Document:

Employment Agreement--Jyrki Matilla, M.D., Ph.D.

 EXHIBIT 10.18 
  
 EMPLOYMENT AGREEMENT 
  
 (Jyrki Matilla, M.D., Ph.D.) 
  
 THIS EMPLOYMENT AGREEMENT (the “Agreement”) entered into as of April 19, 2004, by and between Auxilium Pharmaceuticals, Inc. (the
“Company”) and Jyrki Matilla, M.D., Ph.D. (“Executive”). 
  
 WHEREAS, the Company desires to continue to employ Executive, and Executive desires to continue to be employed by the Company upon the terms and conditions hereinafter set forth; 
  
 NOW, THEREFORE, the parties hereto, intending to be legally bound, hereby
agree as follows: 
  
 1. Employment. The Company hereby
agrees to continue to employ Executive, and Executive hereby accepts such continued employment and agrees to perform Executive’s duties and responsibilities, in accordance with the terms, conditions and provisions hereinafter set forth. This
Agreement shall be effective as of April 19, 2004 (the “Effective Date”) and shall continue until terminated in accordance with Section 2 hereof. Nothing in this Agreement shall be construed as giving Executive any right to be retained in
the employ of the Company, and Executive specifically acknowledges that Executive shall be an employee-at-will of the Company, and thus subject to discharge at any time by the Company with or without cause and without compensation of any nature
except as provided in Section 2 below. 
  
 1.1. Duties and
Responsibilities. Commencing on the Effective Date, Executive shall serve as the Company’s Executive Vice President, Business Development and shall perform all duties and accept all responsibilities incident to such position as may be
reasonably assigned to Executive by the Company’s Board of Directors (the “Board”) or by the Chief Executive Officer of the Company. 
  
 1.2. Extent of Service. Executive agrees to use Executive’s best efforts to carry out Executive’s duties and responsibilities under
Section 1.1 hereof and, consistent with the other provisions of this Agreement, to devote substantially all of Executive’s business time, attention and energy thereto. The foregoing shall not be construed as preventing Executive from making
investments in other businesses or enterprises, provided that Executive agrees not to become engaged in any other business activity which, in the reasonable judgment of the Board, is likely to interfere with Executive’s ability to discharge
Executive’s duties and responsibilities to the Company. 
  
 1.3. Base Salary. For all the services rendered by Executive hereunder, the Company shall pay Executive a base salary (“Base Salary”) at the annual rate of $250,000, payable in installments at such times as the Company
customarily pays its other senior level executives. Executive’s Base Salary shall be reviewed annually for appropriate increases by the Board or compensation committee pursuant to the normal performance review policies for senior level
executives. 

 1.4. Incentive Compensation. Executive shall participate in short-term and long-term incentive
programs established by the Company for its senior level executives generally, at levels determined by the Board or the Chief Executive Officer. Executive’s incentive compensation shall be subject to the terms of the applicable plans and shall
be determined based on Executive’s individual performance and Company performance as determined by the Board or the Chief Executive Officer. 
  
 1.5. Retirement and Welfare Plans. Executive shall participate in employee retirement and welfare benefit plans made available to the
Company’s senior level executives as a group or to its employees generally, as such retirement and welfare plans may be in effect from time to time and subject to the eligibility requirements of the plans. Nothing in this Agreement shall
prevent the Company from amending or terminating any retirement, welfare or other employee benefit plans or programs from time to time as the Company deems appropriate. 
  
 1.6. Reimbursement of Expenses; Vacation. Executive shall be provided with reimbursement of reasonable expenses
related to Executive’s employment by the Company on a basis no less favorable than that which may be authorized from time to time for senior level executives as a group, and shall be entitled to vacation and sick leave in accordance with the
Company’s vacation, holiday and other pay for time not worked policies. 
  
 1.7. Equity Compensation. 
  
 (a) If, on or before August 1, 2004, the Company enters into a definitive license or co-promotion agreement for a product approved by the Food and Drug Administration, the Company shall recommend that, at the Board (or compensation
committee) meeting next following August 1, 2004, Executive be granted a non-qualified stock option to purchase 40,000 shares of common stock of the Company (“Common Stock”) at an exercise price equal to the fair market value of a share of
Common Stock as of the date such option is granted. Such option shall become exercisable in equal annual installments over the four-year period commencing on the date of grant. 
  
 (b) If, on or before August 1, 2004, the Company enters into a definitive in-license agreement to develop or co-develop a
development-stage product, the Company shall recommend that, at the Board (or compensation committee) meeting next following August 1, 2004, Executive be granted a non-qualified stock option to purchase 25,000 shares of Common Stock at an exercise
price equal to the fair market value of a share of Common Stock as of the date such option is granted. Such option shall become exercisable in equal annual installments over the four-year period commencing on the date of grant. 
  
 1.8. Certain Relocation and Educational Expenses. In addition to the
payments and benefits described in this Agreement, the Company shall reimburse Executive for the following expenses. 
  
 (a) If Executive purchases a home on or before August 1, 2007, the Company shall reimburse Executive for any settlement costs associated therewith up to a
maximum of $15,000, upon the Company’s receipt of appropriate documentation. 
  

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 (b) The Company shall reimburse Executive for educational expenses incurred by Executive for his two
children through August 1, 2005 up to a maximum of $10,000 per child per school year, upon the Company’s receipt of appropriate documentation. 
  

	2.	Termination. Executive’s employment shall terminate upon the occurrence of any of the following events: 

  

	2.1.	Termination Without Cause Before A Change of Control. 

  
 (a) The Company may remove Executive at any time without Cause (as defined in Section 2.9) from the position in which Executive is employed hereunder upon
not less than 30 days’ prior written notice to Executive. 
  
 (b) If Executive’s employment terminates as described in subsection (a) above and Executive executes and does not revoke a written release upon such removal, in a form provided by the Company, of any and all claims against the Company
and all related parties with respect to all matters arising out of Executive’s employment by the Company, or the termination thereof (the “Release”), Executive shall be entitled to receive the following severance compensation, as long
as Executive complies with the terms of Sections 4, 5, 6 and 7 below: 
  
 (i) Executive shall receive severance payments in an amount equal to 0.75 times Executive’s annual Base Salary at the rate in effect at the time of Executive’s termination. The severance amount shall be paid
in equal monthly installments over the 9-month period following Executive’s termination of employment (the “Severance Period”). Monthly payments shall commence within 30 days after the effective date of the termination (or the end of
the revocation period for the Release, if later). 
  
 (ii) During the Severance Period, Executive shall continue to receive (at no cost to Executive) the medical, dental and prescription drug coverage in effect at the date of Executive’s termination (or generally comparable coverage) for
Executive and, where applicable, Executive’s spouse and dependents, as the same may be changed from time to time for employees generally, as if Executive had continued in employment during such period. To the extent that continued participation
is neither permissible nor practicable, the Company shall take such actions as may be necessary to provide Executive with substantially comparable benefits (at no cost to the Executive) outside the scope of such plans, including, without limitation,
reimbursing Executive for his costs in obtaining such coverage, such as COBRA premiums paid by Executive and/or his eligible dependents. The COBRA health care continuation coverage period under Section 4980B of the Internal Revenue Code of 1986, as
amended (the “Code”) shall run concurrently with the Severance Period. 
  
 (iii) Executive shall receive any benefits accrued in accordance with the terms of any applicable benefit plans and programs of the
Company. 
  
 (iv) Executive agrees that if
Executive fails to comply with Section 4, 5, 6 or 7 below, all payments under this Section 2.1 shall immediately cease. 
  

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 2.2. Termination Without Cause; Resignation for Good Reason After A Change of Control. 

 
 (a) If a Change of Control occurs and the Company terminates
Executive’s employment without Cause at any time upon or after a Change of Control or Executive resigns for Good Reason (as defined in Section 2.9) upon or at any time during the two-year period following the Change of Control, this Section 2.2
shall apply. 
  
 (b) If Executive’s employment terminates as
described in subsection (a) above and Executive executes and does not revoke a Release, Executive shall be entitled to receive the following severance compensation, as long as Executive complies with the terms of Sections 4, 5, 6 and 7 below:

  
 (i) Executive shall receive a lump sum
severance payment in an amount equal to (A) 1.25 times Executive’s annual Base Salary at the rate in effect at the time of Executive’s termination, plus (B) 1.25 times Executive’s average annual bonus paid by the Company to Executive
for the two fiscal years preceding Executive’s termination of employment. The payment shall be made within 30 days after the effective date of the termination of employment (or the end of the revocation period for the Release, if later).

  
 (ii) During the 15-month period following
Executive’s termination of employment (the “Severance Period”), Executive shall continue to receive (at no cost to Executive) the medical, dental and prescription drug coverage in effect at the date of Executive’s termination (or
generally comparable coverage) for Executive and, where applicable, Executive’s spouse and dependents, as the same may be changed from time to time for employees generally, as if Executive had continued in employment during such period. To the
extent that continued participation is neither permissible nor practicable, the Company shall take such actions as may be necessary to provide Executive with substantially comparable benefits (at no cost to the Executive) outside the scope of such
plans, including, without limitation, reimbursing Executive for his costs in obtaining such coverage, such as COBRA premiums paid by Executive and/or his eligible dependents. The COBRA health care continuation coverage period under Section 4980B of
the Code shall run concurrently with the Severance Period. 
  
 (iii) All outstanding stock options held by Executive at the date of Executive’s termination of employment shall become fully exercisable on the date of termination and all stock awards held by Executive at the
date of Executive’s termination of employment shall become fully vested and exercisable as of the date of termination. 
  
 (c) Executive shall receive any benefits accrued in accordance with the terms of any applicable benefit plans and programs of the Company. 
  
 (d) Executive agrees that if Executive materially breaches Section 4, 5, 6 or
7 below, all payments under this Section 2.2 shall immediately cease. 
  

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 2.3. Increase in Payments Upon a Change of Control. 
  
 (a) Anything in this Agreement to the contrary notwithstanding, in the event
that it shall be determined that any payment or distribution by the Company to or for the benefit of Executive, whether paid or payable or distributed or distributable pursuant to the terms of this Agreement or otherwise (a “Payment”),
would constitute an “excess parachute payment” within the meaning of Section 280G of the Code, the Company shall pay to Executive an additional amount (the “Gross-Up Payment”) such that the net amount retained by Executive after
deduction of any excise tax imposed under Section 4999 of the Code, and any federal, state and local income tax, employment tax and excise tax imposed upon the Gross-Up Payment, shall be equal to the Payment. For purposes of determining the amount
of the Gross-Up Payment, unless Executive specifies that other rates apply, Executive shall be deemed to pay federal income tax and employment taxes at the highest marginal rate of federal income and employment taxation in the calendar year in which
the Gross-Up Payment is to be made and state and local income taxes at the highest marginal rate of taxation in the state and locality of Executive’s residence on Executive’s termination date, net of the maximum reduction in federal income
taxes that may be obtained from the deduction of such state and local taxes. 
  
 (b) All determinations to be made under this Section 2.3 shall be made by the Company’s independent public accountant immediately prior to the Change of Control or by another independent public accounting firm
mutually selected by the Company and Executive before the date of the Change of Control (the “Accounting Firm”), which firm shall provide its determinations and any supporting calculations both to the Company and Executive within 20 days
after Executive’s termination date. Any such determination by the Accounting Firm shall be binding upon the Company and Executive. Within 10 days after the Accounting Firm’s determination, the Company shall pay the Gross-Up Payment to
Executive. 
  
 (c) All of the fees and expenses of the Accounting
Firm in performing the determinations referred to in this Section 2.3 shall be borne solely by the Company. The Company agrees to indemnify and hold harmless the Accounting Firm from any and all claims, damages and expenses resulting from or
relating to its determinations pursuant to this Section 2.3, except for claims, damages or expenses resulting from the gross negligence or willful misconduct of the Accounting Firm. 
  
 2.4. Voluntary Termination. Executive may voluntarily terminate Executive’s employment for any reason upon 30
days’ prior written notice. In such event, after the effective date of such termination, except as provided in Section 2.2 with respect to a resignation for Good Reason, no further payments shall be due under this Agreement, except that
Executive shall be entitled to any benefits accrued in accordance with the terms of any applicable benefit plans and programs of the Company. 
  
 2.5. Disability. The Company may terminate Executive’s employment if Executive has been unable to perform the material duties of
Executive’s employment for a period of 90 days in any 12-month period because of physical or mental injury or illness (“Disability”); provided, however, that the Company shall continue to pay Executive’s Base Salary until the
Company acts to terminate Executive’s employment. Executive agrees, in the event of a dispute under this Section 2.5 relating to Executive’s Disability, to submit to a physical examination by a licensed physician jointly selected by the
Board and Executive. If the Company terminates Executive’s employment for Disability then Executive shall be entitled to any benefits accrued in 
  

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 accordance with the terms of any applicable benefit plans and programs of the Company, and in addition, if Executive
executes and does not revoke a Release, then Executive shall be entitled to receive the severance compensation set forth in Section 2.1(b) above, as long as Executive complies with the terms of Sections 4, 5, 6 and 7 below. 
  
 2.6. Death. If Executive dies while employed by the Company, the
Company shall pay to Executive’s executor, legal representative, administrator or designated beneficiary, as applicable, any benefits accrued under the Company’s benefit plans and programs. Otherwise, the Company shall have no further
liability or obligation under this Agreement to Executive’s executors, legal representatives, administrators, heirs or assigns or any other person claiming under or through Executive. 
  
 2.7. Cause. The Company may terminate Executive’s employment at
any time for Cause (as defined in Section 2.9) upon written notice to Executive, in which event all payments under this Agreement shall cease. Executive shall be entitled to any benefits accrued before Executive’s termination in accordance with
the terms of any applicable benefit plans and programs of the Company. 
  
 2.8. Notice of Termination. Any termination of Executive’s employment shall be communicated by a written notice of termination to the other party hereto given in accordance with Section 11. The notice of termination shall (i)
indicate the specific termination provision in this Agreement relied upon, (ii) briefly summarize the facts and circumstances deemed to provide a basis for a termination of employment and the applicable provision hereof, and (iii) specify the
termination date in accordance with the requirements of this Agreement. 
  
 2.9. Definitions. 
  
 (a)
“Cause” shall mean any of the following grounds for termination of Executive’s employment: 
  
 (i) Executive shall have been convicted of, or entered a plea of guilty to, a felony, 
  
 (ii) Executive intentionally and continually fails to
perform Executive’s reasonably assigned material duties to the Company (other than a failure resulting from Executive’s incapacity due to physical or mental illness), which failure has continued for a period of at least 30 days after a
written notice of demand for substantial performance, signed by a duly authorized officer of the Company, has been delivered to Executive specifying the manner in which Executive has failed substantially to perform, 
  
 (iii) Executive engages in willful misconduct in the
performance of Executive’s duties, or 
  
 (iv) Executive materially breaches Section 4, 5, 6 or 7 below. 
  

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 (b) “Change of Control” as used herein, a “Change of Control” shall be deemed
to have occurred if: 
  
 (i) Any
“person” (as such term is used in sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) becomes a “beneficial owner” (as defined in Rule 13d-3 under the Exchange Act),
directly or indirectly, of securities of the Company representing more than 50% of the voting power of the then outstanding securities of the Company; provided that a Change of Control shall not be deemed to occur as a result of a transaction in
which the Company becomes a subsidiary of another corporation and in which the stockholders of the Company, immediately prior to the transaction, will beneficially own, immediately after the transaction, shares entitling such stockholders to more
than 50% of all votes to which all stockholders of the parent corporation would be entitled in the election of directors; or 
  
 (ii) The consummation of (A) a merger or consolidation of the Company with another corporation where the stockholders of the Company,
immediately prior to the merger or consolidation, will not beneficially own, immediately after the merger or consolidation, shares entitling such stockholders to more than 50% of all votes to which all stockholders of the surviving corporation would
be entitled in the election of directors, (B) a sale or other disposition of all or substantially all of the assets of the Company, or (C) a liquidation or dissolution of the Company. 
  
 (iii) After the Effective Date, directors are elected such that a majority of the members of the Board shall
have been members of the Board for less than two years, unless the election or nomination for election of each new director who was not a director at the beginning of such two-year period was approved by a vote of at least two-thirds of the
directors then still in office who were directors at the beginning of such period. 
  
 (c) “Good Reason” shall mean the occurrence of any of the following events or conditions, unless Executive has expressly consented in writing thereto, or except as a result of Executive’s
physical or mental incapacity or as described in the last sentence of this subsection (c): 
  
 (i) a reduction in Executive’s Base Salary; 
  

(ii) a substantial reduction of Executive’s duties and responsibilities hereunder; or 
  
 (iii) the Company requires that Executive’s principal
office location be moved to a location more than 50 miles from Executive’s principal office location immediately before the change. 
  
