a certificate of compliance and C of A
8 Shipping the material to Inhibitex (TBD)
AVID'S IN-HOUSE FILL/FINISH
Avid is reviewing its filling capabilities and will make a determination as to
its ability to provide fill/finish services, If Avid determines it can provide
such service, it will provide Inhibitex with a written proposal to fill
Inhibitex's bulk antibody at Avid's facilities.
PART 5 - REGULATORY CONSULTING
Avid will provide Inhibitex with regulatory consulting services outside the
scope described in part 1. Services included in part 1 are:
- Generating an initial strategic and regulatory plan for the CMC section
of an IND including testing, viral clearance studies
- Assisting with preparing the CMC section of the IND
- General regulatory questions that may occasionally arise during the
project (not requiring research or written reports)
Avid's Regulatory Affairs department shall provide regulatory assistance outside
the scope of Part 1 at a flat rate of $[ *** ] per day. Teleconferences shall be
billed at a rate of $[ *** ] per hour for the participation of the VP of
Regulatory Affairs / QA. Services outside the scope of Part 1 include:
- FDA meeting strategy
- Attending meetings with the FDA (pre-IND, end of phase I, end of phase
II)
- Participating in FDA teleconferences
- Participating in the End of Phase 2 meeting
Page 9 of 15
PART 6 - STABILITY STUDIES
Avid shall write the draft stability protocols for drug substance and final
vialed product for approval by Inhibitex. After approval, Avid shall initiate
stability studies for the time frame specified in the protocol.
Avid shall xxxx Inhibitex for these services as follows;
1. Protocol write up and approval, $[ *** ] per hour (estimated maximum of
$[ *** ])
2. Stability study costs will be based on number of time points, storage
conditions and tests conducted. These will be determined after the drug
substance and final vialed product specifications have been approved,
This will include review of test data and generation of quarterly
reports for submission to Inhibitex.
3. No charge for storage of retains for up to one year. In excess of one
year, at a flat rate of $[ *** ] per year. Retains not to exceed 25
units of final vialed product or 5 vials of drug substance.
Page 10 of 15
GENERAL TERMS
PROJECT AUTHORIZATION
a) Each project will be defined by a project authorization and
pre-approved by both parties in writing. Project authorization
forms will be an addendum to the Agreement and Proposal for
Development which defines a project and is executed by
Inhibitex and Avid and which specifies the project tasks to be
performed by one or more project teams. The project
authorization form will list project objectives, the project
deliverables, the project milestones, an estimated project
cost, the project schedule, and any special conditions/
requirements which might apply to the project.
Additional work performed outside the scope of this Proposal
for Development will be billed at $[ *** ] per hour upon prior
approval by Inhibitex and completion of the project
authorization.
b) Notwithstanding anything else contained herein or in the
Agreement (including but not limited to Section 12(k)),
Inhibitex shall have right to terminate the Project and have
no further payment obligations, provided that Inhibitex shall
be obligated for payments due under all Project Authorizations
entered into prior to such termination,
c) An example of a project authorization form is attached as
Exhibit A.
PROJECT COMMUNICATION
The parties have each appointed a Project Manager to assume responsibility for
their respective roles and obligations under the Agreement and Proposal for
Development as follows:
For Inhibitex, Xxxx Xxxxxxx
For Avid, Xxxxxxx Xxxxxxxx
The parties' respective Project Managers will be responsible for:
- Coordinating all implementation of the Project, including overseeing
the performance and (together with the Quality Assurance Department of
the parties) quality thereof;
- Arranging and personally attending at Inhibitex sole cost, except as
otherwise provided in Part 1, including Avid's travel expenses and
personnel time outside the scope of the Agreement and Proposal for
Development, progress and other meetings at intervals and locations as
agreed between the parties from time to time, to discuss developments
and seek to resolve any issues arising under the Agreement and Proposal
for Development. The parties' respective Project Managers shall use all
reasonable best efforts to resolve all such issues, but shall refer all
problems which are outside their ordinary authority to resolve to
appropriate members of the parties' respective senior management or
the Project Team;
- Day-to-day liaison between the parties;
- Identifying which Inventions have been created or developed, prior to
or as soon as reasonably practicable following creation or development
of the same in the course of the Project; and
- Such other matters as may be agreed between the parties from time to
time.
Page 11 of 15
Either party may replace its appointed Project Manager at any time on prior
written notice to the other party.
Upon reasonable notice as mutually agreed by the parties, Avid shall permit
Inhibitex Project Manager (and other representatives duly authorized by
Inhibitex) access to its premises while the Project is being conducted as may be
reasonably appropriate, as long as it will not interfere with Avid's GMP
operations.
