Document:

Exhibit 10.3

 

EMPLOYMENT
AGREEMENT

 

This Employment Agreement (“Agreement”) is
made as of the 1st day of October, 2014, between Brightcove Inc., a Delaware corporation (the “Company”),
and Paul Goetz (the “Executive”).

 

WHEREAS, the Company and the Executive were
previously parties to that certain employment offer letter dated February 26, 2010 (the “Prior Agreement”)
which the Company and the Executive intend to supersede and replace with this Agreement;

 

WHEREAS, the Company desires to continue
to employ the Executive and the Executive desires to continue to be employed by the Company on the new terms and conditions contained
herein.

 

NOW, THEREFORE, in consideration
of the mutual covenants and agreements herein contained and other good and valuable consideration, the receipt and sufficiency
of which is hereby acknowledged, the parties agree as follows:

 

1.           Employment.

 

(a)          Term.
The Company hereby employs the Executive and the Executive hereby accepts such employment pursuant to the terms of this Agreement
until this Agreement is terminated in accordance with the provisions of Section 3. (Such period of employment shall hereinafter
be referred to as the “Term”).

 

(b)          Position
and Duties. During the Term, the Executive shall serve as the Senior Vice President of Worldwide Field Operations of the Company,
and shall have such powers and duties as may from time to time be prescribed by the Chief Executive Officer of the Company
(the “CEO”), or other authorized executive, provided that such duties are consistent with the Executive’s position
or other positions that he may hold from time to time. The Executive shall devote his full working time and efforts to the business
and affairs of the Company. Notwithstanding the foregoing, the Executive may serve on other boards of directors, with the prior
written approval of the Board, or engage in religious, charitable or other community activities as long as such services and activities
do not interfere with the Executive’s performance of his duties to the Company as provided in this Agreement.

 

2.           Compensation
and Related Matters.

 

(a)          Base
Salary. During the Term, the Executive’s initial annual base salary shall be $300,000. The Executive’s base salary
may be redetermined annually by the Board or the Compensation Committee. The base salary in effect at any given time is referred
to herein as “Base Salary.” The Base Salary shall be payable in a manner that is consistent with the Company’s
usual payroll practices for senior executives.

 

(b)          Incentive
Compensation. During the Term, the Executive shall be eligible to receive cash incentive compensation as determined by the
Board or the Compensation Committee from time to time. The Executive’s target annual incentive compensation shall be $230,000.
To earn incentive compensation, the Executive must be employed by the Company on the last day of the period on which such incentive
compensation is measured.

 

    	 

    	 

    

 

(c)          Expenses.
The Executive shall be entitled to receive reimbursement for all reasonable expenses incurred by him during the Term in performing
services hereunder, in accordance with the policies and procedures then in effect and established by the Company for its senior
executive officers.

 

(d)          Other
Benefits. During the Term, the Executive shall be entitled to continue to participate in or receive benefits under the Company’s
Employee Benefit Plans in effect on the date hereof. As used herein, the term “Employee Benefit Plans” includes,
without limitation, each pension and retirement plan; supplemental pension, retirement and deferred compensation plan; savings
and profit-sharing plan; stock ownership plan; stock purchase plan; stock option plan; life insurance plan; medical insurance plan;
disability plan; and health and accident plan or arrangement established and maintained by the Company on the date hereof for employees
of the same status within the hierarchy of the Company. The Executive shall be entitled to participate in or receive benefits under
any employee benefit plan or arrangement which may, in the future, be made available by the Company to its executives and key management
employees, subject to and on a basis consistent with the terms, conditions and overall administration of such plan or arrangement.
Any payments or benefits payable to the Executive under a plan or arrangement referred to in this Section 2(d) in respect
of any calendar year during which the Executive is employed by the Company for less than the whole of such year shall, unless otherwise
provided in the applicable plan or arrangement, be prorated in accordance with the number of days in such calendar year during
which he is so employed. Should any such payments or benefits accrue on a fiscal (rather than calendar) year, then the proration
in the preceding sentence shall be on the basis of a fiscal year rather than calendar year.

 

(e)          Place
of Performance. Unless otherwise agreed to by the Executive and the Company, the Executive shall perform his duties for the
Company from the headquarters of the Company, initially located at 290 Congress Street, 4th Floor, Boston, MA 02210;
provided, however, Executive shall be required to travel to the extent reasonably required to perform his
job duties.

 

(f)          Vacation.
During the Term, the Executive shall be entitled to participate in the Company’s Vacation Policy. The Executive shall also
be entitled to all paid holidays given by the Company to its executives.

 

3.           Termination.
The Executive’s employment hereunder may be terminated without any breach of this Agreement under the following circumstances:

 

(a)          Death.
The Executive’s employment hereunder shall terminate upon his death.

 

(b)          Disability.
The Company may terminate the Executive’s employment if he is disabled and unable to perform the essential functions of the
Executive’s then existing position or positions under this Agreement with or without reasonable accommodation for a period
of 180 days (which need not be consecutive) in any 12 month period. Nothing in this Section 3(b) shall be construed to
waive the Executive’s rights, if any, under existing law including, without limitation, the Family and Medical Leave Act
of 1993, 29 U.S.C. §2601 et seq. and the Americans with Disabilities Act, 42 U.S.C. §12101 et seq.

 

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(c)          Termination
by Company for Cause. The Company may terminate the Executive’s employment hereunder for Cause by a vote of the Board
at a meeting of the Board called and held for such purpose. For purposes of this Agreement, “Cause” shall mean:
(i) conduct by the Executive constituting an act of misconduct in connection with the performance of his duties, including,
without limitation, misappropriation of funds or property of the Company or any of its subsidiaries or affiliates other than the
occasional, customary and de minimis use of Company property for personal purposes; (ii) the commission by the Executive of
any felony or a misdemeanor involving moral turpitude, deceit, dishonesty or fraud, or any conduct by the Executive that would
reasonably be expected to result in injury or reputational harm to the Company or any of its subsidiaries and affiliates if he
were retained in his position; (iii) continued non-performance by the Executive of his duties hereunder (other than by reason
of the Executive’s physical or mental illness, incapacity or disability) which has continued for more than 30 days following
written notice of such non-performance from the Board; (iv) a breach by the Executive of any of the provisions contained in
Section 7 of this Agreement; (v) a violation by the Executive of the Company’s written employment policies; or
(vi) failure to cooperate with a bona fide internal investigation or an investigation by regulatory or law enforcement authorities,
after being instructed by the Company to cooperate, or the destruction or failure to preserve documents or other materials known
to be relevant to such investigation or the inducement of others to fail to cooperate or to produce documents or other materials
in connection with such investigation.

 

(d)          Termination
Without Cause. The Company may terminate the Executive’s employment hereunder at any time without Cause. Any termination
by the Company of the Executive’s employment under this Agreement which does not constitute a termination for Cause under
Section 3(c) and does not result from the death or disability of the Executive under Section 3(a) or (b) shall
be deemed a termination without Cause.

 

(e)          Termination
by the Executive. The Executive may terminate his employment hereunder at any time for any reason, including but not limited
to Good Reason. For purposes of this Agreement, “Good Reason” shall mean that the Executive has complied with
the Good Reason Process (hereinafter defined) following the occurrence of any of the following events: (i) a material
diminution in the Executive’s responsibilities, authority or duties; (ii) a material diminution in the Executive’s
Base Salary except for across-the-board salary reductions based on the Company’s financial performance similarly affecting
all or substantially all senior management employees of the Company; (iii) a material change in the principle geographic location
at which the Executive is required to provide services to the Company; or (iv) the material breach of this Agreement by the
Company. “Good Reason Process” shall mean that (A) the Executive reasonably determines in good faith that
a “Good Reason” condition has occurred; (B) the Executive notifies the Company in writing of the first occurrence
of the Good Reason condition within 30 days of the first occurrence of such condition; (C) the Executive cooperates in good
faith with the Company’s efforts, for a period not less than 30 days following such notice (the “Cure Period”),
to remedy the condition; (D) notwithstanding such efforts, the Good Reason condition continues to exist; and (E) the
Executive terminates his employment within 60 days after the end of the Cure Period. If the Company cures the Good Reason condition
during the Cure Period, Good Reason shall be deemed not to have occurred.

 

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(f)          Notice
of Termination. Except for termination as specified in Section 3(a), any termination of the Executive’s employment
by the Company or any such termination by the Executive shall be communicated by written Notice of Termination to the other party
hereto. For purposes of this Agreement, a “Notice of Termination” shall mean a notice which shall indicate the
specific termination provision in this Agreement relied upon.

 

(g)          Date
of Termination. “Date of Termination” shall mean: (i) if the Executive’s employment is terminated
by his death, the date of his death; (ii) if the Executive’s employment is terminated on account of disability under
Section 3(b) or by the Company for Cause under Section 3(c) or by the Company without Cause under Section 3(d),
the date on which a Notice of Termination is given; (iii) if the Executive’s employment is terminated by the Executive
under Section 3(e) without Good Reason, 30 days after the date on which a Notice of Termination is given, and (iv) if
the Executive’s employment is terminated by the Executive under Section 3(e) with Good Reason, the date on which
a Notice of Termination is given after the end of the Cure Period. Notwithstanding the foregoing, in the event that the Executive
gives a Notice of Termination to the Company, the Company may unilaterally accelerate the Date of Termination and such acceleration
shall not result in a termination by the Company for purposes of this Agreement.

 

(h)          Resignation
on Termination. On the Date of Termination, the Executive shall resign from all positions with the Company and its subsidiaries.
In addition, if the Executive is then serving as a member of the Board or the Board of Directors of a subsidiary, the Executive
shall tender his resignation from such directorship(s) on the Date of Termination.

 

4.          Compensation
Upon Termination.

 

(a)          Termination
Generally. If the Executive’s employment with the Company is terminated for any reason, the Company shall pay or provide
to the Executive (or to his authorized representative or estate) any earned but unpaid base salary, incentive compensation earned
and payable but not yet paid and unpaid expense reimbursements (the “Accrued Benefit”) on or before the time
required by law but in no event more than 30 days after the Executive’s Date of Termination.

