Exhibit 10.1

CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

THE GENERAL HOSPITAL CORPORATION

EXCLUSIVE PATENT LICENSE AGREEMENT

MGH Agreement No: A223525

MGH Case No: 02289 and 23317

This License Agreement (“Agreement”) is made as of the 25th day of March, 2015
(“Effective Date”), by and between Columbia Laboratories Inc., a Delaware
corporation, having a principal place of business at Four Liberty Square,
Boston, MA 02109 (“Company”) and The General Hospital Corporation, d/b/a
Massachusetts General Hospital, a not-for-profit Massachusetts corporation, with
a principal place of business at 55 Fruit Street, Boston, Massachusetts 02114
(“Hospital”), each referred to herein individually as a “Party” and collectively
as the “Parties”.

RECITALS

Hospital, as a center for patient care, research and education, is the co-owner
of certain Patent Rights (defined below) and desires to grant a license of those
Patent Rights to Company in order to benefit the public by disseminating the
results of its research via the commercial development, manufacture,
distribution and use of Products and Processes (defined below).

Company has the capability to commercially develop, manufacture, distribute and
use Products and Processes for public use and benefit and desires to license
such Patent Rights.

Hospital and the Massachusetts Institute of Technology (“MIT”) have entered into
an Invention and License Administration Agreement (the “ILAA”) effective
April 29, 2003 under which Hospital has been granted exclusive agency rights to
grant licenses and options to the Patent Rights hereunder.

For good and valuable consideration, the sufficiency of which is hereby
acknowledged, the Parties hereby agree as follows:

1. CERTAIN DEFINITIONS

As used in this Agreement, the following terms shall have the following
meanings, unless the context requires otherwise.

1.1 “Affiliate” with respect to either Party shall mean any corporation or other
legal entity other than that Party in whatever country organized, controlling,
controlled by or under common control with that Party. The term “control” shall
mean (i) in the case of Company, direct or

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CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

indirect ownership of fifty percent (50%) or more of the voting securities
having the right to elect directors, and (ii) in the case of Hospital, the
power, direct or indirect, to elect or appoint fifty percent (50%) or more of
the directors or trustees, or to cause direction of management and policies,
whether through the ownership of voting securities, by contract or otherwise.

1.2 “Claim” shall mean any pending or issued claim of any Patent Right that has
not been permanently revoked, nor held unenforceable or invalid by a decision of
a court or other governmental agency of competent jurisdiction that is
unappealable or unappealed in the time allowed for appeal.

1.3 “Commercially Reasonable Efforts” shall mean with respect to the efforts to
be expended by Company with respect to the objective that is the subject of such
efforts, reasonable, good faith efforts and resources to accomplish such
objective that a US-based pharmaceutical company of similar size and market
capitalization would normally use to accomplish a similar objective under
similar circumstances when developing a women’s health product, it being
understood and agreed that with respect to the development or commercialization
of a Product or Process, such efforts shall be similar to those efforts and
resources consistent with the usual practice of such US-based pharmaceutical
company in pursuing the development or commercialization of a potential women’s
health medical product owned by it or to which it has exclusive rights, with
similar product characteristics as the relevant Product or Process.

1.4 “Distributor” shall mean any third party entity to whom Company, a Company
Affiliate or a Sublicensee has granted, express or implied, the right to
distribute any Product or Process pursuant to Section 2.1(b)(ii).

1.5 “First Commercial Sale” shall mean the initial Sale in an arms-length
transaction to a third party anywhere in the applicable License Territory after
obtaining necessary marketing and pricing approval from regulatory authorities
of a specific Product or Process, but excluding any Sale of a reasonable
quantity of Products for clinical trial purposes or marketing samples.

1.6 “License Field” shall mean all human and animal pharmaceutical, therapeutic,
preventative, diagnostic and palliative uses, including, without limitation
vaginal delivery of pharmaceuticals and shall not include any other field not
specifically set forth herein.

1.7 “License Territory” shall mean worldwide.

1.8 “Net Sales” shall be calculated as set forth in this Section 1.8, all in
accordance with Generally Accepted Accounting Principles (“GAAP”).

 

  (a) Subject to the conditions set forth below, “Net Sales” shall mean:

 

2

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CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

  (i)     

(x) the gross amount invoiced, or if no such invoice is issued, the amount
received by Company and its Affiliates for or on account of Sales of Products
and Processes, and

(y) with respect to royalties based on Net Sales due from Sublicensee as set
forth in Section 4.4(a), the gross amount invoiced, or if no such invoice is
issued, the amount received by Sublicensee for or on account of Sales of
Products and Processes (“Sublicensee Net Sales”);

 

  (ii) less the following amounts to the extent separately stated on the
invoice, actually paid or credited by Company and its Affiliates in effecting
such Sale:

 

  1. amounts repaid or credited by reason of charge-backs, retroactive price
reductions, billing errors, rejection or return of applicable Products or
Processes, and cash, credit or free goods allowances;

 

  2. reasonable and customary trade, quantity or cash rebates (including without
limitation, government mandated and managed care rebates) or discounts to the
extent allowed and taken;

 

  3. amounts for outbound transportation, insurance, packaging, handling and
shipping, but only to the extent separately invoiced in a manner that clearly
specifies the charges applicable to the applicable Products; and

 

  4. import, export, excise and sales taxes, customs duties, value added taxes,
and other governmental charges levied on or measured by Sales of Products or
Processes, whether paid by or on behalf of Company, but not franchise or income
taxes of any kind whatsoever.

 

  (b) [reserved]

 

  (c) Specifically excluded from the definition of “Net Sales” are amounts
attributable to any Sale of any Product or Process between or among Company and
any Company Affiliate and/or Sublicensee, unless the transferee is the end
purchaser, user or consumer of such Product or Process.

 

3

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CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

  (d) No deductions shall be made for any commissions paid to any individuals or
for any costs or expenses of collections.

 

  (e) Net Sales shall be deemed to have occurred and the applicable Product or
Process “Sold” on the earliest of the date of billing, invoicing, delivery or
payment or the due date for payment.

 

  (f) If any Product or Process is Sold at a discounted price that is
substantially lower than the customary non-discounted and discounted price
charged, or for non-cash consideration (whether or not at a discount), Net Sales
for such Product or Process shall be calculated based on the non-discounted cash
amount charged to an independent third party for the Product or Process during
the same Reporting Period or, in the absence of such transaction, on the fair
market value of the Product or Process. Non-cash consideration that could affect
any payment due to Hospital hereunder shall not be accepted without the prior
written consent of Hospital.

 

  (g) In the event Company or an Affiliate or Sublicensee (as used in this
Section 1.8(g) each a “Combination Product Seller”) uses a functionally active
component (for clarity, functionally active components shall exclude routine
components including without limitation common buffers and standard cell culture
media) not licensed by Hospital to Company hereunder (“Other Components”) to
form a product that is a combination of a Product and/or Process and Other
Component(s) (a “Combination Product”), Net Sales for the purposes of
calculating the royalty owed to Hospital on Sales of such Product and/or Process
shall be calculated as described in the subsections below:

 

  (i)

If all Products and/or Processes and Other Components contained in the
Combination Product(s) are Sold separately, Net Sales for Sales of Products
and/or Processes for the purposes of calculating royalty payments shall be
determined by multiplying the greatest of the gross amount invoiced, or if no
such invoice is issued the amount received by the Combination Product Seller for
or on account of Sales of Combination Products (for the purposes of this
Section 1.8(g), the “Gross Sales Price”) by the fraction A/(A+B), in which “A”
is the Gross Sales Price of the Product and/or Process portion of the
Combination Product when Sold separately during the most recent Reporting Period
in the country in which the Sale was made, and “B” is the Gross Sales Price of
the Other Components of the Combination Product Sold separately during said
Reporting Period in said country. For clarity, a Product or Process that

 

4

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CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

  delivers a drug either sold separately by Company or acquired from a third
party shall not be considered a Combination Product with respect to such drug
being included in such Product or Process.

 

  (ii) If the Combination Product contains Products and/or Processes or Other
Components not sold separately (and thus the Gross Sales Price is not available
for such Products and/or Processes or Other Components), then Net Sales for
purposes of determining royalty payments will be calculated as above, but the
Gross Sales Price in the above equation shall be determined by mutual agreement
reached in good faith by the Parties prior to the end of the accounting period
in question based on an equitable method of determining same that takes into
account, in the applicable country, variations in dosage units and the relative
fair market value of each Other Component in the Combination Product. If the
Parties are unable to reach such an agreement prior to the end of the applicable
accounting period, then the Parties will refer such matter for dispute
resolution pursuant to Section 12.15.

1.9 “Patent Rights” shall mean, inclusively, U.S. patent number 7,833,545, filed
on April 29, 2004, and U.S. provisional patent application 62/121,893 filed
February 27, 2015, and (a) any patent applications resulting from the
provisional applications listed on Appendix A, (b) any foreign counterparts
thereof, (c) all divisionals, continuations, continuations in-part (but only to
the extent the claims are directed to the subject matter specifically described
in the aforementioned applications in this paragraph) thereof, and (d) all
patents issued or issuing on any of the foregoing, and any foreign counterparts
thereof, together with all registrations, reissues, re-examinations, renewals,
supplemental protection certificates, or extensions of any of the foregoing, and
any foreign counterparts thereof, as may be further described in Appendix A.

1.10 “Process” shall mean any process, method or service the use or performance
of which, in whole or in part:

 

  (a) absent the license granted hereunder would infringe, or is covered by, one
or more Claims of Patent Rights (“Patented Process”); or

 

  (b) does not meet the requirements of the foregoing clause “(a)” but
incorporates or is based upon Technological Information (“Unpatented Process”).