 Notwithstanding the foregoing, Executive shall not have Good Reason for termination unless Executive gives written notice of termination for Good Reason
within 30 days after the event giving rise to Good Reason occurs and the Company does not correct the action or failure to act that constitutes the grounds for Good Reason, as set forth in Executive’s notice of termination, within 30 days after
the date on which Executive gives written notice of termination. 
  
 3. Non-Exclusivity of Rights. Nothing in this Agreement shall prevent or limit Executive’s continuing or future participation in or rights under any benefit, bonus, incentive or 
  

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 other plan or program provided by the Company and for which Executive may qualify; provided, however, that if Executive
becomes entitled to and receives the payments provided for in Section 2 of this Agreement, Executive hereby waives Executive’s right to receive payments under any severance plan or similar program applicable to all employees of the Company.

  
 4. Confidentiality. Executive agrees that
Executive’s services to the Company and its subsidiaries and any successors or assigns (collectively, the “Employer”) were and are of a special, unique and extraordinary character, and that Executive’s position places Executive
in a position of confidence and trust with the Employer’s customers and employees. Executive also recognizes that Executive’s position with the Employer will give Executive substantial access to Confidential Information (as defined below),
the disclosure of which to competitors of the Employer would cause the Employer to suffer substantial and irreparable damage. Executive recognizes, therefore, that it is in the Employer’s legitimate business interest to restrict
Executive’s use of Confidential Information for any purposes other than the discharge of Executive’s employment duties at the Employer, and to limit any potential appropriation of Confidential Information by Executive for the benefit of
the Employer’s competitors and to the detriment of the Employer. Accordingly, Executive agrees as follows: 
  
 (a) Executive will not at any time, whether during or after the termination of Executive’s employment, reveal to any person or entity any of the
trade secrets or confidential information of the Employer or of any third party which the Employer is under an obligation to keep confidential (including but not limited to trade secrets or confidential information respecting inventions, products,
designs, methods, know-how, techniques, systems, processes, software programs, works of authorship, customer lists, projects, plans and proposals) (“Confidential Information”), except as may be required in the ordinary course of performing
Executive’s duties as an employee of the Employer, and Executive shall keep secret all matters entrusted to Executive and shall not use or attempt to use any such information in any manner which may injure or cause loss or may be calculated to
injure or cause loss whether directly or indirectly to the Employer. 
  
 (b) The above restrictions shall not apply to: (i) information that at the time of disclosure is in the public domain through no fault of Executive; (ii) information received from a third party outside of the Employer that was disclosed
without a breach of any confidentiality obligation; (iii) information approved for release by written authorization of the Employer; or (iv) information that may be required by law or an order of any court, agency or proceeding to be disclosed;
provided Executive shall provide the Employer notice of any such required disclosure once Executive has knowledge of it and will help the Employer to the extent reasonable to obtain an appropriate protective order. 
  
 (c) Further, Executive agrees that during Executive’s employment
Executive shall not take, use or permit to be used any notes, memoranda, reports, lists, records, drawings, sketches, specifications, software programs, data, documentation or other materials of any nature relating to any matter within the scope of
the business of the Employer or concerning any of its dealings or affairs otherwise than for the benefit of the Employer. Executive further agrees that Executive shall not, after the termination of Executive’s employment, use or permit to be
used any such notes, memoranda, reports, lists, records, drawings, sketches, specifications, software programs, data, documentation or other materials, it being agreed that all of the foregoing shall 
  

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 be and remain the sole and exclusive property of the Employer and that immediately upon the termination of
Executive’s employment Executive shall deliver all of the foregoing, and all copies thereof, to the Employer, at its main office. 
  
 (d) Executive agrees that upon the termination of Executive’s employment with the Employer, Executive will not take or retain without written
authorization any documents, files or other property of the Employer, and Executive will return promptly to the Employer any such documents, files or property in Executive’s possession or custody, including any copies thereof maintained in any
medium or format. Executive recognizes that all documents, files and property which Executive has received and will receive from the Employer, including but not limited to scientific research, customer lists, handbooks, memoranda, product
specifications, and other materials (with the exception of documents relating to benefits to which Executive might be entitled following the termination of Executive’s employment with the Employer), are for the exclusive use of the Employer and
employees who are discharging their responsibilities on behalf of the Employer, and that Executive has no claim or right to the continued use, possession or custody of such documents, files or property following the termination of Executive’s
employment with the Employer. 
  
 5. Intellectual Property.

  
 (a) If at any time or times during Executive’s
employment Executive shall (either alone or with others) make, conceive, discover or reduce to practice any invention, modification, discovery, design, development, improvement, process, software program, work of authorship, documentation, formula,
data, technique, know-how, secret or intellectual property right whatsoever or any interest therein (whether or not patentable or registrable under copyright or similar statutes or subject to analogous protection) (herein called
“Developments”) that (i) relates to the business of the Employer or any customer of or supplier to the Employer or any of the products or services being developed, manufactured or sold by the Employer or which may be used in relation
therewith, (ii) results from tasks assigned to Executive by the Employer or (iii) results from the use of premises or personal property (whether tangible or intangible) owned, leased or contracted for by the Employer, such Developments and the
benefits thereof shall immediately become the sole and absolute property of the Employer and its assigns, and Executive shall promptly disclose to the Employer (or any persons designated by it) each such Development, and Executive hereby assigns any
rights Executive may have or acquire in the Developments and benefits and/or rights resulting therefrom to the Employer and its assigns without further compensation and shall communicate, without cost or delay, and without publishing the same, all
available information relating thereto (with all necessary plans and models) to the Employer. 
  
 (b) Upon disclosure of each Development to the Employer, Executive will, during Executive’s employment and at any time thereafter, at the request and cost of the Employer, sign, execute, make and do all such
deeds, documents, acts and things as the Employer and its duly authorized agents may reasonably require: 
  
 (i) to apply for, obtain and vest in the name of the Employer alone (unless the Employer otherwise directs) letters patent, copyrights or
other analogous protection in any country throughout the world and when so obtained or vested to renew and restore the same; and 
  

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 (ii) to defend any opposition proceedings in respect of such applications and any
opposition proceedings or petitions or applications for revocation of such letters patent, copyright or other analogous protection. 
  
 (c) In the event the Employer is unable, after reasonable effort, to secure Executive’s signature on any letters patent, copyright or other analogous
protection relating to a Development, whether because of Executive’s physical or mental incapacity or for any other reason whatsoever, Executive hereby irrevocably designates and appoints the Employer and its duly authorized officers and agents
as Executive’s agent and attorney-in-fact, to act for and on Executive’s behalf and stead to execute and file any such application or applications and to do all other lawfully permitted acts to further the prosecution and issuance of
letter patents, copyright and other analogous protection thereon with the same legal force and effect as if executed by Executive. 
  
 6. Non-Competition. While Executive is employed at the Employer and for a period of nine months after termination of Executive’s employment
(for any reason whatsoever, whether voluntary or involuntarily), Executive will not, without the prior written approval of the Board, whether alone or as a partner, officer, director, consultant, agent, employee or stockholder of any company or
other commercial enterprise, directly or indirectly engage in any business or other activity in the United States or Canada which competes directly with the Employer in the sale of the pharmaceutical or other products being manufactured, marketed,
distributed or developed by the Employer while Executive is employed by Employer and at the time of termination of such employment. The foregoing prohibition shall not prevent Executive’s employment or engagement after termination of
Executive’s employment by any company or business organization, as long as the activities of any such employment or engagement, in any capacity, do not involve work on matters related to the products being directly developed, manufactured, or
marketed by the Employer at the time of termination of Executive’s employment. Executive shall be permitted to own securities of a public company not in excess of five percent of any class of such securities and to own stock, partnership
interests or other securities of any entity not in excess of five percent of any class of such securities and such ownership shall not be considered to be in competition with the Employer. 
  
 7. Non-Solicitation. 
  
 (a) While Executive is employed at the Employer and for a period of one (1)
year after termination of such employment (for any reason, whether voluntary or involuntarily), Executive agrees that Executive will not: 
  
 (i) directly or indirectly solicit, entice or induce any customer of the Employer to become a customer of any other person, firm or
corporation with respect to products of such person, firm or corporation that are directly competitive with products then sold or under development by the Employer, or to cease doing business with the Employer, and Executive shall not approach any
such person, firm or corporation for such competitive purpose or authorize or knowingly approve the taking of such actions by any other person; or 
  

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 (ii) directly or indirectly solicit or recruit any employee of the Employer to work for a
third party other than the Employer (excluding newspaper or similar print or electronic solicitations of general circulation). 
  
 (b) This Section 7 does not apply to any general solicitation not focused to any group of customers itemized on a customer list of the Employer.

  
 8. General Provisions. 
  
 (a) Executive acknowledges and agrees that the type and periods of
restrictions imposed in Sections 4, 5, 6 and 7 of this Agreement are fair and reasonable, and that such restrictions are intended solely to protect the legitimate interests of the Employer, rather than to prevent Executive from earning a livelihood.
Executive recognizes that the Employer competes worldwide, and that Executive’s access to Confidential Information makes it necessary for the Employer to restrict Executive’s post-employment activities in any market in which the Employer
competes, and in which Executive’s access to Confidential Information and other proprietary information could be used to the detriment of the Employer. In the event that any restriction set forth in this Agreement is determined to be overbroad
with respect to scope, time or geographical coverage, Executive agrees that such a restriction or restrictions should be modified and narrowed, either by a court or by the Employer, so as to preserve and protect the legitimate interests of the
Employer as described in this Agreement, and without negating or impairing any other restrictions or agreements set forth herein. 
  
 (b) Executive acknowledges and agrees that if Executive should breach any of the covenants, restrictions and agreements contained herein, irreparable loss
and injury would result to the Employer, and that damages arising out of such a breach may be difficult to ascertain. Executive therefore agrees that, in addition to all other remedies provided at law or at equity, the Employer shall be entitled to
have the covenants, restrictions and agreements contained in Sections 4, 5, 6, and 7 specifically enforced (including, without limitation, by temporary, preliminary, and permanent injunctions and restraining orders) by any state or federal court in
the Commonwealth of Pennsylvania having equity jurisdiction and Executive agrees to subject Executive to the jurisdiction of such court. 
  
 (c) Executive agrees that if the Employer fails to take action to remedy any breach by Executive of this Agreement or any portion of the Agreement, such
inaction by the Employer shall not operate or be construed as a waiver of any subsequent breach by Executive of the same or any other provision, agreement or covenant. 
  
 (d) Executive acknowledges and agrees that the payments and benefits to be provided to Executive under this Agreement are
provided as consideration for the covenants in Sections 4, 5, 6, and 7 hereof. 
  
 9. Survivorship. The respective rights and obligations of the parties under this Agreement shall survive any termination of Executive’s employment to the extent necessary to the intended preservation of
such rights and obligations. 
  

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 10. Mitigation. Executive shall not be required to mitigate the amount of any payment or benefit
provided for in this Agreement by seeking other employment or otherwise and there shall be no offset against amounts due Executive under this Agreement on account of any remuneration attributable to any subsequent employment that Executive may
obtain. 
  
 11. Notices. All notices and other
communications required or permitted under this Agreement or necessary or convenient in connection herewith shall be in writing and shall be deemed to have been given when hand delivered or mailed by registered or certified mail, as follows
(provided that notice of change of address shall be deemed given only when received): 
  
 If to the Company, to: 
  
 Auxilium Pharmaceuticals, Inc. 
 Norriton Office Center 
 160 West Germantown Pike 
 Suite D-5 
 Norristown, PA 19401 
  
 If to Executive, to: 
  
 Jyrki Matilla, M.D., Ph.D. 
 522 Oakley Road 
 Haverford, PA 19041 
  
 or to such other names or addresses as the
Company or Executive, as the case may be, shall designate by notice to each other person entitled to receive notices in the manner specified in this Section. 
  
 12. Contents of Agreement; Amendment and Assignment. 
  
 (a) This Agreement sets forth the entire understanding between the parties hereto with respect to the subject matter hereof and supersedes any and all
prior agreements and understandings concerning Executive’s employment by the Company, including the offer letter between the Company and Executive dated August 1, 2003, and cannot be changed, modified, extended or terminated except upon written
amendment approved by the Board and executed on its behalf by a duly authorized officer and by Executive. 
  
 (b) All of the terms and provisions of this Agreement shall be binding upon and inure to the benefit of and be enforceable by the respective heirs,
executors, administrators, legal representatives, successors and assigns of the parties hereto, except that the duties and responsibilities of Executive under this Agreement are of a personal nature and shall not be assignable or delegatable in
whole or in part by Executive. The Company shall require any successor (whether direct or indirect, by purchase, merger, consolidation, reorganization or otherwise) to all or substantially all of the business or assets of the Company, within 15 days
of such succession, expressly to assume and agree to perform this Agreement in the same manner and to the same extent as the Company would be required to perform if no such succession had taken place. 
  

 12 

 13. Severability. If any provision of this Agreement or application thereof to anyone or under any
circumstances is adjudicated to be invalid or unenforceable in any jurisdiction, such invalidity or unenforceability shall not affect any other provision or application of this Agreement which can be given effect without the invalid or unenforceable
provision or application and shall not invalidate or render unenforceable such provision or application in any other jurisdiction. If any provision is held void, invalid or unenforceable with respect to particular circumstances, it shall
nevertheless remain in full force and effect in all other circumstances. 
  
 14. Remedies Cumulative; No Waiver. No remedy conferred upon a party by this Agreement is intended to be exclusive of any other remedy, and each and every such remedy shall be cumulative and shall be in
addition to any other remedy given under this Agreement or now or hereafter existing at law or in equity. No delay or omission by a party in exercising any right, remedy or power under this Agreement or existing at law or in equity shall be
construed as a waiver thereof, and any such right, remedy or power may be exercised by such party from time to time and as often as may be deemed expedient or necessary by such party in its sole discretion. 
  
 15. Withholding. All payments under this Agreement shall be made
subject to applicable tax withholding, and the Company shall withhold from any payments under this Agreement all federal, state and local taxes as the Company is required to withhold pursuant to any law or governmental rule or regulation. Except as
otherwise provided by Section 2.3, Executive shall bear all expense of, and be solely responsible for, all federal, state and local taxes due with respect to any payment received under this Agreement. 
  
 16. Miscellaneous. This Agreement may be executed in counterparts,
each of which is an original. It shall not be necessary in making proof of this Agreement or any counterpart hereof to produce or account for any of the other counterparts. 
  
 17. Governing Law. This Agreement shall be governed by and interpreted under the laws of the Commonwealth of
Pennsylvania without giving effect to any conflict of laws provisions or canons of construction that construe agreements against the draftsperson. 
  
 IN WITNESS WHEREOF, the undersigned, intending to be legally bound, have executed this Agreement as of the date first above written. 
  

	
	 AUXILIUM PHARMACEUTICALS, INC.

	
	 By: /s/    GERRI A. HENWOOD

	 Name:  Gerri A. Henwood

	 Title:    President and GEO

	
	 EXECUTIVE

	
	 /s/    JYRKI MATILLA, M.D., PH.D.

	 Jyrki Matilla, M.D., Ph.D.

  

 13Development and License Agreement

 Exhibit 10.19 
  

	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

  

  
  
 DEVELOPMENT AND LICENSE AGREEMENT 
 dated as of June 3, 2004 
  
 by and between 
  
 BIOSPECIFICS TECHNOLOGIES CORP. 
 (a Delaware corporation) 
  
 and 
  
 AUXILIUM PHARMACEUTICALS, INC. 
 (a Delaware corporation) 
  

 SCHEDULES 
  

			
	Schedule 1.7	  	BTC Patents
	Schedule 1.16	  	Cost of Goods
	Schedule 1.21	  	Enzyme
	Schedule 3.2	  	Clinical Trials

  

 i 

 DEVELOPMENT AND LICENSE AGREEMENT 
  
 This DEVELOPMENT AND LICENSE AGREEMENT (this “Agreement”) dated the 3rd day of June, 2004 (the
“June 3, 2004”) is by and between BioSpecifics Technologies Corp., a corporation organized and existing under the laws of Delaware and having its principal office at 35 Wilbur Street, Lynbrook, New York 11563, and its Affiliates
(“BTC”), and Auxilium Pharmaceuticals, Inc., a corporation organized and existing under the laws of the State of Delaware and having its principal office at 160 West Germantown Pike, Norristown, PA
19401(“Auxilium”). BTC and Auxilium shall sometimes be referred to herein individually as a “Party” and collectively as “Parties.” 
  