 

(b)          Termination
by the Company Without Cause or by the Executive with Good Reason. If the Executive’s employment is terminated by the
Company without Cause as provided in Section 3(d), or the Executive terminates his employment for Good Reason as provided
in Section 3(e), then the Company shall, through the Date of Termination, pay the Executive his Accrued Benefit. In addition,
subject to the Executive signing a separation agreement and general release of claims in favor of the Company and related persons
and entities in a form and manner satisfactory to the Company (the “Release”) and the expiration of the
seven-day revocation period for the Release within 60 days after the Date of Termination:

 

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(i)          the
Company shall pay the Executive an amount equal to the sum of (A) one times the Executive’s Base Salary and (B) one times
the Executive’s target incentive compensation for the then current fiscal year (the “Severance Amount”).
The Severance Amount shall be paid out in substantially equal installments in accordance with the Company’s payroll practice
over twelve (12) months commencing within 60 days after the Date of Termination; provided, however, that
if the 60-day period begins in one calendar year and ends in a second calendar year, the Severance Amount shall begin to be paid
in the second calendar year. Solely for purposes of Section 409A of the Internal Revenue Code of 1986, as amended (the “Code”),
each installment payment is considered a separate payment. Notwithstanding the foregoing, if the Executive breaches any of the
provisions contained in Section 7 of this Agreement, all payments of the Severance Amount shall immediately cease; and

 

(ii)         notwithstanding
anything to the contrary in any applicable option agreement or stock-based award agreement, the vesting schedule for stock options
and other stock-based awards held by the Executive as of the Date of Termination shall immediately accelerate by twenty five percent
(25%) and such accelerated awards shall become fully exercisable, vested and/or nonforfeitable as of the Date of Termination;

 

(iii)        if
the Executive was participating in the Company’s group health plan immediately prior to the Date of Termination, then the
Company shall pay to the Executive a single lump sum cash payment equal to twelve (12) months of monthly employer contributions
that the Company would have made to provide health insurance to the Executive if the Executive had remained employed by the Company.

 

5.          Payment
Upon Involuntary Termination in Connection with or Following a Change in Control. The provisions of this Section 5 shall
apply in lieu of, and expressly supersede, the provisions of Section 4(b) regarding severance pay and benefits if a termination
of employment occurs on or within 12 months after the occurrence of a Change in Control, provided that such Change in Control occurs
during the Executive’s employment. These provisions shall terminate and be of no further force or effect beginning twelve (12)
months after the occurrence of a Change in Control.

 

(a)          Involuntary
Termination in Connection with or Following a Change in Control.

 

(i)          If
within twelve (12) months after a Change in Control, the Executive’s employment is terminated by the Company without
Cause as provided in Section 3(d) or the Executive terminates his employment for Good Reason as provided in Section 3(e),
then, subject to the Executive signing a Release and the expiration of the seven-day revocation period for the Release within
60 days after the Date of Termination, notwithstanding anything to the contrary in any applicable option agreement or stock-based
award agreement, the vesting schedule for stock options and other stock-based awards held by the Executive as of such Date of Termination
shall immediately accelerate by one hundred percent (100%) and such accelerated awards become fully exercisable, vested and/or
nonforfeitable as of the date of such Date of Termination.

 

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(ii)         In
addition, if within twelve (12) months after a Change in Control, the Executive’s employment is terminated by the Company
without Cause as provided in Section 3(d) or the Executive terminates his employment for Good Reason as provided in Section 3(e),
then, subject to the Executive signing a Release and the expiration of the seven-day revocation period for the Release within
60 days after the Date of Termination:

 

(A)         the
Company shall pay the Executive an amount equal to the sum of (A) one times the Executive’s Base Salary and (B) one times
the Executive’s incentive compensation for the then current fiscal year (the “CIC Amount”). The CIC Amount
shall be paid within 60 days after the Date of Termination in a lump sum in cash provided that if such 60-day period begins in
one calendar year and ends in a second calendar year, the CIC Amount shall be paid in the second calendar year; and provided further,
that if the Change in Control does not constitute a “change in ownership or effective control” of the Company or a
“change in the ownership of a substantial portion of the assets” of the Company for purposes of Section 409A of the
Code, the CIC Amount shall be paid at the same time and on the same schedule as provided in Section 4(b)(i) with respect to the
Severance Amount; and

 

(B)         if
the Executive was participating in the Company’s group health plan immediately prior to the Date of Termination, then the
Company shall pay to the Executive a single lump sum cash payment equal to twelve (12) months of monthly employer contributions
that the Company would have made to provide health insurance to the Executive if the Executive had remained employed by the Company.

 

(b)          Additional
Limitation.

 

(i)          Anything
in this Agreement to the contrary notwithstanding, in the event that the amount of any compensation payment or distribution by
the Company to or for the benefit of the Executive, whether paid or payable or distributed or distributable pursuant to the terms
of this Agreement or otherwise, calculated in a manner consistent with Section 280G of the Code and the applicable regulations
thereunder (the “Payments”), would be subject to the excise tax imposed by Section 4999 of the Code, the following
provisions shall apply:

 

(A)         If
the Payments, reduced by the sum of (1) the Excise Tax and (2) the total of the Federal, state, and local income and employment
taxes payable by the Executive on the amount of the Payments which are in excess of the Threshold Amount, are greater than or equal
to the Threshold Amount, the Executive shall be entitled to the full benefits payable under this Agreement.

 

(B)         If
the Threshold Amount is less than (x) the Payments, but greater than (y) the Payments reduced by the sum of (1) the Excise Tax
and (2) the total of the Federal, state, and local income and employment taxes on the amount of the Payments which are in excess
of the Threshold Amount, then the Payments shall be reduced (but not below zero) to the extent necessary so that the sum of all
Payments shall not exceed the Threshold Amount. In such event, the Payments shall be reduced in the following order: (1) cash payments
not subject to Section 409A of the Code; (2) cash payments subject to Section 409A of the Code; (3) equity-based payments and acceleration;
and (4) non-cash forms of benefits. To the extent any payment is to be made over time (e.g., in installments, etc.), then the payments
shall be reduced in reverse chronological order.

 

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(ii)         The
determination as to which of the alternative provisions of Section 5(d) shall apply to the Executive shall be made a nationally
recognized accounting firm selected by the Company (the “Accounting Firm”), which shall provide detailed supporting
calculations both to the Company and the Executive within 15 business days of the Date of Termination, if applicable, or at such
earlier time as is reasonably requested by the Company or the Executive. For purposes of determining which of the alternative provisions
of Section 5(b) shall apply, the Executive shall be deemed to pay federal income taxes at the highest marginal rate of federal
income taxation applicable to individuals for the calendar year in which the determination is to be made, and state and local income
taxes at the highest marginal rates of individual taxation in the state and locality of the Executive’s residence on the
Date of Termination, net of the maximum reduction in federal income taxes which could be obtained from deduction of such state
and local taxes. Any determination by the Accounting Firm shall be binding upon the Company and the Executive.

 

(c)          Definitions.
For purposes of this Agreement, the following terms shall have the following meanings:

 

(i)          “Change
in Control” shall mean any of the following:

 

(A)         the
date any “person,” as such term is used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934,
as amended (the “Act”) (other than the Company, any of its subsidiaries, or any trustee, fiduciary or other
person or entity holding securities under any employee benefit plan or trust of the Company or any of its subsidiaries), together
with all “affiliates” and “associates” (as such terms are defined in Rule 12b-2 under the Act) of
such person, shall become the “beneficial owner” (as such term is defined in Rule 13d-3 under the Act), directly or
indirectly, of securities of the Company representing fifty percent (50%) or more of the combined voting power of the Company’s
then outstanding securities having the right to vote in an election of the Board (“Voting Securities”) (in
such case other than as a result of an acquisition of securities directly from the Company); or

 

(B)         the
date a majority of the members of the Board is replaced during any 12-month period by directors whose appointment or election is
not endorsed by a majority of the members of the Board before the date of the appointment or election; or

 

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(C)         the
consummation of (A) any consolidation or merger of the Company where the stockholders of the Company, immediately prior to
the consolidation or merger, would not, immediately after the consolidation or merger, beneficially own (as such term is defined
in Rule 13d-3 under the Act), directly or indirectly, shares representing in the aggregate more than fifty percent (50%) of
the voting shares of the Company issuing cash or securities in the consolidation or merger (or of its ultimate parent corporation,
if any), or (B) any sale or other transfer (in one transaction or a series of transactions contemplated or arranged by any
party as a single plan) of all or substantially all of the assets of the Company.

 

(ii)         “Excise
Tax” shall mean the excise tax imposed by Section 4999 of the Code, and any interest or penalties incurred by the
Executive with respect to such excise tax.

 

(iii)        “Threshold
Amount” shall mean three times the Executive’s “base amount” within the meaning of Section 280G(b)(3) of
the Code and the regulations promulgated thereunder less one dollar ($1.00).

 

6.           Section 409A.

 

(a)          Anything
in this Agreement to the contrary notwithstanding, if at the time of the Executive’s separation from service within the meaning
of Section 409A of the Code, the Company determines that the Executive is a “specified employee” within the meaning
of Section 409A(a)(2)(B)(i) of the Code, then to the extent any payment or benefit that the Executive becomes entitled
to under this Agreement on account of the Executive’s separation from service would be considered deferred compensation subject
to the 20 percent additional tax imposed pursuant to Section 409A(a) of the Code as a result of the application of Section 409A(a)(2)(B)(i) of
the Code, such payment shall not be payable and such benefit shall not be provided until the date that is the earlier of (A) six
months and one day after the Executive’s separation from service, or (B) the Executive’s death. If any such delayed
cash payment is otherwise payable on an installment basis, the first payment shall include a catch-up payment covering amounts
that would otherwise have been paid during the six-month period but for the application of this provision, and the balance of the
installments shall be payable in accordance with their original schedule.

 

(b)          All
in-kind benefits provided and expenses eligible for reimbursement under this Agreement shall be provided by the Company or incurred
by the Executive during the time periods set forth in this Agreement. All reimbursements shall be paid as soon as administratively
practicable, but in no event shall any reimbursement be paid after the last day of the taxable year following the taxable year
in which the expense was incurred. The amount of in-kind benefits provided or reimbursable expenses incurred in one taxable year
shall not affect the in-kind benefits to be provided or the expenses eligible for reimbursement in any other taxable year. Such
right to reimbursement or in-kind benefits is not subject to liquidation or exchange for another benefit.

