Exhibit 10.5
CHILDREN'S HOSPITAL SPONSORED RESEARCH AGREEMENT
THIS AGREEMENT is entered into effective the 31st day of December, 1998
(the "Effective Date") by and between CHILDREN'S HOSPITAL, a charitable
corporation duly organized and existing under the laws of the Commonwealth of
Massachusetts and having a principal place of business located at 000 Xxxxxxxx
Xxxxxx, Xxxxxx, Xxxxxxxxxxxxx ("Hospital") and ORAPHARMA, INC., a business
corporation duly organized and existing under the laws of the State of Delaware
and having a principal place of business located at 000 Xxxxx Xxxxx, Xxxxxxxxxx,
Xxxxxxxxxxxx ("Sponsor").
WHEREAS, Sponsor has entered into a license agreement of even date (the
"License Agreement") with Children's Medical Center Corporation ("CMCC"), an
affiliate of Children's Hospital, pertaining to the commercial development of
"Licensed Products" (as that term is defined in the License Agreement).
WHEREAS, the research program contemplated by this Agreement is of mutual
interest and benefit to Hospital and to Sponsor and may further the practice of
medicine and the research mission of Hospital in a manner consistent with its
status as a non-profit, tax-exempt, teaching hospital;
WHEREAS, Sponsor desires to provide to Hospital funding to support said
research program on the terms and conditions of this Agreement;
WHEREAS, Hospital desires to accept such funding on the terms and
conditions of this Agreement.
NOW, THEREFORE, the parties agree as follows:
1. Scope of Work/Period of Performance
(a) Subject to the terms and conditions of this Agreement, Hospital
agrees to use reasonable efforts to cause the Principal Investigators to conduct
the research program entitled "Mechanisms of Wound Healing in Oral Tissue," and,
additionally, Xxxx Xxxxxx, Ph.D. to conduct the research programs entitled
"Expression of OPN in Human Embryonic Cells" and "Biomimetic Peptides in Bone
Reconstruction" as further described in Appendix A attached hereto and
incorporated herein by reference (as the same hereafter may be amended,
supplemented or otherwise modified from time to time with the prior written
consent of the parties the "Program"). The parties acknowledge that the Program
will be conducted during the period commencing on the date funding is initiated
September 1, 1998 (the "Initiation Date"),
and ending four (4) years and one (1) month thereafter, unless sooner terminated
as provided hereafter or unless extended by mutual written agreement of the
parties.
(b) The Program shall be conducted at Hospital by the Principal
Investigators and by such additional research staff working under the Principal
Investigators' supervision as the Principal Investigators shall reasonably
determine in consultation with Hospital.
(c) Any material alteration in or significant amendment to the Program
must be approved in writing by both Hospital and Sponsor prior to such
alteration or amendment becoming effective.
(d) Sponsor acknowledges that the Principal Investigators are engaged in
certain other sponsored research projects as listed on Appendix B attached
hereto and that such projects, as well as any projects unrelated to the subject
matter hereof, are not subject to this Agreement and are explicitly excluded
from the scope of the Program.
(e) Sponsor and Principal Investigators agree that all animal protocols
are subject to review and approval by the Hospital's Animal Care and Use
Committee, and that no work on any such protocol shall begin until the approval
is granted.
2. Principal Investigators
(a) The Principal Investigators for the Program will be Xxxx Xxxxxx,
Ph.D. and Xxxxxxx Xxxxx, MD. In the event either Principal Investigator becomes
unable to complete the Program for any reason, the remaining Principal
Investigator will complete the program. If both Principal Investigators are
unable to complete the program, Hospital will, to the extent possible, propose a
substitute principal investigator with qualifications reasonably similar to
either Principal Investigator for Sponsor's approval, which approval shall not
be unreasonably withheld. In the event Sponsor and Hospital agree upon a
substitute Principal Investigator, this Agreement shall continue in full force
and effect. If Sponsor and Hospital are unable to agree on a substitute
Principal Investigator, this Agreement may be terminated in accordance with the
provisions of Paragraph 8(a) of this Agreement.
(b) Throughout the Program, Hospital agrees (i) to use its reasonable
efforts to cause the Principal Investigators diligently and faithfully to
perform their obligations hereunder and to carry out and complete the Program
and (ii) not to unreasonably interfere with or restrict the ability of the
Principal Investigators to perform such obligations or to carry out and complete
the Program.
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3. Payment
(a) On the Effective Date, Sponsor shall pay Two-Hundred Thousand Dollars
($200,000) to Hospital, that Hospital may use at its discretion for
reimbursement of expenses incurred prior to July 31, 1998 for research related
to the development of technologies licensed to Sponsor in the License Agreement
dated as of December 31, 1998
(b) In consideration of Hospital undertaking to perform the Program,
Sponsor shall, subject to the terms and conditions of this Agreement, pay to
Hospital One Million Two Hundred Seventy Thousand Dollars (1,270,000) to be paid
according to the following schedule:
Sponsored Research Agreement
----------------------------
Payment Schedule
----------------
Timing Amount to Children's Hospital
Prior to 1/1/99 $41,666.66*
12/31/98 $58,333.34
12/31/98 $125,599.99
3/31/99 $105,533.33
6/30/99 $105,533.33
9/30/99 $69,444.44
12/31/99 $69,444.44
3/31/00 $69,444.44
6/30/00 $69,444.44
9/30/00 $69,444.44
12/31/00 $69,444.44
3/31/01 $69,444.44
6/30/01 $69,444.44
9/30/01 $69,444.44
12/31/01 $69,444.44
3/31/02 $69,444.44
6/30/02 $69,444.44
-------------
Total $1,270,000.00
*Remitted in two payments of $20,833.33 delivered in mid-September 1998 and
early November 1998
(c) The Principal Investigators shall be free to reallocate funds from
one line item to another within the limit for any year as necessary to meet the
objectives of the Program without prior approval of Sponsor, so long as the
total budget for that year shall not be exceeded. If funding for any year is not
completely expended during that year, the balance remaining shall be rolled
forward and added to the next year's total funded amount, and in the event funds
remain unspent at the end of the four year period, the Agreement and Program
shall be automatically extended so that research conducted utilizing the balance
shall be subject to this Agreement.
(d) Any equipment purchased as part of the Program shall be owned by
Hospital, shall be physically located at Hospital and shall remain the property
of Hospital following completion of the Program.