1.11 “Product” shall mean any article, device or composition, the manufacture,
use, or sale of which, in whole or in part:

 

5

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CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

  (a) absent the license granted hereunder would infringe, or is covered by, one
or more Claims of Patent Rights; (“Patented Product”) or

 

  (b) does not meet the requirements of the foregoing clause “(a)” but
incorporates or is based upon Technological Information (“Unpatented Product”).

1.12 “Reporting Period” shall mean each three month period ending
March 31, June 30, September 30 and December 31.

1.13 “Sell” (and “Sale” and “Sold” as the case may be) shall mean to sell or
have sold, to lease or have leased, to import or have imported for valuable
consideration (in the form of cash or otherwise), or otherwise to transfer or
have transferred a Product or Process for valuable consideration (in the form of
cash or otherwise), and further in the case of a Process to use or perform such
Process for the benefit of a third party.

1.14 “Sublicense Income” shall mean consideration in any form received
by Company and/or Company’s Affiliate(s) in connection with or otherwise
attributable to a grant of a sublicense or any other right, license, privilege
or immunity (regardless of whether such grantee is a “Sublicensee” as defined in
this Agreement) to make, have made, use, have used, Sell or have Sold Products
or Processes, but excluding royalties on or consideration included within Net
Sales except to the extent provided under Section 4.4(a). Sublicense Income
shall include without limitation any license signing fee, license maintenance
fee, milestone payment (other than for a milestone event for which Hospital
receives a milestone payment under Section 4.3 hereof), unearned portion of any
minimum royalty payment, distribution or joint marketing fee whether or not
including sublicense rights, research and development funding in excess of the
cost of performing such research and development plus reasonable overhead
charges, and any consideration received for an equity interest in, extension of
credit to or other investment in Company or Company’s Affiliates to the extent
such consideration exceeds the fair market value of the equity or other interest
received as determined by agreement of the Parties or by an independent
appraiser mutually agreeable to the Parties. Sublicense Income shall not include
payments made to reimburse direct costs such as (i) payments or reimbursement
for documented sponsored research and/or development activities, valued at the
actual direct cost of such activities plus reasonable overhead charges; or
(ii) payment or reimbursement of reasonable patent expenses actually incurred or
paid by Company and not otherwise reimbursed, or payment of patent expenses
required to be paid by Company hereunder. Sublicense Income shall also not
include (iii) payments received with respect to a change of control of the
Company; and (iv) payments for the purchase of equity in the Company at the fair
market value of such equity. In the event a sublicense grants rights to both the
Company’s or third party’s patented technology and the Patent Rights and/or
Technological Information, the Sublicense Income will be reduced by an amount
proportional to the relative value of the Company’s or third party’s patented

 

6

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CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

technology as determined by agreement of the Parties or by an independent
appraiser mutually agreeable to the Parties.

1.15 “Sublicensee” shall mean any sublicensee of rights granted in accordance
with Section 2.1(a)(ii). For purpose of this Agreement, a Distributor of a
Product or Process shall not be included in the definition of Sublicensee unless
such Distributor (i) is granted any right to make, have made, use or have used
Products or Processes in accordance with Section 2.1(a)(ii), or (ii) has agreed
to pay to Company or its Affiliate(s) royalties on such Distributor’s sales of
Products or Processes, in which case such Distributor shall be a Sublicensee for
all purposes of this Agreement. For clarity, a clinic that is granted the right
to use or have used Products or Processes to treat patients shall not be
considered a Sublicensee if the Company or its Affiliate(s) do not receive
royalties or other payments (other than the price paid for the Product) related
to such clinic’s use of Products or Processes

1.16 “Technological Information” shall mean any materials, reports, data
summaries, and other information, methods, protocols, data, know-how, or other
intellectual property for which no patent has been filed whether or not
patentable, but excluding Patent Rights, pertaining to the vaginal ring
technology platform that is the subject of the Patent Rights and owned or
controlled by Hospital and/or MIT as applicable, as of the Effective Date, with
the right to license (other than the Patent Rights). In particular,
Technological Information shall include the know-how possessed by investigators
Crowley, Langer, and Ron as of the Effective Date and that is not confidential
information of or otherwise obligated to any third party and which any of Drs.
Crowley, Langer, and Ron knows as of the Effective Date and reasonably believes
is necessary in order for Company to utilize the licenses granted hereunder.
Company agrees to treat all Technological Information in accordance with the
provisions of Appendix D.

2. LICENSE

2.1 Grant of License.

 

  (a) Subject to the terms of this Agreement and Hospital’s and MIT’s rights in
Patent Rights, Hospital hereby grants to Company in the License Field in the
License Territory:

 

  (i) an exclusive, royalty-bearing license under its rights in Patent Rights to
make, have made, use, have used, Sell, have Sold, import and have imported
Products and Processes;

 

  (ii) a non-exclusive, royalty-bearing license to use the Technological
Information to make, have made, use, have used, Sell, have Sold, import and have
imported Products and Processes; and

 

7

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CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

  (iii) the right to grant sublicenses under the rights granted in Sections
2.1(a)(i) and 2(a)(ii) to Sublicensees (including the right for Sublicensees to
grant further sublicenses consistent with these terms), provided that in each
case Company shall be responsible for the performance of any obligations of
Sublicensees relevant to this Agreement as if such performance were carried out
by Company itself, including, without limitation, the payment of any royalties
or other payments provided for hereunder, regardless of whether the terms of any
sublicense provide for such amounts to be paid by the Sublicensee directly to
Hospital.

 

  (b) The license granted in Section 2.1(a) above includes:

 

  (i) the right to grant to the final purchaser, user or consumer of Products
the right to use such purchased Products in a method coming within the scope of
Patent Rights and Technological Information within the License Field and License
Territory; and

 

  (ii) the right to grant a Distributor the right to Sell, have Sold, use, have
used, import and have imported (but not to make and have made) such Products
and/or Processes for or on behalf of Company, its Affiliates and Sublicensees in
a manner consistent with this Agreement.

 

  (c) The foregoing license grant shall include the grant of such license to any
Affiliate of Company, provided that such Affiliate shall assume the same
obligations as those of Company and be subject to the same terms and conditions
hereunder; and further provided that Company shall be responsible for the
performance of all of such obligations and for compliance with all of such terms
and conditions by Affiliate. Company shall provide to Hospital and MIT a fully
signed, non-redacted copy of each agreement with each Affiliate that assumes the
aforesaid obligations, including all exhibits, attachments and related documents
and any amendments, within thirty (30) days of request by Hospital.

2.2 Sublicenses. Each sublicense granted hereunder shall be consistent with and
comply with all relevant terms of this Agreement, shall incorporate terms and
conditions sufficient to enable Company to comply with this Agreement, shall
provide that Company shall be responsible for performance of all such
obligations and for compliance with all such terms and conditions by
Sublicensees Company shall provide to Hospital and MIT a fully signed redacted
(to remove content unrelated to obligations due Hospital or MIT) copy of all
sublicense agreements and amendments thereto, including all exhibits,
attachments and related documents, within thirty (30)

 

8

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CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

days of executing the same. Upon termination of this Agreement or any license
granted hereunder for any reason, any Sublicenses shall be addressed in
accordance with Section 10.7.

2.3 Retained Rights; Requirements. Any and all licenses granted hereunder are
subject to:

 

  (a) the right of Hospital, Hospital’s Affiliates, MIT and other academic,
government and not-for-profit institutions to make, have made, and to use the
subject matter described and/or claimed in the Patent Rights for research,
teaching, and educational purposes (such research, teaching and educational
purposes shall not include the production and manufacture of Products or
Processes for sale); and

 

  (b) for Patent Rights supported by federal funding, the rights, conditions and
limitations imposed by U.S. law (see 35 U.S.C. § 202 et seq. and regulations
pertaining thereto), including without limitation:

 

  (i) the royalty-free non-exclusive license granted to the U.S. government; and

 

  (ii) the requirement (to the extent required by law) that any Products used or
sold in the United States shall be manufactured substantially in the United
States.

2.4 No Additional Rights. It is understood that nothing in this Agreement shall
be construed to grant Company or any of its Affiliates a license, express or
implied, under any patent owned solely or jointly by Hospital and/or MIT other
than the Patent Rights expressly licensed hereunder. Hospital shall have the
right to license any Patent Rights to any other party for any purpose outside of
the License Field or the License Territory.

2.5 Disclosure of Technological Information. At Company’s request prior to
execution of this Agreement, Hospital (through Dr. Langer and Dr. Crowley) shall
use reasonable efforts to disclose in confidence within three (3) months after
execution of this Agreement the Technological Information licensed hereunder.

 

9

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CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

3. DUE DILIGENCE OBLIGATIONS

3.1 Diligence Requirements. Company shall use, and shall cause its Affiliates
and Sublicensees, as applicable, to use, Commercially Reasonable Efforts to
develop and make available to the public at least one Product and/or Processes
in the License Territory in the License Field. Such efforts shall include
achieving the following objectives within the time periods designated below, the
achievement of which shall be deemed to fully satisfy Company’s, or its
Affiliates’ or Sublicensee’s obligation to use Commercially Reasonable Efforts
as set forth in this Section 3.1:

 

  (a) Pre-Sales Requirements.

 

  (i) Within [****] of the Effective Date, invest at least [****] in the
development and/or commercialization of Products or Processes.

 

  (ii) Within [****] of the Effective Date, invest at least [****] in the
development and/or commercialization of Products or Processes.

