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CONFIDENTIAL TREATMENT REQUESTED
FOR PORTIONS OF THIS DOCUMENT
EXHIBIT 10.15
MANUFACTURING AGREEMENT
AGREEMENT dated as of February 11, 1998 by and between UNITED THERAPEUTICS
CORPORATION ("UNITED THERAPEUTICS"), a Delaware corporation with principal
offices at 0000 X Xxxxxx XX, Xxxxxxxxxx XX 00000 and Steroids, Ltd. ("STEROIDS")
an Illinois corporation with principal offices at 0000 Xxxx Xxxxxxxx Xxxx Xxxxx,
Xxxxxxx, Xxxxxxxx 00000.
WHEREAS, STEROIDS has the expertise, personnel, and facilities for the
manufacture of active pharmaceutical ingredients (API's), and desires to provide
such service to contracting parties;
WHEREAS, UNITED THERAPEUTICS has worldwide exclusive rights to make and
sell the stable prostacyclin analog formerly known as 15AU81 and now known as
UT-15;
WHEREAS, UNITED THERAPEUTICS and STEROIDS are parties to an agreement
("EXISTING AGREEMENT') consisting of STEROIDS' Proposal for Process Development
Program for Synthesis of 15AU81 dated February 7, 1997, and UNITED THERAPEUTICS'
acceptance of STEROIDS' aforementioned proposal, dated March 14" 1997, and of
STEROIDS' proposal for process development dated November 4, 1997 and UNITED
THERAPEUTICS' acceptance of STEROIDS' proposal dated November 11, 1997 and of
STEROIDS' letter quotation for the cGMP synthesis of 300 grams of 15AU81 dated
October 8, 1997 and UNITED THERAPEUTICS's acceptance of STEROIDS' proposal dated
October 21, 1997.
NOW, THEREFORE, STEROIDS and UNITED THERAPEUTICS wish to continue, expand
and further formalize their EXISTING AGREEMENT with this Manufacturing Agreement
and thus hereby agree as follows:
1. DEFINITIONS
The Defined terms used in this Agreement shall have the following meanings:
1.01 "Affiliate" means (a) any company owned or controlled to the extent of
more than fifty percent (50%) of its issued and voting capital by a party to
this Agreement and any other company so owned or controlled, directly or
indirectly, by any such company or the owner of any such company, or (b) any
partnership, joint venture or other entity directly or indirectly controlled by,
controlling, or under common control of, to the extent of more than fifty
percent (50%) of voting power, or otherwise having power to control its general
activities, a party to this Agreement, but in each case only for so long as such
ownership or control shall continue.
1.02 "API" means the active pharmaceutical ingredient manufactured by
STEROIDS in accordance with the procedures developed under Exhibit A and
provided to UNITED THERAPEUTICS pursuant to this Agreement.
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1.03 "Confirmed Purchase Order" means a purchase order issued by UNITED
THERAPEUTICS and received by STEROIDS for the manufacturing of the API, for
which a completion date has been scheduled.
1.04 "CDER" means FDA's Center for Drugs Evaluation and Research.
1.05 "API Substance" means the chemical entity UT-15.
1.06 "FDA" means the U.S. Food and Drug Administration.
1.07 "Facility" means STEROIDS' or its authorized agent's manufacturing
facility.
1.08 "Manufacturing Date" means scheduled date on which STEROIDS intends to
begin manufacturing UNITED THERAPEUTICS' API pursuant to a Confirmed Purchase
Order.
1.09 "Good Manufacturing Practices" or "GMP" means current good
manufacturing practices, as specified in regulations promulgated from time to
time by the FDA for the manufacture and testing of pharmaceutical materials and
the corresponding requirements of the European Union, Member States of the
European Union, and Canada.
1.10 "Incoming Acceptance Test" means those analytical tests requested by
UNITED THERAPEUTICS to be performed on a received shipment of API, which tests
will be identified by a separate letter between the parties.