(e) Payment of all sums due hereunder shall be made by check payable as
follows:
Children's Hospital
Research Finance Xxxxxx
000 Xxxxxxxx Xxxxxx
Xxxxxx, XX 00000
Ref: Agreement No. 2568
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(f) Sponsor shall have the right, exercisable ninety (90) days following
the conclusion of any given project year and upon reasonable prior written
notice to and at a mutually convenient time, to audit the expenditure by
Hospital and the Principal Investigator of the funding provided by Sponsor
hereunder for performance of the Program in said project year; provided that
such right may not be exercised by Sponsor more than one time during any
calendar year. Sponsor shall maintain the confidentiality of all information
disclosed or observed in connection with such audits.
(g) Nothing contained herein shall be construed as requiring Hospital or
the Principal Investigator or any Hospital research staff to work on any project
or process which is prohibited by law or by any international treaty to which
the United States of America is a party, or which may be harmful or detrimental
to public health, patient safety or good clinical care or which may be
considered to be immoral.
4. Publications
Sponsor acknowledges that Hospital is an academic medical center and that,
subject to compliance with their respective obligations and the obligations of
Hospital hereunder in this paragraph 4, the Principal Investigator and his/her
collaborators shall be free to publish the results of their research without
restraint. Sponsor further acknowledges that (i) adequate protection of
intellectual property rights which may arise under the Program requires
effective communication between Sponsor and the Principal Investigator
throughout the course of the Program; and (ii) Sponsor has the right,
opportunity and obligation to follow the Program to determine as promptly as
practicable the potential for protecting a patentable invention(s) arising under
the Program. Notwithstanding the above, in order to permit Sponsor an
opportunity to determine if a patentable invention(s) or Sponsor Confidential
Information (as defined in this Agreement) is therein disclosed, Hospital agrees
to use reasonable efforts to cause the Principal Investigators, and other
Program personnel and by acknowledging this Agreement the Principal
Investigators accept their obligations, to (i) submit to Sponsor a substantially
complete draft of any manuscript or abstract reporting on the Program and
submitted for consideration for publication or to a conference, as applicable,
no later than thirty (30) days prior to the day such manuscript or abstract is
so submitted; and (ii) notify Sponsor of any conference at which the results of
the Program will be presented without abstract, but in any event at least thirty
(30) days prior to presentation at such conference. Sponsor agrees to hold all
such submissions and information in confidence. Sponsor agrees to promptly
notify Hospital and the Principal Investigators if any action is necessary to
delete Sponsor Confidential Information or to secure patent protection for a
patentable invention(s) disclosed in any such material. If requested by Sponsor,
Hospital agrees to include in any publication of the results of the Program
acknowledgment of Sponsor's financial support of the Program.
5. Sponsor Confidential Information
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(a) The parties acknowledge that as part of the scientific collaboration
between Sponsor and Hospital in connection with the Program, Sponsor may find it
necessary or desirable to the conduct of the Program to disclose to Hospital's
Office of Research Administration, Finance, Public Affairs or General Counsel
certain confidential and proprietary information and trade secrets of Sponsor.
Such information may take the form of, among other things: data concerning
scientific discoveries made by Sponsor; Sponsor's manufacturing strategies and
processes; Sponsor's marketing plans; data from Sponsor's evaluations in animals
and humans; Sponsor's budget information; Sponsor's strategy for or status of
regulatory approval; or Sponsor's forecasts of sales and sales data, and other
proprietary or confidential information (hereafter referred to collectively as
"Sponsor Confidential Information").
(b) Notwithstanding the above, Sponsor acknowledges and agrees that none
of the information described in subparagraph (a) above will be considered
Sponsor Confidential Information for purposes of this Agreement, unless said
information is disclosed by Sponsor in writing and is clearly marked as
confidential, or, where verbally disclosed by Sponsor, is followed within thirty
(30) days of such verbal disclosure by a writing from Sponsor confirming such
disclosure and indicating that such disclosure is confidential.
(c) Notwithstanding anything herein to the contrary and consistent with
Hospital's policies, Sponsor further acknowledges and agrees that Sponsor
Confidential Information shall not include data generated by Hospital or the
Principal Investigator or his/her associates, coworkers or staff in connection
with the Program. Sponsor and Hospital acknowledge that such data is subject to
the disclosure limitation included in Section 4 of this Agreement.
(d) Subject to the terms and conditions of this Agreement, Hospital
hereby agrees that during the term of the Research Agreement and for a period of
five (5) years thereafter, Hospital shall (i) cause Hospital staff assigned to
any of the Office of Research Administration, Finance, Public Affairs or General
Counsel not to publicly divulge, disseminate, publish or otherwise disclose any
Sponsor Confidential Information without Sponsor's prior written consent; (ii)
limit access to Sponsor Confidential Information to those members of Hospital
staff in the above-mentioned Offices who have a need for such Sponsor
Confidential Information in connection with the administration of this
Agreement; and (iii) cause Hospital staff in the above-mentioned Offices to
return to Sponsor any documents, drawings, sketches, designs, products or
samples containing Sponsor Confidential Information, together with any copies
thereof, promptly upon termination of this Agreement or upon Sponsor's request
therefor; provided that Hospital may retain for its business records a copy of
the following: (aa) the Program protocol; (bb) Program budget information; (cc)
Program payment records; and (dd) such other documents and information as
Hospital shall reasonably determine are necessary for Hospital to conduct the
Program in compliance with Hospital policies and procedures and applicable law.
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(e) Sponsor and Hospital acknowledge and agree that the obligations set
out in this Section 5 shall not apply to any portion of the Sponsor Confidential
Information which Hospital can demonstrate:
(i) was at the time of disclosure to Hospital, or thereafter became
(prior to its publication, divulgence or use) through no fault of Hospital,
a part of the public domain by publication or otherwise; or
(ii) was already properly and lawfully in Hospital's possession at the
time it was received from Sponsor; or
(iii) was lawfully received by Hospital from a third party who was under no
obligation of confidentiality with respect thereto; or
(iv) Hospital independently developed without reference to the Sponsor
Confidential Information; or
(v) is required by law or judicial process (including patent
applications) to be disclosed (but only to the extent of such required
disclosure and only after prompt notification in writing to Sponsor prior
to disclosure in order to provide Sponsor a reasonable opportunity to avoid
and/or to obtain confidential treatment for such information); or
(vi) would jeopardize patient safety or the provision of high quality
health care to patients of the Hospital if not disclosed.