 

  (iii) Within [****] of the Effective Date, invest at least [****] in the
development and/or commercialization of Products or Processes.

 

  (iv) Within [****] of the Effective Date, invest at least [****] in the
development and/or commercialization of Products or Processes.

 

  (v) Within [****] of the Effective Date, file for an IND on a Product or
Process or invest at least [****] in the development and/or commercialization of
Products or Processes.

 

  (vi) Within [****] of satisfying 3.1(a)(iv) above, apply for an NDA or PMA on
a Product or Process.

 

  (vii) Within [****] of satisfying 3.1(a)(v) above, make a First Commercial
Sale or file a second IND on a Product or Process.

 

10

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CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

  (b) Purchased Extensions of Time. The Company may elect to extend the time
period for a particular diligence requirement set forth in 3.1(a) by [****] upon
notice to Hospital and payment of a non refundable extension payment of [****].
The extension of time, once elected and paid for, shall have the effect of
extending all subsequent diligence requirements set forth in 3.1(a). Company may
exercise the extension of time under this section no more than two times over
the life of the Agreement (not per diligence requirement).

3.2 Diligence Failures. In the event Company has failed to fulfill any of its
obligations under Section 3.1(a), and subject to resolution under the dispute
resolution provisions of Section 12.15 hereof, then Hospital may treat such
failure as a default and may terminate this Agreement and/or any license granted
to Company hereunder in accordance with Section 10.4.

3.3 Diligence Reports. Company shall provide all reports with respect to its
obligations under Section 3.1 as set forth in Section 5.

4. PAYMENTS AND ROYALTIES

4.1 Patent Cost Reimbursement. Company shall reimburse Hospital for all costs
associated with the preparation, filing, prosecution and maintenance of all
Patent Rights (“Patent Costs”) incurred during the Term. Patent Costs shall not
include the cost of time of staff members of Hospital’s Innovation office to
attend to patent prosecution matters unless previously agreed to in writing by
Company. As of the Effective Date, Hospital and MIT have incurred approximately
[****] in Patent Costs, which amount Company shall pay to Hospital within
forty-five (45) days of the Effective Date of this Agreement. Company shall pay
to Hospital, or at Hospital’s request directly to patent counsel, all other
Patent Costs within forty-five (45) days of Company’s receipt of an invoice for
such Patent Costs either from Hospital or Hospital’s patent counsel. Hospital
shall instruct patent counsel to provide copies to Hospital for Hospital’s
administrative files of all invoices detailing Patent Costs which are sent
directly to Company. If Company pays any Patent Costs directly, Company shall
advise patent counsel that Hospital is and shall remain patent counsel’s client.

4.2 Annual License Fee; Annual Minimum Royalty.

 

  (a) Company shall pay to Hospital the following non-refundable amounts as an
annual license fee within thirty (30) days after each of the following
anniversaries of the Effective Date:

 

  (i) the first anniversary of the Effective Date: fifty thousand dollars
($50,000);

 

11

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CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

  (ii) the second anniversary of the Effective Date: fifty thousand dollars
($50,000);

 

  (iii) the third anniversary of the Effective Date: fifty thousand dollars
($50,000);

 

  (iv) the fourth anniversary of the Effective Date: fifty thousand dollars
($50,000);

 

  (v) the fifth anniversary of the Effective Date: fifty thousand dollars
($50,000);

 

  (vii) the sixth anniversary and on each subsequent anniversary of the
Effective Date thereafter: one hundred thousand dollars ($100,000).

 

  (b) The annual minimum royalty shall be credited against royalties
subsequently due on Net Sales and Sublicense Income made during the same
calendar year, if any, but shall not be credited against royalties due on Net
Sales and Sublicense Income made in any other year.

4.3 Milestone Payments. In addition to the payments set forth in Sections 4.1
and 4.2 above, Company shall pay Hospital milestone payments of one million
two-hundred thousand dollars ($1,200,000), as follows:

 

  (a) [****] within thirty (30) days of completion of the first successful Phase
2B trial or equivalent of a Product or Process,

 

  (b) [****] within thirty (30) days of completion of the first successful Phase
3 or equivalent trial of a Product or Process,

 

  (c) [****] within thirty (30) days of completion of the First Commercial Sale
in the US of a Product or Process,

 

  (d) [****] within thirty (30) days of completion of the First Commercial Sale
of a subsequent distinct Product or Process such as (i) a new Product or Process
other than a product line extension, or (ii) a Product or Process containing a
new active ingredient, and

 

  (e)

[****] within thirty (30) days of completion of the First Commercial Sale of a
second subsequent distinct Product or Process such as (i) a new Product or
Process other than

 

12

--------------------------------------------------------------------------------

CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

  a product line extension, or (ii) a Product or Process containing a new active
ingredient.

For the avoidance of doubt, each of the milestones (a) through (e) above shall
be paid only once, regardless of the number of disease indications or Products
or Processes developed under the Agreement.

4.4 Royalties and Sublicense Income.

 

  (a) Subject to Section 4.4(d), beginning with the First Commercial Sale in any
country in the License Territory, Company shall pay Hospital based on Net Sales
in each calendar year:

 

  (i) a royalty of [****] of the Net Sales of all Patented Products and Patented
Processes on that portion of aggregate Net Sales of all Patented Products and
Patented Processes equal to or less than three hundred fifty million dollars
($350,000,000) in such calendar year; and

 

  (ii) a royalty of [****] of the Net Sales of all Patented Products and
Patented Processes on that portion of aggregate Net Sales of all Patented
Products and Patented Processes greater than three hundred fifty million dollars
($350,000,000) in such calendar year; or

 

  (iii) in lieu of any royalty payable under (i) or (ii) above, a royalty of
[****] of the Net Sales of all Unpatented Products and Unpatented Processes.

Provided that with respect to Sublicensee Net Sales, the royalty to be paid to
the Hospital on such Sublicensee Net Sales will be the greater of: (i) [****] of
Sublicensee Net Sales or (ii) the amount of Sublicense Income that Company would
owe to Hospital if such royalties paid by sublicensee to Company were deemed to
be included in Sublicense Income. Notwithstanding the foregoing, Hospital shall
be entitled to a minimum royalty of [****] of Sublicensee Net Sales. Such
minimum royalty is an absolute minimum royalty rate and cannot be further
reduced by any means including but not limited to adjustments for royalty
stacking or combination products, except to the extent Company is also subject
to such combination product adjustments as applied to the royalties paid by
sublicensee to Company, provided that such combination product adjustment will
be consistent with the combination product language in Section 1.8(g).

 

13

--------------------------------------------------------------------------------

CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

Royalties due hereunder will terminate Product by Product and Process by Process
on a country by country basis upon such Product or Process becoming subject to
generic competition.

 

  (b) In the event that Company is legally required to make royalty payments to
one or more third parties in order to develop or commercialize the Product or
Process, Company may offset a total of [****] of such third-party payments
against any royalty payments that are due under Section 4.4(a) to Hospital in
the same Reporting Period, provided that in no event shall the royalty payments
under Section 4.4(a), when aggregated with any other offsets and credits allowed
under this Agreement, be reduced by more than [****] in any Reporting Period.

 

  (c) Company shall pay Hospital [****] of any and all Sublicense Income for
Sublicenses executed before the second anniversary of the Effective Date and
[****] of any and all Sublicense Income for Sublicenses executed after the
second anniversary of the Effective Date.

 

  (d) To the extent any Net Sales or Sublicensee Net Sales arise from the Sale
of Product by Company or its Affiliates or Sublicensees for or on account of
Sales of Products and Processes to Hospital and Hospital’s Affiliates, then
Company shall, in lieu of paying any royalties to Hospital hereunder, pay
directly to MIT [****] of the royalties that would have been due to Hospital
with respect to such Net Sales or Sublicensee Net Sales, as the case may be, in
accordance with this Section 4.4(d). These Net Sales or Sublicensee Net Sales,
as the case may be, will be reported separately and specifically indicated per
the reporting requirements of Section 5.3(c). Hospital reserves the right to
modify or eliminate this Section 4.4(d) at any time upon written notice to
Company to reflect changes in Hospital’s policies that would allow the Hospital
to receive full or partial royalty payments on the Sales of Products or
Processes to Hospital and Hospital’s Affiliates.

 

  (e) All payments due to Hospital (or MIT pursuant to Section 4.4(d)) under
this Section 4.4 shall be due and payable by Company within sixty (60) days
after the end of each Reporting Period, and shall be accompanied by a report as
set forth in Sections 5.3 and 5.4.

4.5 Form of Payment. All payments due under this Agreement shall be drawn on a
United States bank and shall be payable in United States dollars. Each payment
shall reference this Agreement and its Agreement Number and identify the
obligation under this Agreement that the payment satisfies. Conversion of
foreign currency to U.S. dollars shall be made at the conversion rate existing
in the United States, as reported in The Wall Street Journal, on the last
working day of the applicable Reporting Period, consistent with GAAP. Such
payments shall be

 

14

--------------------------------------------------------------------------------

CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

without deduction of exchange, collection or other charges, and, specifically,
without deduction of withholding or similar taxes or other government imposed
fees or taxes, except as permitted in the definition of Net Sales.

