EXHIBIT 10.28
CONFIDENTIAL TREATMENT REQUESTED
(*) Denotes information for which confidential treatment has been requested.
Confidential portions omitted have been filed separately with the Commission.
MANUFACTURING AND SUPPLY AGREEMENT
THIS AGREEMENT, made effective as of October 24, 1996 (the "Effective Date"), is
entered into by and between Neurex Corporation, a Delaware corporation
("Neurex") and Mallinckrodt Chemical, Inc., a Delaware corporation
("Mallinckrodt").
RECITAL
WHEREAS, Neurex has developed a proprietary Product called SNX- 111 for
analgesia indications and desires Mallinckrodt to manufacture SNX-111 for
Neurex;
WHEREAS, Mallinckrodt has developed proprietary manufacturing processes for
manufacturing peptide products such as SNX-111 and desires to manufacture
SNX-111 for Neurex;
WHEREAS, SNX- 111 is still in the development process but Neurex wants to enter
into a supply contract before it knows the amounts or delivery times of Products
but wants to assure a source of supply of SNX-111;
WHEREAS, Mallinckrodt has limited capacity to manufacture SNX-111 within given
time limits but desires to develop the means to provide continuity of supply to
Neurex within its limited manufacturing capacity.
AGREEMENT
NOW, THEREFORE, in consideration of the foregoing and of the mutual promises
contained herein, the parties agree as follows:
1. Definitions. As used in this Agreement:
1.1 "Affiliate" shall mean any corporation or other business entity
controlling, controlled by or under common control with such party. For purposes
of this Section 1.1, "control" shall mean the direct or indirect ownership of
fifty percent (50%) or more of the voting or income interest in such corporation
or other business entity, or such other relationship as, in fact, constitutes
actual control.
1.2 "Batch" shall mean the amount of the Product coming out of a
single synthesis.
1.3 "Product" shall mean the bulk form of SNX-111, as more fully
described in Schedule A which is attached hereto and made a part hereof.
1.4 "Mallinckrodt Proprietary Technology" shall mean the
proprietary process information relating to the manufacture of the Product which
is considered to be a trade secret of Mallinckrodt.
1.5"Calendar Half-Year" shall mean each of the six (6) month
periods, during the term hereof, beginning with April 1 st and October 1 st.
1.6 "Neurex Patent Rights" or "NPR" shall mean any claim of
any unexpired patent owned by or licensed to Neurex or an Affiliate thereof,
that has not been declared invalid or unenforceable in an unappealed or
unappealable decision of a court of competent jurisdiction.
1.7 "Term" shall mean the duration of this Agreement as
determined in accordance with the terms hereof.
1.8 "Yield" shall mean the weight of the net Product obtained
divided by the weight of the starting peptide resin to obtain that Product.
2. Manufacture and Supply of Product.
2.1 (a) Subject to the provisions of this Agreement,
Mallinckrodt shall manufacture and Neurex shall purchase from Mallinckrodt at
least fifty percent (50%) of Neurex's requirements of the Product for the United
States market for Neurex's Analgesia indication.
(b) Neurex may order amounts of SNX-111 for other
research and development purposes other than the analgesia indication. On each
firm order placed by Neurex pursuant to ss.5.2 hereof, Neurex shall indicate
which amounts ordered are for analgesia and which amounts ordered are for
research and development of other possible indications. Section 6 and 11 shall
not apply to any non-analgesia research and development materials. In no event
will Neurex order any SNX-111 for commercial production except for Product for
analgesia indications. In no event will the amounts ordered exceed the amounts
listed in Exhibit D.
2.2 Subject to the provisions of this Agreement, Neurex agrees
to purchase Mallinckrodt's current inventory of 45 grams of Product at the price
outlined in Schedule B.
3. Manufacturing Fees.
3.1 Neurex shall pay Mallinckrodt for the manufacture of the
Product in accordance with the Payment/Yield Schedule attached hereto as
Schedule B and made a part hereof.
3.2 Upon shipment of the Product to Neurex, Mallinckrodt shall
submit its invoice for its fees for manufacturing the Product shipped according
to the applicable Yields for that particular Batch and provide Neurex with each
Batch documentation supporting the Yield claimed. Neurex shall pay the full
amount of each invoice within forty five (45) days after receipt of invoice.
3.3 In the event that Yield rates for three (3) consecutive
batches are consistently greater than [*], Mallinckrodt acknowledges and agrees
to negotiate in good faith a new manufacturing fee schedule consistent with the
ratios for price set forth in Schedule B.