(f) Notwithstanding anything herein to the contrary, Sponsor agrees that
it shall not disclose to Hospital staff in any of the above-mentioned Offices
any information which is Sponsor Confidential Information: (i) except to the
extent reasonably necessary for Sponsor to fulfill its obligations under this
Agreement; or (ii) unless the Principal Investigator has requested such
information and Hospital has agreed in writing to accept such disclosure. All
other information and communications between Sponsor and Hospital shall be
deemed to be provided to Hospital by Sponsor on a non-confidential basis.
(g) Sponsor agrees that Hospital shall not be liable to Sponsor or to any
third party claiming by or through Sponsor for any unauthorized disclosure or
use of Sponsor Confidential Information which occurs despite Hospital's
compliance with its obligations under this Agreement.
(h) If Sponsor requires the Principal Investigators to execute a
confidentiality agreement in connection with the Program, such executed
agreement, in the form of the Hospital's Confidential Disclosure Agreement,
shall he attached hereto for reference only as Appendix A.
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6. Intellectual Property
(a) Hospital represents that the Hospital's principal investigators and
staff are required to assign inventions and rights to intellectual property to
Children's Medical Center Corporation.
(b) It is anticipated that one or more inventions will be conceived and
at least partially reduced to practice in the performance of the program during
the term of this Agreement. Any patentable invention conceived or first reduced
to practice by Hospital, Principal Investigators, and/or other Hospital
personnel in the performance of the Program shall be owned by Hospital and
Hospital shall have the first right to determine whether to file patent
applications thereon or to add such inventions to any existing Patent Rights (as
defined in the License Agreement) and to determine disposition of any patents or
other rights resulting therefrom (subject to Sponsor's licenses, options and
other rights under the terms of this Agreement and the License Agreement).
Hospital shall promptly notify Sponsor of the disclosure to Hospital of any such
invention (but in any event within thirty (30) days of such disclosure to
Hospital), and shall advise Sponsor whether such invention falls under Section
6(c) or 6(d) below. Hospital shall provide to Sponsor at Sponsor's request and
at Sponsor's expense copies of documents relevant to the preparation, filing,
prosecution and maintenance of any such patent application. Subject to the terms
of this Agreement, any such information shall be held in confidence by Sponsor.
Sponsor shall have the right to comment and render advice, concerns and opinions
thereon, and Hospital shall use its reasonable efforts to incorporate said
comments, advice and opinions as appropriate, in any such patent application.
Sponsor shall reimburse Hospital for any out-of-pocket expenses Hospital incurs
in evaluating, or consulting with Sponsor with regard to any patent application
described herein. In the event Hospital elects not to file a patent application
relating to an invention, it shall so notify Sponsor no later than sixty (60)
days after Hospital's receipt of disclosure of an invention. In the event
Hospital elects not to prosecute or maintain any patent or patent application
described herein, Hospital shall so notify Sponsor at least thirty (30) days
prior to taking, or not taking, any action which would result in abandonment,
withdrawal or lapse of such patent or patent application. In any such event,
Sponsor shall then have the right to file, prosecute or maintain the patent or
patent application in Hospital's name at Sponsor's expense.
(c) If an invention as contemplated under 6(b) is a composition, process
or 2method of use, the practice or use of which would infringe an issued or
pending claim of the Patent Rights (as defined in the License Agreement)
covering the Licensed Products and/or Licensed Processes in the Field of Use, or
if the invention is an improvement of, or enabling to the commercial
exploitation in the Field of Use of Licensed Products and/or Licensed Processes
in the Field of Use already licensed under the License Agreement, that invention
will be incorporated into the Patent Rights under the License Agreement by
amendment of Appendix I of the License Agreement. Any such invention shall be
deemed automatically to be added to Appendix I to the
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License Agreement at the time of notification to Sponsor, and the parties agree
to execute and deliver such documents and otherwise cooperate with each other in
order to add such invention to Appendix I to the License Agreement and grant to
Sponsor the appropriate rights and licenses with respect thereto. Sponsor shall
reimburse Hospital for patent expenses for such inventions in accordance with
the provisions of the License Agreement.
(d) If an invention is not subject to subparagraph (c) above, Hospital
hereby grants to Sponsor the exclusive option, exercisable as provided in
subparagraph (e) below, to negotiate and enter into an exclusive, world-wide
license to make, have made, use, offer for sale, sell, have sold, import and
export products under any patent application and resulting patent rights
resulting from inventions conceived and reduced to practice by Hospital or
Hospital personnel in the performance of the Program, on terms and conditions to
be negotiated by the parties hereto, but including the following:
(i) Rights of the United States government, if any, reserved under Public
Laws 96-517, 97-256, and 98-620, codified at 35 U.S.C. 200-212, and any
regulations promulgated thereunder.
(ii) Licensee will accomplish certain milestones negotiated by the parties
to commercialize products.
(iii) Any license granted pursuant to an agreement between Hospital and
Sponsor shall be subject to a reservation of the unrestricted right of
Hospital to use subject matter claimed in the licensed patent(s) for
research purposes at no cost to Hospital and to license to other nonprofit
institutions the right to use such subject matter solely for research
purposes; provided that no commercial third party shall gain any rights in
conflict with those granted to Sponsor hereunder.
(iv) Any license granted pursuant to an agreement between Hospital and
Sponsor shall include the CRICO Uniform Indemnification and Insurance
provisions then in effect.
(v) Licensee shall be granted a non-exclusive license to Know-How as
defined in the License Agreement.
(vi) Royalties shall be reasonable and consistent with industry standards.
If the parties shall be unable to agree on financial terms within two (2)
months ("Arbitration Date") of Sponsor's exercising its option under
subparagraph (f) below, each shall promptly submit to the other names of
one or more neutral experts as royalty arbitrator. If a mutual expert
cannot be agreed on within two (2) weeks after the Arbitration Date, each
party shall appoint an expert and the two experts shall select the royalty
arbitrator within three (3) weeks after the Arbitration Date. The parties
shall meet with the royalty arbitrator to determine the financial terms of
such license within five (5) weeks after the Arbitration Date and the
royalty arbitrator shall render binding financial terms within six (6)
weeks of
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the Arbitration Date. The parties shall execute a license agreement based
on such terms within four (4) months of the option exercise date or the
default provisions of subparagraph (f) shall apply, unless such delay is
beyond the control of Licensee.