Checks for all payments due to the Hospital under this Agreement shall be made
payable to the Hospital and addressed as set forth below:

Massachusetts General Hospital

BOA-Lockbox Services

PCSR Lockbox #415007

MA5-527-02-07

2 Morrissey Blvd

Dorchester, MA 02125

Reference Agreement #: A223525

Payments via wire transfer should be made as follows:

ACH Credit: ABA # 011-000-138

Federal Reserve Wire: ABA#026-009-593

SWIFT Code: BOFAUS3N

Account #0050169434

Massachusetts General Hospital

Bank of America

100 Federal Street

Boston, MA 02110

Reference Agreement #: A223525

Checks for all payments to be made to MIT in pursuant to Section 4.4(d) shall be
made payable to “Massachusetts Institute of Technology” and sent to the address
below:

Massachusetts Institute of Technology

Technology Licensing Office, Room NE18-501

255 Main Street

Cambridge, MA 02142-1601

Attention: Director

4.6 Overdue Payments. The payments due under this Agreement shall, if overdue,
bear interest beginning on the first day following the Reporting Period to which
such payment was incurred and until payment thereof at a per annum rate equal to
[****] above the prime rate in

 

15

--------------------------------------------------------------------------------

CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

effect on the due date as reported by The Wall Street Journal, such interest
rate being compounded on the last day of each Reporting Period, not to exceed
the maximum permitted by law. Any such overdue payments when made shall be
accompanied by all interest so accrued. Said interest and the payment and
acceptance thereof shall not preclude Hospital from exercising any other rights
it may have as a consequence of the lateness of any payment.

5. REPORTS AND RECORDS

5.1 Diligence Reports. Within sixty (60) days after the end of each calendar
year, Company shall report in writing to Hospital on progress made toward the
objectives set forth in Section 3.1 during such preceding 12 month period,
including, without limitation, progress on research and development, status of
applications for regulatory approvals, manufacturing, sublicensing and the
number of sublicenses entered into and marketing.

5.2 Milestone Achievement Notification. Company shall report to Hospital the
dates on which it achieves the milestones set forth in Section 4.3 within sixty
(60) days of each such occurrence.

5.3 Sales Reports. Company shall report to Hospital the date of the First
Commercial Sale in each country of the License Territory within the later of
sixty (60) days after the applicable Reporting Period of each such occurrence,
or sixty (60) days after Company is notified by a Sublicensee of a First
Commercial Sale made by such Sublicensee, but in no event later than one-hundred
twenty (120) days after the date of such First Commercial Sale. Following the
First Commercial Sale, Company shall deliver reports to Hospital within the
later of sixty (60) days after the end of each Reporting Period, or sixty
(60) days after Company receives a corresponding report from its Sublicensee,
but in no event later than one-hundred twenty (120) days after the end of such
Reporting Period. Each report under this Section 5.4 shall have substantially
the format outlined in Appendix B, shall be certified as correct by an officer
of Company and shall contain at least the following information as may be
pertinent to a royalty accounting hereunder for the immediately preceding
Reporting Period:

 

  (a) the number of Products and Processes Sold by Company, its Affiliates and
Sublicensees in each country;

 

  (b) the amounts billed, invoiced and received by Company, its Affiliates and
Sublicensees for each Product and Process, in each country, and total billings
or payments due or made for all Products and Processes;

 

  (c) calculation of Net Sales for the applicable Reporting Period in each
country, including an itemized listing of permitted offsets and deductions;

 

16

--------------------------------------------------------------------------------

CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

  (d) total royalties payable on Net Sales in U.S. dollars, together with the
exchange rates used for conversion; and

 

  (e) any other payments due to Hospital under this Agreement.

If no amounts are due to Hospital for any Reporting Period, the report shall so
state.

5.4 Sublicense Income Reports. Company shall, along with delivering payment as
set forth in Section 4.5, report to Hospital within sixty (60) days of receipt
the amount of all Sublicense Income received by Company, and Company’s
calculation of the amount due and paid to Hospital from such income, including
an itemized listing of the source of income comprising such consideration, and
the name and address of each entity making such payments in substantially the
format outlined in Appendix C.

5.5 Audit Rights. Company shall maintain, and shall cause each of its Affiliates
and Sublicensees to maintain, complete and accurate records relating to the
rights and obligations under this Agreement and any amounts payable to Hospital
in relation to this Agreement, which records shall contain sufficient
information to permit Hospital to confirm the accuracy of any payments and
reports delivered to Hospital and compliance in all other respects with this
Agreement. Company shall retain and make available, and shall cause each of its
Affiliates and Sublicensees to retain and make available as set forth below,
such records for at least five (5) years following the end of the calendar year
to which they pertain, to Hospital upon at least fifteen (15) days’ advance
written notice, for examination during normal business hours, by independent
certified public accountants hired by Hospital and reasonably acceptable to
Company, its Affiliates and Sublicensees, as the case may be, to verify any
reports and payments made and/or compliance in other respects under this
Agreement. Company may require such accountants to enter into a reasonably
acceptable confidentiality agreement, and in no event shall such accountants
disclose to Hospital any information, other than such as relates to the accuracy
of the corresponding reports pursuant to Section 5. Such confidentiality
agreement shall permit such accountants to perform all activities typically
associated with an audit of a license agreement. The foregoing right of
examination may be exercised only once in relation to each twelve (12)-month
period during the Term. If any examination conducted by such independent
certified public accountants pursuant to the provisions of this Section show an
underreporting or underpayment of five percent (5%) or more in any payment due
to Hospital hereunder, Company shall bear the full cost of such audit and shall
remit any amounts due to Hospital (including interest due in accordance with
Section 4.6) within thirty (30) days of receiving notice thereof from Hospital.

 

17

--------------------------------------------------------------------------------

CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

6. PATENT PROSECUTION AND MAINTENANCE

6.1 Prosecution. Hospital shall be responsible for the preparation, filing,
prosecution and maintenance of all patent applications and patents included in
Patent Rights by outside patent counsel selected by Hospital and reasonably
acceptable to Company. Company shall reimburse Hospital for Patent Costs
incurred by Hospital relating thereto in accordance with Section 4.1.

6.2 Copies of Documents. With respect to any Patent Right licensed hereunder,
Hospital shall instruct the patent counsel prosecuting such Patent Right to
(i) promptly copy Company on patent prosecution documents that are received from
or filed with the United States Patent and Trademark Office and foreign
equivalent, as applicable; (ii) promptly provide Company with copies of draft
submissions to the USPTO prior to filing with reasonably sufficient time for
Company and its patent counsel to review and provide comments for incorporation
into such submission; and (iii) consult with Company, and take any of Company’s
or its patent counsel’s comments and requests into good faith consideration,
with respect to the preparation, prosecution and maintenance of the Patent
Rights.

6.3 Company’s Election Not to Proceed. Company may elect to surrender any patent
or patent application in Patent Rights in any country upon sixty (60) days
advance written notice to Hospital (“Waived Patent Rights”). Such notice shall
relieve Company from the obligation to pay for future Patent Costs but shall not
relieve Company from responsibility to pay Patent Costs incurred prior to the
expiration of the sixty (60) day notice period:

 

  (a) If the Waived Patent Rights are in [****], such patent application or
patent in such country shall thereupon cease to be a Patent Right hereunder and
Hospital shall be free to license its rights to that particular U.S. or foreign
patent application or patent to any other party on any terms.

 

  (b) If the Waived Patent Rights are in any other country (i.e., other than a
country set forth above in (a)), the licenses granted with respect to such
patent application or patent in such other country under Section 2.1(a)(i) shall
thereupon become non-exclusive, Company will be obligated to pay a royalty on
Unpatented Products and Unpatented Processes in those countries at the rates set
forth in Section 4.4, and Hospital shall be free to license its rights
non-exclusively to that particular patent application or patent in such other
country to any other party on any terms.

6.4 Confidentiality of Prosecution and Maintenance Information. Company agrees
to treat all information related to prosecution and maintenance of Patent Rights
as Confidential Information in accordance with the provisions of Appendix D.

 

18

--------------------------------------------------------------------------------

CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

7. THIRD PARTY INFRINGEMENT AND LEGAL ACTIONS

7.1 Company Right to Prosecute. Each Party agrees to immediately notify the
other Party in writing upon becoming aware of any infringement of the Patent
Rights in the License Field and provide to the other Party all
reasonably-available evidence of such infringement. Company shall have the first
right, but not the obligation, to protect Patent Rights from infringement and
prosecute infringers in the License Field in the License Territory. Before
commencing such action, Company and, as applicable, any Affiliate, shall consult
with Hospital, concerning, among other things, Company’s standing to bring suit,
the advisability of bringing suit, the selection of counsel and the jurisdiction
for such action (provided Company must have Hospital’s and MIT’s prior written
consent, not to be unreasonably withheld, conditioned or delayed, with respect
to selection of jurisdiction for any action in which Hospital and/or MIT may be
joined as a party-plaintiff) and shall use reasonable efforts to accommodate the
views of Hospital regarding the proposed action, including without limitation
with respect to potential effects on the public interest. Company shall be
responsible for all costs, expenses and liabilities in connection with any such
action and shall indemnify and hold Hospital and MIT harmless therefrom,
regardless of whether Hospital and/or MIT is a party-plaintiff, except for the
expense of any independent counsel retained by Hospital or MIT in accordance
with Section 7.5 below. If Hospital shall have supplied Company with written
evidence demonstrating to Company’s reasonable satisfaction prima facie
infringement of a claim of a Patent Right in the License Field in the License
Territory by a third party, Hospital may by notice request Company to take steps
to protect such Patent Right. Company shall notify Hospital within three
(3) months of the receipt of such notice whether Company intends to prosecute
the alleged infringement. If Company notifies Hospital that it intends to so
prosecute, Company shall, within three (3) months after its notice to Hospital
either (i) cause such infringement to terminate, or (ii) initiate legal
proceedings against the infringer.