1.11 "Lot" means the API produced in a single production run, which may be
contained in one or more containers thereof.
1.12 "New Procedure" means a method, process, or test that is not included
within STEROIDS' SOPS, but which is requested by UNITED THERAPEUTICS in writing
that STEROIDS perform.
1.13 "Sensitive Regulatory Submission Period" means the period between six
(6) months prior and subsequent to a defining date set forth by UNITED
THERAPEUTICS, in which period UNITED THERAPEUTICS intends to file an
Investigational New Drug amendment or a NDA.
1.14 "SOPS" means written standard operating procedures and methods of
STEROIDS.
2. MANUFACTURE, STORAGE AND DISTRIBUTION OF API.
The following provisions relate to the manufacture, storage and
distribution of API for UNITED THERAPEUTICS by STEROIDS.
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2.01 Terms of Supply. The following terms relate to categories of
manufacturing:
2.01.1 Subject to the terms and conditions hereof, during the Term and
any Renewal Terms of the Agreement, STEROIDS agrees to provide and
UNITED THERAPEUTICS agrees to accept from STEROIDS manufacturing
services provided that such services are performed in accordance with
STEROIDS' SOPS and UNITED THERAPEUTICS's written instructions,
including, but not limited to those contained in Exhibit A.
2.01.2 Subject to the terms and conditions of this Agreement, during
the Term and any Renewal Terms of this Agreement, STEROIDS agrees to
sell and UNITED THERAPEUTICS agrees to purchase from STEROIDS API
manufactured under this Agreement in accordance with the terms of
Attachment A:
2.02 Terms of Storage and Distribution. The following terms relate to
storage and distribution of API:
2.02.1 STEROIDS will maintain the appropriate storage conditions
throughout holding and shipping of the manufactured API in accordance
with Sections 7.01 and 7.02, and UNITED THERAPEUTICS's written
instructions.
2.02.2 UNITED THERAPEUTICS will be responsible for order entry and
return material authorization, including all costs attendant thereto.
Such costs include, but are not limited to return postage,
telephone-related services, storage of returned API and other
material, and disposal of returned API and other material.
2.02.3 STEROIDS will only ship API Substance per written instructions
from UNITED THERAPEUTICS, via Facsimile and confirming originals.
STEROIDS will track all shipments, and record and maintain GMP
documentation, including Lot traceability.
(a) STEROIDS may ship API Substance for testing purposes pursuant to
written requests by UNITED THERAPEUTICS.
2.02.4 If requested, STEROIDS will conduct shipping validation in
accordance with a plan to be developed jointly with UNITED
THERAPEUTICS and written by STEROIDS, including a cost estimate. Upon
the conclusion of the shipping validation, STEROIDS will prepare and
submit a report detailing the shipping validation program and its
results. STEROIDS will invoice UNITED THERAPEUTICS therefore at
STEROIDS' reasonable cost.
2.02.5 Unless otherwise instructed by UNITED THERAPEUTICS, STEROIDS
will dispose of all returned API and invoice UNITED THERAPEUTICS for
STEROIDS' cost of disposal; however, costs of handling and disposing
API returned due to an FDA or UNTIED THERAPEUTICS mandated recall of
an entire Lot of API Substance will be invoiced to UNITED THERAPEUTICS
at
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STEROIDS' cost plus [ ]. The cost of return shipping will be invoiced
to UNITED THERAPEUTICS at STEROIDS' cost. Labor and costs relating to
investigation of returned API Substance are not included in this
Agreement.
3. PAYMENT FOR SERVICES
STEROIDS will invoice UNITED THERAPEUTICS for charges related to
manufacturing API as specified in the Proposal in Attachment A with a goal of [
] per kilogram. Payment for services will be in accordance with Attachment A.
Payments shall be due within 30 days of receipt of STEROIDS invoice.