 

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(c)          To
the extent that any payment or benefit described in this Agreement constitutes “non-qualified deferred compensation”
under Section 409A of the Code, and to the extent that such payment or benefit is payable upon the Executive’s termination
of employment, then such payments or benefits shall be payable only upon the Executive’s “separation from service.”
The determination of whether and when a separation from service has occurred shall be made in accordance with the presumptions
set forth in Treasury Regulation Section 1.409A-1(h).

 

(d)          The
parties intend that this Agreement will be administered in accordance with Section 409A of the Code. To the extent that any
provision of this Agreement is ambiguous as to its compliance with Section 409A of the Code, the provision shall be read in
such a manner so that all payments hereunder comply with Section 409A of the Code. The parties agree that this Agreement may
be amended, as reasonably requested by either party, and as may be necessary to fully comply with Section 409A of the Code
and all related rules and regulations in order to preserve the payments and benefits provided hereunder without additional cost
to either party.

 

(e)          The
Company makes no representation or warranty and shall have no liability to the Executive or any other person if any provisions
of this Agreement are determined to constitute deferred compensation subject to Section 409A of the Code but do not satisfy
an exemption from, or the conditions of, such Section.

 

7.          Confidential
Information, Noncompetition and Cooperation.

 

(a)          The
Executive agrees to continue to comply with the Employee Non-Competition, Non-Solicitation, Confidentiality and Assignment Agreement
attached hereto as Exhibit A (“Proprietary Information Agreement”), the terms of which are hereby incorporated
by reference into Section 7 of this Agreement.

 

(b)          Confidentiality.
The Executive understands and agrees that the Executive’s employment creates a relationship of confidence and trust between
the Executive and the Company with respect to all Confidential Information. At all times, both during the Executive’s employment
with the Company and after its termination, the Executive will keep in confidence and trust all such Confidential Information,
and will not use or disclose any such Confidential Information without the written consent of the Company, except as may be necessary
in the ordinary course of performing the Executive’s duties to the Company.

 

(c)          Documents,
Records, etc. All documents, records, data, apparatus, equipment and other physical property, whether or not pertaining to
Confidential Information, which are furnished to the Executive by the Company or are produced by the Executive in connection with
the Executive’s employment will be and remain the sole property of the Company. The Executive will return to the Company
all such materials and property as and when requested by the Company. In any event, the Executive will return all such materials
and property immediately upon termination of the Executive’s employment for any reason. The Executive will not retain with
the Executive any such material or property or any copies thereof after such termination.

 

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(d)          Third-Party
Agreements and Rights. The Executive hereby confirms that the Executive is not bound by the terms of any agreement with any
previous employer or other party which restricts in any way the Executive’s use or disclosure of information or the Executive’s
engagement in any business. The Executive represents to the Company that the Executive’s execution of this Agreement, the
Executive’s employment with the Company and the performance of the Executive’s proposed duties for the Company will
not violate any obligations the Executive may have to any such previous employer or other party. In the Executive’s work
for the Company, the Executive will not disclose or make use of any information in violation of any agreements with or rights of
any such previous employer or other party, and the Executive will not bring to the premises of the Company any copies or other
tangible embodiments of non-public information belonging to or obtained from any such previous employment or other party.

 

(e)          Litigation
and Regulatory Cooperation. During and after the Executive’s employment, the Executive shall cooperate fully with the
Company in the defense or prosecution of any claims or actions now in existence or which may be brought in the future against or
on behalf of the Company which relate to events or occurrences that transpired while the Executive was employed by the Company.
The Executive’s full cooperation in connection with such claims or actions shall include, but not be limited to, being available
to meet with counsel to prepare for discovery or trial and to act as a witness on behalf of the Company at mutually convenient
times. During and after the Executive’s employment, the Executive also shall cooperate fully with the Company in connection
with any investigation or review of any federal, state or local regulatory authority as any such investigation or review relates
to events or occurrences that transpired while the Executive was employed by the Company. The Company shall reimburse the Executive
for any reasonable out-of-pocket expenses incurred in connection with the Executive’s performance of obligations pursuant
to this Section 7(e).

 

(f)          Injunction.
The Executive agrees that it would be difficult to measure any damages caused to the Company which might result from any breach
by the Executive of the promises set forth in this Section 7, and that in any event money damages would be an inadequate remedy
for any such breach. Accordingly, the Executive agrees that if the Executive breaches, or proposes to breach, any portion of this
Agreement, the Company shall be entitled, in addition to all other remedies that it may have, to an injunction or other appropriate
equitable relief to restrain any such breach without showing or proving any actual damage to the Company.

 

8.           Consent
to Jurisdiction. The parties hereby consent to the jurisdiction of the Superior Court of the Commonwealth of Massachusetts
and the United States District Court for the District of Massachusetts. Accordingly, with respect to any such court action, the
Executive (a) submits to the personal jurisdiction of such courts; (b) consents to service of process; and (c) waives
any other requirement (whether imposed by statute, rule of court, or otherwise) with respect to personal jurisdiction or service
of process.

 

9.           Integration.
This Agreement, including Exhibits A and B attached hereto, constitutes the entire agreement between the parties with respect to
the subject matter hereof and supersedes all prior agreements between the parties concerning such subject matter including, without
limitation, the Prior Agreement.

 

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10.         Withholding;
Taxes. All payments made by the Company to the Executive under this Agreement shall be net of any tax or other amounts required
to be withheld by the Company under applicable law. Nothing in this Agreement shall be construed to require the Company to make
any payments to compensate you for any adverse tax effect associated with any payments or benefits or for any deduction or withholding
from any payment or benefit.

 

11.         Successor
to the Executive. This Agreement shall inure to the benefit of and be enforceable by the Executive’s personal representatives,
executors, administrators, heirs, distributees, devisees and legatees. In the event of the Executive’s death after his termination
of employment but prior to the completion by the Company of all payments due him under this Agreement, the Company shall continue
such payments to the Executive’s beneficiary designated in writing to the Company prior to his death (or to his estate, if
the Executive fails to make such designation).

 

12.         Enforceability.
If any portion or provision of this Agreement (including, without limitation, any portion or provision of any section of this Agreement) shall
to any extent be declared illegal or unenforceable by a court of competent jurisdiction, then the remainder of this Agreement,
or the application of such portion or provision in circumstances other than those as to which it is so declared illegal or unenforceable,
shall not be affected thereby, and each portion and provision of this Agreement shall be valid and enforceable to the fullest extent
permitted by law.

 

13.         Survival.
The provisions of this Agreement shall survive the termination of this Agreement and/or the termination of the Executive’s
employment to the extent necessary to effectuate the terms contained herein.

 

14.         Waiver.
No waiver of any provision hereof shall be effective unless made in writing and signed by the waiving party. The failure of any
party to require the performance of any term or obligation of this Agreement, or the waiver by any party of any breach of this
Agreement, shall not prevent any subsequent enforcement of such term or obligation or be deemed a waiver of any subsequent breach.

 

15.         Notices.
Any notices, requests, demands and other communications provided for by this Agreement shall be sufficient if in writing and delivered
in person or sent by a nationally recognized overnight courier service or by registered or certified mail, postage prepaid, return
receipt requested, to the Executive at the last address the Executive has filed in writing with the Company or, in the case of
the Company, at its main offices, attention of the Board.

 

16.         Amendment;
Amended Terms. This Agreement may be amended or modified only by a written instrument signed by the Executive and by a duly
authorized representative of the Company. Every two years following the date of this Agreement, the Compensation Committee shall
make recommendations for changes to the amount and type of consideration payable upon termination and/or a change of control pursuant
to Sections 4 and 5 of this Agreement, respectively. Such recommendations shall be based upon on a review of information presented
to the Compensation Committee by a third-party compensation consultant retained by the Compensation Committee in connection with
a review of the Company’s executive compensation. Executive and the Company hereby agree to negotiate in good faith any amendments
to this Agreement which are necessary to give effect to any such recommendations.

 

    	11

    	 

    

 

17.         Governing
Law. This is a Massachusetts contract and shall be construed under and be governed in all respects by the laws of the Commonwealth
of Massachusetts, without giving effect to the conflict of laws principles of such Commonwealth. With respect to any disputes concerning
federal law, such disputes shall be determined in accordance with the law as it would be interpreted and applied by the United
States Court of Appeals for the First Circuit.

 

18.         Counterparts.
This Agreement may be executed in any number of counterparts, each of which when so executed and delivered shall be taken to be
an original; but such counterparts shall together constitute one and the same document.

 

19.         Successor
to Company. The Company shall require any successor (whether direct or indirect, by purchase, merger, consolidation or otherwise) to
all or substantially all of the business or assets of the Company expressly to assume and agree to perform this Agreement to the
same extent that the Company would be required to perform it if no succession had taken place. Failure of the Company to obtain
an assumption of this Agreement at or prior to the effectiveness of any succession shall be a material breach of this Agreement.

 

20.         Gender
Neutral. Wherever used herein, a pronoun in the masculine gender shall be considered as including the feminine gender unless
the context clearly indicates otherwise.

 

    	12

    	 

    

 

IN WITNESS WHEREOF, the parties have executed
this Agreement effective on the date and year first above written.

 

	 	COMPANY:
	 	 
	 	BRIGHTCOVE INC.
	 	 	 
	 	By:	/s/ David Mendels
	 	Name:	David Mendels
	 	Title:	CEO
	 	 	 
	 	EXECUTIVE:
	 	 	 
	 	/s/ Paul Goetz
	 	Paul Goetz

 

Signature Page to Employment Agreement

 

    	 

    	 

    

 

EXHIBIT
A

 

EMPLOYEE NONCOMPETITION,

NONDISCLOSURE AND DEVELOPMENTS AGREEMENT

 

In consideration of and as a condition of
my employment or continued employment by Brightcove Inc., its affiliates, subsidiaries, successors and assigns (collectively,
the “Company”), I hereby agree with the Company as follows:

 

1.           Noncompetition:
During the period of my employment by the Company, I shall devote my full time and best efforts to the business of the Company.
Further, during the period of my employment by the Company and for twelve months after the termination of such employment
(for any reason whatsoever) (the “Restricted Period”), I shall not, directly or indirectly, in any geographic area
where the Company does business or sells or markets its products and/or services or is actively planning to do business or sell
or market its products and/or services, as of my termination of employment, (a) provide services to, become employed by, or retained
as a consultant or independent contractor of, an entity that is competitive with the Company; or (b) alone or as a partner, officer,
director, employee, member, consultant, independent contractor, agent or stockholder of any entity, engage in any business activity
that competes with the products or services being developed, designed, manufactured, provided or sold by the Company at the time
of my termination of employment. My ownership of less than 3% of the equity securities of any publicly traded Company or less than
5% of any private company will not by itself violate the terms of this Section.