7.2 Hospital Right to Prosecute. In the event Company notifies Hospital that
Company does not intend to prosecute infringement identified under Section 7.1,
or in the event that Company is unsuccessful in persuading the alleged infringer
to desist, Hospital has the right, but not the obligation, upon notice to
Company, to initiate legal proceedings against the infringer at Hospital’s
expense with respect to a claim of a Patent Right in the License Field in the
License Territory, and any recovery obtained shall first be applied to
reimbursement of any legal fees and expenses incurred by either Party and the
remainder shall belong to Hospital.

7.3 Hospital and MIT Joined as Party-Plaintiff. If Company elects to commence an
action as described in Section 7.1 above, Hospital and MIT shall each have, in
its sole discretion, the option to join such action as party-plaintiffs. If
Hospital and MIT are required by law to join such action as party-plaintiffs,
Hospital and MIT may either (i) in their joint discretion, permit themselves to
be joined as party-plaintiffs at the sole expense of Company, or (ii) assign to
Company all of Hospital’s and MIT’s right, title and interest in and to the
Patent Right which is

 

19

--------------------------------------------------------------------------------

CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

the subject of such action (subject to all of Hospital’s and MIT’s obligations
to the government under law and any other rights that others may have in such
Patent Right). If Hospital and MIT make such an assignment, such action by
Company shall thereafter be brought or continued without Hospital or MIT as a
party; provided, however, that Hospital and MIT shall continue to have all
rights of prosecution and maintenance with respect to Patent Rights and Company
shall continue to meet all of its obligations under this Agreement as if the
assigned Patent Right were still licensed to Company hereunder.

7.4 Notice of Actions; Settlement. The Party commencing an action as described
under this Section 7 shall promptly inform the other of any action or suit
relating to Patent Rights and shall not enter into any settlement, consent
judgment or other voluntary final disposition of any action relating to Patent
Rights, including but not limited to appeals, without the prior written consent
of such other Party, such consent not to be unreasonably withheld, conditioned
or delayed.

7.5 Cooperation. Each Party agrees to cooperate reasonably in any action under
Section 7 which is controlled by the other Party, provided that the controlling
party reimburses the cooperating party for any costs and expenses incurred by
the cooperating party in connection with providing such assistance, except for
the expense of any independent counsel retained by the cooperating party in
accordance with this Section 7.5. Such controlling party shall keep the
cooperating party informed of the progress of such proceedings and shall make
its counsel available to the cooperating party. The cooperating party shall also
be entitled to independent counsel in such proceedings but at its own expense,
said expense to be offset against any damages received by the Party bringing
suit in accordance with Section 7.6.

7.6 Recovery. Any award paid by third parties as the result of proceedings
brought by Company under Section 7.1 (whether by way of settlement or otherwise)
shall first be applied to reimbursement of any legal fees and expenses incurred
by either Party (or MIT as applicable); and then Company shall receive an amount
equal to its lost profits or a reasonable royalty on the infringing sales, or
whichever measure of damages the settlement or court shall have applied
(“Damages”), such Damages will be deemed to constitute Net Sales hereunder for
which Hospital will receive the royalty amounts set forth in Section 4.4, and
then the remainder shall be shared equally by the Parties.

8. INDEMNIFICATION AND INSURANCE

8.1 Indemnification.

 

  (a)

Company shall indemnify, defend and hold harmless MIT, Hospital and its
Affiliates and their respective trustees, directors, officers, medical and
professional staff, employees, faculty, students, and agents and their
respective

 

20

--------------------------------------------------------------------------------

CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

  successors, heirs and assigns (the “Indemnitees”), against any liability,
damage, loss or expense (including reasonable attorney’s fees and expenses of
litigation)(collectively, “Losses”) incurred by or imposed upon the Indemnitees
or any one of them in connection with any claims, suits, actions, demands or
judgments arising out of or related to the exercise of any rights granted to
Company under this Agreement, any breach of this Agreement by Company, or any
theory of product liability (including, but not limited to, actions in the form
of contract, tort, warranty, or strict liability) concerning any product,
process or service made, used, or sold or performed pursuant to any right or
license granted under this Agreement (collectively, “Claims”), except to the
extent such Losses arise from the gross negligence or willful misconduct of an
Indemnitee.

 

  (b) An Indemnitee that intends to claim indemnification under this Section 8.1
shall promptly notify Company of any claim in respect of which the Indemnitee
intends to claim such indemnification reasonably promptly after the Indemnitee
is aware thereof before any formal deadline for responding to a such claim has
passed, and Company shall assume the defense of such Claim with counsel mutually
satisfactory to the Parties; provided, however, that an Indemnitee shall have
the right to retain its own counsel and participate in the defense thereof at
its own cost and expense, and further provided, that any Indemnitee shall have
the right to retain its own counsel, at the expense of Company, if
representation of such Indemnitee by counsel retained by Company would be
inappropriate because of conflict of interests of such Indemnitee and any other
party represented by such counsel.

 

  (c) The indemnity obligation in this Section 8.1 shall not apply to amounts
paid in settlement of any Claim if such settlement is effected by or on behalf
of an Indemnitee without the consent of Company. The Indemnitee under this
Section 8.1 shall cooperate fully with Company and its legal representatives in
the investigation and defense of any matter covered by this indemnification.
Company agrees to keep Hospital and MIT informed of the progress in the defense
and disposition of such claim and to consult with Hospital and MIT prior to any
proposed settlement.

 

  (d) This section 8.1 shall survive expiration or termination of this
Agreement.

8.2 Insurance.

 

  (a)

Company shall, at its sole cost and expense, procure and maintain commercial
general liability and products-completed operations liability insurance
policy(ies) in amounts not less than [****] per incident and [****] annual
aggregate which

 

21

--------------------------------------------------------------------------------

CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

  shall be issued by an insurer licensed to practice in the Commonwealth of
Massachusetts and which shall name the Indemnitees as additional insureds. Such
insurance shall provide (i) product liability coverage (ii) errors and omissions
liability coverage and (iii) contractual liability coverage. The limits of such
insurance shall not be less than [****] per occurrence with an annual aggregate
of [****] for bodily injury including death; [****] per occurrence with an
annual aggregate of [****] for property damage; and [****] per occurrence with
an annual aggregate of [****] for errors and omissions. If Company desires to
self-insure all or part of the limits described above (including deductibles or
retentions which are in excess of [****] annual aggregate) such self-insurance
program must be acceptable to the Hospital, MIT and the Risk Management
Foundation. The minimum amounts of insurance coverage required under this
Section 8.2 shall not be construed to create a limit of Company’s liability with
respect to its indemnification under Section 8.1 of this Agreement.

 

  (b) Company shall provide Hospital with written evidence of such insurance
upon request of Hospital. Company shall provide Hospital with written notice at
least fifteen (15) days prior to the cancellation, non-renewal or material
change in such insurance; if Company does not obtain replacement insurance
providing comparable coverage prior to the expiration of such fifteen (15) day
period, Hospital shall have the right to terminate this Agreement effective at
the end of such fifteen (15) day period without notice or any additional waiting
periods.

 

  (c) Company shall maintain such commercial general liability insurance beyond
the expiration or termination of this Agreement during (i) the period that any
such product, process, or service is being commercially distributed, sold,
leased or otherwise transferred, or performed or used (other than for the
purpose of obtaining regulatory approvals), by Company or by a licensee,
affiliate or agent of Company and (ii) a reasonable period after the period
referred to in (c) (i) above which in no event shall be less than fifteen
(15) years.

 

  (d) This section 8.2 shall survive expiration or termination of this
Agreement.

9. DISCLAIMER OF WARRANTIES; LIMITATION OF LIABILITY

9.1 Title to Patent Rights. To the best actual knowledge of Hospital’s
Innovation Office as of the Effective Date without investigation, Hospital
represents that (i) Hospital and/or MIT own all right, title and interest in the
Patent Rights, and that Hospital has not received any notice of any current
claims, liens or encumbrances with respect to such Patent Rights, except as
otherwise stated in this agreement, (ii) Hospital and MIT are the owners by
assignment from Dr. Robert Langer, Dr. William Crowley and Dr. Eyal Ron of the
Patent Rights, (iii) Hospital has the

 

22

--------------------------------------------------------------------------------

CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

authority to enter into this Agreement, (iv) Hospital has received no current
claims of a third party to rights in the Patent Rights, (v) the Patent Rights
are subsisting, and Hospital has not received any claim or notice that the
Patent Rights are invalid or unenforceable, and (vi) Hospital has not received
any notice of any current claims, liens or encumbrances with respect to the
rights and licenses to the Patent Rights granted to Company hereunder, except as
otherwise stated in this agreement. For the purposes of this section, the
definition of Patent Rights does not include provisional patent application
number 62/121,893 filed on February 27, 2015. Hospital makes no representations
with respect to such patent application.

9.2 No Warranties. EXCEPT WITH RESPECT TO HOSPITAL AS SET FORTH IN SECTION 9.1,
HOSPITAL AND MIT MAKE NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR
IMPLIED, CONCERNING THE PATENT RIGHTS AND THE RIGHTS GRANTED HEREUNDER,
INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, NONINFRINGEMENT, VALIDITY OF PATENT RIGHTS CLAIMS, WHETHER
ISSUED OR PENDING, AND THE ABSENCE OF LATENT OR OTHER DEFECTS, WHETHER OR NOT
DISCOVERABLE, AND HEREBY DISCLAIMS THE SAME. SPECIFICALLY, AND NOT TO LIMIT THE
FOREGOING, HOSPITAL AND MIT MAKE NO WARRANTY OR REPRESENTATION (i) REGARDING THE
VALIDITY OR SCOPE OF ANY OF THE CLAIM(S), WHETHER ISSUED OR PENDING, OF ANY OF
THE PATENT RIGHTS, AND (ii) THAT THE EXPLOITATION OF THE PATENT RIGHTS OR ANY
PRODUCT WILL NOT INFRINGE ANY PATENTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF
HOSPITAL, MIT, OR OF ANY THIRD PARTY.