3.01 Late Payments. For any payment owed under this Agreement and not
received by the applicable Due Date, interest will accrue at the monthly rate of
1.5% (18% per year) calculated on daily outstanding balance, and compounded
monthly, on all outstanding balances starting from the applicable Due Date. Any
subsequent payments received will first be applied to the outstanding interest
and then to any then current balance. UNITED THERAPEUTICS agrees to pay for the
costs of collecting any payments due STEROIDS under this Agreement, including
the costs of reasonable collection costs and attorney's fees. If UNITED
THERAPEUTICS does not pay an invoice in full, including interest charges, after
three (3) months of mailing, then UNITED THERAPEUTICS will be in breach of this
Agreement and STEROIDS, at its discretion, may terminate this Agreement under
the provisions of Section 11. 03 hereof.
4. SUPERVISION BY UNITED THERAPEUTICS
4.01 UNITED THERAPEUTICS will be responsible for Quality Control testing
and approval/release of the API unless otherwise provided in writing.
4.02 The following employee of UNITED THERAPEUTICS is hereby designated as
having the responsibility for Quality Control and Quality Assurance and ensuring
that STEROIDS' activities hereunder are carried out in accordance with UNITED
THERAPEUTICS's written instructions and GMP:
Name: Xxxxxxx X. Xxxxxxxxx, Xx.
Title: Director of Operations
Address: UNITED THERAPEUTICS CORPORATION
0 Xxxxx Xxxxx
Xxxxxxxx Xxxxxxxx Xxxx, XX 00000
Telephone: 000-000-0000
Other employees of UNITED THERAPEUTICS may be designated from time to time,
provided STEROIDS is notified in advance in writing of his or her name, title,
address and telephone number. At no time, however, shall there be more than two
UNITED THERAPEUTICS employees sharing this responsibility.
4.03 The individual(s) designated by UNITED THERAPEUTICS pursuant to
Section 4.02 shall carry out his/her responsibilities through periodic on-site
visits, observation of
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STEROIDS' Facility and activity therein through its observation window,
telephonic reports and written memoranda. UNITED THERAPEUTICS will continue to
monitor STEROIDS' operations as they relate to API by conducting periodic audits
of STEROIDS' facility to assure ongoing compliance with UNITED THERAPEUTICS's
written instructions and GMP. Such individuals as designated shall use due
diligence and best efforts in conducting such Quality Control activities so as
not to delay STEROIDS ability to release Bulk Substance or Product and secure
payment therefore on a regularly scheduled basis.
5. STANDARD OPERATING PROCEDURES AND FORMS
5.01 All activities conducted hereunder by STEROIDS will be conducted in
accordance with Standard Operating Procedures prepared by STEROIDS that comply
with Sections 7.01 and 7.02, and any other written specifications or procedures
provided by UNITED THERAPEUTICS and accepted by STEROIDS.
5.02 STEROIDS agrees that for each Lot of API filled and packaged
hereunder, STEROIDS will complete and furnish to UNITED THERAPEUTICS one (1)
copy of the Batch production records, the originals of which will be retained by
STEROIDS to the extent required by federal regulation. Both parties acknowledge
that such records will include in-process test data for each Lot.
5.02.1 The aforementioned original Batch production records shall be
retained as noted herein, and while so retained shall be available for
inspection by regulatory authorities, UNITED THERAPEUTICS, and UNITED
THERAPEUTICS' authorized representatives,
5.02.2 Sections 5.02 and 5.02.1 shall survive termination of this
Agreement for such period as such records are required to be
maintained by federal regulation.
5.03 STEROIDS and UNITED THERAPEUTICS both agree to maintain a complete
record of information for each Lot and Batch for the period required by law,
including the information referred to in Section 5.02. Each of STEROIDS and
UNITED THERAPEUTICS acknowledges that maintenance of summaries of such
information, as opposed to complete copies of the original records themselves,
will not constitute fulfillment of the obligation referred to in the immediately
preceding sentence.