(e) Hospital shall notify each Principal Investigator that he shall not,
and by acknowledging this Agreement such Principal Investigator agrees that he
shall not, seek or accept funding from a third party commercial sponsor within
the scope of the Program which confers rights on such third party commercial
sponsor or obligations on Hospital and/or the Principal Investigator, without
express written consent of Sponsor. The Principal Investigator may seek and
accept funding from a non-commercial sponsor within the Scope of the Program
during the period in which Sponsor is funding research hereunder. The Principal
Investigator shall notify Sponsor in writing concerning the research to be
performed and his acceptance of the funding and Hospital shall disclose to
Sponsor in writing on a confidential basis any invention or discovery within the
scope of the Program disclosed by Principal Investigator to Hospital and arising
from such research, whether or not funded by Sponsor. Hospital shall make good
faith efforts to determine whether funding or support (including money,
personnel, equipment, information or other resources) provided by Sponsor was
used in connection with such research. Hospital agrees to notify the Principal
Investigators and obtain their agreement to disclose to Sponsor any United
States government funding that has been obtained, used or applied for by or on
behalf of Hospital in the name of the Principal Investigators within the scope
of the Research Program or based upon the subject matter of any Patent Rights.
(f) Sponsor must exercise its option under subparagraph (d) above by
providing to Hospital written notice of its desire to negotiate and execute a
mutually acceptable license agreement and payment for costs incurred by Hospital
in connection with the patent. Such notice and payment must be received within
the three (3) month period immediately following the date of filing (and receipt
of notice of such filing by Sponsor) the applicable patent application. In the
event such a mutually acceptable license agreement is not executed within four
(4) months following the date Sponsor exercises its option hereunder, Hospital
shall have no further obligation to Sponsor with respect thereto.
(g) Title to and the right to determine the disposition of any copyrights
or copyrightable material first produced or composed by Hospital in the
performance of the Program shall remain with Hospital provided, however, that
Hospital hereby grants to Sponsor an irrevocable, royalty-free, non-exclusive
right to make and use copies of such material as may be reasonably necessary for
internal use in the conduct of its business, subject to any patent rights
retained by Hospital, provided however, that with respect to computer software
and its programming documentation, such right is applicable only to computer
software and its programming documentation specifically delivered under the
Scope of Work described in Section 1 above.
(h) The Transfer of Materials resulting from the Program and/or Licensed
to Sponsor. The parties agree that Hospital has a responsibility to the
nonprofit academic community to
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transfer materials that have resulted from the Program and/or have been licensed
to Sponsor and that have been described in a publication. The parties agree that
distribution of materials provides important benefits to both parties by
allowing wider use and development of the materials. The parties agree that the
goals of such transfers are to permit the advancement of knowledge and to ensure
that the Hospital's ownership rights to the materials and any potential rights
in any patent or patent applications, and consequently any rights obligated to
Sponsor, are respected.
For the purposes of this Agreement, the materials are defined as follows:
-Research Materials are tangible research property created in the
performance of the Program solely by Hospital personnel without
information or materials provided by Sponsor;
-The parties agree to the following procedure will be applied when
request for materials are received by the Principal Investigators:
(i) In keeping with Hospital policy, no Research Materials will be
distributed prior to the execution of a Materials Transfer Agreement
similar to that appended as Appendix D.
(ii) Sponsor has the responsibility for distribution of Research Materials
requested by for-profit organizations for use within the Field of Use (as
defined in the License Agreement) at its sole discretion.
(iii) Hospital has the responsibility for distribution of Research
Materials to not-for-profit entities, and to for-profit organizations for
use outside the Field of Use. Hospital will inform Sponsor of all requests
for Licensed and Research Materials. The transfer will be at Hospital's
sole discretion after full consideration of Sponsor's concerns. Hospital
will send Sponsor copies of each agreement.
(iv) In the event Hospital is notified of an invention or pending patent
application under Section 4(c) of the Material Transfer Agreement, Hospital
will seek to assert its ownership rights and to obtain exclusive
responsibility for licensing any rights held jointly with the recipient
institution. Any resulting Hospital rights will be subject to this Section
6 of this Agreement.
7. Limitation of Liabilities and Indemnification
(a) Sponsor shall indemnify, defend and hold harmless Hospital, its board
members, officers, agents, servants, employees and medical and professional
staff (the "Sponsor's Indemnitees") from and against any and all liability,
loss, damage, claims, costs, actions, and suits, including costs, expenses, and
attorneys fees, arising out of, resulting from, or directly or
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indirectly relating to, any third party claims, suits, actions, demands or
judgments arising out of Sponsor's performance under this Agreement, to the
extent such liability, loss, damage or expense is not attributable to the
negligent act or omission or reckless conduct or willful misconduct of Sponsor's
Indemnitees.
(b) Hospital shall indemnify, defend and hold harmless Sponsor, its board
members, officers, agents, servants and employees (the "Hospital's Indemnitees")
from and against any and all liability, loss, damage, claims, costs, actions and
suits, including costs, expenses, and attorneys fees, arising out of, resulting
from, or directly or indirectly relating to, any third party claims, suits,
actions, demands or judgments arising out of Hospital's performance under this
Agreement, to the extent such liability, loss, damage or expense is not
attributable to the negligent act or omission or reckless conduct or willful
misconduct of Hospital's Indemnitees.
8. Termination
This Agreement may be terminated upon the occurrence of any of the following
events:
(a) In the event Sponsor and Hospital cannot agree on a substitute
Principal Investigator after a substitute Principal Investigator meeting the
requirements of Section 2(a), if any, has been proposed, performance under this
Agreement may be terminated by either party upon thirty (30) days prior written
notice to the other party. In this event, any license agreement then in effect
shall remain unchanged.
(b) Hospital may terminate this Agreement immediately upon the
bankruptcy, liquidation, dissolution or cessation of operations of Sponsor; or
the filing of any voluntary petition for bankruptcy, dissolution, liquidation or
winding-up of the affairs of Sponsor; or any assignment by Sponsor for the
benefit of creditors; or the filing of any involuntary petition for bankruptcy,
dissolution, liquidation or winding-up of the affairs of Sponsor which is not
dismissed within ninety (90) days of the date on which it is filed or commenced.