 

2.           Nonsolicitation
of Customers: During the Restricted Period, I shall not, directly or indirectly, alone or as a partner, officer, director,
employee, consultant, independent contractor, agent or stockholder of any entity, (i) solicit, or do business in competition with
the Company, or assist any other entity that competes with the Company to solicit or do business with (a) an entity that is a customer
of the Company at the time of my termination of employment from the Company or was a customer of the Company at any time within
six months prior thereto; or (b) an entity that is or was known to be a prospective customer of the Company at the time of my termination
of employment from the Company; or (ii) interfere with or disrupt, or assist any other person or business organization to interfere
with or disrupt, any existing relationships between the Company and any customer, licensee, supplier, vendor, distributor, dealer
or manufacturer of the Company.

 

3.           Nonsolicitation/Non-hire
of Employees: During the Restricted Period, I shall not, directly or indirectly, (a) hire or employ; (b) recruit or attempt
to recruit, solicit or attempt to solicit, attempt to hire, interfere with or endeavor to entice away; or (c) assist any entity,
business organization or person to recruit or attempt to recruit, solicit or attempt to solicit, attempt to hire, interfere with
or endeavor to entice away, any person who is or was employed by the Company at any time within the six month period prior to the
termination of my employment with the Company.

 

    	 

    	 

    

 

4.          Nondisclosure
Obligation: I shall not at any time, whether during or after the termination of my employment (for any reason whatsoever),
reveal to any person or entity any Confidential Information of the Company or of any third parties which the Company is under an
obligation to keep confidential, except to employees of the Company who need to know such information for the purposes of their
employment, or as otherwise authorized by the Company in writing. “Confidential Information” includes, but is not limited
to, confidential and/or proprietary information or trade secrets concerning the business, organization or finances of the Company,
including but not limited to, research and development activities, product designs, prototypes and technical specifications, show
how and know how, business, financial, sales and/or marketing plans and strategies, pricing and costing policies, customer and
suppliers lists and related information, nonpublic financial information, systems, source code and related unpublished documentation,
compensation and other personnel-related information, processes, software programs, works of authorship, inventions, projects,
plans and proposals as well as any other information as may be treated by the Company as confidential. I shall keep secret all
matters entrusted to me and shall not use or rely upon, or attempt to use or rely upon, any Confidential Information except as
may be required in the ordinary course of performing my duties as an employee of the Company.

 

5.          Company
Documentation: Furthermore, I agree that during my employment I shall maintain for the benefit of the Company, and shall not
make, use or permit to be used, any Company Documentation otherwise than for the benefit of the Company. “Company Documentation”
includes, but is not limited to, notes memoranda, reports, lists, records, drawings, sketches, specifications, software programs,
data documentation or other materials of any nature and in any form, whether written, printed or in digital format or otherwise
relating to any matter within the scope of the business of the Company or concerning any of its dealings or affairs, whether or
not they contain or embody any Confidential Information or any Developments (as hereinafter defined). I further agree that I shall
not, after the termination of my employment, use or permit others to use any such Company Documentation, and that all Company Documentation
shall be and remain the sole and exclusive property of the Company. Immediately upon the termination of my employment (or earlier,
if requested by the Company) I shall deliver all Company Documentation and Confidential Information in my possession, and all copies
thereof, to the Company, at its main office.

 

6.          Assignment
of Inventions:

 

(a)          If
at any time or times during my employment, I shall (either alone or with others) make, conceive, create, discover, invent or reduce
to practice any Development that: (i) relates to the business of the Company or any customer of or supplier to the Company
or any of the products or services being developed, manufactured or sold by the Company or which may be used in relation therewith;
or (ii) results from tasks assigned to me by the Company or work performed by me for the Company; or (iii) results from
the use of Confidential Information; or (iv) results from the use of premises or personal property (whether tangible or intangible)
owned, leased or contracted for by the Company, then all such Developments and the benefits thereof are and shall immediately become
the sole and absolute property of the Company and its assigns, as works made for hire or otherwise. The term “Development”
shall include, but not be limited to, any invention, modification, discovery, design, development, improvement, process, software
program, work of authorship, documentation, formula, data, technique, know-how, trade secret or intellectual property right whatsoever
or any interest therein (whether or not patentable or registrable under copyright, trademark or similar statutes (including but
not limited to the Semiconductor Chip Protection Act) or subject to analogous protection). I shall promptly disclose to the Company
(or any persons designated by it) each Development. I hereby assign all rights (including, but not limited to, rights to inventions,
patentable subject matter, copyrights and trademarks) I may have or may acquire in the Developments and all benefits and/or rights
resulting therefrom to the Company and its assigns without further compensation and shall communicate, without cost or delay, and
without disclosing to others, all available information relating thereto (with all necessary plans and models) to the Company.

 

    	2

    	 

    

 

(b)         I
represent that the Developments identified in the Appendix attached hereto, if any, comprise all the Developments that I have
made or conceived prior to my employment by the Company, which Developments are excluded from this Employee Noncompetition, Nondisclosure
and Developments Agreement (the “Agreement”). I understand that it is only necessary to list the title of such Developments
and the purpose thereof, but not details of the Development itself. IF THERE ARE ANY SUCH DEVELOPMENTS TO BE EXCLUDED, THE UNDERSIGNED
SHOULD INITIAL HERE; OTHERWISE IT WILL BE DEEMED THAT THERE ARE NO SUCH EXCLUSIONS.               .
I understand and agree that if I incorporate into any Company product, process or machine any Developments set forth on the Appendix
or otherwise made, conceived or reduced to practice by me prior to my employment with the Company, the Company is hereby granted
and shall have a nonexclusive, royalty-free, irrevocable, perpetual, world-wide license to make, have made, modify, use and sell
any such Development as part of or in connection with such product, process or machine.

 

(c)         I
shall, during my employment and at any time thereafter, at the request and cost of the Company, promptly sign, execute, make and
do all such deeds, documents, acts and things as the Company and its duly authorized officers may reasonably require: (i) to apply
for, obtain, register and vest in the name of the Company alone (unless the Company otherwise directs) patents, copyrights, trademarks
or other analogous protection in any country throughout the world relating to a Development and when so obtained or vested to renew
and restore the same; and (ii) to defend any judicial, opposition or other proceedings in respect of such applications and any
judicial, opposition or other proceeding, petition or application for revocation of any such patent, copyright, trademark or other
analogous protection.

 

(d)         If
the Company is unable, after reasonable effort, to secure my signature on any application for patent, copyright, trademark or other
analogous registration or other documents regarding any legal protection relating to a Development, whether because of my physical
or mental incapacity or for any other reason whatsoever, I hereby irrevocably designate and appoint the Company and its duly authorized
officers and agents as my agent and attorney-in-fact, to act for and in my behalf and stead to execute and file any such application
or applications or other documents and to do all other lawfully permitted acts to further the prosecution and issuance of patent,
copyright or trademark registrations or any other legal protection thereon with the same legal force and effect as if executed
by me.

 

7.          Acknowledgements/Remedies
Upon Breach: I agree that the Company’s Confidential Information, customer goodwill and workforce are vital to the success
of the Company’s business and have been or will be developed or attained by great efforts and expense to the Company. I acknowledge
that as of the date of this Agreement and continuing thereafter, I will be provided by the Company with Confidential Information,
including trade secrets, and I recognize the importance of protecting the Company’s rights in and to such Confidential Information
and goodwill that the Company has developed or will develop with its customers. I further agree that the restrictions set forth
in this Agreement are reasonable and necessary to protect the Company’s Confidential Information, its customer goodwill and
its workforce. I agree that any breach of this Agreement by me will cause irreparable damage to the Company and that in the event
of such breach or threatened breach the Company shall have, in addition to any and all remedies of law, the right to an injunction,
specific performance or other equitable relief to prevent or cease the violation of my obligations hereunder.

 

    	3

    	 

    

 

8.   
       Absence of Conflicting Agreements: I understand that the Company does not
desire to acquire from me any trade secrets, know how or confidential business information that I may have acquired from
others. I represent that I will not use such information in the performance of my duties for the Company and will not bring
any such information onto Company premises. I also represent that I am not bound by any agreement or any other existing or
previous business relationship which conflicts with or prevents the full performance of my duties and obligations to the
Company during the course of employment.

 

9.          Notification:
In the event that my employment with the Company terminates for any reason, I hereby consent to notification by the Company to
my new employer or any new entity to which I may provide services about my rights and obligations under this Agreement.

 

10.         Conflict
of Interest Guidelines: I hereby agree to comply with the Company’s conflict of interest guidelines attached hereto as
Exhibit B.

 

11.         Severability
and Reformation: I hereby agree that each provision herein shall be treated as a separate and independent clause, and the unenforceability
of any clause shall in no way impair the enforceability of any of the other clauses of the Agreement. Moreover, if one or more
of the provisions contained in this Agreement shall for any reason be held to be excessively broad as to scope, activity, subject
or otherwise so as to be unenforceable at law, such provision or provisions shall be construed by the appropriate judicial body
by limiting or reducing it or them, so as to be enforceable to the maximum extent compatible with the applicable law as it shall
then appear. I hereby further agree that the language of all parts of this Agreement shall in all cases be construed as a whole
according to its fair meaning and not strictly for or against either of the parties.

 

12.         At-Will
Employment: I understand that neither this Agreement nor any other document I have signed regarding my employment with the
Company constitutes an express or implied employment contract and that my employment with the Company is on an “at-will”
basis. Accordingly, I understand that either the Company or I may terminate my employment at any time, for any or no reason, with
or without prior notice.

 

13.         Continued
Effect. I agree and understand that any change or changes in my position, duties, salary, compensation or other terms and conditions
of employment with the Company will in no manner affect the validity, enforceability or scope of this Agreement, and that I am
entering into this Agreement in consideration for my employment with the Company, which employment includes any such changes that
may occur after the date hereof.