6. PERMISSION TO INSPECT
6.01 STEROIDS hereby agrees and acknowledges that upon prior reasonable
written notice it will permit authorized representatives of the FDA or
comparable foreign regulatory authority, including, without limitation,
authorized representatives of CDER, to inspect those portions of the STEROIDS
Facility in which STEROIDS performs the activities provided for in this
Agreement.
6.01.1 To the extent STEROIDS has prior notice, STEROIDS agrees to
notify UNITED THERAPEUTICS of any inspection by the FDA that relates
specifically
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to STEROIDS API and give UNITED THERAPEUTICS timely updates on the
inspection. UNITED THERAPEUTICS may send a representative to STEROIDS
on the day of the inspection, however UNITED THERAPEUTICS's
representative may not participate in or observe the inspection itself
or have any substantive written or verbal communication with the FDA
inspectors, unless so requested by STEROIDS. STEROIDS agrees to
provide a timely verbal update to UNITED THERAPEUTICS regarding any
such inspection.
6.02 STEROIDS will provide in a timely manner copies of written
communications from such FDA inspections that pertain to API,
including but not limited to documents entitled Observations. Any such
written communications shall be redacted with respect to information
relating to STEROIDS' APIs and any third party.
6.03 This Article 6 shall survive termination of this Agreement in
perpetuity.
7. COMPLIANCE WITH CURRENT GMP
7.01 STEROIDS agrees that, in performing the activities provided for in
this Agreement, it will comply with GMP.
7.02 STEROIDS agrees to perform all of the activities provided for in this
Agreement in accordance with written instructions provided by UNITED
THERAPEUTICS, unless STEROIDS has previously advised UNITED THERAPEUTICS that it
is not able to do so. In the event UNITED THERAPEUTICS desires to modify its
instructions, UNITED THERAPEUTICS agrees to notify STEROIDS of the planned
modifications in writing and to provide a reasonable period of time before
submitting such modifications to the FDA, if necessary, so that STEROIDS has
sufficient time to implement those modifications that affect its activities
hereunder.
8. FDA REGISTRATION OF THE FACILITY
STEROIDS will perform the activities provided for in this Agreement at its
Facility, unless otherwise specified or approved in advance by UNITED
THERAPEUTICS and the appropriate regulatory authorities. The current Facility
will be registered with the FDA and any new facility where API is synthesized
will also be registered.
9. LABEL CONTROL
9.01 In-process labels are to be used by STEROIDS in performing the
activities provided for in this Agreement. The parties agree that STEROIDS has
the right to modify said labels to the extent permitted by law, upon written
notice to UNITED THERAPEUTICS and, where required, after authorization by CDER.
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10. TERM
10.01 This Agreement will be effective as of the date first set forth above
and will remain in effect for a term of five (5) years ("Term") subject to early
termination in accordance with the terms of the provisions of Section 11. The
parties agree to renew this Agreement automatically for renewal terms of one (1)
year ("Renewal Term") unless either party objects to doing so in writing no
later than four (4) months prior to the expiration of a Term or Renewal Term.
11. TERMINATION
11.01 UNITED THERAPEUTICS will have the right, exercisable in its sole
discretion, with or without cause, to terminate this Agreement by giving to
STEROIDS four (4) months advance written notice of termination. After giving
notice of termination and throughout the period ending on the date the notice of
termination becomes effective, UNITED THERAPEUTICS agrees to continue to perform
all of its obligations hereunder.
11.02 If either STEROIDS or UNITED THERAPEUTICS materially breaches or
defaults in the performance or observance of any of the provisions of this
Agreement and such breach or default is not cured within two (2) months after
the giving of notice by the other party specifying such breach or default, the
other party will have the right to terminate this Agreement in full upon a
further one (1) month's notice. Each party shall also have the right to
terminate this Agreement in full upon a one (1) month's notice in the event that
there has been a loss, destabilization, alteration or contamination of API while
in STEROIDS' possession, wherein the loss, etc. resulted in a material adverse
effect. Termination under this Section 11.04 shall relieve the parties of all
future obligations relating to purchase and performance of services under
Article 2 from and after such termination date.