(c) Hospital may terminate this Agreement upon thirty (30) days prior
written notice in the event Sponsor fails to make any payment required of
Sponsor hereunder in a timely manner; provided such breach is not cured within
said thirty (30) day notice period.
(d) Either party may terminate this Agreement immediately in the event
the other party engages in criminal, unprofessional or fraudulent conduct, or if
either party engages in any other improper or illegal conduct that materially
and adversely discredits or is detrimental to the reputation or standing of the
other party.
(e) Except as otherwise provided above in subparagraph (c), Hospital may
terminate this Agreement upon sixty (60) days prior written notice in the event
of any material breach by
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Sponsor of any material term or condition hereof, provided such breach is not
cured within said sixty (60) day notice period.
(f) Sponsor may terminate this Agreement upon sixty (60) days prior
written notice in the event the Program is suspended by Hospital or the
Principal Investigator and a substitute Principal Investigator cannot be agreed
upon, or if circumstances reasonably beyond Hospital's control preclude Hospital
from continuing the Program, and such suspension of the Program exceeds sixty
(60) consecutive days or ninety (90) days in the aggregate in any year during
the term (or renewal) of this Agreement.
(g) Sponsor shall have the right to terminate this Agreement at any time
upon three (3) months prior written notice to Hospital, and upon payment by
Licensee of all amounts due Hospital through the effective date of termination,
including any "noncancellable obligations" incurred by Hospital prior to notice
of termination. "Noncancellable obligations" shall include, but not be limited
to salaries and benefits for Program personnel for the remainder of the contract
year in which the effective date of termination falls, but excluding overhead on
such salaries. Hospital shall make reasonable efforts to mitigate such salary
expense obligation by redeploying such personnel to other funded projects.
(h) Sponsor may terminate this Agreement upon sixty (60) days prior
written notice for cause (which, as used herein, means the material breach by
the Hospital of any material term of this Agreement); provided such breach is
not cured within said sixty (60) day period.
9. Effect of Termination
Except as otherwise provided herein, termination of this Agreement shall not be
construed to release either party from any obligation hereunder which has
matured prior to the date of said termination. Notwithstanding anything herein
to the contrary, during the term of this Agreement, in the event Sponsor
terminates the Agreement without cause or in the event Hospital terminates this
Agreement in accordance with any of subparagraphs (b), (c), (d), or (e) of
Section 8 above, Hospital shall be under no further obligation to grant to
Sponsor any further options or licenses hereunder and Hospital may terminate any
licenses or options granted to Sponsor prior to the date of any such
termination. During any subsequent renewal period, in the event Sponsor
terminates the Agreement without cause or in the event Hospital terminates this
Agreement in accordance with any of subparagraphs (b), (c), (d), or (e) of
Section 8 above, Hospital shall be under no further obligation to grant to
Sponsor any further options or licenses hereunder and Hospital may terminate any
licenses or options granted to Sponsor during the renewal period prior to the
date of any such termination.
10. Communications.
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(a) Hospital agrees that Sponsor shall be advised of the progress of the
Program by verbal reports as reasonably requested by Sponsor and by written
reports reviewing such progress prepared under the supervision of the Principal
Investigator and submitted to Sponsor following the written request of Sponsor,
but no more frequently than quarterly during the Period of Performance specified
in Paragraph 1 above. A Final Written Report relating to the Program shall be
submitted to Sponsor no later than sixty (60) days after the expiration of the
period of performance specified in Paragraph 1 above.
(b) Upon termination of this Agreement prior to expiration of the Period of
Performance specified in Paragraph 1 above, the Principal Investigator shall
submit to Sponsor an Investigator's Final Report in a form mutually agreed upon
by Hospital and Sponsor.
(c) All medical/scientific and other communications, reports and notices
shall be delivered by hand, by facsimile or sent by first class mail postage
prepaid and addressed as follows:
If to Sponsor:
President
OraPharma, Inc.
000 Xxxxx Xxxxx
Xxxxxxxxxx, Xxxxxxxxxxxx 00000
If to Hospital:
Xxxx Xxxxxx, Ph.D. and Xxxxxxx Xxxxx, MD
Children's Hospital
000 Xxxxxxxx Xxxxxx
Xxxxxx, XX 00000
With a copy to:
Director, Technology Transfer
Children's Hospital
000 Xxxxxxxx Xxxxxx
Xxxxxx, XX 00000
(d) All reports submitted to Sponsor under this Paragraph 10, whether
verbal or in writing, shall be held in confidence by Sponsor, unless otherwise
agreed in writing by Hospital and Sponsor.
11. Use of Names
Sponsor shall not use the name of Children's Medical Center Corporation or
Children's Hospital nor the name of any of its corporate affiliates or
employees, nor any adaptation thereof,
13
in any advertising, promotional or sales literature without prior written
consent obtained from CMCC in each case, except that Sponsor may state that it
is licensed by CMCC under one or more of the patents and/or applications
comprising the Patent Rights, and Sponsor may comply with disclosure
requirements of all applicable laws relating to its business, including United
States and state security laws. To seek CMCC's consent for a given use of the
name of CMCC (or its affiliates or employees), Sponsor may telefax the proposed
statement to the Children's Hospital Public Affairs Office. The Public Affairs
Office shall make reasonable efforts to respond promptly. The parties may create
an Appendix to this Agreement setting forth statements approved by CMCC that
Sponsor may make, which Appendix may be amended from time to time by mutual
consent.
12. Assignment
(a) Except as otherwise provided herein, this Agreement is not assignable
in whole or in part, and any attempt to do so shall be void.
(b) Either party may assign this Agreement at any time to any affiliate of
such party without the prior consent of the other party.
(c) Except as otherwise provided in subparagraph (b) above and (d) below,
Sponsor may assign this Agreement to another entity only with the prior written
consent of Hospital, which consent shall not be unreasonably withheld or
delayed.
