License and Cooperation Agreement

1.

Definitions

For purposes of this Agreement, the following terms shall have the following meanings:

1.1

" Affiliate " shall mean and include in relation to each Party, any person, firm, corporation or other entity: (i) if at least fifty percent (50%) of the voting stock or other equity interest thereof is owned, directly or indirectly, by that Party; (ii) which owns, directly or indirectly, at least fifty percent (50%) of the voting stock or other equity interest of that Party; or (iii) if at least fifty percent (50%) of the voting stock or other equity interest thereof is owned, directly or indirectly, by a person, firm, corporation or other entity that owns, directly or indirectly, at least fifty percent (50%) of the voting stock or other equity interest of that Party.

1.2

 " Agreement " shall mean this agreement and all Exhibits attached hereto, and the terms "herein", "hereunder", "hereto" and such similar expressions shall refer to this Agreement.

1.3

" Confidential Information " shall mean and include all know-how, data and information, not in the public domain, relating to the Contract Products or Perifosine, the Field, or the business, affairs, research and development activities, results of clinical trials, national and multinational regulatory proceedings and affairs, finances, plans, contractual relationships and operations of the Parties.

1.4

" Contract Products " shall mean and include all pharmaceutical products, whether as mono-preparations or combination-preparations, with Perifosine as an active ingredient, for use in the Field, in any form of administration whatsoever, where the development, manufacture, use, sale, offer for sale, or importation thereof by or for AOI is covered by a Valid Claim of Zentaris' Patent Rights.

1.5

" Co-ordination Committee " shall mean the committee established pursuant to Section 5 hereof.

1.6

  "CRADA" shall mean the Cooperation Research and Development Agreement (CACR-0774) prepared by the Technology Development and Commercialization Branch of the National Cancer Institute regarding the clinical development of Perifosine.

1.7

" Development Data " shall mean reports of clinical studies and all other documentation containing or embodying any pre-clinical, clinical and CMC data relating to the application for Regulatory Approval for the Contract Products and/or Perifosine or the use of the Contract Products and/or Perifosine in the Field, including, but not limited to, registration dossiers.

1.8

" Effective Date " of this Agreement shall mean the date on which this Agreement is executed by the duly authorized representatives of each of the parties hereto.

1.9

" Field " shall mean the development and commercialization of Perifosine and Contract Products for human therapeutic use.

1.10

" First Commercial Sale " shall mean in relation to each country within the Territory, first sale by AOI or its Affiliates, licensees, or distributors of any of the Contract Products for use in any of the indications in the Field in that country, after obtaining all of the applicable Regulatory Approvals.

1.11

" Improvements " to the Contract Products or Perifosine shall mean and include any and all Inventions, and any and all changes, modifications and amendments to Zentaris' Know-How which: (i) improve the performance or efficacy of the Contract Products or Perifosine; (ii) reduce any side effects, drug interactions or other adverse effects of the Contract Products or Perifosine; or (iii) reduce the cost and/or increase the efficiency or productivity of the manufacturing and production processes for the Contract Products or Perifosine.

1.12

" Insolvency Event " shall mean any event whereby a party: (i) becomes insolvent or bankrupt; (ii) makes an assignment for the benefit of its creditors; (iii) has a trustee or receiver for all or a substantial part of its property appointed; or (iv) has any case or proceeding or other action commenced or taken against or by it in bankruptcy or otherwise seeking reorganization, liquidation, dissolution, winding-up, arrangement, composition or readjustment of its debts or any relief under any bankruptcy, insolvency, reorganization or other similar act or law of any jurisdiction now or hereinafter in effect. 

1.13

" Inventions " shall mean and include any and all inventions and discoveries which are, or may be, patentable or otherwise protectable under the patent or other intellectual property laws of any country, which relate to Perifosine and the Contract Products, and which are conceived, discovered or reduced to practice during the continuance of this Agreement.

1.14

"NCI" shall mean the National Cancer Institute, Rockville, Maryland, United States of America.

1.15

" Net Sales " shall mean the amount invoiced by AOI, its Affiliates, its licensees, sublicensees or distributors on account of sales of Contract Products to Third Parties in the Territory, less the following deductions to the extent (except in the case of (v) below) actually allowed or specifically allocated to the Contract Products by the selling party using generally accepted accounting standards:

(i)

sales and excise taxes and duties paid or allowed by the selling party and any other governmental charges imposed upon the production, importation, use or sale of such Contract Products;

(ii)

trade, quantity and cash discounts allowed on Contract Products;

(iii)

allowances or credits to customers on account of rejection or return of Contract Products or on account of retroactive price reductions affecting such Contract Products;

(iv)

Contract Product rebates and Contract Product charge backs including those granted to managed-care entities;

(v)

freight and insurance costs, if they are included in the selling price for the Contract Products invoiced to Third Parties, provided always that such deduction shall not be greater than the balance between the selling price actually invoiced to the Third Party and the standard selling price which would have been charged to such Third Party for such Contract Products exclusive of freight and insurance in the respective country or in a comparable country; and

(vi)

fifty percent (50%) of any write-offs for bad debt.  The same applies, if an Insolvency Event occurs to a sublicensee or a customer of AOI.