11.03 Upon termination of this Agreement, whether or not for cause,
STEROIDS will provide written notice to UNITED THERAPEUTICS of any inventory of
API and other materials either provided by or purchased, invoiced and paid for
by UNITED THERAPEUTICS and request written instructions from UNITED THERAPEUTICS
as to where to ship same. Such shipment shall be at UNITED THERAPEUTICS's
expense, and UNITED THERAPEUTICS shall be responsible for all storage costs,
payable prior to release of the inventory and associated materials.
12. WARRANTIES
12.01 Mutual Representations and Warranties. Each Party hereby represents
and warrants to the other Party that this Agreement constitutes the legal, valid
and binding obligation of such Party, enforceable in accordance with its terms,
subject to applicable bankruptcy, reorganization, insolvency, moratorium and
similar laws affecting creditors' rights generally, and that the execution,
delivery and performance of this Agreement does not conflict with any material
agreement, instrument or understanding, oral or written, to which such Party may
be bound, nor violates any law or regulation of any court, governmental body or
administrative or
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other agency having jurisdiction over it, except for such conflicts or
violations that would not have a material adverse effect on the business,
properties or financial condition of the other party.
12.02 UNITED THERAPEUTICS Warranties.
12.02.1 UNITED THERAPEUTICS warrants:
(a) that all activities of UNITED THERAPEUTICS under this
Agreement will be accomplished in accordance with the terms of
this Agreement;
(b) that, to the best of its knowledge, there are no
intellectual property rights, such as, but not limited to
valid United States patents, that would be infringed by the
manufacture, use or sale of API or the use of any New
Procedure. Notwithstanding the preceding sentence, UNITED
THERAPEUTICS makes no warranty with respect to intellectual
property rights relating to any processes performed by
STEROIDS hereunder, except for a New Procedure.
12.03 STEROIDS Warranties.
12.03.1 STEROIDS warrants:
(a) that all activities of STEROIDS under this Agreement will
be accomplished in accordance with (i) the terms of this
Agreement and all Attachments, (ii) all written manufacturing
instructions received from UNITED THERAPEUTICS and accepted by
STEROIDS, (iii) GMP, and (iv) other applicable laws, rules and
regulations;
(b) that, upon delivery of API to a carrier on behalf of
UNITED THERAPEUTICS or UNITED THERAPEUTICS's designee, API
will not be misbranded or otherwise of a nature that may not
be introduced in United States interstate commerce, unless so
directed by UNITED THERAPEUTICS in writing, however, this
warranty of Section 12.03.1 (b) shall not apply if and to the
extent that such condition obtains because UNITED THERAPEUTICS
has breached its warranties in Section 12.02.1;
(c) that it shall not knowingly ship API that has not passed
USP sterility testing or is beyond its labeled expiration
date, or is materially adversely affected due to misbranding,
contamination, having been handled contrary to GMP, or having
been subjected to negligence, unless so instructed in writing
by UNITED THERAPEUTICS, STEROIDS shipping of API is not
intended for any further "Commercial Purpose"
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(d) that, to the best of its knowledge, there are no
intellectual property rights, such as, but not limited to
valid United States patents, that would be infringed by any
processes performed by STEROIDS under this Agreement
12.04 No Other Warranties. The express warranties made in this Agreement
are made in lieu of all other warranties, express or implied, including, without
limitation, the warranties of merchantability and fitness for a particular
purpose.