(d) Notwithstanding anything herein to the contrary, in the event Sponsor
merges with another entity, is acquired by another entity, or sells all or
substantially all of its assets to another entity, Sponsor may assign its rights
and obligations hereunder to, in the event of a merger or acquisition, the
surviving entity, and in the event of a sale, the acquiring entity, without
Hospital's consent so long as: (i) Sponsor is not then in breach of this
Agreement; (ii) the proposed assignee has a net worth at least equivalent to the
net worth Sponsor had as of the date of this Agreement; (iii) the proposed
assignee has available resources and sufficient scientific, business and other
expertise to satisfy Sponsors obligations hereunder; (iv) Sponsor provides
written notice of the assignment to Hospital, together with documentation
sufficient to demonstrate the requirements set forth in subparagraphs (i)
through (iii) above, at least twenty (20) days prior to the effective date of
the proposed assignment; and (v) Hospital receives from the proposed assignee,
in writing, at least twenty (20) days prior to the effective date of the
assignment: (aa) reaffirmation of the terms of this Agreement; (bb) an agreement
to be bound by the terms of this Agreement; and (cc) an agreement to perform the
obligations of Sponsor under this Agreement.
(e) Any assignment in violation of this Paragraph 12 shall be null and void
and of no force or effect.
14
13. General Provisions
(a) All rights and remedies hereunder will be cumulative and not
alternative, and this Agreement shall be construed and governed by the laws of
the Commonwealth of Massachusetts.
(b) This Agreement may be amended only by written agreement signed by both
parties.
(c) Sponsor and Hospital agree to conduct the Program in accordance with
all applicable Federal, State and local laws and regulations, as well as with
applicable regulations of Hospital. Hospital agrees to obtain all necessary
Committee on Clinical Investigation approvals.
(d) It is expressly agreed by the parties hereto that Hospital and Sponsor
are independent contractors and nothing in this Agreement is intended to create
an employer relationship, joint venture, or partnership between the parties.
Neither party has the authority to bind the other.
(e) This Agreement constitutes the entire agreement between the parties
with respect to the subject matter hereof and supersedes all proposals,
negotiations and other communications between the parties, whether written or
oral, with respect to the subject matter hereof.
(f) If any provisions of this Agreement shall be held to be invalid,
illegal or unenforceable, the validity, legality and enforceability of the
remaining provisions of this Agreement shall not be impaired thereby.
(g) NEITHER PARTY MAKES ANY WARRANTY, EXPRESS OR IMPLIED, INCLUDING,
WITHOUT LIMITATION, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR ANY IMPLIED
WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO ANY PATENT,
TRADEMARK, SOFTWARE, TRADE SECRET, TANGIBLE RESEARCH PROPERTY, INFORMATION OR
DATA LICENSED OR OTHERWISE PROVIDED TO THE OTHER PARTY HEREUNDER AND HEREBY
DISCLAIMS THE SAME. HOSPITAL SHALL NOT BE LIABLE FOR ANY DIRECT, CONSEQUENTIAL
OR OTHER DAMAGES SUFFERED BY SPONSOR OR ANY LICENSEE OR OTHERS RESULTING FROM
USE OF THE RESEARCH OR ANY SUCH INVENTION OR PRODUCT, EXCEPT AS PROVIDED IN
SUBPARAGRAPH 7(b) ABOVE.
(h) This Agreement may be executed in any number of counterparts, each of
which shall be deemed an original as against the party whose signature appears
thereon, but all of which taken together shall constitute but one and the same
instrument.
(i) Each party hereto agrees to execute, acknowledge and deliver such
further instruments and do all such further acts as may be necessary or
appropriate in order to carry out the purposes and intent of this Agreement.
15
(j) The paragraph headings contained in this Agreement are for reference
purposes only and shall not in any way affect the meaning or interpretation of
this Agreement.
16
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date
first written above.
CHILDREN'S MEDICAL CENTER CORPORATION ORAPHARMA, INC.
By: /s/ Xxxxxxx New By: /s/ Xxxxxxx Xxxxxxxxx
----------------------------------- ---------------------------
Xxxxxxx New Name: Xxxxxxx Xxxxxxxxx
-------------------------
Vice President, Research Administration Title: President and CEO
------------------------
Date: 1/20/99 Date: 1/22/99
--------------------------------- -------------------------
ACKNOWLEDGED BY:
/s/ Xxxx Xxxxxx /s/ Xxxxxxx Xxxxx
------------------------- ---------------------------
Xxxx Xxxxxx, Ph.D. Xxxxxxx Xxxxx, M.D.
17
APPENDIX A-1
Part 1
[The confidential material contained herein has been omitted and has been
separately filed with the commission.]
Part 2.
[The confidential material contained herein has been omitted and has been
separately filed with the commission.]
Part 3.
[The confidential material contained herein has been omitted and has been
separately filed with the commission.]
Part 4:
[The confidential material contained herein has been omitted and has been
separately filed with the commission.]
Part 5
[The confidential material contained herein has been omitted and has been
separately filed with the commission.]
18
APPENDIX A-2
[The confidential material contained herein has been omitted and has been
separately filed with the commission.]
00
XXXXXXXX X
Name: Xxxx Xxxxxx Active: X Pending: None:
1. Source and identifying number: N.I.H. P.I.: X. Xxxxxx
2. Title: T-cell Populations in Transplantation Immunity
3. Your role on project: Co-Investigator % Effort: 10%
4. Specific aims of project: This grant is currently a merit award to HC. This
grant is funding a study into the role of osteopontin in T-cell and
macrophage development with special emphasis on transplantation immunity
5. Describe scientific and budgetary overlap: None
Name: Xxxx Xxxxxx Active: X Pending: None:
1. Source and identifying number: N.I.H. P.I.: Xxxxxxx Xxxxxxx
2. Title: Prostate cancer bone interaction: Regulated secretion of EGFR ligands.
3. Your role on project: Consultant % Effort: 2%
4. Specific aims of project: To study the role of EGF-like molecules in
mediating prostate cancer metastasis to bone
5. Describe scientific and budgetary overlap: None
Name: Xxxx Xxxxxx Active: X Pending: None:
1. Source and identifying number: N.I.H. P.I.: X. Xxxxx
2. Title: Role of CD44 in T-Cell activation.
3. Your role on project: Collaborator % Effort: 5%
4. Specific aims of project: To Study the Role of CD44 in T-cell development
and clonal deletion
5. Describe scientific and budgetary overlap: None
Name: Xxxx Xxxxxx Active: X Pending: None:
1. Source and identifying number: Mass Department of Public Health
2. Title: Molecular Mechanisms of Bone Specific Metastasis
3. Your role on project: Principle Investigator % Effort: 40%
4. Specific aims of project: To investigate the Role of CD44 and OPN in specific
recruitment of Tumor Cells to Bone
5. Describe scientific and budgetary overlap: None
Name: Xxxx Xxxxxx Active: X Pending: None:
1. Source and identifying number: NIH
2. Title: Osteopontin biomimetics and gene expression in Xenoenviroments
3. Your role on project: Principle Investigator % Effort: 40%
4. Specific aims of project: Several biomimetics molecules have been constructed
to modulate the in vivo behaviour of tissue in response to transplanted
material.