If Avid wants to deviate from the Project Plan, Avid shall notify Inhibitex in
writing, by facsimile or at least by e-mail, about the planned change before it
is implemented. In any event, any change in the process which might have an
impact on compliance with cGMP is deemed to be a material deviation which must
be reported to the Inhibitex Project Manager.
Should any unforeseen and unwanted material deviations occur, Avid shall inform
the Inhibitex Project Manager promptly and without undue delay. During cGMP
manufacturing, such unplanned and unwanted material deviations must be
communicated to the Inhibitex Project Manager preferably within 24 hours, but no
later than 72 hours, Such deviations shall be documented and processed according
to Avid relevant SOP's.
PRODUCTION SLOT RESERVATION
Scheduling of production slots is subject to facility availability. Inhibitex
can lock-in and secure an available production slot by paying Avid a
non-refundable deposit equal to 25% of the anticipated production run. In the
event that Inhibitex has reserved a production slot and the process development
timeline does not meet the timing of the reserved production slot, Inhibitex
shall have the right to shift or move its reserved product slot to an a
non-reserved production slot at no charge to Inhibitex only if (i) Avid has not
denied another customer's contract manufacturing needs who was interested in
Inhibitex's reserved time slot being shifted or moved or (ii) the production
plan has been delayed due to no fault of Inhibitex.
Available production slots as of the date of this Proposal for Development are
attached hereto as Exhibit B.
PAYMENT TERMS
All fees, expenses, costs due under the Proposal for Development as specified in
the Parts 1 through 5 shall be billed by AVID at the end of each month. Unless
as otherwise agreed upon in Parts 1 through 5, Payments will be due within 30
days after invoicing.
If Inhibitex has not made payment within 30 days of invoicing, Avid will send a
reminder notice to Inhibitex, If payment is not made within 10 business days of
receiving the reminder notice, the outstanding balance due Avid shall accrue
interest at an annual rate of 5% above the then-current U.S. Prime Rate, and
Avid may (i) stop performing the Project and/or (ii) withhold delivery of any
Product until payment is received in full, including any interest due thereon.
Unless as other agreed to herein, all equipment, materials, and supplies
required in conjunction with any of the above projects will be billed at [ ***
]. All equipment/material purchased will be dedicated to Inhibitex and not be
used for any other application. Any outsourced services required in conjunction
with any of the above projects will be billed at [ *** ].
Page 12 of 15
EMERGENCY BACK-UP SYSTEM
At its sole cost and expense, Avid shall investigate and use it best efforts, to
determine and procure a back-up generator system to backup critical equipment as
soon as is reasonably possible. Avid and Inhibitex understand that such system
will require, among other items, certain permits, consents of third parties,
engineering drawings and plans, an approved contractor, and validation studies,
including full load testing.
SECURITY
At its sole cost and expense, Avid shall investigate and use it best efforts to
implement as soon as reasonably possible, a security system to insure the safety
and integrity of the manufacturing operations 24 hours a day, seven days a week.
21 CFR, CHAPTER 11 REGULATIONS
At its sole cost and expense, Avid will generate and fill a position responsible
for bringing all of Avid's information systems into compliance with 21 CFR
chapter 11. The new position will be responsible for developing a strategy for
reviewing Avid's current information systems and implementing a program to bring
Avid into compliance with federal regulations. It is expected that the position
will be filled within 30 days of execution of the Agreement.
CONFIDENTIALITY
All terms and conditions in the Agreement and Proposal for Development are
confidential and cannot be disclosed without the prior written consent of both
parties, unless as required by law or by the Securities & Exchange Commission.
CONTAMINATED PRODUCTION RUNS
Production runs (including upstream and downstream processing to bulk
filtration) that become contaminated or otherwise unusable due to errors on the
part of Avid's production staff or equipment will be repeated at no cost to
Inhibitex. Avid will use its best efforts to complete the run as soon as
possible and preferably in the next time slot.
Page 13 of 15
EXHIBIT A
INHIBITEX - AVID
PROJECT AUTHORIZATION
Project Authorization Number: ________________________
Estimated Total Costs: $_________________________
GIMP Production [ ] Technology Transfer [ ] R&D [ ]
Project Description:
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
PROJECT DELIVERABLES:
Authorization:
INHIBITEX
Name:
---------------------------
Signature:
---------------------------
Title:
---------------------------
Date:
---------------------------
AVID
Name:
---------------------------
Signature:
---------------------------
Title:
---------------------------
Date:
---------------------------
Page 14 of 15
AMENDMENT NO. 1
TO THE AGREEMENT FOR SERVICES DATED MARCH 14, 2002
BY AND BETWEEN AVID BIOSERVICES, INC. AND INHIBITEX, INC.