 INTRODUCTION 
  
 WHEREAS, BTC controls certain BTC Patents and BTC Know-How (each as defined below) related to the Enzyme and the Product (each as defined below), and has
the right to grant certain rights and licenses thereunder as set forth herein, and 
  
 WHEREAS, Auxilium has certain expertise in the development and commercialization of pharmaceutical products, and Auxilium wishes to obtain certain licenses and options to develop and commercialize the Product for
certain therapeutic uses in humans, and 
  
 WHEREAS, BTC wishes to
convey such licenses to Auxilium. 
  
 NOW, THEREFORE, in
consideration of the mutual promises, covenants and agreements hereinafter set forth, the sufficiency of which is hereby acknowledged, the Parties to this Agreement mutually agree as follows: 
  
 ARTICLE 1 
 DEFINITIONS 
  
 For purposes of this Agreement, the following initially capitalized terms in this Agreement, whether used in the singular or plural, shall have the following meanings: 
  
 1.1 “Additional Indication” shall mean any Indication for a Product outside of the Field. 
  
 1.2 “Additional Indication Option” has the meaning set forth
in Section 2.2(b). 
  
 1.3 “Adverse Drug
Experience” shall mean any of the following as such terms are defined at either 21 C.F.R. § 312.32 or 21 C.F.R. § 314.80: an “adverse drug experience,” a “life-threatening adverse drug experience,” a
“serious adverse drug experience,” or an “unexpected adverse drug experience” and the foreign counterparts thereof. 
  
 1.4 “Affiliate” shall mean any corporation, company, partnership, joint venture or firm which controls, is controlled by, or is under
common control with a specified person or entity. For purposes of this Section 1.4, “control” shall be presumed to exist if one of the following conditions is met: (a) in the case of corporate entities, direct or indirect ownership of

 at least fifty percent (50%) of the stock or shares having the right to vote for the election of directors, and (b) in
the case of non-corporate entities, direct or indirect ownership of at least fifty percent (50%) of the equity interest with the power to direct the management and policies of such non-corporate entities. The Parties acknowledge that in the case of
certain entities organized under the laws of certain countries outside of the United States, the maximum percentage ownership permitted by law for a foreign investor may be less than fifty percent (50%), and that in such cases such lower percentage
shall be substituted in the preceding sentence, provided that such foreign investor has the power to direct the management and policies of such entity. 
  
 1.5 “Auxilium Remaining Indication” shall mean an Additional Indication for a Product that Auxilium believes has a reasonable probability
of obtaining Regulatory Approval and achieving commercial success, but for which BTC does not wish to undertake Stage I Development. 
  
 1.6 “BTC Know-How” shall mean any proprietary information or materials related to the Manufacture, preparation, formulation, use or
development of the Enzyme or the Product Controlled by BTC during the Term and shall include formulations, processes, techniques, formulas, biological, chemical, assay control and manufacturing, technical, pre-clinical, clinical or other data,
methods, know-how, and trade secrets. 
  
 1.7 “BTC
Patents” shall mean those Patents Controlled by BTC with at least one claim directed to the Enzyme or the Product (or processes, improvements, uses and intermediates for the foregoing) including those listed on Schedule 1.7 attached
hereto as it may be amended from time to time. 
  
 1.8
“BTC Product” shall mean any pharmaceutical product that includes Enzyme as an active ingredient and is under development for an Indication (or is indicated for use) outside the Field. 
  
 1.9 “Business Day” shall mean any day on which banking
institutions in New York, New York are open for business. 
  
 1.10
“Clinical Trials” shall mean tests and studies in human subjects or patients that are required to obtain, maintain, or sustain Regulatory Approval in a country in the Territory. 
  
 1.11 “Commercialization” or “Commercialize”
shall mean activities directed to marketing, promoting, co-promoting, distributing, importing, exporting, offering for sale and selling the Product. When used as a verb, “Commercialize” means to engage in Commercialization. 
  
 1.12 “Commercially Reasonable Efforts” means, with respect
to a Party, the efforts and resources which would be used by that Party relating to a certain activity or activities, consistent with its normal business practices, which are consistent with the general level of effort and resources in the
pharmaceutical industry for a company similar in size and scope. 
  

 2 

 1.13 “Competing Product” shall mean a product that contains Enzyme and is sold in a
country by a Person (other than Auxilium) in an Indication for which Auxilium is marketing a Product in such country. 
  
 1.14 “Confidential Information” has the meaning set forth in Section 10.1 
  
 1.15 “Controlled” or “Controls”, when used in reference to intellectual property, shall
mean the legal authority or right of a Party hereto (or any of its Affiliates) to grant a license or sublicense of intellectual property rights to another Party, or to otherwise disclose proprietary or trade secret information to such other Party,
without breaching the terms of any agreement with a Third Party, infringing upon the intellectual property rights of a Third Party, or misappropriating the proprietary or trade secret information of a Third Party. 
  
 1.16 “Cost of Goods” shall mean the total cost of Product in
Final Packaging, including, but not limited to, the sum of the following actual costs: (i) manufacturing, shipping and storage of Enzyme; (ii) manufacturing, shipping and storage of Product, prior to sale to a Third Party; (iii) commercial packaging
and labeling; (iv) routine quality compliance and quality assurance programs; and (v) customs or excise taxes, import duties, sales taxes and other taxes or duties (other than those taxes resulting from sales to a Third Party of Product in finished
packaged and labeled form). In the event that BTC manufactures Enzyme or Products, Cost of Goods shall be calculated in accordance with Schedule 1.16. 
  
 1.17 “Develop” or “Development” shall mean Stage I Development and Stage II Development. When used as a verb,
“Developing” means to engage in Development. For purposes of clarity, in no event shall Development include Manufacture. 
  
 1.18 “Development Costs” shall mean costs associated with Development activities. 
  
 1.19 “Effective Date” shall mean the date specified in the
first paragraph of this Agreement. 
  
 1.20
“EMEA” shall mean the European Medicines Evaluation Agency or any successor agency thereto. 
  
 1.21 “Enzyme” shall mean an enzyme more particularly described on Schedule 1.21, and any variants or derivatives thereof.

  
 1.22 “European Union” shall mean the
countries of the European Union, as it is constituted as of the Effective Date and as it may be expanded from time to time. 
  
 1.23 “Exercised Indication” has the meaning set forth in Section 2.2(c). 
  
 1.24 “Exercised Indication Date” has the meaning set forth in Section 2.2(c). 
  
 1.25 “Exercise Period” has the meaning set forth in Section
2.2(c). 
  
 1.26 “FDA” shall mean the U.S. Food
and Drug Administration or its successor agency. 
  

 3 

 1.27 “Field” shall mean, subject to expansion pursuant to Section 2.2, the prevention or
treatment of Dupuytren’s Disease and Peyronie’s Disease. 
  
 1.28 “Final Packaging” means the labeling and packaging to be used in connection with the Product labeled for use in the Field in the Territory, including the packaging of package inserts and components reasonably necessary
for sale of the finished Product to the ultimate consumer. 
  
 1.29 “Indemnified Party” has the meaning set forth in Section12.3. 
  
 1.30 “Indemnifying Party” has the meaning set forth in Section 12.3. 
  
 1.31 “Indication” shall mean a pharmaceutical application for the Product. 
  
 1.32 “Infringement Claim” has the meaning set forth in Section 8.2(a). 
  
 1.33 “Law” shall mean any applicable statute, law,
ordinance, regulation, order, or rule of any federal, state, local, foreign, or other governmental agency or body or of any other type of regulatory body (including common law) or securities exchange, including those covering pharmaceutical sales,
environmental, pollution, energy, safety, health, transportation, bribery, record-keeping, zoning, antidiscrimination, antitrust, wage and hour, and price and wage control matters. 
  
 1.34 “Licensed Technology” shall mean the BTC Patents and the BTC Know-How. 
  
 1.35 “Loss” has the meaning set forth in Section 12.1.

  
 1.36 “Major Market Country” shall mean the
[**]. 
  
 1.37 “MAA” shall mean an
application seeking Regulatory Approval of the Regulatory Authority in the European Union to market and sell a Product in the Field in the European Union. 
  
 1.38 “MAA Acceptance” shall mean the written notification by the applicable Regulatory Authority that the MAA has met all the criteria
for filing acceptance. 
  
 1.39 “Manufacture” or
“Manufacturing” shall mean manufacturing, filling, processing, testing, engineering, designing, redesigning, packaging, storing, quality control, quality assurance, releasing, disposing, handling, shipping, and all other activities
undertaken or required to be undertaken in order to manufacture and supply the Product in its Final Packaging and related devices and apparatus for administration thereof, in the case of commercial supplies, or packaged in accordance with Laws, in
the case of clinical supplies. 

	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

  

 4 

 1.40 “NDA” or “New Drug Application” shall mean a new drug application
filed with the FDA pursuant to 21 C.F.R. §314, seeking permission to market the Product for a particular Indication in the Field in interstate commerce in the United States. 
  
 1.41 “NDA Filing Acceptance” shall mean the written notification by the FDA that the NDA has met all the
criteria for filing acceptance. 
  
 1.42 “Net
Sales” shall mean the gross amount invoiced by Auxilium and its Affiliates or Sublicensees on account of sales of the Product in Final Packaging to Third Parties in the Territory, less the total of: (a) trade, cash or quantity discounts not
already reflected in the amount invoiced; (b) excise, sales and other consumption taxes and customs duties to the extent included in the invoice price; (c) freight, insurance and other transportation charges to the extent specifically included in
the invoice price; (d) returns or retroactive price reductions; and (e) compulsory payments and rebates directly related to the sale of the Product accrued, paid or deducted pursuant to governmental regulations. 
  
 1.43 “Orphan Drug Designation” shall mean the special
designation of Product by FDA’s Orphan Product Division which provides the Product with the opportunity to obtain additional market exclusivity from the date the drug receives FDA approval and also possible tax and regulatory approval benefits.
The term “Orphan Drug Designation” shall include any foreign counterparts of the foregoing. 
  
 1.44 “Patents” shall mean any patents or patent applications and any continuations, continuations-in-part, divisions, provisionals,
substitutions, patents of addition, reissues, reexamination, renewals or extensions thereof (including any supplemental patent certificates) and any confirmation patent or registration patent and all foreign counterparts of any of the foregoing.

  
 1.45 “Person” shall mean any individual,
corporation, partnership, association, joint-stock company, trust, unincorporated organization or government or political subdivision thereof. 
  
 1.46 “Phase II Clinical Trials” shall mean a Clinical Trial for the Product on a number of patients, no fewer than the number required to
allow for the detection of statistical differences between the control and treated patients, for the purposes of determining dose and evaluating safety and efficacy in the proposed therapeutic indication, conducted in accordance with current good
clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same. 
  
 1.47 “Phase III Clinical Trials” shall mean a Clinical Trial for the Product on sufficient numbers of patients to generate safety and
efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or
concerns raised by the same. 
  
 1.48 “Product”
shall mean pharmaceutical product containing Enzyme as an active ingredient and any reformulation, improvement, enhancement, combination, refinement, or modification thereof; provided however, Product shall specifically exclude dermal formulations
labeled for topical administration. 
  

 5 

 1.49 “Product Data” shall mean the physical embodiment, to the extent available of: (a)
the know-how, including relevant laboratory notebook information, screening data and synthesis schemes, including descriptions in any form, data and other information, and (b) all other data including Regulatory Data and any other pre-clinical and
clinical data and information, technical, chemical, safety and scientific data, information and know-how, obtained or generated in connection with Development of the Product in the Field. 
  
 1.50 “Product Details” shall mean a face-to-face meeting, in an individual or group practice setting,
between a healthcare professional with prescribing authority who is a target prescriber of a Product in the Field and a professional representative of the applicable Party during which the key attributes of a Product are verbally presented to such
healthcare professional. When used as a verb, “detail” or “detailing” shall mean to engage in a Detail. 
  
 1.51 “Regulatory Approval” shall mean, with respect to a country or group of countries in the Territory, all authorizations by the
appropriate governmental entity or entities necessary for commercial sale of the Product in the Field for a particular Indication in that country or group of countries including, where applicable, approval of labeling, price, reimbursement and
manufacturing. 
  
 1.52 “Regulatory Authority”
shall mean the FDA or any foreign counterpart or additional governmental or regulatory agencies in the Territory responsible for applicable Regulatory Approvals. 
  
 1.53 “Regulatory Data” shall mean any and all research data, pharmacology data, chemistry, manufacturing,
and control data, preclinical data, clinical data or all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product in the Field (including any Drug Master Files
(DMFs), Chemistry, Manufacturing and Control (“CMC”) data, or similar documentation). 
  
 1.54 “Remaining Indication” shall mean an Additional Indication for which Auxilium has not exercised an Additional Indication Option
within the Exercise Period. 
  
 1.55 “Stage I
Development” shall mean pre-clinical and clinical drug development activities reasonably necessary to completing all development activities up to and including the completion of Phase II Clinical Trials for the Product in the Field,
including pre-clinical studies, test method development, statistical analysis, Clinical Trials, regulatory affairs, and activities directed to seeking Regulatory Approvals. 
  
 1.56 “Stage I Development Costs” shall mean costs associated with Stage I Development activities.

  
 1.57 “Stage II Development” shall mean
non-clinical and clinical drug development activities reasonably necessary to the development and submission of Regulatory Data to a Regulatory Authority for the purpose of achieving Regulatory Approval, including non-clinical studies, test method
development, statistical analysis, Clinical Trials, regulatory affairs, and activities directed to seeking Regulatory Approvals. 
  

 6 

 1.58 “Stage II Development Costs” shall mean costs associated with Stage II Development
activities. 
  
 1.59 “Standard Terms” has the
meaning set forth in Section 6.4(d). 
  
 1.60 “Sublicense
Income” shall mean (a) the upfront payment, if any, actually received from a Sublicensee by Auxilium upon execution of an agreement with such Sublicensee, and (b) any milestone payments actually received from a Sublicensee by Auxilium in
consideration for the grant of a sublicense to such Sublicensee under the Licensed Technology in the Field; provided, however, that Sublicense Income shall not include any such consideration received by Auxilium from any such Sublicensee in return
for, as payment for or otherwise in respect of: (i) equity or debt of Auxilium (provided, however, that the exclusion contained in this sub-clause (i) shall not apply to transactions between Auxilium and its Affiliates), (ii) the manufacture or
supply of ingredients or products, (iii) the performance of services (including research and development services other than screening services performed on behalf of a Sublicensee) or other similar payments, (iv) reimbursement of Auxilium’s
out of pocket costs and expenses, including patent expenses, or (v) the sale of Auxilium in whole or in part. 
  
 1.61 “Sublicensee” shall mean a Person to whom Auxilium grants any right or license to use the Licensed Technology to make, use or sell
the Product in the Field in the Territory. 
  
 1.62
“Supply Agreement” has the meaning set forth in Section 6.4. 
  
 1.63 “Term” has the meaning set forth in Section11.1(a). 
  
 1.64 “Territory” shall mean all the countries and territories of the world. 
  
 1.65 “Third Party” shall mean any Person or other entity other than Auxilium, BTC or their respective
Affiliates. 
  
 1.66 “Vial” shall means a single
dose unit of Product. 
  
 ARTICLE 2 
 LICENSE AND OPTION 
  
 2.1 License Grant to Auxilium 
  
 (a) Subject to the terms and conditions of this Agreement, on the Effective Date, BTC hereby grants to Auxilium an exclusive license under the Licensed
Technology to research, Develop, use, Commercialize, market, sell and distribute the Product for the Field in the Territory. 
  
 (b) Subject to the terms and condition of this Agreement, BTC hereby grants to Auxilium a non-exclusive right and license under the Licensed Technology to
Manufacture or have Manufactured the Product for the Field in the Territory. Notwithstanding the foregoing provisions of this Section 2.1(b), Auxilium shall not exercise its license pursuant to this Section 2.1(b) to Manufacture the Product except
as permitted by, and solely for the purposes set forth in, Article 6. 
  

 7 

 (c) The licenses granted under Sections 2.1(a) and 2.2(b) shall include the right to grant sublicenses
(and in the case of Section 2.1(a), distribution rights); provided, however, that all such sublicenses shall contain terms and conditions which are consistent with the terms and conditions contained in this Agreement. 
  