 

14.         Entire
Agreement. This Agreement sets forth the entire agreement and understanding between the Company and me relating to the subject
matter herein and merges and supersedes all prior discussions, representations, understandings and agreements by and between us,
provided that this Agreement shall supplement, and shall not limit or be limited by, any other or obligation I have to the Company
regarding noncompetition, nonsolicitation, confidentiality, assignment of inventions, and related covenants.

 

    	4

    	 

    

 

15.         Miscellaneous:
Any amendment to or modification of this Agreement, or any waiver of any provision hereof, shall be in writing and signed by the
Company. Any waiver by the Company of a breach of any provision of this Agreement shall not operate or be construed as a waiver
of any subsequent breach of such provision or any other provision hereof. The captions of this Agreement are for reference only
and do not define, limit or affect the scope of any section of this Agreement. My obligations under this Agreement shall survive
the termination of my employment regardless of the reason for or manner of such termination and shall be binding upon my heirs,
executors, administrators and legal representatives. The Company shall have the right to assign this Agreement to its successors
and assigns, and all covenants and agreements hereunder shall inure to the benefit of and be enforceable by said successors or
assigns. I acknowledge and agree that this Agreement shall be governed by and construed in accordance with the internal laws of
Massachusetts without giving effect to the principles of conflicts of laws thereof and any claims or legal actions by one party
against the other shall be commenced and maintained in any state or federal court located in Massachusetts and I hereby submit
to the jurisdiction and venue of any such court.

 

IN WITNESS WHEREOF, the undersigned has
executed this Agreement as a sealed instrument as of the date first above written.

 

	 	 
	 	Signature                                                  Date
	 	 
	 	 
	 	Name - Please Print
	 	 
		Address:	 
	 	 
	 	 	 

 

    	5

    	 

    

 

APPENDIX A

 

EXCLUDED DEVELOPMENTS

 

    	6

    	 

    

 

EXHIBIT B

 

CONFLICT OF INTEREST GUIDELINES

of

BRIGHTCOVE INC.

 

It is the policy of Brightcove Inc. to conduct its affairs in
strict compliance with the letter and spirit of the law and to adhere to the highest principles of business ethics. Accordingly,
all officers, employees and independent contractors must avoid activities that conflict, or give the appearance of being in conflict,
with these principles and with the interests of the Company. The following examples (which are not an exhaustive list) are potentially
compromising situations that must be avoided. Any exceptions must be reported to the President of the Company and written approval
for continuation must be obtained.

 

		(a)	Revealing confidential information to outsiders or misusing
confidential information. Unauthorized divulging of information is a violation of this policy whether or not for personal gain
and whether or not harm to the Company is intended. (The Employee Nondisclosure and Developments Agreement elaborates on this
principle and is a binding agreement.)

 

		(b)	Accepting or offering gifts, excessive entertainment, favors
or payments which may be deemed to constitute undue influence or otherwise be improper or embarrassing to the Company.

 

		(c)	Participating in civic or professional organizations that
might involve divulging confidential information of the Company.

 

		(d)	Initiating or approving personnel actions affecting reward
or punishment of employees or applicants where there is a family relationship or is or appears to be a personal or social involvement.

 

		(e)	Initiating or approving any form of personal or social
harassment of employees.

 

		(f)	Investing or holding outside directorship in suppliers,
customers, or competing companies, including financial speculations, where such investment or directorship might influence in
any manner a decision or course of action of the Company.

 

		(g)	Borrowing from or lending to employees, customers or suppliers.

 

		(h)	Acquiring real estate of interest to the Company.

 

		(i)	Improperly using or disclosing to the Company any proprietary
information or trade secrets of any former or concurrent employer or other person or entity with whom obligations of confidentiality
exist.

 

		(j)	Unlawfully discussing prices, costs, customers, sales or
markets with competing companies or their employees.

 

    	7

    	 

    

 

		(k)	Making any unlawful agreement with distributors with respect
to prices.

 

		(l)	Improperly using or authorizing the use of any inventions
which are the subject of patent claims of any other person or entity.

 

		(m)	Engaging in any conduct that is not in the best interest
of the Company. Each officer, employee and independent contractor must take every necessary action to ensure compliance with these
guidelines and to bring problem areas to the attention of the Company’s management for its review.

 

    	8exhibit_4-16.htm

Exhibit 4.16

 

 

  

  

  

 

 

Part A: Overview

 

This change of scope describes development activities to be performed for Prana Biotechnology Limited (“Client”) by Patheon Inc. (“Patheon”) under the terms and conditions of a Development Manufacturing Agreement P-TRP-54564-R1 by and between Patheon and the Client, dated April 16, 2013, which is hereby revised to include this change of scope in its entirety.

 

This change of scope reflects the costs associated to manufacture, package, and release two active lots of PBT2 Capsules for a Phase I bioequivalency clinical trial. Also included are the costs for the stability studies on these same batches.

 

	  	  
	
COS Reference #: P-TRP-54564-R1-COS-01-R0

	
Prana Biotechnology Limited

	
Issue Date: July 10, 2013

	
PBT2 Capsules - Phase I BE Batch Manufacturing

	
Confidential

	
Page 2 of 5

 

  

  

  

	  	  	  	  	  	  	  	  	  	  	  	  	  
	
Part B: Pricing

	  	  
	  	  	  
	
BUDGET SUMMARY

	  	  	  	  	  	  	  	  
	  	
THE FOLLOWING COSTS ARE ALL QUOTED IN:

	
USD

	  	  	  	  	  
	  	  	  	  	  	  	  	  
	  	
CTM BATCHES (ED)

	  	  	  	  	  	
USD

	  	  	
ACTIVITY

	  	
MILESTONE PRICE

	  	
PRICE

	  	  	  	  	  	  	  	  	  	  	  	  
	  	
First Batch 

	
Manufacturing

	  	  	
$

	
37,632

	  	  	  	  	  
	  	  	
Packaging

	  	  	
$

	
 9,403

	  	  	  	  	  
	  	  	
Analytical Support

	  	  	
$

	
19,142

	  	  	  	  	  
	  	  	  	
Total Per Batch

	  	
$

	
66,177

	  	  	  	  	  
	  	  	  	
1 Batch TOTAL

	  	  	  	  	  	
$

	
66,177

	  
	  	
Back to Back Batch 

	
Manufacturing

	  	  	
$

	

33,638

	  	  	  	  	  
	  	  	
Packaging

	  	  	
$

	

8,328

	  	  	  	  	  
	  	  	
Analytical Support

	  	  	
$

	

10,400

	  	  	  	  	  
	  	  	  	
Total Per Batch

	  	
$

	

52,366

	  	  	  	  	  
	  	  	  	
1 Back to Back Batch TOTAL

	  	  	  	  	  	
$

	
52,366

	  
	  	  	  	  	  	  	  	  	  	  	  	  
	  	  	
Total

	  	  	  	  	  	  	
$

	
118,543

	  
	  	  	  	
Material and Supply Fee:

	  	
$

	
5,927

	  
	
24.0

	
STABILITY - CTM

	  	  	  	  	  	
USD

	  	  	
ACTIVITY

	  	  	  	  	  	  	  	
PRICE

	  	  	  	  	  	  	  	  	  	  	  	  	  
	  	  	

Number of Lots

	

2

	  	  	  	  	  	  	  	  	  
	  	  	

Total Samples

	

24

	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  	  	  
	  	  	

Protocol Generation

	  	  	  	  	  	  	  	
$

	
791

	  

 

	  	  	  	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  	
Samples

	  	
Cost per pullpoint

	
Pullpoint

	  	  	  	  	  	  	  	  	  	  	
per

	  	
(Milestone Price)

	
Months

	  	
40°C / 75% RH

	  	
25°C / 60% RH

	  	  	
Microbiology

	  	
AET

	  	
pullpoint

	  	  
	

T=1

	  	
X

	  	
X

	  	  	  	  	  	  	
4

	
$

	
9,505

	

T=3

	  	
X

	  	
X

	  	  	  	  	  	  	
4

	
$

	
9,505

	

T=6

	  	
X

	  	
X

	  	  	  	  	  	  	
4

	
$

	
9,505

	

T=9

	  	  	  	
X

	  	  	  	  	  	  	
2

	
$

	
6,380

	

T=12

	  	  	  	
X

	  	  	
X

	  	  	  	
2

	
$

	
7,593

	

T=18

	  	  	  	
X

	  	  	  	  	  	  	
2

	
$

	
6,380

	

T=24

	  	  	  	
X

	  	  	
X

	  	  	  	
2

	
$

	

7,593

	

T=36

	  	  	  	
X

	  	  	
X

	  	  	  	
2

	
$

	

7,593

	

T=48

	  	  	  	
X

	  	  	
X

	  	  	  	
2

	
$

	

7,593

	  	  	  	  	
Summary Report Generation

	  	  	  	  	
$

	
1,130

	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	
Total

	  	  	  	  	
$

	
73,568

	  	  	  	  	
Material and Supply Fee:

	  	  	  	  	
$

	
3,678

	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  
	  	
BUDGET TOTAL

	  	
USD

	
$

	
192,111

	  	
Material and Supply Fee

	  	
USD

	
$

	
9,605

	  	
GRAND TOTAL

	  	
USD

	
$

	
201,716

 

	  	  	  
	
COS Reference #: P-TRP-54564-R1-COS-01-R0

	  	
Prana Biotechnology Limited

	
Issue Date: July 10, 2013

	  	
PBT2 Capsules - Phase I BE Batch Manufacturing

	
Confidential

	  	
Page 3 of 5

 

  

  

  

 

	  	  
	
Part C:

	
Descriptions of work to be added to the Project Scope

	
1.

	
Clinical Trial Material (CTM) Active Manufacturing

 

Process train: high shear granulation (PMA-25), fluid bed drying (S2), encapsulation (Romaco)

 

Patheon will manufacture:

	  	  
	
●

	
2 CTM Active batches (one 100 mg, one 250 mg strength), back-to-back manufacturing and testing

	

●

	
Approximately 5 kilograms per batch

	

●

	
Excipients released as per USP/NF/EP

	

●

	
Batch record, cGMP conditions & QA review

	

●

	
Packaged into HDPE bottles (i.e. 35’s)

	

●

	
In-Process Testing: Blend Homogeneity (one blend, 10 samples); Bulk & Tap Densities (including one sieve analysis), Flow Properties, Moisture (LOD or KF) and Physical Parameters (i.e. appearance, weight, weight variation) for beginning, middle and end of run

	

●

	
Finished  Product Testing:  Potency &  Related  Substances;  Content Uniformity  (n=10); Dissolution (profile, n=6); Moisture (LOD or KF); Microbial Limit Testing (MLT)

	
2.