5. Describe scientific and budgetary overlap: No budgetary overlap. Effort will
be adjusted accordingly
Name: Xxxx Xxxxxx Active: X Pending: None:
1. Source and identifying number: NIH
2. Title: Chimeric Molecules Enhances apatite osseoinduction Xxxx Xxxx PI
3. Your role on project: Collaborator % Effort: 10%
4. Specific aims of project: To test several recombinant molecules that have
been engineered to bind to apaptite in accelerating osseointegration.
5. Describe scientific and budgetary overlap: No budgetary overlap. Effort will
be adjusted accordingly
Name: Xxxx Xxxxxx Active: X Pending: None:
1. Source and identifying number: NIH
2. Title: Polar lipids effects on bone regeneration X. Xxxxx PI
3. Your role on project: Co-PI % Effort: 10%
4. Specific aims of project: A pilot study on the involvement of polar lipids in
bone healing and regeneration
5. Describe scientific and budgetary overlap: No budgetary overlap. Effort will
be adjusted accordingly
Name: Xxxx Xxxxxx Active: X Pending: None:
1. Source and identifying number: NIH
2. Title: Effect of diabetes on implant wound healing. X. Xxxxxxxxxx PI
3. Your role on project: Consultant % Effort: 10%
4. Specific aims of project: To investigate the molecular mechanisms that result
in diabetes mediated impairment of healing.
5. Describe scientific and budgetary overlap: No budgetary overlap. Effort will
be adjusted accordingly
Name: Xxxx Xxxxxx Active: X Pending: None:
1. Source and identifying number: NIH
2. Title: Cell and matrix modifications to Enhance Wound Healing.
3. Your role on project: Principal Investigator % Effort: 10%
4. Specific aims of project: A biomimetic approach to accelerating and modifying
cutaneous and skeletal wound healing
5. Describe scientific and budgetary overlap: None
Name: Xxxx Xxxxxx Active: X Pending: None:
1. Source and identifying number: March of Dimes
2. Title: Biomimetic biomaterial in the correction congenital abnormalities of
the oral tissues
3. Your role on project: Principle Investigator % Effort: 10%
4. Specific aims of project:
5. Describe scientific and budgetary overlap: None
Name: Xxxx Xxxxxx Active: X Pending: None:
1. Source and identifying number: Harvard interquad research grant
2. Title: Third generation of guided tissue regeneration material in
periodontology
3. Your role on project: Principle Investigator % Effort: 10%
4. Specific aims of project: Design and applications for novel bio-membranes in
periodontology. A tissue engineering approach
5. Describe scientific and budgetary overlap: None
20
APPENDIX C
Xxxxxxx Xxxxx, M.D.
Laboratory for Tissue Engineering and Cellular Therapeutics
Current Projects
[The confidential material contained herein has been omitted and has been
separately filed with the commission.]
21
APPENDIX D
BIOLOGICAL MATERIAL TRANSFER AGREEMENT
For Materials Resulting from
Research Sponsored or Licensed to OraPharma, Inc.
Children's Hospital to Nonprofit Institution
Definitions
Provider: Children's Medical Center Corporation, 000 Xxxxxxxx Xxxxxx, Xxxxxx,
XX 00000.
Provider's Scientist:
---------------------------------------------------------
Recipient: Institution receiving the Original Material, (Name and address of
Institution)
--------------------------------------------------------------------------------
Recipient's Scientist is:
---------------------------------------------------------
Original Material:
--------------------------------------------------------------
Material: Original Material plus Progeny and Unmodified Derivatives. The
Material shall not include (i) Modifications or (ii) other substances created by
the Recipient through the use of the Material which are not Progeny or
Unmodified Derivatives.
Progeny: unmodified descendant from the Material, such as virus from virus,
cell from cell, or organism from organism.
Unmodified Derivatives: substances created by Recipient which constitute an
unmodified functional sub-unit or an expression product of the Original
Material. Some examples include: subclones of unmodified cell lines, purified or
fractionated sub-sets of the Original Material, proteins expressed by DNA/RNA
supplied by Provider, monoclonal antibodies secreted by a hybridoma cell line,
sub-sets of the Original Material such as novel plasmids or vectors.
Modifications: substances created by Recipient which contain/incorporate the
Material (Original Material, Progeny or Unmodified Derivatives).
Field of Use:
Terms and Conditions
1. PROVIDER has certain ownership rights and/or certain other interests in the
MATERIAL and has granted certain of these rights in and to the MATERIAL to
OraPharma, Inc. to permit them to develop and transfer to market various
products which have been or will be derived or produced from the MATERIAL.
PROVIDER has retained the right to use the MATERIAL and to license other
non-profit research organizations to use the MATERIAL in the Field of Use
solely for their own non-commercial, research purposes. The MATERIAL is to
be used by RECIPIENT solely for research purposes at RECIPIENT's
institution only as described in the attached letter and only under the
direction of the Recipient's Scientist; and RECIPIENT shall not assign or
sublicense any rights to use the MATERIAL without the prior written consent
of PROVIDER and OraPharma, Inc. The MATERIAL will not be used in human
subjects or in clinical trials involving human subjects without the written
permission of PROVIDER.
2. RECIPIENT'S SCIENTIST is permitted to publish the results of the research
utilizing the MATERIAL. To the extent supplies are available, PROVIDER or
Provider's Scientist agrees to make the MATERIAL available
under an agreement similar to this one to other scientists (at least those
at non-profit or governmental institutions) who wish to replicate
Recipient's Scientist's research. The Recipient's Scientist agrees not to
transfer the MATERIAL to anyone who does not work under his or her direct
supervision at RECIPIENT's institution without the prior written consent of
PROVIDER and OraPharma, Inc.. Recipient's Scientist shall refer any request
for the MATERIAL to PROVIDER.