4. Specifications.
4.1 Each Batch manufactured and supplied by Mallinckrodt to
Neurex hereunder shall conform to the specifications therefor as set forth in
Schedule A hereto, as the same may be amended from time to time by written
agreement of the parties hereto ("the Specifications"). The Specifications shall
be adjusted to meet any new requirements of any changes to applicable law or
regulation. Any resulting change in the manufacturing fee will be reflected in
accordance with Mallinckrodt's standard cost accounting system.
4.2 Each Batch shall be analyzed in accordance with the
methods of analysis specified in Schedule C attached hereto and made a part
hereof, as the same may be amended from time to time by written agreement of the
parties hereto. Mallinckrodt shall send to Neurex with each Batch a Certificate
of Analysis specifying, inter alia, the results of each of the determinations
required to show conformance of such Batch with the Specifications therefor. The
figures set forth in such Certificate of Analysis shall be accepted as accurate
for the purposes of this Agreement unless Neurex within forty five (45) days
after the receipt of such Batch not)fies Mallinckrodt in writing that it has
analyzed such Batch in accordance with the methods of analysis specified in
Schedule C and has determined that all or any portion of such Batch does not
conform to the Specifications therefor. If Neurex fails to notify Mallinckrodt
within such forty five (45) days then said Batches shall be deemed to be
accepted ("Accepted Product"). Those Batches that fail to meet the
Specifications as agreed upon by Neurex and Mallinckrodt shall be returned by
Neurex to Mallinckrodt, at Mallinckrodt's expense, and Mallinckrodt shall, as
soon as reasonably practical, but not more than three (3) months from receipt of
the written notice described above, replace such Batch with a new Batch that
meets the Specifications. Said replacement of Product by Mallinckrodt shall be
Neurex's sole remedy for the failure of any Product hereunder to meet the
Specifications.
4.3 If there is a difference of opinion concerning the
conformance of the Batch with the Specifications therefor, Neurex and
Mallinckrodt agree to consult with each other in order to explain and resolve
the discrepancy between each other's determinations. If such consultation does
not resolve the discrepancy, Neurex shall furnish representative samples for
analysis by a mutually agreed upon independent laboratory, using methods of
analysis set forth in Schedule C, and the reasonably resulting determinations
shall be binding on Neurex and Mallinckrodt for the purposes hereof. Each party
shall have the right to have representatives thereof present, at their own
expense, during such independent analysis. If the Product is found to meet the
requirements of the Specifications in all material respects, Neurex shall pay
the costs of such tests and shall be deemed to have accepted the affected Batch
as Accepted Product. If the Product is not found to meet the requirements of the
Specifications in all material respects, Mallinckrodt shall pay the costs of
such tests and shall promptly credit Neurex's account for the manufacturing fee
paid pursuant to Section 3 related to that Batch.
5. Forecasts and Orders.
5.1 Neurex will keep Mallinckrodt reasonably informed of the
regulatory development of SNX-111 including the status of clinical trials and
filing of the NDA with the FDA so that Mallinckrodt may anticipate when to
prepare for commercial production of an FDA approved SNX- 111. Mallinckrodt
shall keep all such information confidential.
At the beginning of the Calendar Half-Year starting on April
1, 1997, and at the beginning of each Calendar Half-Year thereafter during the
term of this Agreement, Neurex will provide Mallinckrodt with a written twelve
(12) month rolling forecast of the quantities of Product that Neurex expects to
purchase during each of the next twelve (12) months. The first six (6) months of
each forecast shall constitute firm orders deliverable as provided in Section
5.2, except for the period October 1, 1998 to December 31, 1998 for which the
order period will be three (3) months. The balance of each twelve month forecast
given by Neurex pursuant to this Section 5.1 is not a firm commitment on the
part of Neurex to order the quantities of the Product set forth therein, but are
given so that Mallinckrodt will have aufficient information upon which to
schedule its manufacturing operations so as to be able to meet Neurex's firm
orders for the Product that may be placed pursuant to Section 5.2.
5.2 At the beginning of each Calendar Half-Year, Neurex shall
submit the six (6) month firm orders in writing for the quantity of the Product
desired by Neurex at least six (6) months prior to the delivery date, except for
the period October 1, 1998 to December 31, 1998 for which the order period will
be three (3) months, and Mallinckrodt shall supply such quantities of the
Product in accordance with Schedule D attached hereto and made a part hereof.