For the avoidance of doubt, for each Contract Product the Net Sales shall be calculated only once for the first sale of such Contract Product by either AOI, its Affiliate, its sublicensee or its distributor, as the case may be, to a Third Party which is neither an Affiliate, sublicensee or distributor of AOI.  A sale of Contract Products by AOI, its Affiliate, its sublicensee or its distributor to a wholesaler shall be regarded as the first sale of the Contract Product for the purpose of calculating Net Sales.

1.16

" Party " or " Parties " shall mean AOI or Zentaris, or AOI and Zentaris, whichever the context admits.

1.17

" Perifosine " shall mean the compound described in Exhibit 1.17 hereto, which may be covered by one or more of Zentaris' Patent Rights, as listed in Exhibit 1.24 hereto, for use in the Field.

1.18

" Regulatory Approvals " shall mean and include all licenses, permits, authorizations and approvals of, and all registrations, filings and other notifications to, any governmental agency or department within the Territory, including, without limitation, the United States Food and Drug Administration, necessary or appropriate for the manufacture, production, distribution, marketing, sale and/or use of the Contract Products or Perifosine within the Territory.

1.19

" Relevant Information " shall mean all information in Zentaris' possession or known to Zentaris that a reasonably diligent person in evaluating Perifosineor Contract Products would consider important in determining whether or not to in-license Perifosine or Contract Products, including without limitation, pre-clinical data, clinical data, data from any toxicology studies, information related to the manufacturing of Perifosine or Contract Products, information relating to the patent protection surrounding Perifosine or Contract Products as well as regulatory status and correspondence with regulatory agencies.

1.20

" Territory " shall mean and include the United States and its protectorates, Canada, and Mexico.

1.21

" Third Party " shall mean any other party that is independent from AOI and its Affiliates and Zentaris and its Affiliates.

1.22

" Valid Claim " shall mean (i) a claim of an issued and unexpired patent included within Zentaris' Patent Rights, which claim has not been held invalid in a final decision of a court of competent jurisdiction from which no appeal may be taken and which has not been disclaimed or admitted to be invalid or unenforceable through reissue or otherwise or (ii) a claim of a pending patent application that is not pending more than ten (10) years from its priority or effective filing date.

1.23

" Zentaris' Know-How " shall mean and include all specifications, results of clinical trials, technical data and other information relating to the design, formulation, manufacture, production, quality control, Regulatory Approvals, distribution, sale and/or use of Contract Products or Perifosine, to which Zentaris has rights as at the Effective Date. Without limiting the generality of the definition set forth in this Section 1.23, Zentaris' Know-How is described in more detail in Exhibit 1.23 hereto.

1.24

" Zentaris' Patent Rights " shall mean patents, patent applications, divisions, continuations, continuation-in-part applications, divisionals, extensions, substitutions, renewals, confirmations, supplementary protection certificates and reissues or re-registrations that (a) are owned or controlled by Zentaris relating to, embodied in, or associated with Perifosine and/or the Contract Products; or (b) any Improvements (other than Improvements developed by Zentaris, which are covered by Section 7.1) , to the extent that Zentaris has the right to include such Improvements within the terms of this Agreement.  Without limiting the generality of the definition set forth in this Section 1.24, Zentaris' Patent Rights are listed in more detail in Exhibit 1.24 hereto, which shall be updated from time to time.

2.

Grant and Scope of License

2.1

Zentaris hereby grants to AOI, and AOI hereby accepts an exclusive license to use Zentaris' Patent Rights and Zentaris' Know-How in the Territory to develop, have developed, manufacture, have manufactured, use, have used, sell, have sold, offer for sale, have offered for sale, import, or have imported, Perifosine and Contract Product, in accordance with the terms and conditions, and subject to the limitations of this Agreement.

2.2

AOI shall be entitled to sublicense all or any of its rights under this Agreement to any Affiliate and, in respect of the manufacture and/or commercialization of Perifosine and Contract Products, any Third Party.  AOI may sublicense its rights under this Agreement in respect of the development of Perifosine and Contract Products, including activities related to the obtainment of Regulatory Approvals for Perifosine and Contract Products, to any Third Party only upon prior written consent of Zentaris, such consent only to be withheld for reasonable cause.  In case AOI grants sublicenses hereunder, AOI always shall secure appropriate covenants, obligations and rights from any such sublicensee so as to ensure that such sublicensee is also able to comply with AOI's covenants and obligations hereunder to the extent that AOI shall not be performing such covenants and obligations. AOI shall inform Zentaris of any sublicenses granted hereunder, and provide to Zentaris a copy of the sublicense agreement concluded with such sublicensee. Zentaris acknowledges that all and any information provided by AOI to Zentaris under this Section 2.2 will be deemed to be Confidential Information of AOI and will be subject to the terms of Section 12 below.