	
Stability - CTM Active

 

Patheon shall design a stability program to monitor 1 batch of PBT2 Capsules under ICH conditions. Additional samples will be stored as contingency samples if required to generate data for long-term stability of the product.

 

The following storage conditions and test-points are suggested for testing:

	 	  	  
	 	

●

	
1, 3 and 6 months for 40°C ± 2°C / 75% ± 5% RH

	 	

●

	
1, 3, 6, 9, and 12 months for 30°C ± 2°C / 65% ± 5% RH*

	 	

●

	
1, 3, 6, 9, 12, 18, 24, 36, and 48 months for 25°C ± 2°C / 60% ± 5% RH

 

(* Tested only if required due to significant changes in the next level condition)

 

The analytical data used for the release of each lot manufactured at Patheon will be considered as initial (T=0) data provided that stability initiation occurs within 30 days of release testing. Should this not be the case the cost for the additional T=0 testing will be the subject of a future change of scope.

 

Cost efficiencies for analytical testing have been built into the stability program based upon the number of samples pulled in a given month.

	  	  	  	  	  	  	  	  	  	  
	
Pullpoint Month

	
1

	
3

	
6

	
9

	
12

	
18

	
24

	
36

	
48

	
Number of Samples Pulled

	
4

	
4

	
4

	
2

	
2

	
2

	
2

	
2

	
2

 

	  	  	  
	
COS Reference #: P-TRP-54564-R1-COS-01-R0

	  	
Prana Biotechnology Limited

	
Issue Date: July 10, 2013

	  	
PBT2 Capsules - Phase I BE Batch Manufacturing

	
Confidential

	  	
Page 4 of 5

 

  

  

  

 

 

Therefore, the stability sample breakdown is:

	  
	
0 single sample pullpoints (0 samples)

	
6 double sample pullpoints (12 samples)

	
3 three to four sample pullpoints (12 samples)

	
0 more than five sample pullpoints (0 samples)

	
The following standard tests will be performed as part of the stability program:

	  	  	  
	  	
●

	
Potency & related substances

	  	

●

	
Physical appearance

	  	

●

	
Moisture

	  	

●

	
Dissolution (profile by HPLC)

	  	

●

	
MLT (annually)

 

Appendix 1 – COS Revision History

	  	  	  
	
COS Revision Number

	
Description of Activities

	
Overall Cost (USD)

	
R0

	
Phase I BE batch manufacturing

	
$201,716

 

	  	  	  
	
COS Reference #: P-TRP-54564-R1-COS-01-R0

	  	
Prana Biotechnology Limited

	
Issue Date: July 10, 2013

	  	
PBT2 Capsules - Phase I BE Batch Manufacturing

	
Confidential

	  	
Page 5 of 5

 

  

  

  

 

 

  

  

  

 

Part A: Overview

 

This change of scope describes development activities to be performed for Prana Biotechnology Limited (“Client”) by Patheon Inc. (“Patheon”) under the terms and conditions of a Development Manufacturing Agreement P-TRP-54564-R1 by and between Patheon and the Client, dated April 16, 2013, which is hereby revised to include this change of scope in its entirety.

 

This change of scope adjusts the costs of the T=1m and T=2m stability time-points on the formulation development batches to include dissolution testing on all 4 batches, as opposed to the originally planned 2 batches. The original cost of the deliverables quoted in P-TRP-54564-R1 is cancelled within.

 

The grand total cost for all added activities is $18,604 USD. 

 

The total value for all cancelled tasks is ($15,214) USD. 

 

The net project budget impact is $3,390 USD.

 

Part B: Pricing

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	BUDGET SUMMARY
	 	 	 	 	 	 	 
	THE FOLLOWING COSTS ARE ALL QUOTED IN:         USD  	 	 	 	 	 	 
	 	 	 	 	 	 	 
	STABILITY - PROTOTYPE BATCH	 	 	 	 	 	
USD

	 
	 	 	 	 	 	
ACTIVITY

	 	 	 	 	 	 	 	
PRICE

	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	
Number of Lots

	2	 	 	 	 	 	 	 	 
	  	 	 	 	 	
Total Samples

	6	 	  	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	

Pullpoint

Months

	 	
40°C / 75% RH

	 	 	
25°C / 60% RH

	 	
Microbiology

	
AET

	 	
 

Samples

per

pullpoint

	 	 	
Cost per pullpoint (Milestone Price)

	 
	
T = 1

	 	 	X	 	 	 	X	 	  	  	 	 	4	 	 	$	11,060	 
	
T = 2

	 	 	X	 	 	 	 	 	  	  	 	 	2	 	 	$	6,658	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	  	 	 	 	 	Total	 	  	  	 	 	 	 	 	$	17,718	 
	  	 	 	 	 	 	 	 	Material and Supply Fee:	  	 	 	 	 	 	$	886	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

	  	 	 	 	 	 	 
	
BUDGET TOTAL

	 	
USD

	 	 	$	17,718	 
	
Material and Supply Fee

	 	
USD

	 	 	$	886	 
	
GRAND TOTAL

	 	
USD

	 	 	$	18,604	 

	 	 
	
COS Reference #: P-TRP-54564-R1-COS-02-R0

	
Prana Biotechnology Limited

	
Issue Date: August 13, 2013

	
PBT2 Capsules - Stability

	
Confidential

	
Page 2 of 3

 

  

  

  

 

 

	
Part C:

	
Descriptions of work to be added to the Project Scope

 

	
1.

	
Stability

 

Patheon shall design a stability program (single orientation, single container type) to monitor:

 

	
●

	
2 batches* under ICH conditions

	*: 4 batches to be tested in dissolution only

 

The following storage conditions and test-points are suggested for testing:

	 	 
	
=>

	
1 and 2 months for 40°C ± 2°C / 75% ± 5% RH

	
=>

	
1 months for 25°C ± 2°C / 60% ± 5% RH

 

	
●

	
Testing per sample: potency & related substances; dissolution (profile, n=6)*; physical (appearance, moisture)

 

	
Part D:

	
Descriptions of work to be Cancelled from the Project Scope

 

	
Project Name: 11311 - Prana Biotechnology Ltd, - PBT2 Immediate Release Capsules

	
Client Name: Prana Biotechnology Ltd.

	
Product Name: PBT2 Immediate Release Capsules

	
Currency: USD

	 	 	 
	
Task Name

	 	
Fee

	
P-TRP-54564-R1

	 	  
	
STABILITY - T = 1 (Includes 5% Material and Supply Fee)

	 	
$9,169

	
STABILITY - T = 2 (Includes 5% Material and Supply Fee)

	 	
$6,045

	
Fee Summary:

	 	
-$15,214

 

Appendix 1 – COS Revision History

 

	
COS Revision Number

	
Description of Activities

	
Overall Cost (USD)

	
R0

	
Stability

	
$3,390

 

	 	 
	
COS Reference #: P-TRP-54564-R1 -COS-02-R0

	
Prana Biotechnology Limited

	
Issue Date: August 13, 2013

	
PBT2 Capsules - Stability

	
Confidential

	
Page 3 of 3

 

  

  

  

 

 

  

  

  

 

 

Part A: Overview

 

This change of scope describes development activities to be performed for Prana Biotechnology Ltd. (“Client”) by Patheon Inc. (“Patheon”) under the terms and conditions of a Development Manufacturing Agreement P-TRP-54564-R1 by and between Patheon and the Client, dated April 16, 2013, which is hereby revised to include this change of scope in its entirety.

 

This change of scope reflects the costs associated with the manufacture of two active CTM batches plus stability. The Phase I stability study quoted for two batches in P-TRP-54564-R1-COS-01-R0 is revised to cover one batch.

 

The grand total cost for all added activities is $291,269 USD. 

 

The total value for all cancelled tasks is ($130,209) USD. 

 

The net project budget impact is $161,060 USD.

 

	
Part B:

	
Descriptions of Work to be Added to the Project Scope

 

	
1.

	
Clinical Trial Material (CTM) Active Manufacturing

 

Process train: high shear granulation (PMA-65), fluid bed drying (S2), encapsulation (Romaco)

 

Patheon will manufacture:

	 	 
	
●

	
2 CTM Active batches (one 100 mg, one 250 mg strength), back-to-back manufacturing and testing

	●	
Approximately 12 kilograms per batch

	●	
Excipients released as per USP/NF/EP

	●	
Batch record, cGMP conditions & QA review

	●	
Packaged into HDPE bottles (i.e. 35’s)

	●	
In-Process Testing: Blend Homogeneity (one blend, 10 samples); Bulk & Tap Densities (including one sieve analysis), Flow Properties, Moisture (LOD or KF) and Physical Parameters (i.e. appearance, weight, weight variation) for beginning, middle and end of run

	
●

	
Finished Product Testing: Potency & Related Substances; Content Uniformity (n=10); Dissolution (profile, n=6); Moisture (LOD or KF); Microbial Limit Testing (MLT)

 

	
2.

	
Stability – Phase III CTM Active

 

Patheon shall design a stability program to monitor 2 batches of PBT2 Capsules under ICH conditions. Additional samples will be stored as contingency samples if required to generate data for long-term stability of the product.

 

The following storage conditions and test-points are suggested for testing:

	 	 
	
Change of Scope COS-03-R0 to Proposal No. P-TRP-54564-R1

	
Prana Biotechnology Ltd.

	
Issue Date: February 11, 2014

	
Page 2 of 6

	
Confidential

	  

 

  

  

  

 

	
●

	
1, 3 and 6 months for 40°C ± 2°C / 75% ± 5% RH

	
●

	
1, 3, 6, 9, and 12 months for 30°C ± 2°C / 65% ± 5% RH*

	
●

	
1, 3, 6, 9, 12, 18, 24, 36, and 48 months for 25°C ± 2°C / 60% ± 5% RH

 

(* Tested only if required due to significant changes in the next level condition)

 

The analytical data used for the release of each lot manufactured at Patheon will be considered as initial (T=0) data provided that stability initiation occurs within 30 days of release testing. Should this not be the case the cost for the additional T=0 testing will be the subject of a future change of scope.