9.3 Limitation of Liability. IN NO EVENT SHALL COMPANY, HOSPITAL, OR MIT OR ANY
OF THEIR AFFILIATES OR ANY OF THEIR RESPECTIVE TRUSTEES, DIRECTORS, OFFICERS,
MEDICAL OR PROFESSIONAL STAFF, EMPLOYEES, STUDENTS AND AGENTS BE LIABLE
HEREUNDER FOR INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND
ARISING IN ANY WAY OUT OF THIS AGREEMENT OR THE LICENSE OR RIGHTS GRANTED
HEREUNDER, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, INCLUDING WITHOUT
LIMITATION ECONOMIC DAMAGES OR INJURY TO PROPERTY OR LOST PROFITS, REGARDLESS OF
WHETHER SUCH PARTY SHALL BE ADVISED, SHALL HAVE OTHER REASON TO KNOW, OR IN FACT
SHALL KNOW OF THE POSSIBILITY OF THE FOREGOING; PROVIDED HOWEVER THAT (A) SUCH
LIMITATION SHALL NOT APPLY TO ANY BREACH BY COMPANY OF SECTION 12.7 HEREOF AND
(B) NOTHING IN THIS SECTION 9.3 SHALL BE CONSTRUED TO LIMIT COMPANY’S
INDEMNIFICATION OBLIGATIONS UNDER SECTION 8 OF THE AGREEMENT WITH RESPECT TO
THIRD PARTY CLAIMS.

 

23

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CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

10. TERM AND TERMINATION

10.1 Term. The term of this Agreement shall commence on the Effective Date and
shall remain in effect until the later of:

 

  (a) the date on which all issued patents and filed patent applications within
the Patent Rights have expired or been abandoned, and

 

  (b) one (1) year after the last Sale for which a royalty is due under
Section 4.4(a)(ii) or ten (10) years after such expiration or abandonment date
set forth in Section 10.1(a) above, whichever is earlier;

unless this Agreement is terminated earlier in accordance with any of the other
provisions of Section 10. Upon expiration per this Section 10.1, the licenses
granted herein shall convert automatically to fully-paid irrevocable licenses.
For clarity, the grant conversion of this Section 10.1 shall not apply if the
Agreement is terminated pursuant to Sections 10.2, 10.3 or 10.4, or the
obligations of Section 10.8 are not met.

10.2 Termination for Failure to Pay. If Company fails to make any payment due
hereunder, Hospital shall have the right to terminate this Agreement upon
fifteen (15) business days written notice, unless, subject to Company’s right to
dispute such payment under the provisions of Section 12.15, Company makes such
payments plus any interest due, as set forth in Section 4.6, within said fifteen
(15) day notice period. If undisputed payments are not made, Hospital may
immediately terminate this Agreement at the end of said fifteen (15) day period.
Company shall be entitled to two (2) such cure periods in a calendar year; for a
third failure to make an undisputed payment on time in such calendar year,
Hospital shall have the right to terminate this Agreement immediately upon
written notice.

10.3 Termination for Insurance and Insolvency.

 

  (a) Insurance. Hospital shall have the right to terminate this Agreement in
accordance with Section 8.2(b) if Company fails to maintain the insurance
required by Section 8.2.

 

  (b) Insolvency and other Bankruptcy Related Events. Hospital shall have the
right to terminate this Agreement immediately upon written notice to Company
with no further notice obligation or opportunity to cure if Company: (i) shall
become insolvent; (ii) shall make an assignment for the benefit of creditors; or
(iii) or shall have a petition in bankruptcy filed for or against it.

 

24

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CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

10.4 Termination for Non-Financial Default. If Company, any of its Affiliates or
any Sublicensee shall default in the performance of any of its other obligations
under this Agreement not otherwise covered by the provisions of Section 10.2 and
10.3, and if such default has not been cured within sixty (60) days after notice
by Hospital in writing of such default, Hospital may immediately terminate this
Agreement and/or any license granted hereunder at the end of said sixty (60) day
cure period. Hospital shall also have the right to terminate this Agreement
and/or any such license immediately, upon written notice, in the event of
repeated defaults even if cured within such sixty (60) day periods.

10.5 Challenging Validity. During the term of this Agreement, Company shall not
challenge, and shall restrict Company Affiliates and Sublicensees from
challenging, the validity, enforceability or patentability of the Patent Rights
and in the event of any breach of this provision Hospital shall have the right
to terminate this Agreement and any license (and sublicense in the case of a
challenge from a Sublicensee) granted hereunder immediately. In addition, if the
Patent Rights are upheld Company shall reimburse Hospital for its legal costs
and expenses incurred in defending any such challenge.

10.6 Termination by Company. Company shall have the right to terminate this
Agreement by giving ninety (90) days advance written notice to Hospital and upon
such termination shall immediately cease all use and Sales of Products and
Processes, subject to Section 10.9.

10.7 Effect of Termination on Sublicenses. Upon the termination of this
Agreement, any and all sublicenses granted pursuant to Section 2.1 to a
Sublicensee that has operations directed to the research and development of
pharmaceutical drug products that are at least equal to Company’s operations in
scope and quality shall remain in effect and be assigned on substantially the
same terms with Hospital deemed for all purposes to be the licensor thereunder
provided that (i) Sublicensee is in good standing under its sublicense agreement
at the time of termination; (ii) the sublicense is consistent with the terms of
this Agreement; (iii) Hospital shall have no obligations under such sublicenses
other than to preserve the effectiveness, scope, and validity of the licenses
granted therein under the Patent Rights and Technological Information; (iv) the
relevant sublicense(s), when taken together, provide Hospital with similar or
greater benefits than this Agreement, including without limitation, with respect
to reimbursement of patent costs; (v) Hospital and MIT shall not assume any
obligation of Company to such Sublicensee pursuant to any representation,
warranty or indemnification provision; (vi) MIT shall have no obligations under
such sublicenses; and (vii) further provided that such Sublicensee enters into
an agreement directly with Hospital to effectuate such assignment. Hospital
shall be entitled to all payments due Company and Hospital (but excluding any
duplicate payments) from each Sublicensee under any such sublicense in
accordance with the terms of such sublicense; and such sublicense shall be
deemed assigned to Hospital if necessary to ensure continued payments.

 

25

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CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

10.8 Effects of Termination of Agreement. Upon termination of this Agreement or
any of the licenses hereunder for any reason, final reports in accordance with
Section 5 shall be submitted to Hospital and all royalties and other payments,
including without limitation any unreimbursed Patent Costs, accrued or due to
Hospital as of the termination date shall become immediately payable. Company
shall cease, and shall cause its Affiliates and Sublicensees to cease under any
sublicense granted by Company, all Sales and uses of Products and Processes upon
such termination, subject to Sections 10.7 and 10.9. The termination or
expiration of this Agreement or any license granted hereunder shall not relieve
Company, its Affiliates or Sublicensees of obligations arising before such
termination or expiration.

10.9 Inventory. Upon early termination of this Agreement other than for Company
default, Company, Company Affiliates and Sublicensees, subject to Section 10.7,
may complete and sell any work-in-progress and inventory of Products that exist
as of the effective date of termination provided that (i) Company pays Hospital
the applicable running royalty or other amounts due on such Net Sales in
accordance with the terms and conditions of this Agreement, and (ii) Company,
Company Affiliates and Sublicensees, subject to Section 10.7, shall complete and
sell all work-in-progress and inventory of Products within six (6) months after
the effective date of termination. Upon expiration of this Agreement, Company
shall pay to Hospital the royalties set forth in Section 4.4(a) for Sales of any
Product that was in inventory or was a work-in-progress on the date of
expiration of the Agreement.

11. COMPLIANCE WITH LAW

11.1 Compliance. Company shall have the sole obligation for compliance with, and
shall ensure that any Affiliates and Sublicensees comply with, all government
statutes and regulations that relate to Products and Processes, including, but
not limited to, those of the Food and Drug Administration and the Export
Administration, as amended, and any applicable laws and regulations of any other
country in the License Territory. Company agrees that it shall be solely
responsible for obtaining any necessary licenses to export, re-export, or import
Products or Processes covered by Patent Rights and/or Confidential Information.
Company shall indemnify and hold harmless Hospital and MIT (in accordance with
Section 8) for any breach of Company’s obligations under this Section 11.1.

11.2 Patent Numbers. Company shall cause all Products sold in the United States
to be marked with all applicable U.S. Patent Numbers, to the full extent
required by United States law. Company shall similarly cause all Products
shipped to or sold in any other country to be marked in such a manner as to
conform with the patent laws and practices of such country.

 

26

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CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

12. MISCELLANEOUS

12.1 Entire Agreement. This Agreement constitutes the entire understanding
between the Parties with respect to the subject matter hereof.