5.3 Mallinckrodt shall ship the Product in a container closure
system described in Schedule E attached hereto and made a part hereof at
Neurex's expense in accordance with Neurex's instructions, FOB Mallinckrodt's
plant. For purposes of this Agreement, delivery of Product by Mallinckrodt to
Neurex shall be deemed to have taken place upon acceptance of delivery by a
Neurex-designated carrier at Mallinckrodt's plant.
5.4 Title to all finished Product shall pass to Neurex on
delivery.
5.5 Manufacturing Contingencies. Mallinckrodt may, at its
discretion, manufacture Product in anticipation of Neurex's orders. In such
case, Neurex agrees that before or upon termination of this Agreement, it will
purchase Mallinckrodt's inventory of Product up to a maximum of 150 grams.
6. Failure to Deliver.
6.1 If at any time during the Term of this Agreement
Mallinckrodt fails to deliver:
(a) the six (6) month firm order on the delivery
date and up to thirty (30) days after the delivery date, Mallinckrodt shall pay
Neurex a late delivery fee equal [*] of the purchase price per day of each gram
of Product that Mallinckrodt has failed to deliver after the delivery date to
Neurex within such time frame, up to a maximum of [*] per gram of the Product;
(b) the six (6) month firm order on the delivery
date by more than thirty (30) days, then in addition to the late delivery fee
provided in 66.1(a) above, Neurex may in its discretion manufacture or have
manufactured the amount of Product covered by the next following six (6) month
firm order, and Neurex shall no longer be required to purchase at least 50% of
its Product from Mallinckrodt;
(c) the six (6) month firm order on the delivery
date by more than one hundred eighty (180) days or if Mallinckrodt not)fies
Neurex in writing that it is unable or unwilling to provide Product meeting the
Specifications on a consistent ongoing basis and is willing to license its
technology, or has filed against it a petition in bankruptcy which is not
dismissed within ninety (90) days notice to Mallinckrodt, then subject to the
provisions of Section 14 the parties shall negotiate in good faith in order to
reach agreement on a nonexclusive license to Neurex or Neurex's designee which
is acceptable to Mallinckrodt but in no event to a competitor of Mallinckrodt's
peptide business of Mallinckrodt's technology and know-how involved in the
manufacture of the Product. The license will provide, among other things, that
Mallinckrodt shall provide reasonable technical assistance necessary to start
the manufacture by or for Neurex of the Product with no delay if so requested by
Neurex. The license shall also provide without limitation for the payment of a
reasonable royalty to Mallinckrodt based on the full value of the technology and
know-how. The license will be limited solely to the Product for Analgesic
indications and not for any other peptides or other use. In no event shall the
failure of the parties to reach a mutually satisfactory license agreement nor
any specific terms of such license agreement be subject to arbitration
notwithstanding Article 16.2. Neurex shall reimburse Mallinckrodt for the actual
cost to Mallinckrodt of any technical assistance provided pursuant to this
Agreement and/or the license.
7. Records and Audits.
7.1 During the term of this Agreement and for three (3) years
after the expiration date of any particular Product Batches manufactured by
Mallinckrodt, or such time as may be required by applicable regulations,
whichever is greater, Mallinckrodt shall maintain records and samples relating
to such Batch(es) aufficient to substantiate and verify its duties and
obligations hereunder, including but not limited to, records of orders received,
Product manufactured, work in progress, Product analysis and quality control
tests and the like.
7.2 Mallinckrodt shall allow Neurex employees or
representatives of an independent third party auditor selected by Neurex and
agreed upon by Mallinckrodt upon reasonable notice and at reasonable intervals
during normal business hours, to enter Mallinckrodt's facilities for the purpose
of verifying applicable Product Yield rates and compliance with applicable cGMP
regulations. It shall be a pre-condition of any such audit that the auditor
execute a confidentiality and non-use agreement similar to that in Section 14
below. In no event shall Mallinckrodt be obligated to disclose its Mallinckrodt
proprietary technology.
8. Warranties and Indemnification.
8.1 Mallinckrodt represents and warrants that it is not aware
that the making of the Product using or incorporating the Mallinckrodt
Proprietary Technology infringes any third party United States patent rights.
Neurex represents and warrants that it is not aware that the making of SNX- 1 1
1 infringes any third party patent rights.