3. (a) Upon notice to PROVIDER and under a UBMTA (or an agreement at least as
protective of PROVIDER's rights), RECIPIENT may distribute Modifications to
non-profit or governmental organizations for research purposes only.
(b) Upon written permission from PROVIDER and OraPharma, Inc., RECIPIENT
may distribute Modifications for commercial use. It is recognized by
RECIPIENT that such commercial use may require a commercial license from
OraPharma, Inc. and OraPharma, Inc. has no obligation to grant such a
commercial license.
4. (a) Ownership of tangible property as between PROVIDER and RECIPIENT is
defined in Attachment A.
(b) RECIPIENT is free to file patent applications claiming inventions made
by RECIPIENT through the use of the MATERIAL but agrees to notify PROVIDER
prior to filing a patent application claiming Modifications or uses of the
MATERIAL or inventions made through the use of the MATERIAL.
(c) If research involving the MATERIAL results in any invention or
substance which may be commercially useful, RECIPIENT and RECIPIENT'S
SCIENTIST will promptly disclose to PROVIDER in confidence the invention or
substance and provide PROVIDER with samples of the derived material. In
addition, RECIPIENT and RECIPIENT'S SCIENTIST will notify any other entity
which has supported the research which included the MATERIAL of PROVIDER's
and OraPharma, Inc.'s role as the source of MATERIAL. RECIPIENT and
RECIPIENT'S SCIENTIST will take all reasonable steps to see that PROVIDER
and OraPharma, Inc. are provided with appropriate recognition for their
contributions, such as, a first option to negotiation in good faith and on
reasonable terms, an exclusive license (subject to the rights of any
Government or non-profit sponsor) to use the invention or substance or a
reduced royalty should the parties agree to a non-exclusive license.
5. Except as expressly provided in this Agreement, no rights are provided to
RECIPIENT under any patents, patent applications, trade secrets or other
proprietary rights of PROVIDER. In particular, no rights are provided to
use the MATERIAL or Modifications and any related patents of PROVIDER for
profit-making or commercial purposes, such as sale of the MATERIAL or
Modifications, use in manufacturing, provision of a service to a third
party in exchange for consideration (not including sponsored research
activities).
6. The provision of the MATERIAL to RECIPIENT shall not alter any preexisting
right to the MATERIAL.
7. Any MATERIAL delivered pursuant to this Agreement is understood to be
experimental in nature and may have hazardous properties. THE MATERIAL IS
PROVIDED WITHOUT WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR
PURPOSE OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED, AND RECIPIENT AGREES
THAT CHILDREN'S HOSPITAL CORPORATION, CHILDREN'S MEDICAL CENTER
CORPORATION, PROVIDER'S SCIENTIST, AND THEIR RESPECTIVE EMPLOYEES, AGENTS,
AND TRUSTEES HAVE NO LIABILITY IN CONNECTION WITH SUPPLYING RECIPIENT WITH
THE MATERIAL OR RECIPIENT'S USE OF THE SAID MATERIAL.
8. RECIPIENT agrees to waive all claims against Children's Medical Center
Corporation, any of its corporate affiliates, and provider's scientist, and
OraPharma and its affiliates and Sublicensees and their respective
employees, professional staffs, agents, volunteers, officers, and trustees,
and to defend and indemnify and hold harmless Children's Medical Center
Corporation, any of its corporate affiliates, and Provider's Scientist, and
OraPharma and its affiliates and Sublicensees, and their respective
employees, professional staffs, agents, volunteers, officers, and trustees
from all claims and damages asserted by Recipient or third parties arising
from the use, storage, handling or disposal of the Material or
Modifications.
9. This Agreement shall not be interpreted to prevent or delay publication of
research resulting from the use of the MATERIAL or Modifications.
Recipient's Scientist agrees to provide appropriate acknowledgment of the
source of the MATERIAL in all publications.
10. RECIPIENT agrees to use the MATERIAL in compliance with all applicable
statutes and regulations, including, for example, those relating to
research involving the use of animals or recombinant DNA.
11. (a) This Agreement will terminate on the earliest of the following dates:
(1) when the MATERIAL becomes generally available from third parties, for
example, through reagent catalogs or from public depositories, or (2) on
completion of Recipient's current research with the MATERIAL, or (3) on
thirty (30) days written notice by either party to the other, or (4) on the
following date . Paragraphs 4(c)(as to OraPharma, Inc.'s option),
7, 8 and 11 shall survive termination.
(b) If termination should occur under 11(a)(1), RECIPIENT shall be bound to
the PROVIDER by the least restrictive terms applicable to MATERIAL obtained
from the then available sources.
(c) Except as provided in 11(d) below, on termination of this Agreement
under 11(a)(2),(3), or (4) above, RECIPIENT will discontinue its use of the
MATERIAL and will, upon direction of PROVIDER, return or destroy any
remaining MATERIAL. RECIPIENT will also either destroy Modifications or
remain bound by the terms of paragraphs 3, 4 and 5 as they apply to
Modifications.
(d) In the event PROVIDER terminates this Agreement under 11(a)(3) other
than for breach of this Agreement or with cause such as an imminent health
risk or patent infringement, PROVIDER will defer the effective date of
termination for a period of up to one year, upon request from RECIPIENT to
permit completion of research in progress.
If these terms and conditions are acceptable, please sign this Agreement and
have it cosigned by a duly authorized representative of the Recipient and return
one copy to the Director of Technology Transfer at Children's Hospital. A
specimen of the Material will be forwarded promptly upon receipt of the signed
copy.
-------------------------------------------------
Children's Hospital Researcher
------------------------------------------------- -------------
Xxxxxx X. Xxxxxxxx, Director, Technology Transfer Date
ACCEPTED BY RECIPIENT:
-------------------------------------------------
Scientist
-------------------------------------------------
Authorized Official
------------------------------------------------- -------------
Title Date
Attachment A
Belonging to PROVIDER
MATERIAL
Original Material Progeny
Unmodified Derivatives
Belonging to RECIPIENT
Modifications (however, PROVIDER retains ownership rights to any form of the
MATERIAL included therein)
Those substances created through the use of the MATERIAL or Modifications, but
which are not Progeny, Unmodified Derivatives or Modifications (e.g., do not
contain the Original Material or Unmodified Derivatives).
22