 2.2 Option to License Additional Indications 
  
 (a) Development of Additional Indications for Products. The Parties
shall cooperate in good faith in generating ideas and concepts for Additional Indications for Products. BTC shall use Commercially Reasonable Efforts to conduct Stage I Development for the use of the Product for the treatment of Frozen Shoulder. BTC
shall summarize such efforts in reports to be submitted to the Joint Development Committee on a quarterly basis. 
  
 (b) Option Grant. Subject to the terms and conditions of this Agreement, BTC hereby grants to Auxilium an exclusive option to an exclusive license
to Products in the Territory for each Additional Indication on the same terms and conditions as provided for Indications in the Field (each, an “Additional Indication Option”). 
  
 (c) Exercise Period; Exercise of Option. The period during which Auxilium may exercise an Additional Indication
Option (the “Exercise Period”) shall commence on the date on which BTC submits a Phase II Clinical Trial report to Auxilium for the Product for such Additional Indication and ends one hundred and twenty (120) days thereafter. BTC shall
provide Auxilium with a copy of a Phase II Clinical Trial report and, any additional data or results in its control. Auxilium may exercise the Additional Indication Option at any time during the Exercise Period by delivering to BTC a written notice
of exercise with regard to such Additional Indication (each, an “Exercised Indication”) that sets forth the effective date of the exercise (the “Exercised Indication Date”). Upon receipt, BTC shall counter-sign the exercise
notice which shall then be appended to and incorporated by reference into this Agreement effective the Exercised Indication Date. 
  
 (d) License Grant Upon Exercise of Option. Effective on the Exercised Indication Date, the Field definition shall be amended and expanded to
include the relevant Exercised Indication. 
  
 (e) Auxilium
Remaining Indications. Auxilium shall have the right to Develop and Commercialize Auxilium Remaining Indications at its sole cost and expense. Upon notification to BTC of Auxilium’s intent to Develop and Commercialize an Auxilium Remaining
Indication, the Field definition shall be amended and expanded to include such Auxilium Remaining Indication. 
  
 2.3 Remaining Indications BTC may offer Third Parties the right under the Licensed Technology to research, Develop, use Commercialize, market, sell
and distribute the Product for any Remaining Indication (the “Remaining Indication Rights”), provided that, prior to executing a definitive agreement with a Third Party for one or more Remaining Indications, BTC must (a) 

 

 8 

 provide Auxilium with a written summary of the material terms of the proposed agreement (the “Offer Terms”),
and (b) grant Auxilium an option, exercisable for seventy-five (75) days after Auxilium’s receipt of the written summary, to agree to equivalent terms, in which case the Parties shall negotiate in good faith an exclusive license agreement on
such terms as promptly as possible thereafter. In the event that Auxilium does not exercise an option to license a Remaining Indication within such seventy-five (75) day period, the Remaining Indication Rights may be licensed to such Third Party on
terms and conditions no less favorable to BTC than the Offer Terms. 
  
 2.4 Transfer of BTC Know-How Within forty-five (45) days of the Effective Date, BTC shall, or shall cause its Affiliates to, transfer to Auxilium all material Product Data relating to Dupuytren’s Disease and Peyronie’s
Diseases, including but not limited to preclinical, clinical data, clinical trial protocols, study data tabulations, reports, the right of cross-reference and permission to use in Auxilium Regulatory Data and regulatory filings,
investigator-generated data granted by the owners of such data, etc., in reasonably satisfactory form. Promptly, but in no event more than thirty (30) days, after the Exercised Indications Date, BTC shall, or shall cause its Affiliates to, transfer
to Auxilium all Product Data relating to such Exercised Indication, in reasonably satisfactory form. 
  
 2.5 Exclusivity During the Term and any extension thereof, and for two years thereafter, neither BTC nor any of its Affiliates shall, except as
otherwise set forth and provided in this Agreement, (a) directly or indirectly develop, manufacture, market, sell, detail or promote any Competing Product or (b) encourage off-label use of a Competing Product that could affect labeled usage of the
Product in the Field. In addition, in the event that BTC markets a BTC Product outside the Field within a country in the Territory where Auxilium is promoting the Product within the Field, BTC shall promote the BTC Product under a trademark
different from the Auxilium Trademark, and will not knowingly market, ship, distribute, promote, sell or otherwise put into circulation the BTC Products within the Field in such country or in any other country within the Territory. In the event that
BTC enters into any agreements with its distributors or wholesalers for the BTC Products in a country in the Territory, it shall include in any and all said agreements appropriate provisions providing, to the extent not prohibited by Law, that the
BTC Products must be distributed and sold solely outside the Field within such country in the Territory. In the event that Auxilium enters into any agreements with its distributors or wholesalers for the Product in the Field, it shall include in any
and all said agreements appropriate provisions providing, to the extent not prohibited by Law, that the Product must be distributed and sold solely within the Field within such country in the Territory. 
  
 ARTICLE 3 
 PRODUCT DEVELOPMENT 
  
 3.1 Joint Development Committee 
  
 (a) Formation. As soon as practicable after the execution of this Agreement, BTC and Auxilium will establish a Joint Development Committee (the “JDC”) made up of two (2) representatives designated by each Party hereto to
assist in coordinating scientific interactions and resolving potential disagreements between BTC and Auxilium during the course of the Development of Product. The JDC Chair will be appointed by Auxilium from among the 
  

 9 

 members of the committee designated by Auxilium. Each of BTC and Auxilium shall have one vote on the JDC and, in the
event of a deadlock with respect to any action, the vote of Auxilium, rendered after reasonable and open discussion among the members of the JDC, shall be final and controlling. BTC shall not take any action with respect to Remaining Indications
that would be detrimental to the Product or damaging to Auxilium. Notwithstanding the foregoing, BTC will advise the JDC of all Development and Commercialization of Remaining Indications. The JDC shall have the right to discuss and comment on such
activities but shall not have the final vote with respect to such activities as they relate to Remaining Indications. 
  
 (b) Quarterly Meetings. While a Product is under Development, the JDC shall meet formally at least quarterly, or with such other frequency, and at
such time and location, as may be established by the JDC, for the following purposes, among others: (i) to oversee and coordinate Development activities of the Parties for Products; (ii) to receive and review reports by the Parties as may be
submitted to the JDC on a quarterly basis; and (iii) to discuss matters relating to Patents related to the Product, including but not limited to issues of inventorship and decisions relating to the filing, prosecution and maintenance of such
Patents, provided however, when the JCC is established, the JCC and the JDC will coordinate responsibility on such matters. Meetings of the JDC may be held in person or by teleconference, as may be determined by the JDC. 
  
 3.2 Auxilium’s Stage II Development Activities.  
  
 (a) Dupuytren’s Disease and Peyronie’s Disease. As soon as
it has received the relevant Product Data pursuant to Section 2.4, Auxilium shall assume all responsibility for (including financial responsibility), and have sole discretion over, all continuing Development of the Product for Dupuytren’s
Disease and Peyronie’s Disease including all Clinical Trials underway as of the Effective Date and listed on Schedule 3.2. Auxilium shall not have financial responsibility for Development Costs or any other costs incurred in connection
with Development related to Dupuytren’s Disease and Peyronie’s Disease prior to the Effective Date. 
  
 (b) Exercised Indications On each Exercised Indication Date, Auxilium shall be entitled to assume responsibility for, and have sole discretion
over, all continuing Development activities for the Product for each such Exercised Indication. Auxilium shall have one (1) year after the relevant Exercised Indication Date to initiate Stage II Development for such Exercised Indication, provided,
however, that such obligations shall not be binding upon Auxilium to the extent that BTC fails to (i) deliver material Product Data to Auxilium in accordance with Section 2.4, or (ii) supply Auxilium with material amounts of clinical supplies of the
Product for use in the Field in accordance with the delivery scheduled specified by Auxilium under the terms of Section 6.3. 
  
 (c) Cooperation The Parties agree to cooperate with respect to the transfer of Development activities from BTC to Auxilium including transferring
Clinical Trials and making introductions of Auxilium to clinical investigators and opinion leaders. 
  

 10 

 (d) Stage II Development Costs. 
  
 (i) Dupuytren’s Disease and Peyronie’s Disease. Auxilium shall be responsible for all the
Development Costs related to the Product for Dupuytren’s Disease and Peyronie’s Disease and incurred by Auxilium after the Effective Date; provided, however, that BTC shall continue to be responsible for all Development Costs which are
which are incurred prior to the Effective Date. 
  
 (ii) Exercised Indications. In the event Auxilium assumes responsibility for Stage II Development of the Product for an Exercised Indication, Auxilium shall be responsible for all Development Costs related to the Product for such
Exercised Indication and incurred by Auxilium after the Exercised Indication Date; provided, however, that BTC shall continue to be responsible for all Development Costs which are incurred prior to the Exercised Indication Date. 
  
 (iii) Right of Set-Off. To the extent that Auxilium
pays any Stage I Development Costs resulting from additional Stage I Development that is requested or required by a Regulatory Authority after assuming responsibility for Development of the Product for any Indication, Auxilium shall be entitled to
set-off the amount of such Stage I Development Costs against any amounts due to BTC pursuant to Section 7.1. 
  
 3.3 Data and Records 
  
 (a) Ownership of Data. Auxilium shall retain ownership of all Product Data, information and results related to Development activities for the
Product, provided, however, that Auxilium hereby grants to BTC a right of reference with respect to Remaining Indications to the Regulatory Data contained in Regulatory Approvals Controlled by Auxilium for the Product in the Field.
Notwithstanding the foregoing, (a) if Auxilium’s license rights to the Product terminate with respect to an Indication within the Field, Auxilium shall assign BTC its right, title and interest in and to the Product and Regulatory Data for
that Indication, and (b) if Auxilium’s license rights to a Product hereunder terminate entirely, Auxilium shall assign BTC its right, title and interest in and to all such Product and Regulatory Data; provided, however, that Auxilium may
maintain a copy of such Regulatory Data for legal and archival purposes. 
  
 (b) Development Records. Each Party shall each maintain records in sufficient detail and in good scientific manner appropriate for patent purposes and as will properly reflect all work done and results achieved
in the performance of Development activities hereunder (including all Regulatory Data in the form required to be maintained under any applicable governmental regulations). Such records shall include books, records, reports, research notes, charts,
graphs, comments, computations, analyses, recordings, photographs, computer programs and documentation thereof, computer information storage means, samples of materials and other graphic or written data generated in connection with the Development
activities. Subject to the terms and conditions of Article 10 below, each Party shall provide the other the right to inspect (no more than once a year) such records upon reasonable request and during normal business hours, and shall provide copies
of all requested records, to the extent reasonably required for the performance of the requesting Party’s obligations under this Agreement. 
  

 11 

 ARTICLE 4 
 REGULATORY MATTERS 
  
 4.1
Efforts Within [**] of filing for Regulatory Approval in any Major Market Country, Auxilium will file for Regulatory Approval in all the Major Market Countries. Notwithstanding the foregoing, if a different dossier is required for any
such other Major Market Country(ies), Auxilium will exercise Commercially Reasonable Efforts to seek Regulatory Approval with respect to such country(ies). Auxilium may develop additional formulations, dosage forms or delivery systems for the
Product in the Field as may be commercially practicable at its own expense. For purposes of clarity, Remaining Indications shall not be subject to this Article 4; provided, however, that BTC shall not conduct Development or Commercialization of
Product in such Remaining Indication in a manner that jeopardizes Auxilium’s Development or Commercialization of Product in the Field. 
  
 4.2 Regulatory Matters in the Territory. As between the Parties, Auxilium shall be responsible in the Territory for ensuring compliance with all
regulatory requirements relating to the Product labeled for use in the Field (i.e., obtaining, maintaining, and updating all required any Regulatory Approvals). Without limiting the foregoing, Auxilium shall (i) file all regulatory filings and
supporting documentation; (ii) serve as the designated regulatory official for purposes of receiving communications from the Regulatory Authority; and (iii) report any Adverse Drug Experience to Regulatory Authorities. 
  
 4.3 Ownership. All Regulatory Approvals relating to the Products
labeled for use in the Field shall be the property of Auxilium and held in the name of Auxilium or its designee. BTC shall promptly take whatever steps necessary to transition any existing regulatory filings to Auxilium. As promptly as possible
after the Effective Date, BTC shall cause the Investigational New Drug (“IND”)    [**] and IND    [**], and all foreign counterparts thereof, to be assigned to Auxilium. 
  
 4.4 Regulatory Interactions for Product. 
  
 (a) Communications with Regulatory Authority; Advice of Counsel. BTC
shall not communicate with Regulatory Authorities, or take any action regarding an investigation or a request by a Regulatory Authority with respect to a Product in the Field, except (i) with the prior written consent of Auxilium, or (ii) upon the
advice of legal counsel that such communication is required by Law. BTC shall cooperate with Auxilium and provide all reasonable assistance and take all actions reasonably requested by Auxilium that are necessary to comply with any Law applicable to
a Product in the Field. If BTC is advised by its legal counsel that it must communicate with any Regulatory Authority, then BTC shall promptly, but in no event more than two (2) Business Days, advise Auxilium of the same and provide Auxilium in
advance with a copy of any proposed written communication with such Regulatory Authority and comply with any and all reasonable requests of Auxilium concerning any such communication with such Regulatory Authority. 
  

	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

  

 12 

 (b) Receipt of Correspondence; Inspections. Each Party shall promptly, but in any event within
three (3) Business Days, (i) provide to the other copies of any material documents or correspondence received from any Regulatory Authority related to Development activities for a Product and (ii) inform the other Party of any inspections, proposed
regulatory actions, investigations or requests for information or a meeting by any Regulatory Authority with respect to a Product. In the event BTC does not have advance notice of an inspection by a Regulatory Authority, it shall immediately notify
Auxilium of such inspection and it shall cooperate with such Regulatory Authority. 
  
 (c) Recalls and Withdrawals. Subject to the terms and conditions of the Supply Agreement, Auxilium shall have sole responsibility for and shall make all decisions with respect to any recall, market withdrawals
or any other corrective action related to the Products labeled for use in the Field in the Territory; provided however, (i) Auxilium shall immediately notify BTC of any decision to initiate a recall or withdrawal of such Product; (ii) all costs and
expenses with respect to a recall, market withdrawal or other corrective action for such Product shall be borne by Auxilium unless such recall, market withdrawal or other corrective action was due to the negligence, willful misconduct or material
breach of this Agreement or the Supply Agreement by BTC; and (iii) BTC shall immediately notify Auxilium of any decision to initiate a recall or withdrawal of a Product outside of the Field. Each Party shall provide the other Party with recall
information received by it in sufficient detail to allow the Parties to comply with Law. 
  
 (d) Notice. Each Party shall provide the other Party with notice, in a sufficiently timely basis to enable the other Party to comply in all material respects with Laws, of notification or other information
which it receives (directly or indirectly) from, any Regulatory Authority (and providing, as soon as reasonably possible, copies of any associated written requests) that (i) raises any material concerns regarding the safety or efficacy of a Product;
(ii) indicates or suggests a claim of a Third Party arising in connection with a Product, or (iii) is reasonably likely to lead to a recall or market withdrawal of a Product, provided that neither Party shall be obliged to disclose information in
breach of any contractual restriction which it could not reasonably have avoided or which disclosure would waive any legal privilege. 
  
 4.5 Inquiries, Adverse Events, etc. As between the Parties, Auxilium shall be responsible for the surveillance, receipt and evaluation of product
complaints for Product labeled for use in the Field in the Territory and reporting to Regulatory Authorities Adverse Drug Experiences for the Products in the Field. As between the Parties, BTC shall be responsible for the surveillance, receipt and
evaluation of product complaints for Product labeled for use outside the Field and reporting to Regulatory Authorities Adverse Drug Experiences for the Products outside the Field. Each Party shall ensure that, in the Development or Commercialization
of the Product, it will record, investigate, summarize, notify, report and review all Adverse Drug Experiences in accordance with Law. Each Party shall (i) adhere to all requirements of Laws which relate to the reporting and investigation of Adverse
Drug Experiences, and (ii) keep the Parties informed of such events. 
  
 (a) Each Party shall submit reports of all Adverse Drug Experiences associated with the use of the Product and other required safety information (e.g., PSUR’s or annual safety reports) to the Regulatory Authorities in accordance with
Law. Each Party shall submit a copy of each such report to the other Party in advance of such submission to permit the other Party to comply with legal requirements applicable to it and comment on such reports. 
  

 13 

 (b) Each Party shall submit reports of all Adverse Drug Experiences associated with the use of Product
for which Regulatory Approval has not been achieved and other required safety information to the Regulatory Authorities in accordance with Law. Each Party shall submit a copy of each such report to the other Party in advance of such submission to
permit the other Party to comply with legal requirements applicable to it and comment on such reports. 
  