8.2 Mallinckrodt and Neurex each represent and warrant to the
other that:
(a) It is a duly organized and validly existing
corporation in good standing under the laws of its jurisdiction of incorporation
and has taken all required corporate or other necessary action to authorize the
execution, delivery and performance of its obligations under this Agreement;
(b) This Agreement is a valid, binding and legal
agreement by it, enforceable against it in accordance with the terms and
conditions of this Agreement, and it has the full right, power and authority to
enter into this Agreement and perform all of its obligations hereunder; and
(c) The execution, delivery and performance of its
obligations under this Agreement will not result in any breach or violation of
its incorporation documents or bylaws or of any other agreement to which it is a
party, nor result in any violation of any law, rule, regulation, statute or
decree by which it or any of its assets are or may be subject.
8.3 Mallinckrodt warrants (a) that all Product manufactured,
stored, and shipped by it shall on the date of delivery meet the Specifications
attached hereto; (b) that all Product shall be manufactured in the United States
and shall be manufactured in accordance with current Good Manufacturing
Practices and, in all material respects, with all other applicable regulations
of the FDA and other appropriate agencies of the United States, state and local
governments; and (c) that it will make a reasonable good faith effort to improve
the Yield rates of the Product.
8.4 EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT
MALLINCKRODT MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND,
EITHER EXPRESS OR IMPLIED. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
8.5 Neurex shall defend, indemnify, and hold harmless
Mallinckrodt, its officers, agents, employees, and Affiliates from any loss,
claim, action, damage, expense, or liability (including defense costs and
attorneys' fees) ("Claim") including but not limited to the costs of
environmental sampling, clean-up, and remediation, arising out of or related to
the breach or alleged breach of any representation, warranty, or guarantee made
by Neurex herein or the handling, possession, or use of the Product following
acceptance of delivery by a common carrier pursuant to Section 5.5 except to the
extent such claim is due to the negligence or misconduct of Mallinckrodt, its
officers, agents or employees.
It is specifically understood and agreed that the use
of Accepted Product is within the sole control of Neurex and that Neurex will be
exercising sole discretion and control over the conditions of any such use
including without limitation any commercial applications of the Product or use
in clinical trials. It is further understood and agreed that Neurex is in a
unique and superior position to evaluate the suitability of the Product in and
for any such use and the potential hazards associated therewith. Therefore,
Mallinckrodt shall not be liable for and Neurex assumes all responsibility for
and shall defend, indemnify and hold Mallinckrodt harmless against any and all
loss, cost, damage, expense (including reasonable attorneys' fees) arising out
of or related to any claim for personal injury (including death) and/or damage
to property arising out of the possession, transportation, use, sale, testing,
or disposal of any Accepted Product.
8.6 In no event, regardless of the form of action shall
Mallinckrodt be liable for any special, indirect, incidental, consequential or
punitive damages of any nature whatsoever including without limitation loss of
profits or business interruption .
8.7 Mallinckrodt shall promptly notify Neurex of the existence
of any third party claim, demand or other action giving rise to a claim for
indemnification under this Agreement, and shall give Neurex a reasonable
opportunity to defend the same at its own expense and with its own counsel,
provided that Mallinckrodt shall at all times have the right to participate in
such defense at its own expense. If, within a reasonable time after receipt of
notice of a third party claim Neurex shall fail to undertake to so defend,
Mallinckrodt shall have the right, but not the obligation, to defend and to
compromise or settle (exercising reasonable business judgment) the third party
claim for the account and at the risk and expense of Neurex. Each party shall
make available to the other such information and assistance as the other shall
reasonably request in connection with the defense of a third party claim.
8.8 Each party shall maintain policies of comprehensive
general liability insurance, including product liability insurance, during the
term of this Agreement, having appropriate levels of coverage. At the written
request of a party, the other party shall provide to the requesting party
certificates or other evidence of such insurance. Mallinckrodt may satisfy this
requirement through their current program of self-insurance.
9. Term.
9.1 Subject to earlier termination as provided in this
Section 9, this Agreement shall become effective as of the Effective Date hereof
and continue until December 31, 1999. The parties shall negotiate in good faith
for a new Agreement one-hundred-eighty (180) days prior to that time, but if no
such Agreement is reached, the present Agreement shall continue in effect up to
an additional two (2) year period at Neurex's discretion provided that during
such two (2) year period Mallinckrodt shall be able to raise the price of
production in accordance with cost increases for Product since the commencement
of this Agreement according to Mallinckrodt's standard cost system.
9.2 Except with regard to Section 6 - Failure to Deliver, this
Agreement shall be terminable at the option of either party upon notice to the
other party, if such other party shall be in material breach or default with
respect to any term or provision hereof and fails to cure the same within thirty
(30) days after written notice of said breach or default, or is adjudged
bankrupt, or has filed against it a petition under any bankruptcy, which
petition is not withdrawn or dismissed within ninety (90) days. Such termination
may be made effective the date notice of termination is given or, in the case of
a default, at the end of the thirty (30)-day notice period.