13. INDEMNIFICATION
13.01 Subject to the provisions of Section 13.05, UNITED THERAPEUTICS will
defend, indemnify and hold harmless STEROIDS and its directors, officers,
employees, agents, successors, and assigns from and against all suits, claims,
liabilities, losses, and expenses, including reasonable attorneys' fees and
expenses, arising directly or indirectly out of injury to persons or property
alleged to have been caused by the design, manufacture, testing, instructions or
warnings accompanying API, or use or unavailability of API or UNITED
THERAPEUTICS breach of this Agreement, except to the extent that the injury is
alleged to have been caused solely by STEROIDS' breach of this Agreement,
intentional action, willful inaction, or gross negligence while providing the
services described herein, provided, however, that the indemnity provisions of
this section 13.01 remain m effect where STEROIDS' allegedly injury-causing
behavior was effected pursuant to specific instructions of UNITED THERAPEUTICS.
The aforementioned injury to persons or property specifically includes, without
limitation, alleged infringement of patent or other intellectual property rights
of third parties by the manufacture, use, or sale of API or the use of a New
Procedure. UNITED THERAPEUTICS shall have full control over the defense of any
such litigation, and agrees to bear all costs and expenses thereof. STEROIDS, at
its own expense, will be entitled to be represented by its own counsel in any
such litigation.
13.02 UNITED THERAPEUTICS agrees that STEROIDS' liability resulting from
the loss, destabilization, alteration or contamination of API of a particular
Lot, wherein such API is lost, destabilized, altered or contaminated such that
it cannot be used in clinical trials or is not placed into commerce, shall not
exceed the amount of any insurance recoveries net of any applicable deductible
realized by STEROIDS in respect to the foregoing plus the value of services
provided with respect to the Lot in question.
13.03 Subject to the provisions of Section 13.02 and 13.05, STEROIDS will
defend, indemnify and hold harmless UNITED THERAPEUTICS and its directors,
officers, employees, agents, successors, and assigns from and against all suits,
claims, liabilities, losses, and expenses, including reasonable attorneys' fees
and expenses, arising directly or indirectly out of injury to persons or
property alleged to have been caused in whole or in part by STEROIDS' breach of
this Agreement, intentional action, willful inaction, or gross negligence while
providing the services described herein to UNITED THERAPEUTICS; provided,
however, that such indemnity shall not apply if such breach, intentional action,
willful inaction, or gross negligence resulted from specific instructions of
UNITED THERAPEUTICS or in part from any breach, intentional
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action, willful action or gross negligence of UNITED THERAPEUTICS. The
aforementioned injury to persons or property specifically includes, without
limitation, alleged infringement of patent or other intellectual property rights
of third parties by STEROIDS' manufacturing procedures, irrespective of API,
performed under this Agreement provided, however, STEROIDS performance of a New
Procedure is specifically excluded from such indemnity. STEROIDS shall have full
control over the defense of any litigation, and agrees to bear all costs and
expenses therefor. UNITED THERAPEUTICS, at its own expense, will be entitled to
be represented by its own counsel in any such action.
13.04 In the event that a suit, claim, liability, loss or expense,
including reasonable attorneys' fees and expenses, arises out of injury to
persons or property alleged to have been caused by both events or circumstances
for which (i) both UNITED THERAPEUTICS and STEROIDS have indemnity obligations
under Sections 13.01 and 13.04, or (ii) UNITED THERAPEUTICS or STEROIDS have
indemnity obligations under Sections 13.01 and 13.04 and one or more third
parties are alleged to be liable for the injury, then the parties agree to pay
losses and expenses arising from such suit claim, liability, loss or expense in
proportion to each party's respective liability for the injury, as adjudged by a
court of competent jurisdiction or, if a settlement is reached, negotiation
between the parties, wherein the parties agree to negotiate their respective
liability for the injury in good faith. UNITED THERAPEUTICS further agrees that
the liability of any such third party shall be attributed solely to UNITED
THERAPEUTICS and that UNITED THERAPEUTICS shall pay any losses and expenses in
proportion to the sum of UNITED THERAPEUTICS's and the third party or parties'
combined liability relative to the total liability.