This AMENDMENT No. 1 is made this 20 day of January, 2003 by and
between Avid Bioservices, Inc., a Delaware corporation (hereinafter referred to
as "AVID"), having its principal OFFICE AT 00000 Xxxxxxxx Xxxxxx, Xxxxx 000,
Xxxxxx, Xxxxxxxxxx 00000, and INHIBITEX, INC., a Delaware corporation
(hereinafter referred to as "INHIBITEX"), having its principal office at 0000
Xxxxxxxx Xxxxxxx, Xxxxx 000, Xxxxxxxxxx, Xxxxxxx 00000.
WHEREAS, INHIBITEX has requested from AVID certain contract filling
services of its Product.
WHEREAS, AVID has certain experience and expertise to fill antibody
products.
WHEREAS, AVID desires to limit its liability with respect to filling
the Product.
NOW THEREFORE, the Parties hereby agree to the additional terms and
conditions with respect to filling of Product as follow:
During the vial filling operation performed by AVID, AVID's liability
for any loss or damage to the Product shall be limited to the cost of fill as
defined by the Project Authorization. In the event the Product is damaged due to
AVID's negligence or willful misconduct, AVID's liability shall be limited to
the cost to manufacture the bulk material. With respect solely to contract
filling, negligence shall be defined as strictly a departure from AVID's
internal procedures for filling the Inhibtex Product . As an example, negligence
shall not include contaminated Product that was filled under AVID's internal
procedures.
All other terms and conditions set forth in the original agreement
dated March 14, 2002 shall remain in full force and effect.
IN WITNESS THEREOF, the Parties have caused this Agreement to be duly
executed as of the day and year first above written.
INHIBITEX, INC.
By: /s/ Xxxxxx Xxxxxxxxx
------------------------------------
Xxxxxx Xxxxxxxxx - VP Business Dev.
AVID BIOSERVICES, INC.
By: /s/ Xxxx Xxxxx
------------------------------------
Xxxx Xxxxx, CFO
AMENDMENT NO. 2
TO THE AGREEMENT FOR SERVICES DATED MARCH 14, 2002
BY AND BETWEEN AVID BIOSERVICES, INC. AND INHIBITEX, INC.
This AMENDMENT No. 2 is made this 20th day of February, 2003 by and
between Avid Bioservices, Inc., a Delaware corporation (hereinafter referred to
as "AVID"), having its principal office at 00000 Xxxxxxxx Xxxxxx, Xxxxxx,
Xxxxxxxxxx 00000, and INHIBITEX, INC., a Delaware corporation (hereinafter
referred to as "INHIBITEX"), having its principal office at 0000 Xxxxxxxx
Xxxxxxx, Xxxxx 000, Xxxxxxxxxx, Xxxxxxx 00000.
WHEREAS, INHIBITEX has requested from AVID two (2) additional 300 liter
runs of INHIBITEX' Aurexis(TM) antibody per the attached proposal dated January
22, 2003.
WHEREAS, AVID has certain experience and expertise to manufacture and
fill INHIBITEX' Aurexis(TM) antibody.
WHEREAS, INHIBITEX desires to limit its liability with respect to any
power failure that could be avoided if AVID had procured a backup generator.
WHEREAS, AVID is willing to accept the additional liability of the
product with respect solely to any power that could have been avoided by a
backup generator.
NOW THEREFORE, the Parties hereby agree to the additional terms and
conditions with respect to filling of Product as follow:
AVID shall accept all liability of the Product manufactured on or after
the effective date of this Amendment No. 2 pertaining solely to the loss product
caused by a power failure which could have been avoided with a backup generator.
In no event shall AVID's liability exceed the price of the contract per the
attached project proposal.
All other terms and conditions set forth in the original agreement
dated March 14, 2002 and Amendment No. 1 dated January 20th, 2003 shall remain
in full force and effect.
IN WITNESS THEREOF, the Parties have caused this Agreement to be duly
executed as of the day and year first above written.
INHIBITEX, INC.
By: /s/ Xxxxxxx X. Xxxxxxxx
---------------------------------
Xxxxxxx X. Xxxxxxxx, Pres. & CEO
-------------------------------------
Print Name and Title
AVID BIOSERVICES, INC.
By: Xxxxxx Xxxx
---------------------------------
Xxxxxx Xxxx, President
-------------------------------------
Print Name and Title