9.3 Termination or expiration of this Agreement shall not
relieve the parties from any amounts owing between them, and shall not terminate
any rights or obligations arising prior to or upon termination or expiration of
this Agreement (as the case may be).
9.4 In the event of breach or threat of breach by Mallinckrodt
or Neurex of any provisions of this Agreement, the parties agree that the remedy
of the non-breaching party at law will be inadequate and such party shall be
entitled to appropriate injunctive and other relief (e.g., specific performance
and set off) in addition to its remedies at law.
1 0. Regulatory.
10.1 Neurex shall have the sole right to decide whether to
initiate, conduct, file and prosecute, at its expense, any clinical trials, new
drug applications or other relevant regulatory filings with the U.S. FDA or
similar agencies worldwide in connection with the Product. Neurex may designate
a third party to carry out these functions. Mallinckrodt will cooperate with
Neurex in the prosecution of any applications filed by Neurex, its affiliates or
licensees, worldwide in regard to the Product.
10.2 Neurex shall be responsible for compliance of the Product
with FDA standards. Mallinckrodt shall be responsible for compliance with FDA of
the manufacturing and container closure system in accordance with Schedule E.
Each party will provide reasonable assistance to the other, at no charge, if
necessary to respond to United States FDA or other United States or worldwide
regulatory agency's audits, inspections, inquiries or requests concerning the
Product. If Neurex desires Mallinckrodt to manufacture Product to meet third
country requirements, the parties will negotiate in good faith any changes
required to this Agreement to provide for manufacturing to such third country
requirements.
10.3 If the Product must be recalled solely for failure to
meet the Specifications at the time of delivery to Neurex or the failure to meet
applicable FDA cGMP manufacturing regulations for Bulk Drug Substances,
Mallinckrodt will reimburse Neurex for any direct costs reasonably expended by
Neurex to effect the recall and Mallinckrodt shall replace such recalled Product
as rapidly as commercially possible given Mallinckrodt's other existing peptide
manufacturing commitments.
11. Joint Venture; Licensing.
11.1 Notwithstanding the nature of the parties relationship as
set forth in Section 13, the parties acknowledge and agree that if at any time
during the term of this Agreement, the annual quantity of the Product for
Neurex's Analgesia indication for the U.S. market purchased by Neurex exceeds
two (2) kilograms, then Mallinckrodt shall consider in good faith negotiations
the formation of a joint venture with Neurex or its designee acceptable to
Mallinckrodt for the purpose of manufacturing Product. Any such joint venture
will contain among other terms, a provision allowing Mallinckrodt to demand the
dissolution of said joint venture upon sixty (60) days written notice in the
event that the annual quantity of Product for Neurex's Analgesia indication for
the U.S. market purchased by Neurex falls below 2kgs in any year. In the event
of such dissolution, Mallinckrodt shall receive sole right, title and interest
in and to any Mallinckrodt proprietary information contributed by Mallinckrodt
to the joint venture. In no event shall the failure of the parties to reach a
mutually satisfactory joint venture agreement nor any specific terms of such
joint venture agreement be subject to arbitration notwithstanding Article 16.2.
1 2. Debarment.
12.1 Mallinckrodt hereby certifies that it has not been
debarred under the provisions of the Generic Drug Enforcement Act of 1992, 21
U.S.C. ss.306(a) and (b). In the event that Mallinckrodt:
(a) becomes debarred; or
(b) receives notice of action or threat of action
with respect to its debarment during the term of this Agreement, Mallinckrodt
agrees to notify Neurex immediately. In the event that Mallinckrodt becomes
debarred as set forth above, this Agreement shall automatically terminate upon
receipt of such notice without any further action or notice.
12.2 Mallinckrodt hereby certifies that it has not and will
not use in any capacity the services of any individual, corporation, partnership
or association which has been debarred under 21 U.S.C. ss.306(a) and (b). In the
event that Mallinckrodt becomes aware of the debarment of any individual,
corporation, partnership or association providing services to Mallinckrodt,
which directly or indirectly relate to Mallinckrodt's activities under this
Agreement, Mallinckrodt shall notify Neurex immediately and Neurex shall have
the right to terminate this Agreement if such event shall substantially
adversely effect Neurex's or the Product's regulatory status or Mallinckrodt
cannot replace such debarred entity within sixty (60) days of such not)fication.