 

Cost efficiencies for analytical testing have been built into the stability program based upon the number of samples pulled in a given month.

 

	
Pullpoint Month

	
1

	
3

	
6

	
9

	
12

	
18

	
24

	
36

	
48

	
Number of Samples Pulled

	
4

	
4

	
4

	
2

	
2

	
2

	
2

	
2

	
2

 

Therefore, the stability sample breakdown is:

 

0 single sample pullpoints (0 samples)

6 double sample pullpoints (12 samples)

3 three to four sample pullpoints (12 samples)

0 more than five sample pullpoints (0 samples)

 

The following standard tests will be performed as part of the stability program:

	  	  
	
●

	
Potency & related substances

	
●

	
Physical appearance

	
●

	
Moisture

	
●

	
Dissolution (profile by HPLC)

	
●

	
MLT (annually)

 

3.       Stability – Phase I CTM Active

 

Patheon shall design a stability program to monitor 1 batch of PBT2 Capsules under ICH conditions. Additional samples will be stored as contingency samples if required to generate data for long-term stability of the product.

 

The following storage conditions and test-points are suggested for testing:

	  	  
	
●

	
1, 3 and 6 months for 40°C ± 2°C / 75% ± 5% RH

	
●

	
1, 3, 6, 9, and 12 months for 30°C ± 2°C / 65% ± 5% RH*

	
●

	
1, 3, 6, 9, 12, 18, 24, 36, and 48 months for 25°C ± 2°C / 60% ± 5% RH

 

(* Tested only if required due to significant changes in the next level condition)

	  	  
	
Change of Scope COS-03-R0 to Proposal No. P-TRP-54564-R1

	
Prana Biotechnology Ltd.

	
Issue Date: February 11, 2014

	
Page 3 of 6

	
Confidential

	  

 

  

  

  

 

 

Cost efficiencies for analytical testing have been built into the stability program based upon the number of samples pulled in a given month.

	  	  	  	  	  	  	  	  	  	  
	
Pullpoint Month

	
1

	
3

	
6

	
9

	
12

	
18

	
24

	
36

	
48

	
Number of Samples Pulled

	
2

	
2

	
2

	
1

	
1

	
1

	
1

	
1

	
1

 

Therefore, the stability sample breakdown is:

 

6 single sample pullpoints (6 samples)

3 double sample pullpoints (6 samples)

0 three to four sample pullpoints (0 samples)

0 more than five sample pullpoints (0 samples)

 

The following standard tests will be performed as part of the stability program:

	  	  
	
●

	
Potency & related substances

	
●

	
Physical appearance

	
●

	
Moisture

	
●

	
Dissolution (profile by HPLC)

	
●

	
MLT (annually)

 

Part C: Description of work to be removed from the Project Scope

	  	  	  	  
	
Project Name: 11311 - Prana Biotechnology Ltd. - PBT2 Immediate Release Capsules

	  	  	  
	
Client Name: Prana Biotechnology Ltd.

	  	  	  
	
Product Name: PBT2 Immediate Release Capsules

	  	  	  
	
Currency: USD

	  	  	  
	  	  	  	  
	
Task Name

	  	
                 Fee

	  
	
P-TRP-54564-R1 -COS-01-R0

	  	  	  
	
CTM BATCHES (ED) - Back to Back Batch MZYM Manufacturing (Includes 5% Material and Supply Fee)

	  	
$35,319

	  
	
CTM BATCHES (ED) - Back to Back Batch MZYS Packaging (Includes 5% Material and Supply Fee)

	  	
$8,744

	  
	
CTM BATCHES (ED) - Back to Back Batch MZYM/MZYS Analytical Support (Includes 5% Material and Supply Fee)

	  	
$10,920

	  
	
STABILITY - CTM lots MZYS, MZYN - T= 1 Months (40°C/ 75% RH) (25°C / 60% RH) (Includes 5% Material and Supply Fee)

	  	
$9,980

	  
	
STABILITY - CTM lots MZYS, MZYN - T= 3 Months (40°C/ 75% RH) (25°C / 60% RH) (Includes 5% Material and Supply Fee)

	  	
$9,980

	  
	
STABILITY - CTM lots MZYS, MZYN - T = 6 Months (40°C / 75% RH) (25°C / 60% RH) (Includes 5% Material and Supply Fee)

	  	
$9,980

	  
	
STABILITY - CTM lots MZYS, MZYN - T= 9 Months (25°C / 60% RH) (Includes 5% Material and Supply Fee)

	  	
$6,699

	  
	
STABILITY - CTM lots MZYS, MZYN - T = 12 Months (25°C / 60% RH) (Includes 5% Material and Supply Fee)

	  	
$7,972

	  
	
STABILITY - CTM lots MZYS, MZYN - T = 18 Months (25°C / 60% RH) (Includes 5% Material and Supply Fee)

	  	
$6,699

	  
	
STABILITY - CTM lots MZYS, MZYN - T = 24 Months (25°C / 60% RH) (Includes 5% Material and Supply Fee)

	  	
$7,972

	  
	
STABILITY - CTM lots MZYS, MZYN - T= 36 Months (25°C / 60% RH) (Includes 5% Material and Supply Fee)

	  	
$7,972

	  
	
STABILITY - CTM lots MZYS, MZYN - T = 48 Months (25°C / 60% RH) (Includes 5% Material and Supply Fee)

	  	
$7,972

	  
	
Fee Summary:

	  	
-$130,209

	  

	  	  
	
Change of Scope COS-03-R0 to Proposal No. P-TRP-54564-R1

Issue Date: February 11, 2014

Confidential

	
Prana Biotechnology Ltd.

Page 4 of 6

 

  

  

  

 

 

Part D: Pricing

	  	  	  	  	  	  	  	  	  	  	  	  	  	  
	  	  	
          BUDGET SUMMARY

	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  
	  	
THE FOLLOWING COSTS ARE ALL QUOTED IN:

	
USD

	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  
	
21.0 CTM BATCHES (LD)

	  	  	  	  	  	  	  	
USD

	  
	  	  	  	
ACTIVITY

	  	
MILESTONE PRICE

	
PRICE

	 	 	 	 	 	 	 
	  	
First Batch

	  	
Manufacturing

	  	  	
$

	
51,954

	  	  	  	  	  
	  	  	  	
Packaging

	  	  	
$

	
17,377

	  	  	  	  	  
	  	  	  	
Analytical Support

	  	  	
$

	
10,124

	  	  	  	  	  
	  	  	  	  	
Total Per Batch

	  	
$

	
79,455

	  	  	  	  	  
	  	  	  	  	
1 Batch TOTAL

	  	  	  	  	  	
$

	
79,455

	  
	  	
Back to Back Batch

	  	
Manufacturing

	  	  	
$

	
47,697

	  	  	  	  	  
	  	  	  	
Packaging

	  	  	
$

	
15,780

	  	  	  	  	  
	  	  	  	
Analytical Support

	  	  	
$

	
10,124

	  	  	  	  	  
	  	  	  	  	
Total Per Batch

	  	
$

	
73,601

	  	  	  	  	  
	  	  	  	  	
1 Back to Back Batch TOTAL

	  	  	  	  	  	
$

	
73,601

	  
	  	  	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	
$

	
153,056

	  
	  	  	  	
Total

	
Material and Supply Fee:

	
$

	
7,653

	  
	  	  	  	  	  	  	  	  	  	  	  	  	  
	
24.0 STABILITY - Phase III CTM

	  	  	  	  	  	  	  	
USD

	  
	  	  	  	
ACTIVITY

	  	  	  	  	  	  	
PRICE

	  	  	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	
Number of Lots

	
2

	  	  	  	  	  	  	  	  	  
	  	  	  	
Total Samples

	
24

	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	
Protocol Generation

	  	  	  	  	  	  	
$

	
994

	  

	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  
	
Pullpoint

Months

	  	
40C/ 75% RH

	  	
25C/ 60% RH

	  	  	  	
Microbiology

	  	
AET

	  	
Samples

per

pullpoint

	  	
Cost per pullpoint

(Milestone Price)

	
T = 1

	  	
X

	  	

X

	  	  	  	  	  	  	  	
4

	
$

	
8,185

	  
	
T = 3

	  	

X

	  	

X

	  	  	  	  	  	  	  	
4

	
$

	
8,185

	  
	
T = 6

	  	

X

	  	

X

	  	  	  	  	  	  	  	
4

	
$

	
8,185

	  
	
T = 9

	  	  	  	

X

	  	  	  	  	  	  	  	
2

	
$

	
6,380

	  
	
T = 12

	  	  	  	

X

	  	  	  	

X

	  	  	  	
2

	
$

	
7,593

	  
	
T = 18

	  	  	  	

X

	  	  	  	  	  	  	  	
2

	
$

	
6,380

	  
	
T = 24

	  	  	  	

X

	  	  	  	

X

	  	  	  	
2

	
$

	
7,593

	  
	
T = 36

	  	  	  	

X

	  	  	  	

X

	  	  	  	
2

	
$

	
7,593

	  
	
T = 48

	  	  	  	

X

	  	  	  	

X

	  	  	  	
2

	
$

	
7,593

	  
	  	  	  	  	
Summary Report Generation

	  	  	  	  	  	  	
$

	
1,420

	  
	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	
Total

	  	  	  	  	  	  	
$

	
70,101

	  
	  	  	  	  	  	  	
Material and Supply Fee:

	
$

	
3,505

	  
	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  
	
25.0 STABILITY - Phase I CTM

	  	  	  	  	  	  	  	
USD

	  
	  	  	  	  	
ACTIVITY                                                             

	  	  	  	  	  	  	  	
PRICE

	  
	  	  	  	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	
Number of Lots                                                     1 

	  	  	  	  	  	  	  	  	  
	  	  	  	  	
Total Samples                                                        12

	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  
	
Pullpoint

Months

	  	
40C / 75% RH

	  	
25C/ 60% RH

	  	  	  	
Microbiology

	  	
AET

	  	
Samples

per

pullpoint

	  	
Cost per pullpoint

(Milestone Price)

	
T = 1

	  	