 (c) In order to accomplish the objectives of this Section and to the extent required by Law, within one hundred and eighty (180) days of the Effective
Date, the Parties shall discuss and develop an agreement containing mutually acceptable guidelines and procedures for the receipt, recordation, communication, exchange and reporting of Adverse Drug Experiences for the Product. 
  
 4.6 Approval of Labeling and Promotional Materials. Auxilium shall be
responsible to seek or obtain any necessary Regulatory Authority approvals of any label, labeling, package inserts or outserts, monographs and packaging, and promotional materials for use in connection with the Products labeled for use in the Field
and for determining whether the same requires approval from Regulatory Authority. The Parties shall cooperate in such efforts to seek and obtain such approvals. 
  

4.7 Cooperation. The Parties shall cooperate to provide each other all reasonable assistance and take all actions reasonably requested that are
necessary to comply with Laws, including safety updates, amendments, annual reports, pharmacovigilance filings, investigator notifications, facility inspections, and certifications and maintenance and updates for regulatory filings and Regulatory
Approvals. Unless otherwise provided under the terms of this Agreement, the Parties will cooperate, communicate and provide reasonable assistance to each other with regard to all CMC matters related to the Product. 
  
 ARTICLE 5 
 COMMERCIALIZATION 
  
 5.1 Joint Commercialization Committee. 
  
 (a) Formation. Not later than the commencement of Phase III Clinical Trials for any Product, BTC and Auxilium will establish a Joint Commercialization Committee (the “JCC”) made up of two (2)
representatives designated by each Party hereto to assist in coordinating interactions and resolving potential disagreements between BTC and Auxilium during the course of the Commercialization of Product. The JCC shall meet each and every calendar
quarter. The JCC Chair will be appointed by Auxilium from among the members of the committee designated by Auxilium. Auxilium and BTC shall each have one vote on the JCC. The objective of the JCC shall be to reach agreement by consensus on all
matters falling within its authority hereunder. In the event of a deadlock with respect to any action, the vote of Auxilium, after reasonable opportunity for open discussion among the members of the JCC, shall control. Notwithstanding the foregoing,
the JCC shall not have authority to commit the financial resources of either party. 
  

 14 

 (b) Patent Position. The JCC will coordinate with the JDC in discuss matters relating to Patents
related to the Product, including but not limited to issues of inventorship and decisions relating to the filing, prosecution and maintenance of such Patents. 
  

(c) Coordinated Strategy. The JCC shall meet at least quarterly or with such frequency and at such time and location as may be established by
the JCC and will monitor the overall strategy and oversee the global marketing of all Products. The JCC will have the opportunity to review market research plans and research results, clinical development results and similar items for each Product,
including Products Developed for Remaining Indications, for the purpose of advising and assisting in communicating a unified global marketing strategy; provided, however, that with respect to Remaining Indications, the JCC shall not have the final
vote. 
  
 5.2 Commercialization. Auxilium shall use
Commercially Reasonable Efforts to Commercialize the Product in the Field in each country in the Territory. Subject to Section 5.4 below, Auxilium shall be responsible for and have sole discretion over all aspects of Commercialization of the Product
for use in the Field in the Territory. 
  
 5.3 Orders, Booking
Sales. Auxilium shall have the sole right and responsibility for Product in the Field in each country in the Territory to (a) receive, accept, and fill orders for such Product, (b) control invoicing, order processing, and collection of accounts
receivable for such Product sales, and (c) record such Product sales in its books of account. If, for any reason, BTC receives orders for such Product, BTC shall forward such orders to Auxilium (or, if directed by Auxilium, to Auxilium’
wholesalers) as soon as practicable. If any quantities of such Product are returned to BTC, BTC shall immediately notify Auxilium and ship them to the facility designated by Auxilium. 
  
 5.4 BTC Co-Promotion Rights. In the event that BTC provides written notice of its intent within ninety (90) days
after an NDA Acceptance for a Product in the Field in the Territory indicated for use for any Exercised Indication, BTC will be allowed to provide up to ten percent (10%) of the Product Details for such Indication. In addition, in the event that BTC
provides written notice of its intent within ninety (90) days after an NDA Acceptance for Frozen Shoulder, BTC will be allowed to provide up to ten percent (10%) of the Product Details for Dupuytren’s Disease. Notwithstanding Section 13.10,
BTC’s co-promotion rights granted pursuant to this Section shall not be assignable or transferable to any other Person. 
  
 ARTICLE 6 
 MANUFACTURE AND SUPPLY

  
 6.1 Joint Manufacturing Committee. 
  
 (a) Within forty-five (45) days after the Effective Date, BTC and Auxilium
will establish a Joint Manufacturing Committee (the “JMC”) made up of two (2) representatives designated by each Party hereto to which shall oversee the manufacturing of Product on a worldwide basis, including the planning, manufacturing
and supply (including supply chain 
  

 15 

 management). The JMC Chair will be appointed by BTC from among the members of the committee designated by BTC. Each of
BTC and Auxilium shall have one vote on the JMC. The objective of the JMC shall be to reach agreement by consensus on all matters falling within its authority hereunder. In the event of a deadlock with respect to any action, the vote of BTC, after
reasonable opportunity for open discussion among the members of the JMC, shall control. 
  
 (b) Specific Responsibilities of the JMC. In support of its responsibility for overseeing the Manufacturing of Product on a worldwide basis the JMC shall meet at least quarterly or with such higher frequency,
and at such time and location as may be established by the JMC, and the JMC shall perform the following activities: 
  
 (i) delineate requirements and responsibilities for development and licensure of manufacturing processes and facilities for Product and
for supply of Product in the Territory; 
  
 (ii)
together with the Joint Development Committee, develop a manufacturing strategy to enable development and licensure of manufacturing processes and facilities for Product in the Territory that includes all aspects of manufacture and release,
including but not limited to formulations, intermediate, dosage form, devices, product characterization studies, stability studies and manufacturing plans and forecasts; 
  
 (iii) review quality assurance efforts, including but not limited to those efforts with respect to the
establishment of specifications and quality standards for Product; 
  
 (iv) together with the Joint Development Committee review and comment on the process for Product Development and the drafting and contents of the CMC section of a Drug Approval Application for Product; 
  
 (v) review technology transfer plans for any changes in
manufacturing sites, testing sites, and responsibilities in the supply chain for Product, it being understood that decisions regarding the selection of which of a Party’s own manufacturing and testing sites shall be used to manufacture any
component of a Product, if a Party manufactures any component of a Product pursuant to this Agreement or any related supply agreement, shall remain in the sole control of such Party; 
  
 (vi) prepare for regulatory inspections and ensure adherence to compliance standards with respect to
Product; and 
  
 (vii) review quality compliance
and manufacturing related regulatory issues concerning the Product or any component thereof as important issues arise through meetings and review of relevant written material produced by Auxilium, BTC or any Regulatory Authority. 
  
 6.2 Development and Scale-Up. BTC shall, at its own cost and expense,
develop the formulation and the finished dosage form and scale-up the Manufacture for commercial supply 
  

 16 

 of the Enzyme and the Product for each Indication for use in the Field, including the [**], to be registered with
Regulatory Authorities in accordance with Law and in sufficient time prior to anticipated commercial launch of a Product to provide for sufficient supply of Product for use in the Field. Notwithstanding the foregoing, Auxilium will have the sole
right and responsibility for selecting the finished dosage form and presentation for the Product in the Field. 
  
 6.3 Clinical Supply. 
  
 (a) Supply by BTC. BTC shall be responsible for supplying or arranging for the supply of the Product suitable for use by Auxilium in Clinical
Trials. All the Product shall be Manufactured in accordance with applicable specifications, all Laws, and shall be subject to the Standard Terms set forth in below. BTC will supply Auxilium, free of charge, with bulk vials containing sufficient
quantities of the Product to treat up to [**] patients per year in Clinical Trials. If Auxilium requires additional clinical supplies, BTC will supply Auxilium with such clinical supplies at its Cost of Goods. Auxilium will be entitled to
qualify a back up supplier for the Manufacture of clinical and commercial supplies of Product in the Field (the “Back-Up Supplier “) at any time after the Effective Date. BTC will use Commercially Reasonable Efforts to ensure that
such Back-Up Supplier has sufficient know-how to Manufacture Product, including (i) providing all protocols, registration applications and other substantive regulatory documents, including, but not limited to, all data, scientific dossiers and
governmental authorizations; (ii) providing access and reference to all regulatory dossiers and filings produced by BTC, its Affiliates and sublicensees relating to the Product; (iii) providing access to BTC Know-How in reasonably satisfactory form,
and (iv) providing all technical assistance reasonably requested by the Back-Up Supplier related to the Manufacture of the Product. Auxilium will require that the Back-up Supplier execute a written confidentiality agreement with both Auxilium and
BTC, in a form consistent with industry standards, which includes, among other things, an undertaking by the Back-up Supplier to keep confidential the manufacturing information and know-how disclosed to the Back-up Supplier by BTC. In the
manufacturing information and know-how disclosed to the Back-up Supplier by BTC. In addition, Auxilium will use reasonable commercial efforts to seek the cooperation of the Back-up Supplier in sharing with BTC and Auxilium information concerning the
Manufacture of the Product that Back-up Supplier may acquire in connection with such Manufacture. 
  
 (b) Notification of Requirements. Auxilium will provide BTC with one hundred and eighty (180) days notice of its requirements for clinical supplies
of Product including a delivery schedule and address. BTC will provide notice within three (3) Business Days of receipt of such notice if BTC is unable to supply Auxilium with the quantities of clinical supplies of Product in accordance with the
delivery schedule. In such event, the Parties shall cooperate but BTC shall be primarily responsible, at its sole cost and expense, for procuring such quantities of Product from the Back-Up Supplier as are necessary to compensate for any such
deficiency. 
  

	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

  

 17 

 (c) Late Delivery of Clinical Supply. In the event that BTC is more than thirty (30) days late in
delivering such material amount of clinical supplies, in addition to any other remedies Auxilium may have in Law or equity, BTC will forgive Auxilium seven thousand five hundred dollars ($7500) per day for each additional day, such amounts to be
creditable against any milestone payments due to BTC under Article 7. 
  
 6.4 Commercial Supply; Supply Agreement. BTC will supply or arrange for the supply of all necessary commercial quantities of the Product in the Territory. No later than three (3) months after the Effective Date, the Parties shall
enter into a commercial supply agreement on customary and reasonable terms and conditions (the “Supply Agreement”), such Supply Agreement shall include the following: 
  
 (a) Royalty. Auxilium will pay BTC on a country-by-country and Product by Product basis a royalty payment of
[**] of Net Sales of Products in the Field for the Term. Such royalty may be reduced as follows: 
  
 (i) Competing Product Sales. If a Competing Product is sold in a country in the Territory with a unit based market share of
[**]% or greater, then there shall be no royalty due for sales in that country in the Territory. 
  
 (ii) Third Party Royalties. If the Manufacturing, Development or Commercialization of the Product by the Parties in accordance with
this Agreement would, but for a license from such Third Party, infringe on such Third Party Patents, any royalties or other payments due to Third Parties pursuant to a license acquired by Auxilium then the royalty may be reduced by up to
[**]% by such the royalty amounts to a floor of not less than [**]% in any case. 
  
 (b) Supply Price. 
  
 (i) Basic Supply Price. Subject to the adjustments set forth below, the “Supply Price” for the Product shall be calculated as a percentage of Net Sales as follows: 
  

			
	 Annual Sales Volume (# Vials)

	  	 Supply Price (as % of Net Sales)

	 [**]
	  	[**]%
	 [**]
	  	[**]%
	 [**]
	  	[**]%
	 [**]
	  	[**]%
	 [**]
	  	[**]%

  
 Provided, however, the
Supply Price shall not equal less than [**]% of BTC’s Cost of Goods for the Product as provided in Schedule 1.16 (the “Minimum Supply Price”). 
  

	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

  

 18 

 (ii) Adjustments to Supply Price. 
  
 (A) Most Favored Customer. Notwithstanding anything in this Agreement to the contrary, if at any
time during the Term BTC sells or provides products including Enzyme as an active ingredient to any customer for commercial use at rates more favorable than those accorded to Auxilium, BTC shall promptly offer Auxilium the benefit of such more
favorable terms and conditions or rates, which, upon acceptance, shall be retroactive to the date that such more favorable terms and conditions were first effective for such other customer. In order for Auxilium to receive more favorable cost rates,
Auxilium must accept the same basic business deal conditions as those provided to a party receiving the more favorable rates. Upon Auxilium’s reasonable request, BTC shall provide written confirmation that it is in compliance with the
requirements of this Section. 
  
 (B)
Reduction In Cost of Goods. If BTC is successful in reducing the Cost of Goods, the Supply Price to Auxilium will be reduced by [**]% of such dollar reduction. 
  
 (C) Supply of Samples. Product samples shall be provided at no charge to Auxilium for use in
post-market clinical trials and for selected use as commercial samples for dispensing to patients by an appropriate health care provider, but in no event for direct distribution to patients. The number of Product samples to be provided to Auxilium
shall be set forth in the Supply Agreement. 
  
 (D) Delay in Delivery. If, for any reason other than a force majeure, the BTC delivers any shipment of Product in accordance with this Article later than the date of delivery set out in the purchase order as agreed by the Parties
pursuant to the Supply Agreement then: 
  
 (1) a 5% reduction in
the Supply Price of Product if the shipment is delivered more than thirty (30) days but less than sixty (60) days late; 
  
 (2) a 10% reduction in the Supply Price of Product if the shipment is delivered more than sixty (60) days but less than ninety (90) days late; and

  
 (3) a 15% reduction in the Supply Price of Product if the
shipment is delivered more than ninety (90) days late. 
  
 (4)
Once the price has been reduced in accordance with this Section, it will not revert to the original price unless and until the deliveries are no longer delayed. 
  

	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

  

 19 

 (c) Stand-By Rights; Back Up Supplier. 
  
 (i) Standby Rights. Auxilium will be entitled to seek
from the Back-Up Supplier the greater of (a) 25% its requirements and (b) that quantity of Product that BTC is unable to provide, for a period of one (1) year following the occurrence of any of the events set forth in (A), (B) or (C) below (the
“Standby Rights”). In the event that Auxilium exercises its Standby Rights, the amount of Product that Auxilium is obligated to source from BTC pursuant to the Supply Agreement shall be reduced by such quantity for such one (1) year
period. 
  
 (A) Failure to Meet Firm
Order. If, for any reason, including, without limitation, as a result of a force majeure, BTC is unable to supply at least 75% of the amount of Product specified under a Firm Order, then Auxilium may exercise its Standby Rights by providing
written notice; provided, however, that in the event that BTC is unable to supply the full amount specified in Auxilium’s Firm Order for two consecutive quarters (regardless of the amount of such material shortfall), Auxilium may exercise its
Standby Rights by providing written notice to BTC. In addition, Auxilium shall be permitted to seek supply of any shortfall (regardless of amount of such shortfall or the number of times BTC has fulfill some or all of an Auxilium Firm Order) from
the Back-Up Supplier on a per event basis without specifically invoking its Stand-By Rights. 
  
 (B) Egregious Delivery Delay. If, for any reason, other than a force majeure, BTC delivers any quantity of any Product more than
ninety (90) days after the date such delivery was due, then Auxilium may exercise its Standby Rights by providing written notice. 
  
 (C) Nonconforming Product. If any three (3) consecutive shipments contain nonconforming Product and BTC (1) fails to replace any
nonconforming Product with conforming Product in a timely manner or (2) fails to replace nonconforming Product within fifteen (15) Business Days after a dispute regarding whether any rejected quantity of any Product constitutes nonconforming Product
is decided in Auxilium’s favor, then Auxilium may exercise its Standby Rights by providing written notice. 
  
 (ii) Offset. Auxilium will be entitled to offset any royalties owed to BTC by the amount represented by the difference between the
Back Up Supplier’s supply price and BTC’s supply price. 
  
 (iii) BTC’s Use of the Back Up Supplier. If BTC opts to use the Back Up Supplier to provide Product to Auxilium, then BTC will either reimburse Auxilium for [**] of the documented costs and expenses
Auxilium incurred in qualifying, sourcing and maintaining such Back Up Supplier or [**]. 
  

	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

  

 20 

 (d) Maintenance of Inventory. The Supply Agreement will require that by the time of
Commercialization of the Product, BTC will maintain at least a six (6) month supply of API Enzyme and such reserve supply of Product as may be set forth in the Supply Agreement. 
  