13. Independent Contractor. Both parties shall act solely as
independent contractors, and nothing in this Agreement shall be construed to
give either party the power or authority to act for, bind or commit the other
party. Each party shall indemnify the other and hold it harmless against any
claim based on a representation of authority in excess of that provided herein.
14. Confidentiality.
14.1 Both Mallinckrodt and Neurex recognize that information and
materials disclosed by the parties to the other hereunder, and generated by the
parties pursuant to work conducted under this Agreement, are of proprietary
value to them and are to be considered highly confidential ("Confidential
Information"). Each party agrees not to disclose the Confidential Information of
the other to third parties (except its employees who reasonably require the same
for the purposes hereof and who are bound to it by a like obligation as to
confidentiality) without the express written permission of the other party, and
not to use the Confidential Information, except in connection with work
conducted pursuant to this Agreement, except that neither party shall be
prevented from disclosing or using that portion of Confidential Information
received from the other which (a) can be demonstrated by written records to be
known to the recipient at the time of receipt; or (b) was subsequently otherwise
legally acquired by such party from a third party having an independent right to
disclose the information; or (c) which is now or later becomes publicly known
without breach of this Agreement by either party. The furnishing of information
by a disclosing party shall not constitute any grant, option or license to the
receiving party under any patents or other rights now or hereafter held by the
disclosing party, except as expressly provided for herein. Each party's
obligation of secrecy shall be in force during the term hereof and any extension
hereof and shall extend for a period of ten (10) years from the expiration or
early termination of this Agreement.
14.2 Anything to the contrary in Section 14.1 notwithstanding,
Mallinckrodt or Neurex shall be permitted to disclose Confidential Information
received hereunder (pursuant to obligations of confidentiality comparable to
those contained herein) to regulatory agencies in support of applications to
market the Product to clinicians as are required by law in connection with the
filing of such applications, in which case Neurex shall first obtain the written
approval of Mallinckrodt which shall not be unreasonably withheld.
15. Force Majeure.
15.1 Neither party hereto shall be liable in damages for, nor
shall this Agreement be terminable or cancelable by reason of, any delay or
default in any such party's performance hereunder if such default or delay is
caused by events beyond such party's reasonable control including, but not
limited to, acts of God, regulation or law or other action of any government or
agency thereof, war or insurrection, civil commotion, destruction of production
facilities or materials by earthquake, fire, flood or storm, labor disturbances,
epidemic, or failure of suppliers, public utilities or common carriers.
15.2 Each party shall promptly notify the other party upon
becoming aware of any event of force majeure under Section 15.1.
15.3 Each party agrees to endeavor to resume its performance
hereunder as soon as practicable if such performance is delayed or interrupted
by reason of force majeure.
16. Governing Law and Arbitration.
16.1 This Agreement shall be governed by and interpreted in
accordance with the laws of the State of Illinois (regardless of its, or any
other jurisdiction's, choice of law principles).
16.2 Any dispute, controversy or claim arising out of or
related to this Agreement, or the breach, termination or invalidity thereof,
shall be settled by arbitration in Chicago, Illinois in accordance with the
then-existing rules (the "Rules") of the American Arbitration Association
("AAA"). Any award or decision by the arbitrators shall be final and binding
upon the parties, and judgment thereon may be entered in any court having
jurisdiction thereof. Any award or decision shall be rendered by a majority of
the members of the Board of Arbitration consisting of three (3) members, one (1)
of whom shall be appointed by each party and the third of whom shall be the
chairman of the panel and be appointed by mutual agreement of the two (2) party
appointed arbitrators. In the event of failure of the two (2) arbitrators to
agree within sixty (60) days after the commencement of the arbitration
proceeding upon the appointment of the third arbitrator, the third arbitrator
shall be appointed by the AAA in accordance with the Rules. In the event that
either party shall fail to appoint an arbitrator within thirty (30) days after
the commencement of the arbitration proceeding, such arbitrator and the third
arbitrator shall be appointed by the AAA in accordance with the Rules. An
arbitration proceeding shall be deemed to commence upon request or demand for
arbitration filed with the AAA. The arbitrators shall apply the law as set forth
in Section 16.1 above.
17. Captions. The captions and paragraph headings of this
Agreement are solely for the convenience of reference and shall not affect its
interpretation.
18. Severability. Should any part or provision of this Agreement be
held unenforceable or in conflict with the applicable laws or regulations of any
jurisdiction, the invalid or unenforceable part or provision shall be replaced
with a provision which accomplishes, to the extent possible, the original
business purpose of such part or provision in a valid and enforceable manner,
and the remainder of this Agreement shall remain binding upon the parties
hereto.