13.05 No indemnity under Article 13 shall be applicable unless the
indemnified Party (ii) gives the indemnifying Party prompt notice of any claim,
suit or action brought against the indemnified Party, (ii) allows the
indemnifying Party to defend the same, without prejudice to the right of the
indemnified Party to participate at its expense through counsel of its own
choosing, (iii) renders the indemnifying Party all assistance reasonably
necessary in defending against such claim, suit or action at the indemnifying
Party's expense, and (iv) does not compromise or settle such claim, suit or
action without the indemnifying Party's prior written consent. The indemnifying
party shall not settle such claim, suit or action without the indemnified
party's consent if such settlement results in any obligation or liability on the
part of the indemnified party.
14. CONFIDENTIALITY
14.01 Nondisclosure and Nonuse.
14.01.1 STEROIDS and UNITED THERAPEUTICS shall each retain in
confidence information obtained from the other under this Agreement and shall
not disclose such information to any third party except
(a) consultants and Affiliates who are obligated to maintain
it in confidence pursuant to a written agreement that
incorporates by reference
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the terms of Article 14, or that incorporates substantially
similar terms having equivalent scope of protection as those
of this Article 14.
(b) as necessary to obtain approval from a governmental agency
in order to market and sell the API;
(c) as reasonably may be required in a patent application
covering subject matter that is encompassed with this
Agreement; or
(d) as otherwise may be required by law, regulation or
judicial order.
14.01.2 STEROIDS and UNITED THERAPEUTICS each agree that information
that subject to this Article 14 shall be used only for those purposes
contemplated by this Agreement.
14.01.3 Each party shall take all reasonable precautions to safeguard
the confidentiality of the information.
14.02 Exceptions.
14.02.1 The obligations of nondisclosure and nonuse of this Article 14
shall not apply to information that
(a) is known to the receiving party, as evidenced by written
records maintain by the receiving party, or to the public, or
is in the public domain, prior to its disclosure under this
Agreement;
(b) is hereafter lawfully disclosed to the receiving party by
a third party not under an obligation of confidence to the
other party; or
(c) subsequently enters the public domain or becomes known to
the public some means other than a breach of this Agreement.
14.03 Each party acknowledges that the restrictions contained in this
Article 14 are necessary and reasonable to protect the legitimate interests of
the parties and a violation of this Article 14 by a party may result in
irreparable harm to the other party.
14.04 The provisions of this Article 14 shall survive the expiration or
terminate of this Agreement and continue for ten (10) years thereafter.
14.05 All prior confidentiality agreements between the parties hereto are
hereby superseded Article 14 of this Agreement, such that any information
previously disclosed between parties under any such prior agreement shall
henceforth by treated as if disclosed under this Agreement.
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15. MISCELLANEOUS
15.01 Force Majeure. No party will be liable for failure of or delay in
performing obligations set forth in this Agreement, and no party will be deemed
in breach of its obligations if such failure or delay is due to natural
disasters or any causes reasonably beyond the control or anticipation of such
party. Each party agrees to use its best efforts to mitigate the impact on its
performance under this Agreement caused by a force majeure.
15.02 The parties agree that their rights (except for the rights to receive
and obtain payments owed in accordance with this Agreement) and obligations
under this Agreement may not be delegated, transferred or assigned to a third
party without the prior consent of the other party; whether by operation of law
or contract. Nevertheless, either party may transfer or assign its rights and
obligations under this Agreement to any entity which acquires substantially all
of its assets and business, or is an Affiliate of the assigning party.
15.03 Status of Parties. For the purpose of carrying out this Agreement
each party will act an independent contractor and not as partner, joint
venturer, or agent with respect to the other party, and neither party will bind
nor attempt to bind the other party to any contract.