12.2 Notices. Any notices, reports, waivers, correspondences or other
communications required under or pertaining to this Agreement shall be in
writing and shall be delivered by hand, or sent by a reputable overnight mail
service (e.g., Federal Express), or by first class mail (certified or
registered), or by facsimile confirmed by one of the foregoing methods, to the
other party. Notices will be deemed effective (a) three (3) working days after
deposit, postage prepaid, if mailed, (b) the next day if sent by overnight mail,
or (c) the same day if sent by facsimile and confirmed as set forth above or
delivered by hand. Unless changed in writing in accordance with this Section,
the notice address for Hospital shall be as follows:

If to Hospital:

Executive Director, Innovation

Massachusetts General Hospital

101 Huntington Avenue, 4th Floor

Boston, MA 02199

Fax: (617) 954-9361

If to MIT:

Massachusetts Institute of Technology

Technology Licensing Office, Room NE18-501

255 Main Street

Cambridge, MA 02142-1601

Attention: Director

Tel: 617-253-6966

Fax: 617-258-6790

If to Company:

Columbia Laboratories, Inc.

4 Liberty Square

Boston, MA 02109

Tel: 617-639-1516

Fax: 617-482-0618

Attn: Chief Financial Officer

12.3 Amendment; Waiver. This Agreement may be amended and any of its terms or
conditions may be waived only by a written instrument executed by an authorized
signatory of

 

27

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CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

the Parties or, in the case of a waiver, by the Party waiving compliance. The
failure of either Party at any time or times to require performance of any
provision hereof shall in no manner affect its rights at a later time to enforce
the same. No waiver by either Party of any condition or term shall be deemed as
a further or continuing waiver of such condition or term or of any other
condition or term.

12.4 Binding Effect. This Agreement shall be binding upon and inure to the
benefit of and be enforceable by the Parties hereto and their respective
permitted successors and assigns.

12.5 Assignment.

 

  (a) Company shall not assign this Agreement or any of its rights or
obligations under this Agreement without the prior written consent of Hospital;
provided, however, that if Company is not in breach of this Agreement and there
are no disputes pending under Section 12.15, no such consent will be required to
assign this Agreement to a successor of the Company’s business to which this
Agreement pertains or to a purchaser of substantially all of the Company’s
assets related to this Agreement, so long as such successor or purchaser shall
agree in writing to be bound by all of the terms and conditions hereof prior to
such assignment.

 

  (b) Further, no Sublicensee shall be permitted to assign a sublicense
agreement with Company or any of its rights or obligations thereunder without
the prior written consent of Hospital; provided, however, that if such
Sublicensee is not in breach of this Agreement, no such consent will be required
to assign this Agreement to a successor of the Sublicensee’s business to which
this Agreement pertains or to a purchaser of substantially all of the
Sublicensee’s assets related to this Agreement, so long as such successor or
purchaser shall agree in writing to be bound by all of the terms and conditions
thereof prior to such assignment.

 

  (c) Company shall notify Hospital in writing of any such assignment of this
Agreement or a Sublicense and provide a copy of all assignment documents and
related agreements to Hospital within thirty (30) days of such assignment.
Failure of an assignee to agree to be bound by the terms hereof or failure of
Company to notify Hospital and provide copies of assignment documentation shall
be grounds for termination of this Agreement for default.

12.6 Force Majeure. Neither Party shall be responsible for delays resulting from
causes beyond the reasonable control of such Party, including without limitation
fire, explosion, flood, war, sabotage, terrorism, strike or riot, provided that
the nonperforming Party uses commercially reasonable efforts to avoid or remove
such causes of nonperformance and continues performance under this Agreement
with reasonable dispatch whenever such causes are removed.

 

28

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CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

12.7 Use of Name. Company and its Affiliates and Sublicenses shall not use the
name of Hospital, Massachusetts Institute of Technology,, Lincoln Laboratory or
any trustee, director, officer, staff member, faculty, employee, student or
agent of Hospital or MIT or any adaptation variation or abbreviation thereof, or
any terms of this Agreement in any advertising, promotional or sales literature,
publicity or in any document employed to obtain funds or financing without the
prior written approval of Hospital and/or MIT, as applicable. For Hospital, such
approval shall be obtained from Hospital’s VP of Public Affairs. For MIT, such
approval shall be obtained from the Use of Name Officer at the MIT Technology
Licensing Office. Notwithstanding anything contained in this Agreement to the
contrary, this Agreement shall not prohibit the Company from disclosing the name
of Hospital, MIT, or any trustee, director, officer, staff member, employee,
student or agent of Hospital or MIT or any adaptation thereof to the extent
required in order for Company to comply with applicable laws and regulations
(including, without limitation, stock exchange rules or the rules of any
regulatory authority), provided that Company provides prior written notice of
such required disclosure to Hospital and/or MIT, as applicable, and takes
reasonable and lawful actions to avoid and/or minimize the extent of such
disclosure.

12.8 Governing Law. This Agreement shall be governed by and construed and
interpreted in accordance with the laws of the Commonwealth of Massachusetts,
excluding with respect to conflict of laws, except that questions affecting the
construction and effect of any patent shall be determined by the law of the
country in which the patent shall have been granted. Each Party agrees to submit
to the exclusive jurisdiction of the Superior Court for Suffolk County,
Massachusetts, and the United States District Court for the District of
Massachusetts with respect to any claim, suit or action in law or equity arising
in any way out of this Agreement or the subject matter hereof.

12.9 Hospital Policies. Company acknowledges that Hospital’s employees and
medical and professional staff members and the employees and staff members of
Hospital’s Affiliates are subject to the applicable policies of Hospital and
such Affiliates, including, without limitation, policies regarding conflicts of
interest, intellectual property and other matters. Company shall provide
Hospital with any agreement it proposes to enter into with any employee or staff
member of Hospital or any of Hospital’s Affiliates for Hospital’s prior review
and shall not enter into any oral or written agreement with such employee or
staff member which conflicts with any such policy. Hospital shall provide
Company, at Company’s request, with copies of any such policies applicable to
any such employee or staff member.

12.10 U.S. Manufacturing. Company agrees that any Products or Processes used or
sold in the United States will be manufactured substantially in the United
States to the extent required by law.

 

29

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CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

12.11 Severability. If any provision(s) of this Agreement are or become invalid,
are ruled illegal by any court of competent jurisdiction or are deemed
unenforceable under then current applicable law from time to time in effect
during the term hereof, it is the intention of the parties that the remainder of
this Agreement shall not be effected thereby. It is further the intention of the
parties that in lieu of each such provision which is invalid, illegal or
unenforceable, there be substituted or added as part of this Agreement a
provision which shall be as similar as possible in economic and business
objectives as intended by the parties to such invalid, illegal or enforceable
provision, but shall be valid, legal and enforceable.

12.12 Survival. In addition to any specific survival references in this
Agreement, Sections 1, 2.4, 4.1, 4.5, 4.6, 5.3, 5.4, 5.5, 6.4, 8.1, 8.2, 9.2,
9.3, 10.7, 10.8, 10.9, 12.1, 12.2, 12.3, 12.4, 12.7, 12.8, 12.9, 12.11, 12.12,
12.13, 12.14 and 12.15 shall survive termination or expiration of this
Agreement. Any other rights, responsibilities, obligations, covenants and
warranties which by their nature should survive this Agreement shall similarly
survive and remain in effect.

12.13 Interpretation. The parties hereto are sophisticated, have had the
opportunity to consult legal counsel with respect to this transaction and hereby
waive any presumptions of any statutory or common law rule relating to the
interpretation of contracts against the drafter.

12.14 Headings. All headings are for convenience only and shall not affect the
meaning of any provision of this Agreement.

12.15 Dispute Resolution.

 

  (a) Any dispute or issue relating to or in connection with this Agreement (a
“Dispute”) shall initially be referred to Hospital’s Director of Innovation and
Company’s CEO to resolve the Dispute. However, notwithstanding any of the terms
of this Section 12.15 and without limiting any other remedies that may be
available, each Party shall have the right to seek immediate injunctive relief
and other equitable relief from any court of competent jurisdiction to enjoin
any breach or violation of this Agreement concerning confidential information or
any other intellectual property licensed under this Agreement, without any
obligation to undertake extra-judicial dispute resolution of any such Dispute or
claim or otherwise to comply with this Section 12.15.

 

  (b)

If the Director of Innovation and Company’s CEO are unable to resolve the
Dispute within thirty (30) days after such referral, then such Dispute shall be
referred to a mediator who has been mutually selected by the Parties. If the
Parties are unable to agree upon a mediator, then either Party may petition a
court of competent jurisdiction in the Commonwealth of Massachusetts and such
court

 

30

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CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

  shall appoint an independent mediator with relevant experience and sufficient
qualifications to provide mediation services to the Parties.

 

  (c) If the Parties are unable to resolve the Dispute with the assistance of a
mediator within sixty (60) business days of the selection or appointment
thereof, each Party shall have the right to seek other equitable relief from any
court of competent jurisdiction.

 

  (d) Each Party shall bear its own costs in obtaining the dispute resolution,
as outlined above.

[Remainder of page intentionally left blank.]

 

31

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INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their duly authorized representatives as of the Effective Date first written
above.