1 9. Waiver.
19.1 No failure or delay on the part of a party in exercising
any right hereunder will operate as a waiver of, or impair, any such right. No
single or partial exercise of any such right will preclude any other or further
exercise thereof or the exercise of any other right. No waiver of any such right
will be deemed a waiver of any other right hereunder.
19.2 The parties agree that all Product supplied hereunder
shall be subject to and governed by the terms and provisions set forth herein,
and none of the terms and conditions contained in any purchase or order form,
invoice, or similar document shall have any effect upon or change the provisions
of this Agreement unless signed and delivered on behalf of both parties hereto
and clearly indicating that the parties intended to vary the terms hereof.
19.3 Any waiver on the part of either party hereto of any
right or interest hereunder shall be effective only if made in writing and shall
not (unless expressly so stated) constitute or imply a waiver of any other right
or interest, or a subsequent waiver.
20. Survival.
20.1 The provisions of Articles 7, 8, 9.3, 12, 14 and 16 shall
survive the termination or expiration of this Agreement.
20.2 The provisions of this Agreement which do not survive
termination or expiration hereof (as the case may be) shall, nonetheless, be
controlling on, and shall be used in construing and interpreting, the rights and
obligations of the parties hereto with regard to any dispute, controversy or
claim that may arise under, out of, in connection with, or relating to this
Agreement.
21. Assignment and Devolution.
21.1 Neurex may, at its sole discretion, assign this Agreement
and transfer all or any portion of its rights and obligations hereunder to any
Affiliate or licensee. Mallinckrodt may, with the written approval of Neurex,
which shall not be unreasonably withheld, assign this Agreement and transfer all
or any portion of its rights and obligations hereunder except that such approval
shall not be required in the event of assignment by Mallinckrodt to an
Affiliate. In any such assignment or transfer, Neurex and Mallinckrodt shall
respectively guarantee each and every obligation of its Affiliate hereunder, or
alternatively demonstrate to the other that the affiliate has greater financial
security than the assigning entity. Except as permitted under this Section 21.1,
this Agreement shall not be assignable by either party without the written
consent of the other party.
21.2 This Agreement shall extend to and be binding upon the
successors, legal representatives and permitted assigns of the parties;
provided, however, that if Mallinckrodt is acquired by a third party, by stock
purchase, asset purchase, merger or otherwise, or if that portion of
Mallinckrodt's business relating to the subject matter of this Agreement is
purchased by a third party, Mallinckrodt shall give written notice to Neurex
within five (5) business days of any such acquisition, and Neurex shall have the
option, by written notice thereof within thirty (30) days of such notice of
acquisition, to (a) terminate this Agreement, termination to be effective on the
date of acquisition unless otherwise agreed by the parties, or (b) continue
under this Agreement with the acquiring party guaranteeing each and every
obligation of Mallinckrodt hereunder.
22. Notices.
22.1 Any notice, payment, report, or other correspondence
(hereinafter collectively referred to as "correspondence") required or permitted
to be given hereunder shall be mailed or delivered by hand to the party to whom
such correspondence is required or permitted to be given hereunder. If mailed,
any such notice shall be deemed to be given when mailed as evidenced by the
postmark at point of mailing. If delivered by hand, any such correspondence
shall be deemed to have been given when received by the party to whom such
correspondence is given, as evidenced by written and dated receipt by the
receiving party.
22.2 All correspondence to Mallinckrodt shall be addressed as
follows:
Mallinckrodt Chemical, Inc.
00000 Xxxxxxxx Xxxxx Xxxxx
Xxxxxxxxxxxx XX 00000
Attention: President, Pharmaceutical Specialties Division
with a copy to:
:
Mallinckrodt Chemical, Inc.
00000 Xxxxxxxx Xxxxx Xxxxx
Xxxxxxxxxxxx XX 00000
Attention: Division Counsel, Pharmaceutical Specialties Division
22.3 All correspondence to Neurex shall be addressed as
follows:
Neurex Corporation
0000 Xxxxx Xxxxxx
Xxxxx Xxxx, XX 00000
Attention: President
with a copy to:
Wise & Xxxxxxx 0000
Xxxxxx Xxx Xxxxx
000 Xxxx Xxxx, XX 00000
Attention: Xxxxxx Xxxxxx
22.4 Any entity may change the address to which correspondence
to it is to be addressed by notification as provided for herein.