 (e) Allocation of Supply. In the event of a shortage of raw materials necessary to Manufacture the Product, BTC shall
allocate ninety percent (90%) of the total available supply of raw materials and Product to Auxilium. 
  
 (f) Continuous Improvement and Reduction of Cost of Goods. BTC shall use reasonable efforts to continuously improve its performance, and any
Product suppliers’ performance in the supply of the Product, including but not limited to, reducing Cost of Goods, increasing yield, and optimizing delivery timing. 
  
 (g) Standard Terms of Supply. With respect to the supply of the Product, BTC shall make the following
representations, warranties, and covenants (the “Standard Terms”): 
  
 (i) The Product shall be Manufactured in accordance with all Laws and, at the time of delivery of the Product, such the Product will
comply with the specifications, shall be free from defects in materials and workmanship, shall be fit for the purpose for which it is intended, and shall not be adulterated or misbranded within the meaning of the Act, and shall not constitute an
article which may not, under the Act, be introduced into interstate commerce. BTC provides no other warranties, express or implied, regarding the Product and disclaims all other express or implied warranties, including the implied warranties of
merchantability and fitness for a particular purpose. 
  
 (ii) The Product sold and shipped shall be Manufactured in accordance with all Laws in effect at the time and place of Manufacture of the Product, and all waste, including all hazardous waste, generated at the time of Manufacture of the
Product shall be disposed of in accordance with all Laws; 
  
 (iii) All records as are necessary and appropriate to demonstrate compliance with Laws shall be maintained by BTC and such Manufacture of the Product shall be performed in a facility maintaining a current drug
establishment registration with the FDA as set forth in 21 C.F.R. § 207; 
  
 (iv) BTC shall ensure that it, its Affiliates, and its subcontractors maintain all Governmental Permits that may be necessary to Manufacture and ship the Product; 
  
 (v) BTC shall advise Auxilium of any information which
arises out of BTC’s, its Affiliates, and its subcontractors, as applicable, Manufacturing, relating to the Product, which have adverse regulatory compliance or reporting consequences concerning such the Product; 
  
 (vi) BTC shall provide to Auxilium any information
reasonably requested by Auxilium and shall consult Auxilium before providing any information to any Regulatory Authority in connection with Manufacture of the Product. BTC shall as 
  

 21 

 promptly as possible, but in no event later than within ten (10) days, advise Auxilium of any requests by
any Regulatory Authority for inspections at the premises of BTC or any of its Affiliates or subcontractors with respect to the Product; 
  
 (vii) In the event BTC, its Affiliates, or its subcontractors are inspected by the FDA or any similar or related Regulatory Authority
relating to the Product, BTC agrees to notify Auxilium of any such inspection and will use Commercially Reasonable Efforts to ensure that Auxilium shall have the right to be present during such inspection. BTC shall promptly notify Auxilium of any
alleged violations or deficiencies relating to a Manufacturing facility at which the Product are Manufactured, packaged, or stored, and shall promptly disclose to Auxilium all relevant portions of any notice of observations or potential violations
as well as a copy of its response thereto; 
  
 (viii) Neither BTC, its Affiliates nor subcontractors shall use, in the Manufacture of any the Product, in any capacity the services of any person, including any firm or individual, debarred or subject to debarment under the Generic Drug
Enforcement Act of 1992, amending the Act at 21 U.S.C. § 335a. BTC agrees to notify Auxilium immediately in the event any person providing services to BTC, its Affiliates, or subcontractors relating to this Agreement is debarred or becomes
subject to debarment; and 
  
 (ix) For the
purpose of permitting a quality and compliance audit, BTC, its Affiliates, and subcontractors shall grant to authorized representatives of (or a Third Party hired on behalf of Auxilium who is reasonably acceptable to BTC), in general not more than
once per month, upon reasonable notice, access to areas of each of its plants to the extent permitted by Law. Auxilium shall have the right, subject to any Third Party confidentiality obligations and at its sole expense, to examine those technical
records made by BTC, its Affiliates or subcontractors that relate to the Manufacture of the Product. 
  
 (h) Customary Terms. The Supply Agreement shall also include provisions for: forecasting and ordering, inventory maintenance requirements;
packaging obligations; back-up suppliers, compliance with applicable regulatory requirements, Auxilium guidelines, and specifications, and all Laws. 
  

 22 

 ARTICLE 7 
 PAYMENTS 
  
 7.1
Milestone Payments by Auxilium. 
  
 (a) Amount of
Milestone Payments. 
  

							
	 #

	  	 Milestone

	  	United States Dollars

	 1
	  	 The Effective Date
	  	$[**]
			
	 2
	  	 The delivery to Auxilium of the Product Data relating to Dupuytren’s Disease and Peyronie’s Disease in accordance with Section 2.4
of this Agreement.
	  	$[**]
				
	 3
	  	 The one (1) year anniversary of the Effective Date
	  	$[**]	 	 
				
	 4
	  	 Upon first of either NDA Acceptance or MAA Acceptance for the following Indications on an Indication by Indication basis:
	  	Dupuytren’s
Disease	 	 $[**]

	 	  	 	  	Peyronie’s
Disease	 	 $[**]

				
	 5
	  	 Receipt by Auxilium or its Affiliate of first Regulatory Approval in the United States or [**] with labeling approved for the following
Indications on an Indication by Indication basis:
	  	Dupuytren’s
Disease
Peyronie’s
Disease	 	 $[**]
  

$[**]

  
 (b) Timing of
Milestone Payments. For milestones 1, 2 and 3, payment shall be made within ten (10) Business Days after the occurrence of the event giving rise to a payment obligation hereunder. For milestones 4 and 5, payment shall be made within thirty (30)
days after the occurrence of the event giving rise to a payment obligation hereunder. All payments shall be made by wire transfer in United States Dollars to the credit of such bank account as may be designated, from time to time, by BTC in
writing. 
  
 7.2 Process Development Milestones
Within thirty (30) days following the Effective Date, BTC will provide Auxilium with a plan for the scale-up of Manufacturing for clinical and commercial supplies of Product (the “Manufacturing Plan”) which is acceptable to Auxilium. The
Manufacturing Plan shall contain, among other things, a schedule setting forth a timeline for the achievement of certain manufacturing process development milestones (the “Process Development Milestones”). Auxilium shall pay to BTC the
amount of $[**] monthly upon achieving the Process Development Milestones (the “Process Development Payments”); provided, however, that Auxilium may suspend the Process Development Payments at anytime if it determines, in its
reasonable judgement that BTC has not consistently met the Process Development Milestones. For purposes of clarification, in no event will the Process Development Payments exceed $[**] in the aggregate. 
  
 7.3 Payments for Exercised Indications. 
  
 (a) Upon Exercise of Option. Within ten (10) Business Days of the
inclusion on Exercised Indications in the Field, Auxilium shall make the following one-time license fee payments to BTC on a per Indication basis: 
  

			
	 Amount

	  	Indication

	 $[**]
	  	[**]
	 $[**]
	  	[**]
	 $[**]
	  	Each Additional Indication

	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

  

 23 

 (b) Upon Approval. Within ten (10) Business days of receipt by Auxilium of the first Regulatory
Approval from the FDA for an Exercised Indication, Auxilium shall make the following milestone payments to BTC on a per Indication basis: 
  

			
	 Amount

	  	 Labeling Approved for the following Indication

	 $[**]
	  	 [**]

	 $[**]
	  	 [**]

	 $[**]
	  	 [**]

	 $[**]
	  	 [**]

	 $[**]
	  	 Each Additional Indication

  
 7.4 Payments
Related to Sublicense Income. Within thirty (30) Business Days of receiving Sublicense Income, Auxilium shall make a payment to BTC in the following amount: 
  
 7.4.1 If Auxilium has not conducted a Clinical Trial for Product in the relevant Indication prior to the effective date of
the relevant sublicense, then Auxilium will remit [**]% of the Sublicense Income actually received. 
  
 7.4.2 If Auxilium has conducted Clinical Trials for a Product in the relevant Indication prior to the date of the relevant sublicense, then Auxilium will
remit [**]% of Sublicense Income actually received. 
  
 7.4.3 Auxilium has obtained Regulatory Approval for a Product in the relevant Indication prior to the date of the relevant sublicense, then Auxilium will remit [**]% of Sublicense Income actually received. 
  
 7.4.4 If the field of use of the sublicense to the Product is non-human use,
then Auxilium will remit [**]% of the Sublicense Income actually received for that field of use. 
  
 7.5 Currency. All payments shall be payable in United States Dollars. 
  
 7.6 Books and Records. Auxilium agrees to maintain and retain, in accordance with generally accepted accounting
practices, complete and accurate records showing all transactions and information relating to this Agreement for a period of three (3) years from the date of entry to which they pertain. 
  
 7.7 Audit Rights. Upon the written request of BTC and not more than once in each calendar year, Auxilium shall permit
an independent certified public accounting firm (other than on a contingency fee basis) selected by BTC and acceptable to Auxilium (which acceptance by 
  

	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

  

 24 

 Auxilium shall not be unreasonably withheld) to have access during normal business hours to such records of Auxilium as
may be reasonably necessary to verify Auxilium’s compliance with the payment terms of this Article 7. The accounting firm shall enter into an acceptable and customary confidentiality agreement with Auxilium obligating the accounting firm to
retain in confidence all information of Auxilium which it obtains in performing such audits hereunder, and such audit shall be subject to Auxilium’s third Party confidentiality obligations. Any audit under this Section 7.7 shall be at the
expense of BTC, unless a particular audit reveals an underpayment of five percent (5%) or more of the amount that should have been paid to BTC for the period audited, in which case, Auxilium shall bear the expense of such audit. 
  
 7.8 Taxes. Auxilium shall be entitled to deduct from its payments to
BTC the amount of any withholding taxes required to be withheld by Auxilium or its Affiliates or sublicensees to the extent BTC or sublicensees pay to the appropriate governmental authority on behalf of BTC such taxes. Auxilium shall deliver to BTC,
upon BTC’s request, proof of payment of all such taxes. Each Party shall provide assistance to the other Party in seeking any benefits available to such Party with respect to government tax withholdings by any relevant law or double tax treaty.

  
 7.9 Interest. Any payments payable by either party
which are not paid on or before the date such payments are due under this Agreement (other than such payments which are the subject of a good faith dispute between the Parties) shall bear interest at the prime rate of interest plus 1%, calculated on
the number of days that payment is delinquent. 
  
 7.10 Blocked
Payments. In the event that, by reason of Laws or regulations in any country, it becomes impossible or illegal for Auxilium or an Affiliate or sublicensee of Auxilium, to transfer, or have transferred on its behalf, distribution fees or other
payments to BTC, Auxilium shall promptly notify BTC of the conditions preventing such transfer and such distribution fees or other payments shall be deposited in local currency in the relevant country to the credit of BTC in a recognized banking
institution designated by BTC or, if none is designated by BTC within a period of thirty (30) days, in a recognized banking institution selected by Auxilium or its Affiliate or sublicensee, as the case may be, and identified in a notice given to
BTC. 
  
 ARTICLE 8 
 INTELLECTUAL PROPERTY 
  
 8.1 BTC Patentable Inventions and Know-How. 
  
 (a) BTC Patent Prosecution. 
  
 (i) During the term of the Agreement, BTC shall, diligently and in the reasonable exercise of its commercial discretion, prepare, file,
prosecute, maintain, renew and defend BTC Patents in the countries where such BTC Patents are filed as of the Effective Date; provided, however, that BTC shall select patent counsel with Auxilium’s consent, such consent not to be unreasonably
withheld. 
  
 (ii) If BTC does not intend to file
for patent protection or does not wish to continue preparation, prosecution, or maintenance of a BTC Patent, then it shall give at least thirty (30) days advance notice, and in no event less than a reasonable period of time for Auxilium to act in
its stead. 
  

 25 

 (A) In such case, Auxilium may elect at its sole discretion to continue preparation,
filing and prosecution or maintenance of the discontinued BTC Patent at its sole expense. 
  
 (B) Ownership of any such discontinued BTC Patent shall at the request of Auxilium be assigned to Auxilium and BTC shall execute such
documents and perform such acts as may be reasonably necessary for assigning such ownership to Auxilium. 
  
 (C) Discontinuance may be elected on a country-by-country basis or for a patent application or patent series in total. 
  
 (b) Cooperation. BTC will consult Auxilium and will keep Auxilium
continuously informed of all matters relating to the filing, prosecution and maintenance of BTC Patents including, but not limited to, disclosing to Auxilium the complete text of all such BTC Patents. 
  
 (i) BTC shall provide Auxilium with a copy of any BTC
Patents relating to Enzyme or Product within thirty (30) days of the Effective Date. Prior to filing the first of any new Patents in any jurisdiction, BTC shall provide Auxilium with a copy of any such Patent applications and copies of all material
correspondence with the relevant patent office pertaining to the BTC Patents and directly relating to Enzyme or Product. 
  
 (ii) BTC shall consider all of Auxilium’s comments in good faith and take all steps reasonably necessary to optimize the patent
position for the Product. 
  
 (iii) In no event
shall BTC relinquish control of the prosecution of BTC Patents to a Third Party. 
  
 8.2 Infringement Claims by Third Parties. 
  
 (a) Notice. If the manufacture, use or sale of the Product under the BTC Patents results in a claim or a threatened claim by a Third Party against a Party hereto for patent infringement or for inducing or
contributing to patent infringement (“Infringement Claim”), the Party first having notice of an Infringement Claim shall promptly notify the other in writing. The notice shall set forth the facts of the Infringement Claim in
reasonable detail. 
  
 (b) Third Party Licenses. In the
event that practicing under the BTC Patents in connection with manufacture, use or sale of the Product in a country would infringe a Third Party Patent and a license to such Third Party Patent is available and Auxilium in its sole discretion seeks
such a license, the Parties agree: 
  
 (i)
Auxilium will be responsible for all costs associated with acquiring any Third Party license to the extent required for Auxilium to continue to make, use and 
  

 26 

 sell the Product and the Enzyme, provided however, Auxilium may offset such costs against the Royalty,
with a minimum floor of [**]% in accordance with Section 6.4 or, prior to commercial launch, offset such costs against any milestones due to BTC pursuant to Article 7; and 
  
 (ii) Auxilium will use Commercially Reasonable Efforts to obtain any such required licenses under the Third
Party’s Patents with a right to sublicense to BTC and if requested by BTC will grant such sublicense, under reasonable sublicense terms mutually acceptable to both BTC and Auxilium. 
  
 (c) Litigation. In the event of the institution of any suit by a Third Party against Auxilium as a result of
Auxilium’s Development or Commercialization of the Product or the Enzyme, Auxilium shall have the right but, not the obligation, to defend such suit at its expense; BTC shall cooperate and assist Auxilium in any such litigation at
Auxilium’ expense. In the event of the institution of any suit by a Third Party against BTC as a result of BTC’s Manufacture of the Product or the Enzyme, BTC shall have the right but, not the obligation, to defend such suit at its
expense. Auxilium shall cooperate and assist BTC in any such litigation at BTC’s expense. For purposes of clarity, notwithstanding anything to the contrary in Article 12, to the extent applicable, Auxilium will be entitled to seek
indemnification from BTC for Losses arising in connection with such suit. 
  
 8.3 Infringement Claims Against Third Parties. 
  
 (a) Cooperation. BTC and Auxilium each agree to take reasonable actions to protect BTC Patents from infringement. If one Party brings any such action or proceeding, the second Party may be joined as a Party
plaintiff if necessary for the action or proceeding to proceed and, in case of joining, the second Party agrees to give the first Party reasonable assistance and authority to file and to prosecute such suit. 
  
 (b) Notice. If any BTC Patents are infringed by a Third Party, the
Party to this Agreement first having knowledge of such infringement, or knowledge of a reasonable probability of such infringement, shall promptly notify the other in writing. The notice shall set forth the facts of such infringement in reasonable
detail. 
  
 (c) Institution of Proceedings. BTC, shall have
the primary right, but not the obligation, to institute, prosecute, and control with its own counsel at its own expense any action or proceeding with respect to infringement of the claims of such BTC Patents and Auxilium shall have the right, but
not the obligation at its own expense, to be represented in such action by its own counsel. 
  
 (d) Failure to Institute Proceedings. If BTC fails to institute, prosecute, and control such action or prosecution and fails to do so within a period of one hundred twenty (120) days after receiving notice of
the infringement, Auxilium shall have the right to bring and control any such action by counsel of its own choice, and BTC shall have the right, at its own expense, to be represented in any such action by counsel of its own choice. 
  