X

	  	

X

	  	  	  	  	  	  	  	
2

	
$

	
6,380

	  
	
T = 3

	  	

X

	  	

X

	  	  	  	  	  	  	  	
2

	
$

	
6,380

	  
	
T = 6

	  	

X

	  	

X

	  	  	  	  	  	  	  	
2

	
$

	
6,380

	  
	
T = 9

	  	  	  	

X

	  	  	  	  	  	  	  	
1

	
$

	
5,421

	  
	
T = 12

	  	  	  	

X

	  	  	  	

X

	  	  	  	
1

	
$

	
6,065

	  
	
T = 18

	  	  	  	

X

	  	  	  	  	  	  	  	
1

	
$

	
5,421

	  
	
T = 24

	  	  	  	

X

	  	  	  	

X

	  	  	  	
1

	
$

	
6,065

	  
	
T = 36

	  	  	  	

X

	  	  	  	

X

	  	  	  	
1

	
$

	
6,065

	  
	
T = 48

	  	  	  	

X

	  	  	  	

X

	  	  	  	
1

	
$

	
6,065

	  
	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	
Total

	  	  	  	  	  	  	
$

	
54,242

	  
	  	  	  	  	  	  	
Material and Supply Fee:

	
$

	
2,712

	  
	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  
	  	  	
BUDGET TOTAL

	  	  	  	  	  	
USD

	
$

	
277,399

	  
	  	  	
Material and Supply Fee

	  	  	  	  	  	
USD

	
$

	
13,870

	  
	  	  	
GRAND TOTAL

	  	  	  	  	  	
USD

	
$

	
291,269

	  

	  	  
	
Change of Scope COS-03-R0 to Proposal No. P-TRP-54564-R1

Issue Date: February 11, 2014

Confidential

	
Prana Biotechnology Ltd.

Page 5 of 6

 

  

  

  

 

 

Appendix 1 - COS Revision History

	
COS Revision Number

	
Description of Activities

	
Overall Cost

	
R0

	
CTM manufacturing

	
$161,060 USD

 

	  	  
	
Change of Scope COS-03-R0 to Proposal No. P-TRP-54564-R1

Issue Date: February 11, 2014

Confidential

	
Prana Biotechnology Ltd.

Page 6 of 6

 

  

  

  

 

 

  

  

  

 

 

Part A: Overview

 

This change of scope describes development activities to be performed for Prana Biotechnology Ltd. (“Client”) by Patheon Inc. (“Patheon”) under the terms and conditions of a Development Manufacturing Agreement P-TRP-54564-R1 by and between Patheon and the Client, dated April 16, 2013, which is hereby revised to include this change of scope in its entirety.

This change of scope reflects the costs associated with addendum Phase III method validation for the potency & related substances and dissolution methods.

Part B: Descriptions of Work to be Added to the Project Scope

	1.	Analytical Services

 

Patheon will prepare a protocol and generate a report for each method validation activity for Client review.

 

Method Validation

	 	 
	●	
Product potency and related substances assay (phase III addendum method validation)

	●	
Product dissolution assay – profile by HPLC (phase III addendum method validation)

 

Patheon will validate the test methods required to support the Project. The validation will challenge the following parameters:

	●	
Accuracy (related substances only)

	●	
Robustness

 

	 	 	 
	
Change of Scope COS-04-R0 to Proposal No. P-TRP-54564-R1

	  	Prana Biotechnology Ltd.
	
Issue Date: March 3, 2014

	  	Page 2 of 3
	
Confidential

	  	

 

 

  

  

  

 

 

Part C: Pricing

 

	 	

BUDGET  SUMMARY

	 	 
	 	

THE FOLLOWING COSTS ARE ALL QUOTED IN:          USD

	 	 
	     1.0     ANALYTICAL DEVELOPMENT	 	 	  	

USD

	 	

ACTIVITY

	 	  	

PRICE

	 	 	 	 	 
	 	

Product Potency and Related Substances Assay (Method Validation Phase III)

	 	

$

	

13,686

	 	 	 	 	 
	 	

IR - Product Dissolution Assay by HPLC (Method Validation Phase III)

	 	

$

	

13,686

	 	 	 	 	 
	 	

Total 

	 	

$

	

27,372

	 	Material and Supply Fee:	 	$ 	1,369
	 	 	 	 	 	 
	 	
BUDGET TOTAL

	USD	 	
$

	
27,372

	 	

Material and Supply Fee 

	USD	 	

$

	

1,369

	 	

GRAND TOTAL 

	USD	 	

$

	

28,741

Appendix 1 - COS Revision History

 

	

COS Revision Number   

	Description of Activities	Overall Cost
	

R0

	Analytical services	$28,741 USD

 

	 	 	 
	
Change of Scope COS-04-R0 to Proposal No. P-TRP-54564-R1

	  	Prana Biotechnology Ltd.
	
Issue Date: March 3, 2014

	  	Page 3 of 3
	
Confidential

	  	

 

 

  

  

  

 

 

  

  

  

 

 

Part A: Overview

This change of scope describes development activities to be performed for Prana Biotechnology Ltd. (“Client”) by Patheon Inc. (“Patheon”) under the terms and conditions of a Development Manufacturing Agreement P-TRP-54564-R1 by and between Patheon and the Client, dated April 16, 2013, which is hereby revised to include this change of scope in its entirety.

This change of scope covers the cost to perform an Environmental Health and Safety toxicity categorization of PET434 API. Also included are the costs for the preparation of a CTM manufacturing report.

Part B: Descriptions of Work to be Added to the Project Scope

	
1.

	
Environmental, Health and Safety Assessment

Goal:

	 	  	  
	 	●	
To ensure the correct handling, storage and safety instructions are generated for the PBT434 API.

Deliverables:

	 	  	  
	 	●	
EH&S safety categorisation letter for the API.

	
2.

	
CTM Manufaturing Report

At the Client’s request, Patheon will provide a CTM manufacturing report to the Client upon completion of CTM manufacturing of lot NWCK.

 

	 	 
	
Change of Scope COS-06-R0 to Proposal No. P-TRP-54564-R1

	
Prana Biotechnology Ltd.

	
Issue Date: April 11, 2014

	
Page 2 of 3

	
Confidential

	  

 

  

  

  

 

 

Part D: Pricing

 

	BUDGET SUMMARY
	 	 	 	 	 	 
	  	

THE FOLLOWING COSTS ARE ALL QUOTED IN:         USD

	  	 	 	  
	 	 	 	 	 	 
	

 

	

ENVIRONMENTAL HEALTH AND SAFETY

	  	 	 	

USD

	  	

ACTIVITY

	  	 	 	

PRICE

	  	

EH&S Assessment

	  	 	$	

2,000

	  	

CTM BATCHES (LD)

	  	 	 	

USD

	  	

ACTIVITY

	

MILESTONE PRICE

	 	 	

PRICE

	  	

Manufacturing Report

	  	 	$	

8,600

	 	 	 	 	 	 
	  	

Total

	

 

	 	$	

8,600

	  
	  	

BUDGET TOTAL

	

USD

	 	$	

10,600

 

Appendix 1 - COS Revision History

 

	

COS Revision Number

	

Description of Activities

	

Overall Cost

	

R0

	

EH&S and manufacturing

	

$10,600 USD

	 	 
	
Change of Scope COS-06-R0 to Proposal No. P-TRP-54564-R1

	
Prana Biotechnology Ltd.

	
Issue Date: April 11, 2014

	
Page 3 of 3

	
Confidential

	  

 

  

  

  

 

 

  

  

  

 

	  	  
	
Part A:

	
Overview

 

This change of scope describes development activities to be performed for Prana Biotechnology Ltd. (“Client”) by Patheon Inc. (“Patheon”) under the terms and conditions of a Development Manufacturing Agreement P-TRP-54564-R1 by and between Patheon and the Client, dated April 16, 2013, which is hereby revised to include this change of scope in its entirety.

 

This change of scope covers the cost of additional dissolution method development that was not included as part of the original Proposal.

	  	  
	
Part B:

	
Descriptions of Work to be Added to the Project Scope

 

1. Analytical Development

 

At the Client’s request, Patheon shall perform additional dissolution method development to challenge the operating ranges for the medium buffer concentration, apparatus (i.e. baskets vs. paddles), and stirring rate.

 

Upon completion of the development work a peer-reviewed data summary shall be presented to the Client.

	  	  
	
Part D:

	
Pricing

	  	  	  	  	  	  	  	  	  	  	  	  	  
	
BUDGET SUMMARY

	  	  	  	  	  	  	  	  
	  	
THE FOLLOWING COSTS ARE ALL QUOTED IN:

	
USD

	  	  	  	  	  
	  	  	  	  	  	  	  	  
	  	

ANALYTICAL DEVELOPMENT

	  	  	  	  	  	
USD

	  	  	
ACTIVITY

	  	 	  	
PRICE

	  	  	  	  	  	  	  	  	  	  	  	  
	  	 	

IR - Product Dissolution Assay by HPLC (Method Development)

	  	 	
 

	  	  	
$

	
9,652

	  
	  	  	  	  	  	  	  	  	  	  	  	  
	  	  	
Total

	  	  	  	  	  	  	
$

	

9,652

	  
	  	  	  	
Material and Supply Fee:

	  	
$

	

483

	  

 

	  	  	  	  	  	  	  	  	  	  	  
	  	
BUDGET TOTAL

	  	
USD

	
$

	

9,652

	  	

MATERIAL AND SUPPLY FEE

	  	
USD

	
$

	

483

	  	

GRAND TOTAL

	  	
USD

	
$

	

10,135

 

	  	  	  
	

Change of Scope COS-08-R0 to Proposal No. P-TRP-54564-R1

	  	

Prana Biotechnology Ltd.

	

Issue Date: August 22, 2014

	  	

Page 2 of 3

	

Confidential

	  	
 

 

  

  

  

 

 

Appendix 1 – COS Revision History

	  	  	  
	

COS Revision Number

	

Description of Activities

	Overall Cost
	
R0

	
Analytical development

	

$10,135 USD

 

	  	  	  
	

Change of Scope COS-08-R0 to Proposal No. P-TRP-54564-R1

	  	

Prana Biotechnology Ltd.

	

Issue Date: August 22, 2014

	  	

Page 3 of 3

	

Confidential

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