15.04 Notice. Any notice, consent or approval required under this Agreement
will be in writing sent by registered or certified mail, postage prepaid, or by
facsimile, confirmed by such registered or certified mail, and addressed as
follows:
If to STEROIDS:
Steroids Ltd
0000 Xxxx Xxxxxxxx Xxxx Xxxxx
Xxxxxxx, Xxxxxxxx 00000
Attn: Xxxxxx Xxxxxxxx Ph.D.
President
If to UNITED THERAPEUTICS:
UNITED THERAPEUTICS CORPORATION
0 Xxxxx Xxxxx
Xxxxxxxx Xxxxxxxx Xxxx, XX 00000
Attn: Xxxxx Xxxx, PhD
President
(000) 000-0000
All notices shall be deemed effective on the date of mailing, unless otherwise
stated herein. In case either party changes its address or facsimile number at
which notice is be received, written notice of such change will be given without
delay to the other party.
15.05 Entire Agreement. This Agreement and the exhibits attached hereto set
forth the entire agreement and understanding among the parties hereto as to the
subject matter hereof has
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priority over all documents, verbal consents or understandings made between
STEROIDS and UNITED THERAPEUTICS with respect to the subject matter hereof. None
of the terms of this Agreement may be amended or modified except in writing
signed by both parties hereto.
15.06 Waivers. A waiver by either party of any term or condition of this
Agreement in any one instance will not be deemed or construed to be a waiver of
such term or condition for similar instance in the future or of an subsequent
breach hereof.
15.07 Applicable Law. This Agreement will be governed by and construed in
accordance the laws of the District of Columbia without regard to the conflicts
of laws provisions thereof.
15.08 Remedies. The rights and remedies of a party set forth herein with
respect to failure of the other to comply with the terms of this Agreement,
including, without limitation, rights of full or partial termination of this
Agreement are not exclusive, the exercise thereof will not constitute an
election of remedies and the aggrieved party will in all events be entitled to
seek whatever additional remedies may be available in law or in equity.
15.09 Headings. Headings in this Agreement are included herein for case of
reference only and will have no legal effect. References to sections are to
sections of this Agreement unless otherwise specified.
15.10 Title and Intellectual Property to API. UNITED THERAPEUTICS will
retain title to API and all intellectual property in the API, including but not
limited to the agreed initial process to make the API and any New Procedure,
shall belong solely to UNITED THERAPEUTICS. STEROIDS agrees to cooperate fully
in assigning all patent and other intellectual property rights in or related to
the API to UNITED THERAPEUTICS. STEROIDS agrees to cooperate fully in the
preparation of patent applications related to the synthesis of the API. STEROIDS
will retain title and rights to all inventions, concepts, ideas, proprietary
information, manufacturing processes or chemical synthesis not directly and
solely related to the Product, the agreed initial process to make the API and
any new procedure. UNITED THERAPEUTICS shall have the rights to a perpetual,
fully paid, non-exclusive license to any discovery, invention, etc. to which
STEROIDS retain title.
15.11 Use of API. STEROIDS use of the API shall be limited to the
activities described in this Agreement.
15.12 Assignment. Neither this Agreement nor any of its rights or
obligations may be assigned, delegated or otherwise transferred, in whole or in
part, by either Party without the prior written consent of the other, except
that, without securing such prior consent, any Party shall have the right to
assign this Agreement to any successor of such party by way of merger or
consolidation or the acquisition of substantially all of the entire assets of
such Party relating to the subject matter of this Agreement, provided, however,
that such successor shall expressly assume all of the obligations of such Party
under this Agreement. The Parties agree that this Agreement shall be binding
upon and inure to the benefit of their respective successors and approved
assigns.
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed as of the date first written above by their duly authorized officers.
UNITED THERAPEUTICS CORPORATION STEROIDS, LTD.
/s/ Xxxxx X. Xxxx /s/ Xxxxxx X. Xxxxxxxx
------------------------------ ------------------------------
Xxxxx X. Xxxx, Ph.D. Xxxxxx X. Xxxxxxxx
Dated: Dated:
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