 

Columbia Laboratories Inc. The General Hospital Corporation BY:

 

BY:

 

Name: Name: TITLE:

 

TITLE:

 

DATE:

 

DATE:

 

 

32

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INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

Appendix A

DESCRIPTION OF PATENT RIGHTS

 

IP ID

  

Title

  

Serial Number

  

Original

Filing

Date

  

Filing

Type

  

Country Of
Publication

  

Status

  

Patent

Number

02289.01    Methods for Contraception and Treatment of Female Reproductive
Conditions and Disorders (MIT Case No. 10669)    60/473,579    5/27/2003    PROV
   US    Converted    02289.02    Intra Vaginal Drug Delivery Device (MIT Case
No. 10669)    60/466,318    4/29/2003    PROV    US    Converted    02289.03   
Methods and Devices for the Sustained Release of Multiple Drugs (MIT Case
No. 10669)    PCT/US04/013172    4/29/2004    PCT    WO    Nationalized   
02289.04    Methods and Devices for the Sustained Release of Multiple Drugs (MIT
Case No. 10669)    10/835,414    4/29/2004    UTIL    US    Issued    7,833,545
02289.05    Methods and Devices for the Sustained Release of Multiple Drugs (MIT
Case No. 10669)    2004233997    4/29/2004    PCT    AU    Issued    2004233997
02289.06    Methods and Devices for the Sustained Release of Multiple Drugs (MIT
Case No. 10669)    2006-513416    4/29/2004    PCT    JP    Issued    4898431
02289.07    Methods and Devices for the Sustained Release of Multiple Drugs (MIT
Case No. 10669)    2,523,859    4/29/2004    PCT    CA    Issued    2,523,859
02289.08    Methods and Devices for the Sustained Release of Multiple Drugs (MIT
Case No. 10669)    04760436.8    4/29/2004    PCT    EP    Issued    1620060
02289.11    Methods and Devices for the Sustained Release of Multiple Drugs (MIT
Case No. 10669)    12/125,581    5/22/2008    DIV    US    Issued    7,883,718

 

33

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INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

02289.12 Methods and Devices for the Sustained Release of Multiple Drugs (MIT
Case No. 10669) 12/125,571 5/22/2008 DIV US Issued 7,838,024 02289.13 Methods
and Devices for the Sustained Release of Multiple drugs (MIT Case No. 10669)
12/125,593 5/22/2008 DIV US Issued 7,829,112 02289.14 Multi Component EVA Rings
for the Intra Vaginal Delivery of Sex Steroids alone or in Combination (MIT Case
No. 10669) 04760436.8 4/29/2004 PCT DE Issued 1620060 02289.15 Multi Component
EVA Rings for the Intra Vaginal Delivery of Sex Steroids alone or in Combination
(MIT Case No. 10669) 04760436.8 4/29/2004 PCT FR Issued 1620060 02289.16 Multi
Component EVA Rings for the Intra Vaginal Delivery of Sex Steroids alone or in
Combination (MIT Case No. 10669) 04760436.8 4/29/2004 PCT GB Issued 1620060
23317.01 Transvaginal Ring Delivery System and Methods of Using Same (MIT Case
No. 17796) 62/121,893 2/27/2015 PROV US Filed

 

34

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INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

Appendix B

SALES REPORTS

 

AGREEMENT INCOME REPORT Royalty Income [MGH][BWH] Agreement # -        

 

Licensee -

 

Sub-Licensee -

 

Separate reports must be filed for:

 

  1. Each Product sold.

 

  2. Each country of sale, if different deductions or royalty rates apply.

 

Product Name:

 

Report Time Period:                 From mm/dd/yyyy

 

                To mm/dd/yyyy

 

 

Country of Sale

 

 

 

Quantity Sold

 

 

 

Gross Sales (USD)

$

 

$

 

$

 

Exchange Rate

 

 

 

Deductions (Itemize) Please list each deduction separately. Use same definition
as appears in Agreement and include the contract paragraph as a reference (Std
Section 1.8(a)(ii) line item deductions listed below).
                        A1.

 

 

 

                        A2.

 

 

 

                        A3.

 

 

 

                        A4.

 

 

 

                        B.

 

 

 

Total Deductions

(

 

) (

 

) (

 

)

Net Sales

 

 

 

Royalty Percentage

 

 

 

Credits (itemize)

(

 

) (

 

) (

 

)

Royalties Due

$

 

$

 

$

 

 

35

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INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

PLEASE ATTACH DETAIL SALES REPORTS AS REQUIRED

Appendix C

 

AGREEMENT INCOME REPORT Sublicense Income [MGH][BWH] Agreement # - 

 

Licensee -

 

Sub-Licensee -

 

Separate reports must be filed for Payments associated with each Product:

 

Product Name:

 

 

Report Time Period:                 From mm/dd/yyyy

 

                To mm/dd/yyyy

 

Detailed Explanation of Payment

Required for “Other Payment”

 

Annual Fees/Minimum Royalties

$

 

 

Milestone Payments

$

 

 

Sublicense Fees and Royalties

$

 

 

Other Payment

$

 

 

Other Payment

$

 

 

 

36

--------------------------------------------------------------------------------

CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

Other Payment

$

 

 

TOTAL

$

 

PLEASE ATTACH DETAIL AS REQUIRED

 

37

--------------------------------------------------------------------------------

CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

Appendix D

CONFIDENTIALITY TERMS AND CONDITIONS

1. Definition of Confidential Information. “Confidential Information” shall mean
any information, including but not limited to data, techniques, protocols or
results, or business, financial, commercial or technical information, disclosed
by one Party (each a “Discloser” as applicable) to the other Party (each a
“Recipient” as applicable) in connection with the terms of that certain
Exclusive License Agreement dated March 25, 2015 (the “License Agreement”) and
identified as confidential at the time of disclosure (the “Purpose”). Hospital’s
Confidential Information shall also include all information disclosed by
Hospital to Company in connection with the Patent Rights. Capitalized terms used
in this Appendix that are not otherwise defined herein have the meanings
ascribed in the License Agreement to which this Appendix is attached and made a
part thereof.

2. Exclusions. “Confidential Information” under this Agreement shall not include
any information that (i) is or becomes publicly available through no wrongful
act of Recipient; (ii) was known by Recipient prior to disclosure by Discloser,
as evidenced by tangible records; (iii) becomes known to Recipient after
disclosure from a third party having an apparent bona fide right to disclose it;
(iv) is independently developed or discovered by Recipient without use of
Discloser’s Confidential Information, as evidenced by tangible records; or
(v) is disclosed to another party by Discloser without restriction on further
disclosure.

3. Permitted Purpose. Recipient shall have the right to, and agrees that it
will, use Discloser’s Confidential Information solely for the Purpose as
described in the License Agreement, except as may be otherwise specified in a
separate definitive written agreement negotiated and executed between the
parties.

4. Restrictions. For the term of the License Agreement and a period of three
(3) years thereafter (and indefinitely with respect to any individually
identifiable health information disclosed by Hospital to Company, if any), each
Recipient agrees that: (i) it will not use such Confidential Information for any
purpose other than as specified herein, including without limitation for its own
benefit or the benefit of any other person or entity; and (ii) it will use
reasonable efforts (but no less than the efforts used to protect its own
confidential and/or proprietary information of a similar nature) not to disclose
such Confidential Information to any other person or entity except as expressly
permitted hereunder. Recipient may, however, disclose Discloser’s Confidential
Information only on a need-to-know basis to its and its Affiliates employees,
staff members and agents (“Receiving Individuals”) who are directly
participating in the Purpose and who are informed of the confidential nature of
such information,

 

38

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CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

provided Recipient shall be responsible for compliance by Receiving Individuals
with the terms of this Agreement and any breach thereof. Notwithstanding the
foregoing, Company may disclose Confidential Information regarding the existence
and content of the License Agreement to investors, potential institutional
investors, Sublicensees, potential Sublicensees, partners, potential partners,
bankers, financial institutions, and acquirers and potential acquirers of the
Company. Each party further agrees not to use the name of the other party or any
of its Affiliates or any of their respective trustees, directors, officers,
staff members, employees, students or agents in any advertising, promotional or
sales literature, publicity or in any document employed to obtain funds or
financing without the prior written approval of the party or individual whose
name is to be used, in the case of Hospital such approval to be given by the
Public Affairs Department. This Section 4 shall survive termination or
expiration of this Agreement. Notwithstanding anything contained in this
Agreement to the contrary, this Agreement shall not prohibit the Recipient from
disclosing Confidential Information to the extent required in order for the
Recipient to comply with applicable laws and regulations (including, without
limitation, stock exchange rules or the rules of any regulatory or
self-regulatory authority), provided that the Recipient provides prior written
notice of such required disclosure to the Discloser and takes reasonable and
lawful actions to avoid and/or minimize the extent of such disclosure.

5. Right to Disclose. Discloser represents that to the best of its knowledge it
has the right to disclose to each Recipient all of Discloser’s Confidential
Information that will be disclosed hereunder.

6. Ownership. All Confidential Information disclosed pursuant to this Agreement,
including without limitation all written and tangible forms thereof, shall be
and remain the property of the Discloser. Upon termination of this Agreement, if
requested by Discloser, Recipient shall return or destroy at Discloser’s
discretion all of Discloser’s Confidential Information, provided that Recipient
shall be entitled to keep one copy of such Confidential Information in a secure
location solely for the purpose of determining Recipient’s legal obligations
hereunder.

7. No License. Nothing in this Agreement shall be construed as granting or
conferring, expressly or impliedly, any rights by license or otherwise, under
any patent, copyright, or other intellectual property rights owned or controlled
by Discloser relating to Confidential Information, except as specifically set
forth in the License Agreement.

8. Remedies. Each party acknowledges that any breach of this Agreement by it may
cause irreparable harm to the other party and that each party is entitled to
seek injunctive relief and any other remedy available at law or in equity.

9. General. These Confidentiality Terms and Conditions, along with the License
Agreement, contain the entire understanding of the parties with respect to the
subject matter

 

39

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CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

hereof, and supersede any prior oral or written understandings between the
parties relating to confidential treatment of information. Sections 1, 2, 4, 6,
8 and 9 of these Confidentiality Terms and Conditions shall survive any
expiration or termination of the License Agreement.

 

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