23. Entire Agreement. This Agreement, including the attached
Schedules made a part hereof, constitutes the entire agreement between the
parties hereto respecting the subject matter hereof, and supersedes all prior
agreements, negotiations, understandings, representations and statements
respecting the subject matter hereof, whether written or oral. The terms of this
Agreement shall not be mod)fied, superseded, amended or supplemented by any
invoice or purchase order issued hereunder. No mod)fication, alteration, waiver
or change in any of the terms of this Agreement shall be valid or binding upon
the parties hereto unless made in writing and duly executed by the parties
hereto.
IN WITNESS WHEREOF, the parties have executed this Agreement as of
the date first above written.
NEUREX CORPORATION MALLINCKRODT CHEMICAL, INC.
/S/ Xxxx Xxxxxxx /S/ Xxxxxxx X. Xxxxxxx
----------------- -----------------------
Xxxx Xxxxxxx Xxxxxxx Xxxxxxx
Schedules to the Neurex/Mallinckrodt Manufacturing and Supply Agreement:
Schedule A - Product Specifications
Schedule B - Payment/Yield Terms
Schedule C - Methods of Analysis
Schedule D - Order and Delivery Dates and Maximum Orders
Schedule E - Container Closure System
SCHEDULE A
Protoct Speciflcatlons and
Methods of Analysis
Neurex SNX.111
TEST METHOD SPECIFICATION
Confidential treatment has been requested for the entire contents of this
schedule, which has been filed separately with the Commission.
SCHEDULE B
Pavment/Yield Terms
$ Price/Gram Net Peptide/Yield
Yield per Batch
Quantity
Ordered 5% 6% 7% 8% 9% 10%
1-50 gms. [*] [*] [*] [*] [*] [*]
51-149
150-299
300-499
500-999
1000
* In the event that the yield is less than 5%, the applicable price shall be
based on the 5% yield price.
Yield is defined as weight of net peptide
weight of peptide resin
Example: 100 gms. of SNX-111 = 5%
2000 gms. of peptide resin
SCHEDULE C
UNCONTROLLED COPY 09/23/96 08:50 AM
Specifications and Methods Manual
Confidential treatment has been requested for the entire contents of this
schedule which has been filed separately with the Commission.
CONFIDENTIAL
SCHEDULE D
ORDER AND DELIVERY DATES AND MAXIMUM ORDERS
Order Date Delivery Date Maximum Order
---------- ------------- -------------
April 1, 1997 September 30, 1997 [*]
October 1, 1997 March 31, 1998 [*]
April 1, 1998 September 30, 1998 [*]
October 1, 1998 December 31, 1998 [*]
January 1, 1999 June 30, 1999 [*]
July 1, 1999 December 31, 1999 [*]
January 1, 2000 June 30, 2000 [*]
July 1, 2000 December 31, 2000 [*]
January 1, 2001 June 30, 2001 [*]
July 1, 2001 December 31, 2001 [*]
* All Quantities On A Net Peptide Basis
* * If Agreement is extended 2 years per Section 9.1.
Within three (3) months of Neurex's filing its NDA for Analgesia indications,
Neurex and Mallinckrodt will negotiate in good faith a potential revision to
this Schedule D.
Q:SAR:JAL:NEUREX07.DOC - 10/1 6/96
SCHEDULE E
Container Description
Number
01731 Vial, Type m, Clear, ldrarn, 13-425
09610 Closure, Urea, Green, 13-425, Teflon lining
01650 Bottle, Type III, Clear, French Square, 1/2 oz., 20-405
09600 Closure, Melamine, Green, 20-400, w/Teflonlining
00000 Xxxxxx, Xxxx X, Xxxxx, loz., 24-405
09601 Closure, Melamine, Green, 24-400, w/Teflonlining
01652 Bottle, Type m, Clear, 2OZ., 43-405
09602 Closure, Urea, Green, 43-400, w/Teflon lining
-
01654 Bottle, Type m, Clear, 8OZ., 58-405
09604 Closure, Urea, Green, 58-400, w/Teflon lining
-
01655 Bottle, Type m, Clear, 16 OZ., 63-405
09605 Closure, Urea, Green, 63-400, w/Teflon lining
01656 Bottle, Type W, Clear, 32 OZ., 63-405 - uses CN09605 cap
09605 Closure, Urea, Green, 63-400, w/Teflonlining
01653 Bottle, Type m, Clear, 4 OZ., 48-405
09603 Closure, Urea, Green, 48-400, w/Teflonlining