	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

  

 27 

 (e) Division of Damages Award. Any recovery made in connection with such infringement claim shall
be divided as follows: 
  
 (i) the Party that
initiated and prosecuted such action shall recoup all of its costs and expenses (including reasonable attorney’s fees) incurred in connection with such action, whether the recovery is by settlement or otherwise; 
  
 (ii) the other Party then shall, to the extent possible,
recover its costs and expenses (including reasonable attorney’s fees) incurred in connection with such action; 
  
 (iii) if BTC initiated and prosecuted the action, the amount of any recovery remaining shall be retained by BTC; and 
  
 (iv) if Auxilium initiated and prosecuted the action, the
amount of any recovery remaining shall be retained by Auxilium, except that BTC shall receive a portion equivalent to the amount it would have received in accordance with the terms of Section 6.4 as if such amount were Net Sales of Auxilium.

  
 (f) Settlement. The Parties shall keep each other
informed of the status of and of their respective activities regarding any litigation or settlement thereof concerning Product; provided, however, that no settlement or consent judgment or other voluntary final disposition of a suit under this
Section may be undertaken without the consent of the other Party if such settlement would require the other Party to be subject to an injunction or to make a monetary payment or would otherwise adversely affect the other Party’s rights under
this Agreement or the validity of BTC Patents. 
  
 8.4 Notice
of Certification. BTC and Auxilium each shall immediately give notice to the other of any certification filed under the “U.S. Drug Price Competition and Patent Term Restoration Act of 1984” (or its foreign equivalent) claiming that a
BTC Patent is invalid or that infringement will not arise from the manufacture, use or sale of any Product by a Third Party. 
  
 (a) If BTC decides not to bring infringement proceedings against the entity making such a certification, BTC shall give notice to Auxilium of its decision
not to bring suit within twenty one (21) days after receipt of notice of such certification. 
  
 (b) Auxilium may then, but is not required to, bring suit against the Party that filed the certification; provided, however, that the costs incurred by Auxilium in connection with such suit shall be creditable against
milestone payments payable by Auxilium in accordance with Article 7. 
  
 (c) Any suit by Auxilium or BTC shall either be in the name of Auxilium or in the name of BTC, or jointly in the name of Auxilium and BTC, as may be required by law. 
  

 28 

 (d) For this purpose, the Party not bringing suit shall execute such legal papers necessary for the
prosecution of such suit as may be reasonably requested by the Party bringing suit. 
  
 8.5 Patent Term Extensions. The Parties shall cooperate in good faith with each other in gaining patent term extension wherever applicable to BTC Patents covering Enzyme or Product. 
  
 (a) Auxilium and BTC shall jointly determine which BTC Patents shall be
extended. 
  
 (b) All filings for such extension shall be made by
the Party responsible for prosecution and maintenance of the BTC Patent, provided, however, that in the event that the Party who is responsible for prosecution and maintenance of the BTC Patent elects not to file for an extension, such Party shall
(i) inform the other Party of its intention not to file and (ii) grant the other Party the right to file for such extension. 
  
 8.6 Trademarks. 
  
 (a) Each Party and its Affiliates shall retain all right, title and interest in and to its and their respective corporate names and logos. 
  
 (b) Auxilium shall be solely responsible for selecting a trademark (the
“Auxilium Trademark”) to use for each country in the Territory. The Product shall be promoted and sold, in accordance with the provisions of this Agreement, in the Territory under the Auxilium Trademark. Auxilium (or its local Affiliates,
as appropriate) shall own and retain all rights to Auxilium Trademark, and all goodwill associated therewith throughout the Territory. Auxilium shall also own rights to any internet domain names incorporating the Auxilium Trademark or any variation
or part of Auxilium Trademark as its URL address or any part of such address. 
  
 ARTICLE 9 
 REPRESENTATIONS AND WARRANTIES 
  
 9.1 BTC Represents and Warrants. BTC hereby represents and warrants to
Auxilium that: 
  
 (a) This Agreement has been duly executed and
delivered by BTC and constitutes the valid and binding obligation of BTC, enforceable against BTC in accordance with its terms except as enforceability may be limited by bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium and
other laws relating to or affecting creditors’ rights generally and by general equitable principles. The execution, delivery and performance of this Agreement have been duly authorized by all necessary action on the part of BTC, its officers
and directors; 
  
 (b) As of the Effective Date BTC owns or
possesses adequate licenses or other rights necessary to make, use and sell all technology covered by the BTC Patents, and to grant the licenses herein and the granting of the licenses to Auxilium hereunder does not violate any right known to BTC of
any Third Party; 
  

 29 

 (c) BTC represents that to the best of its knowledge, as of the Effective Date it is not aware that the
development, manufacture, use or sale of the Enzyme or the Product pursuant to this Agreement may infringe or conflict with any Third Party right or Patent, and BTC is not aware of any pending patent application that, if issued, would be infringed
by the development, manufacture, use or sale of the Enzyme or the Product pursuant to this Agreement; 
  
 (d) The execution, delivery and performance of this Agreement by BTC does not conflict with any agreement, instrument or understanding, oral or written,
to which it is a Party or by which it may be bound, and, to the best of its knowledge, does not violate any material law or regulation of any court, governmental body or administrative or other agency having authority over it; 
  
 (e) BTC has disclosed to Auxilium all material information in its control
pertaining to the suitability of Enzyme as a pharmaceutical candidate; 
  
 (f) The Product has valid and effective Orphan Drug Designation under the applicable FDA statutes, rules or regulations, effective, May 23, 1996, and March 12, 1996 BTC has no reason to believe such Orphan Drug Designation shall be
terminated prior to the Effective Date. 
  
 (g) BTC is not
currently a Party to, and during the Term will not enter into, any agreements, oral or written, that are inconsistent with its obligations under this Agreement; 
  

(h) BTC is duly organized and validly existing under the laws of the state of Delaware and has full legal power and authority to enter into this
Agreement; and 
  
 (i) BTC is not subject to any order, decree or
injunction by a court of competent jurisdiction which prevents or materially delays the consummation of the transactions contemplated by this Agreement. 
  
 9.2 Auxilium Represents and Warrants. Auxilium hereby represents and warrants to BTC that: 
  
 (a) The execution, delivery and performance of this Agreement by Auxilium
does not conflict with any agreement, instrument or understanding, oral or written, to which it is a Party or by which it may be bound, and, to the best of its knowledge, does not violate any material law or regulation of any court, governmental
body or administrative or other agency having authority over it; 
  
 (b) Auxilium is not currently a Party to, and during the Term will not enter into, any agreements, oral or written, that are inconsistent with its obligations under this Agreement; 
  
 (c) Auxilium is duly organized and validly existing under the laws of the
state of Delaware and has full legal power and authority to enter into this Agreement; and 
  

 30 

 (d) Auxilium is not subject to any order, decree or injunction by a court of competent jurisdiction which
prevents or materially delays the consummation of the transactions contemplated by this Agreement. 
  
 9.3 Disclaimer of Warranties. THE LIMITED WARRANTIES CONTAINED IN THIS ARTICLE ARE THE SOLE WARRANTIES GIVEN BY THE PARTIES AND ARE MADE EXPRESSLY
IN LIEU OF AND EXCLUDE ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, INFRINGEMENT OR OTHERWISE, AND ALL OTHER EXPRESS OR IMPLIED REPRESENTATIONS AND WARRANTIES PROVIDED BY COMMON LAW, STATUTE OR OTHERWISE ARE
HEREBY DISCLAIMED BY BOTH PARTIES. 
  
 ARTICLE 10

 CONFIDENTIALITY 
  
 10.1 Confidentiality. During the Term, and for a period of five (5) years thereafter, each Party hereto will maintain in confidence all information
disclosed, and reasonably believed by the other party to be confidential whether orally or in writing, by the other Party hereto (“Confidential Information”). Neither Party shall use, disclose or grant use of such Confidential
Information except as required under this Agreement. Each Party shall use at least the same standard of care as it uses to protect its own Confidential Information to ensure that its and its Affiliates’ employees, agents, consultants, and
clinical investigators only make use of Confidential Information for the purpose of this Agreement and do not disclose or make any unauthorized use of such Confidential Information. Each Party shall promptly notify the other upon discovery of any
unauthorized use or disclosure of Confidential Information. Confidential Information shall not include any information which and to the extent: 
  
 (a) was already known to the receiving Party, other than under an obligation of confidentiality, at the time of disclosure by the other Party; 

 
 (b) was generally available to the public or otherwise part of the public
domain at the time of its disclosure to the other Party; 
  
 (c)
becomes generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement; 
  
 (d) was disclosed to the receiving Party, other than under an obligation of
confidentiality, by a Third Party who had no obligation to the other Party not to disclose such information; or 
  
 (e) was independently developed by the receiving Party without reference to the disclosure by the other Party, as documented by written records.

  
 10.2 Terms of Agreement. The Parties agree that the
material financial terms of the Agreement shall be considered the Confidential Information of both Parties. 
  

 31 

 10.3 Permitted Disclosure. Each Party may disclose the Confidential Information to the extent such
disclosure is reasonably necessary in filing or prosecuting patent applications, prosecuting or defending litigation, or complying with any applicable statute or governmental regulation provided such Party has given the disclosing Party prompt
written notice allowing it to limit such disclosure. In addition, either Party may disclose Confidential Information to its Affiliates and to its Sublicensees; provided, however, in connection with any such disclosure the disclosing Party shall
secure confidential treatment of such Confidential Information. 
  
 10.4 Employee Obligations. The Parties shall undertake to ensure that all their employees who have access to Confidential Information of the other Party are under obligations of confidentiality fully consistent with those provided in
this Article. 
  
 10.5 Publication. No Party may publish
confidential or proprietary information of the other Party, without the consent of the other Party. The reviewing Party shall have thirty (30) days from receipt of the proposed oral disclosure or written publication to provide comments or proposed
changes to the disclosing Party. The review period may be extended for an additional two (2) months to permit the reviewing Party to file one or more patent applications as it deems appropriate. This Section 10.5 shall be inapplicable to the
publication of information presented in substantially the same form in which was previously published or disclosed to the public, and to any other disclosures which, on the advice of counsel, are required by law to be disclosed. 
  
 10.6 Prior Agreements. The obligations of Confidentiality and
Nondisclosure set forth in this Section 10 supersede any and all prior and contemporaneous communications, representations, agreements or understandings, whether oral or written concerning the subject matter of this Section 10. 
  
 ARTICLE 11 
 TERM AND TERMINATION 
  
 11.1 Term. 
  
 (a)
Term. Unless earlier terminated as provided herein, the Term shall commence as of the Effective Date and shall remain in full force and effect on a Product by Product and country by country basis until the later of (i) the last to expire
valid claim of a patent covering such Product, (ii) the expiration of the regulatory exclusivity period conveyed by Orphan Drug Designation with respect to such Product, and (iii) twelve (12) years (the “Term”). 
  
 (b) Accrued Obligations. Except where explicitly provided elsewhere
herein, termination of this Agreement for any reason, or expiration of this Agreement, will not affect: (i) obligations, including the payment of any royalties or other sums which have accrued as of the date of termination or expiration, and (ii)
rights and obligations which, from the context thereof, are intended to survive termination or expiration of this Agreement. 
  
 11.2 Termination for Insolvency. Either Party may terminate this Agreement immediately upon delivery of written notice to the other Party (a) upon
the institution by or against the other Party of insolvency, receivership or bankruptcy proceedings or any other proceedings for the settlement of the other Party’s debts; provided, however with respect to involuntary proceedings, that such
proceedings are not dismissed within one hundred and twenty(120) days; (b) upon the other Party’s making an assignment for the benefit of creditors; or (c) upon the other Party’s dissolution or ceasing to do business. 
  

 32 

 11.3 Material Breach. Either Party may terminate this Agreement upon ninety (90) days prior
written notice to the other Party upon the material breach by the other Party of any of its obligations under this Agreement; provided, however, that such termination shall become effective only if the other Party shall fail to remedy or cure the
breach within such ninety (90) day period. 
  
 11.4 Termination
by Auxilium. Auxilium may terminate this Agreement in its entirety or on a country-by-country basis or on an Indication by Indication basis or on a Product by Product basis at any time upon ninety (90) days prior written notice to BTC.

  
 11.5 Effect Of Termination. 
  
 (a) Effect On License. Upon the expiration or earlier termination of
this Agreement, the rights licensed under this Agreement shall be treated as follows: 
  
 (i) Upon the expiration of the Term or the termination of this Agreement by Auxilium pursuant to Section 11.2 or Section 11.3, Auxilium
shall have a fully paid-up, perpetual, irrevocable, royalty-free, transferable, worldwide, non-exclusive right and license under the Licensed Technology existing as of the date of such expiration to make, have made, use, offer to sell, and sell the
Product in the Territory. 
  
 (ii) Upon
termination of this Agreement by BTC pursuant to Section 11.2 or 11.3, or by Auxilium pursuant to Section 11.4 all rights to Product shall revert to BTC. 
  
 (b) Ongoing Obligations. 
  
 (i) Upon expiration or termination of this Agreement for any reason, each Party shall no later than thirty (30) days after such
termination return to the other Party or destroy any Confidential Information disclosed by the other Party, except for one copy which may be retained in its confidential files. 
  
 (ii) Upon termination of this Agreement by BTC pursuant to Sections 11.2 or 11.3 or by Auxilium pursuant to
Section 11.4, Auxilium shall assign and deliver to BTC all Regulatory Data and information (including registration dossiers) obtained for or in pursuing Regulatory Approvals, and all Regulatory Approvals (e.g., to BTC; designee in the Territory as
permitted under the Law) for Product in the Territory received as of such termination date. 
  
 11.6 Inventory. Notwithstanding the foregoing, upon early termination of this Agreement pursuant to Section 11.2, 11.3 or 11.4, Auxilium shall have the right to sell all remaining Product in its inventory
within six (6) months after the date of termination, but shall be bound to the royalty payments provided by Article 7.4 herein.. Thereafter, Auxilium agrees to destroy any remaining supply of Product or return it to BTC at BTC’s request and
direction. 
  

 33 

 ARTICLE 12 
 INDEMNIFICATION 
  
 12.1
Auxilium. Auxilium shall defend BTC at Auxilium’ cost and expense, and will indemnify and hold BTC and their respective directors, officers, employees, consultants, contractors, representatives, and agents harmless from and against any
and all losses, costs, damages, fees, or expenses (including reasonable attorney’s fees and expenses) (“Losses”) incurred in connection with or arising out of any Third Party claim (a “Third Party Claim”) directly relating
to (i) any material breach by Auxilium of its representations or warranties or obligations pursuant to this Agreement, (ii) any gross negligence or willful misconduct of Auxilium, its Affiliates, or their respective directors, officers, employees,
contractors, consultants, agents, representatives, or sublicensees in the exercise of any of Auxilium’ rights or the performance of any of Auxilium’ obligations under this Agreement, and (iii) the handling, packaging, storage, or
Commercialization by Auxilium or any of its Affiliates or sublicensees of any Product in the Territory (excluding all intellectual property infringement or related claims, which are covered in Section 12.2); provided that notwithstanding the
foregoing, in all cases referred to in this Section 12.1, Auxilium shall have no liability to BTC for any Losses to the extent that such Losses were caused by any item for which BTC is required to indemnify Auxilium pursuant to Section 12.2.

  
 12.2 BTC. BTC shall defend Auxilium and its Affiliates
at BTC’s cost and expense, and will indemnify and hold Auxilium and its Affiliates and their respective directors, officers, employees, consultants, contractors, representatives, and agents harmless from and against any and all Losses incurred
in connection with or arising out of any Third Party Claim directly relating to (i) material breach by BTC of any of its representations, warranties or obligations pursuant to this Agreement, (ii) gross negligence or willful misconduct of BTC in the
exercise of any of its rights or the performance of any of its obligations under this Agreement, (iii) personal injury and other product liability resulting from BTC’s Development, Manufacture, or Commercialization of any Product, (iv)
intellectual property infringement or related claims, including any Third Party Claim and trade secret misappropriation liability relating to the Development, Manufacture, or Commercialization of any Product, (v) any liability or other claims from
the Manufacture, handling, packaging, storage, sale, or other disposition of any Product by BTC or any of its Affiliates or sublicensees, and (vi) any liability or claims arising from Product supplied by or on behalf of BTC to Auxilium that was not
Manufactured in accordance with current Good Manufacturing Practices, Good Clinical Practice and Good Laboratory Practices, the specifications or all Laws and regulations except for such Losses that are indemnified pursuant to the Supply Agreement;
provided that notwithstanding the foregoing, in all cases referred to in this Section 12.2, BTC shall have no liability to Auxilium for any Losses to the extent (and only to the extent) that such Losses were caused by any item for which Auxilium is
required to indemnify BTC pursuant to Section 12.1. 
  

 34 

 12.3 Claims Procedures. Each Party entitled to be indemnified by the other Party (an
“Indemnified Party”) pursuant to Section 12.1 or 12.2 hereof shall give notice to the other Party (an “Indemnifying Party”) promptly after such Indemnified Party has actual knowledge of any threatened or asserted
claim as to which indemnity may be sought, and shall permit the Indemnifying Party to assume the defense of any such claim or any litigation resulting therefrom; provided: 
  
 (a) That counsel for the Indemnifying Party, who shall conduct the defense of such claim or any litigation resulting
therefrom, shall be approved by the Indemnified Party (whose approval shall not unreasonably be withheld) and the Indemnified Party may participate in such defense at such Party’s expense (unless (i) the employment of counsel by such
Indemnified Party has been authorized by the Indemnifying Party; or (ii) the Indemnified Party shall have reasonably concluded that there may be a conflict of interest between the Indemnifying Party and the Indemnified Party in the defense of such
action, in each of which cases the Indemnifying Party shall pay the reasonable fees and expenses of one law firm serving as counsel for the Indemnified Party, which law firm shall be subject to approval, not to be unreasonably withheld, by the
Indemnifying Party). 
  
 (b) The failure of any Indemnified Party
to give notice as provided herein shall not relieve the Indemnifying Party of its obligations under this Agreement to the extent that the failure to give notice did not result in harm to the Indemnifying Party. 
  
 (c) No Indemnifying Party, in the defense of any such claim or litigation,
shall, except with the approval of each Indemnified Party which approval shall not be unreasonably withheld, consent to entry of any judgment or enter into any settlement which (i) would result in injunctive or other relief being imposed against the
Indemnified Party; or (ii) does not include as an unconditional term thereof the giving by the claimant or plaintiff to such Indemnified Party of a release from all liability in respect to such claim or litigation. 
  
 (d) Each Indemnified Party shall furnish such information regarding itself or
the claim in question as an Indemnifying Party may reasonably request in writing and shall be reasonably required in connection with the defense of such claim and litigation resulting therefrom. 
  
 12.4 Escrow. In the event of any Third Party Claim against Auxilium
for which BTC is obligated to indemnify Auxilium in accordance with Section 12.2, Auxilium shall be entitled, until a final un-appealable decision has been rendered or a settlement has been reached (a “Final Decision”), to pay an amount
equal to fifty percent (50%) of all amounts due to BTC on Net Sales of Products (such aggregate amount, the “Escrowed Amount”) into an escrow account maintained by a Third Party reasonably acceptable to BTC. To the extent that Auxilium
incurs any Losses in connection with such Third Party Claim, an amount equal to the amount of any such Losses shall be distributed to Auxilium out of such escrow account, with the remainder (if any) to be paid to BTC. In the event that the Escrow
Amount is less than the amount of such Losses, BTC shall pay the difference to Auxilium within thirty (30) days of such Final Decision. 
  
 12.5 Insurance. During the Term, each of Auxilium and BTC shall maintain general liability and product liability insurance in the following
amounts: (i) at all times prior to approval of a NDA for a Product, $3,000,000 per occurrence, and (ii) at all times after approval of a NDA for a Product, $5,000,000. 
  
 12.6 Compliance. The Parties shall comply fully with all Laws and regulations in connection with their respective
activities under this Agreement. 
  

 35 

 ARTICLE 13 
 MISCELLANEOUS PROVISIONS 
  
 13.1 Dispute Resolution. In the event of any controversy or claim arising out of relating to or in connection with any provision of this Agreement, or the rights or obligations hereunder, the Parties shall try to settle their
differences amicably between themselves. Either Party may initiate such informal dispute resolution by sending written notice of the dispute to the other Party, and within ten (10) business days after such notice appropriate representatives of the
Parties shall meet for attempted resolutions by good faith negotiations. If such representatives are unable to resolve such disputed matters, it shall be referred to the Chief Executive Officers of BTC and Auxilium, for discussion and resolution. If
they are unable to resolve the dispute within thirty (30) days of initiating such negotiations, the Parties agree first to submit the dispute to non-binding mediation before resorting to litigation or other mutually agreed dispute resolution
mechanism. The dispute resolution procedures set forth herein shall not limit a court from granting a temporary restraining order or a preliminary injunction in order to preserve the status quo of the Parties pending arbitration or to protect a
Party’s trademark or confidential or proprietary information. 
  
 13.2 Construction. Unless the context of this Agreement clearly requires otherwise, (a) references to the plural include the singular, the singular the plural, the part the whole, (b) references to any gender include all genders, (c)
“or” has the inclusive meaning frequently identified with the phrase “and/or,” (d) “including” has the inclusive meaning frequently identified with the phrase “including but not limited to” or
“including”, and (e) references to “hereunder” or “herein” relate to this Agreement. The section and other headings contained in this Agreement are for reference purposes only and shall not control or affect the
construction of this Agreement or the interpretation thereof in any respect. Section, subsection, and Schedule references are to this Agreement unless otherwise specified. Each accounting term used herein that is not specifically defined herein
shall have the meaning given to it under GAAP. 
  
 13.3
Governing Law; Jurisdiction. This Agreement shall be construed and the respective rights of the Parties determined according to the substantive laws of the State of New York notwithstanding the provisions governing conflict of laws under such
New York law to the contrary, except matters of intellectual property law which shall be determined in accordance with the intellectual property laws relevant to the intellectual property in question. 
  
 13.4 Post-Closing Access to Information. BTC shall afford to
representatives of Auxilium reasonable access to offices, plants, properties, books and records of BTC relating to the Product, during normal business hours, in order that Auxilium may have an opportunity to make such reasonable investigations as it
desires with respect to Product. At all times after the Effective Date, each Party will permit the other Party and its representatives (including its counsel and auditors) during normal business hours, for a proper purpose to have reasonable access
to and examine and make copies of, at the expense of the copying Party, all books, records, files and documents in its possession which relate to the Product. 
  

13.5 Section 365(n) of the Bankruptcy Code. All rights and licenses granted under or pursuant to any section of this Agreement are, and shall
otherwise be deemed to be, for purposes of Section 365(n) of the Bankruptcy Code, licenses of rights to “intellectual property” as defined under Section 101(35A) of the Bankruptcy Code. The Parties shall retain and may fully exercise all
of their respective rights and elections under section 365(n) of the Bankruptcy Code. 
  

 36 

 13.6 Waiver. The failure on the part of Auxilium or BTC to exercise or enforce any rights
conferred upon it hereunder shall not be deemed to be a waiver of any such rights nor operate to bar the exercise or enforcement thereof at any time or times thereafter. The observance of any Term may be waived (either generally or in a particular
instance and either retroactively or prospectively) by the Party entitled to enforce such term, but any such waiver shall be effective only if in writing signed by the Party against whom such waiver is to be asserted. 
  
 13.7 Force Majeure. Neither Party shall be held liable or responsible
to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any Term, other than an obligation to make a payment, when such failure or delay is caused by or results from fire,
floods, embargoes, government regulations, prohibitions or interventions, war, acts of war (whether war be declared or not), insurrections, riots, civil commotions, strikes, lockouts, acts of God, or any other cause beyond the reasonable control of
the affected Party. 
  
 13.8 Severability. It is the
intention of the Parties to comply with all Laws domestic or foreign in connection with the performance of its obligations hereunder. In the event that any provision of this Agreement, or any part hereof, is found invalid or unenforceable, the
remainder of this Agreement will be binding on the Parties hereto, and will be construed as if the invalid or unenforceable provision or part thereof had been deleted, and the Agreement shall be deemed modified to the extent necessary to render the
surviving provisions enforceable to the fullest extent permitted by law. 
  
 13.9 Government Acts. In the event that any act, regulation, directive, or law of a government, including its departments, agencies or courts, should make impossible or prohibit, restrain, modify or limit any
material act or obligation of Auxilium or BTC under this Agreement, the Party, if any, not so affected shall have the right, at its option, to suspend or terminate this Agreement as to such country, if good faith negotiations between the Parties to
make such modifications to this Agreement as may be necessary to fairly address the impact thereof, after a reasonable period of time are not successful in producing mutually acceptable modifications to this Agreement. 
  
 13.10 Assignment. This Agreement may not be assigned or otherwise
transferred by either Party without the prior written consent of the other Party; provided, however, that either Party may assign this Agreement, without the consent of the other Party, in connection with the transfer or sale of all or substantially
all of its assets or business or in the event of its merger or consolidation with another company. In all cases the assigning Party shall provide the other Party with prompt notice of any such assignment. Any purported assignment in contravention of
this Section shall, at the option of the nonassigning Party, be null and void and of no effect. No assignment shall release either Party from responsibility for the performance of any accrued obligation of such Party hereunder. 
  

 37 

 13.11 Counterparts. This Agreement may be executed in duplicate, both of which shall be deemed to
be originals, and both of which shall constitute one and the same Agreement. 
  
 13.12 No Agency. Nothing herein contained shall be deemed to create an agency, joint venture, amalgamation, partnership or similar relationship between BTC and Auxilium. Notwithstanding any of the provisions of
this Agreement, neither Party shall at any time enter into, incur, or hold itself out to third Parties as having authority to enter into or incur, on behalf of the other Party, any commitment, expense, or liability whatsoever, and all contracts,
expenses and liabilities undertaken or incurred by one Party in connection with or relating to the development, manufacture or sale of Enzymes or Product shall be undertaken, incurred or paid exclusively by that Party, and not as an agent or
representative of the other Party. 
  
 13.13 Notice. All
communications between the Parties with respect to any of the provisions of this Agreement will be sent to the addresses set out below, or to other addresses as designated by one Party to the other by notice pursuant hereto, by internationally
recognized courier or by prepaid certified, air mail (which shall be deemed received by the other Party on the seventh business day following deposit in the mails), or by facsimile transmission or other electronic means of communication (which shall
be deemed received when transmitted), with confirmation by letter given by the close of business on or before the next following business day: 
  

	
	 If to BTC, at:

	 Biospecifics Technologies Corp.

	 35 Wilbur Street

	 Lynbrook, New York 11563

	 Attn:
                                        
                                        
                                        
                             

	
	 with a copy to:

	
	 Brown Raysman Millstein Felder & Steiner LLP

	 163 Madison Avenue

	 P.O. Box 1989

	 Morristown, New Jersey 07962-1989

	 Attn.: Leslie Gladstone Restaino, Esq.

	
	 If to Auxilium at:

	 Auxilium Pharmaceuticals Inc.

	 160 West Germantown Pike

	 Norristown, PA 19401

	 Attn:
                                        
                                        
                                        
                             

	
	 with a copy to:

	
	 Morgan, Lewis & Bockius LLP

	 1701 Market Street

	 Philadelphia, PA 19103

	 Attn: Manya S. Deehr, Esq.

  

 38 

 13.14 Headings. The paragraph headings are for convenience only and will not be deemed to affect
in any way the language of the provisions to which they refer. 
  
 13.15 Assurances. Neither Party will take any action, or fail to act in a manner, which would prejudice the rights intended to be granted to the other Party pursuant to this Agreement. 
  
 13.16 Entire Agreement. This Agreement contains the entire
understanding of the Parties relating to the matters referred to herein, and may only be amended by a written document, duly executed on behalf of the respective Parties. 
  
 [Signature Page Follows] 
  

 39 

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

					
	AUXILIUM PHARMACEUTICALS, INC.
		
	 By:
	 	 /s/ Gerri Henwood

	 	 	 Name: Gerri Henwood

	 	 	 Title: CEO

	
	BIOSPECIFICS TECHNOLOGIES CORP.
		
	 By:
	 	 /s/ Edwin H. Wegman

	 	 	 Name: Edwin H. Wegman

	 	 	 Title: Pres.

 Schedule 1.7 BTC Patents 
  

BIOSPECIFICS TECHNOLOGIES CORP. AND SUBSIDIARIES 
 PATENT APPLICATIONS AND EXISTING PATENTS 
  
 1. U.S. Patent 5,393,792, patented February 28, 1995, inventors Dr. Harold Stern and Dr. David Yee, title: High Dosage Topical Forms of Collagenase 
  
 2. U.S. Patent 5,422,103, patented June 6, 1995, inventors Dr. Harold Stern and Dr. David Yee, title: High Dosage Topical Forms of Collagenase 
  
 3. U.S. Patent 5,514,370, patented May 7, 1995, inventors Dr. Harold Stern and Dr. David Yee,
title: High Dosage Forms of Collagenase (Method of Treatment with...). 
 Note: Foreign patent applications corresponding to the above U.S. applications have
been filed in [**] foreign countries (Australia, Canada, 9 countries of the European patent convention, (Austria, France, Germany, Ireland, Italy, Netherlands, Spain, Switzerland, United Kingdom, Hungary, [**],
Russia). Patents have issued in all countries except [**], where the application is pending. 
  
 4. U.S. application inventors [**]. U.S. Patent Application # [**] pending. 
  
 5. U.S. Patent 6.086.872, patented July 11, 2000, inventor Thomas L. Wegman, Amelioration of Dupuytren’s Disease. 
  
 Note: Foreign patents corresponding to the above patent have been granted in 4 countries.
France (2,772,273 granted 4/25/03), Australia (733,208 granted 8/23/01), UK (98050503 granted 10/10/01) and Sweden (9800806-3 granted 3/2/04). Patents have been filed in [**]. 
  
 6. U.S. Patent 6.022,539, patented February 8, 2000, inventor Thomas L. Wegman, Amelioration of Peyronie’s Disease. 
 Note: Foreign patent application corresponding to the above application have been filed in [**] countries. [**], France, [**]. Corresponding patent
French Patent 0006863 has issued. 
  
 7.U.S. Patent 5,173,295, patented December
22, 1992, inventor Peter Wehling, title: Method of Enhancing the Regeneration of Injured Nerves and Adhesive Pharmaceutical Formulation Therefor. 
  
 8. U.S. Patent 5,279,825, patented January 18, 1994, inventor Peter Wehling, title: Method of Enhancing the Regeneration of Injured Nerves and Adhesive Pharmaceutical
Formulation Therefor. 
  
 Note: Foreign patent application corresponding to the
above two cases filed in the [**]. 

	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
 

 9. European Patent Office Patent EPO721781B1 June 2002 – inventors Edwin H. Wegman, Burton Bronsther, and Erwin T.
Jacob, title: Reduction of Adipose Tissue Using Collagenase. This patent is being extended into [**] additional countries. 
  
 Patents licensed to Advance Biofactures Corp. 
  
 10. US Patent 5,851,522, patented December 22, 1998 inventor Dr. I. M Herman titled “Enhancing Keratinocyte Migration. EPO, (9 countries), Canada 
  
 11. US Patent 5,718,897, patented on February 17, 1998. Inventor Dr. Ira Herman, Title:
Enhancing Keratinocyte Migration and Proliferation. 
  
 Note: Foreign patent
application corresponding to the above case has been filed in [**]. 
  
 Updated: May 24, 2004 
  

	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT
REQUEST. 

 Schedule 1.16 
 Cost of Goods 
  
 The cost of Enzyme or a
Product manufactured by BTC shall mean the fully allocated cost of manufacturing, which shall include: 
  
 1. Materials cost, which means the price paid for raw material components and finished goods which are purchased from outside vendors as well as any freight and duty where applicable. 
  
 2. Direct labor costs, which means the employment costs including, salary and employee
benefits within the relevant manufacturing operating unit. 
  
 3. Direct and
factory overheads, which means the cost of specific activities that are provided by support functions. Overhead costs includes expenses associated with quality assurance testing, batch review, equipment maintenance costs, manufacturing energy and
utilities, waste removal, storage, transportation, insurance, management and administrative expenses, general facilities costs, environmental engineering, interest expense and property taxes. 
  
 Cost of Goods shall be calculated in accordance with U.S. Generally Accepted Accounting
Principles. BTC’s Cost of Goods for Enzyme or Product shall in no event exceed [**]% of the cost of Enzyme or Product as supplied, or as could be supplied, by a Third Party, as measured at the request of Auxilium and no more frequently
than once per calendar year. 
  

	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT
REQUEST. 

 Schedule 1.21 
 Enzyme 
  
 Schedule 1.2.1 Enzyme

  
 The enzyme is [**]. 
  

	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
 

 Schedule 3.2 
 Clinical Trials 
  
 Schedule 3.2
Clinical Trials 
  
 Dupuytren’s Disease 
  
 [**] 
  
 Peyronie’s Disease 
  
 [**] 
  

	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

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