2.3

Subject to Section 2.4 below, Zentaris will not at any time during the continuance of this Agreement grant to any person, firm, corporation or entity a license to develop, manufacture, use, sell, offer for sale or import Perifosine and/ or Contract Products in the Territory.

2.4

The grant of licenses by Zentaris to AOI under Section 2.1 hereof shall not preclude Zentaris itself from utilizing Zentaris' Patent Rights and Zentaris' Know-How and any Improvements relating thereto for the purpose of carrying out by itself or through a University, a contract research organization or a non-profit organization (provided that a material transfer agreement is in place to protect any intellectual property rights generated) any further non-commercial exploratory and development work relating to Perifosine.  If Zentaris engages a University, contract research organization or other non-profit organization to undertake such further exploratory or development work, Zentaris shall inform AOI of the nature of such engagement, including but not limited to providing brief details of the exploratory or development work to be conducted, and the name of the relevant University, contract research organization or other non-profit organization.

2.5

In furtherance of the rights and licenses granted by Zentaris to AOI under this Agreement, within thirty (30) days after the Effective Date of this Agreement, Zentaris shall furnish to AOI a data package that shall include all of Zentaris’ Know-How. AOI shall not use any of Zentaris' Know-How furnished by Zentaris under this Section 2.5 for any purpose whatsoever, except as specifically authorized in this Agreement, or as otherwise specifically authorized in writing by Zentaris. In the event that AOI reasonably believes that Zentaris' Know-How included in the data package furnished by Zentaris under this Section 2.5 is incomplete, AOI shall provide written notice thereof to Zentaris, and Zentaris shall furnish corrected copies of Zentaris' Know-How within 30 days after receipt of AOI's written notice hereunder.  Zentaris shall use its reasonable endeavors to answer all questions received from AOI regarding Zentaris' Know-How as soon as reasonably possible after receipt. However, if Zentaris foresees that specific questions of AOI will invoke significant costs and expenses for Zentaris, Zentaris shall provide AOI with an estimate of such costs and expenses.  In such event, Zentaris shall only be obliged to assist AOI if AOI agrees to refund Zentaris any costs and expenses incurred in providing such assistance.

2.6

Zentaris shall execute all documents and give all declarations regarding the licenses granted hereunder and reasonably cooperate with AOI at the costs of AOI to the extent such documents, declarations and/or cooperation are required for the recordal or registration of the licenses granted hereunder at the various patent offices in the Territory for the benefit of AOI.

2.7

Other than as permitted by this Section 2 and subject to any mandatory legal provisions which may apply, AOI shall not knowingly develop, manufacture, sell, use, offer for sale or import any of the Contract Products or Perifosine for any other application or purpose whatsoever, and shall not actively promote, or solicit orders for the sale of the Contract Products outside of the Territory, without the prior written authorization of Zentaris, which Zentaris may grant or withhold in its sole discretion. 

3.

AOI's Obligations

3.1

AOI shall use its commercially reasonable best efforts to develop, and its commercially reasonable best efforts to market and sell the Contract Products in the Territory, in order to maximize the Net Sales derived from such Contract Products throughout the continuance of this Agreement, provided, however, that AOI shall terminate this Agreement in accordance with Section 15.2 if it determines that it will not be commercially reasonable for AOI to develop, market and sell the Contract Products in the Territory for a time period exceeding twelve (12) months and provided, further, that AOI shall not be obligated to develop, market and sell a Contract Product in countries in which there is generic competition to the Contract Product.  AOI shall be deemed to meet its reasonable best efforts obligation, if it adheres to the development plan, as attached hereto in Exhibit 5.1 or to an amended development plan, provided the amendment was agreed upon by the Co-ordination Committee or the CEOs of the Parties in accordance with Section 5.4. Without limiting the generality of AOI's commercially reasonable best efforts obligation under this Section 3.1, AOI shall:

(i)

apply for all required Regulatory Approvals in each country in the Territory as soon as reasonably and commercially practicable following completion of all appropriate clinical trials;

(ii)

apply for all required Regulatory Approvals in each country in the Territory as soon as reasonably and commercially practicable following completion of all appropriate clinical trials;

(iii)

not manufacture, produce, distribute, market or sell any other alkylphospholipid products which are directly competitive with the Contract Products in any country within the Territory, to the extent that any such activities would involve the use of any of Zentaris' Patent Rights, Zentaris' Know-How or any other Zentaris' Confidential Information or would be otherwise inconsistent with any of AOI's obligations under this Agreement.

3.2

Notwithstanding Section 15.3 below, in the event that AOI breaches any of its obligations under Section 3.1 hereof, and if after having received written notice of such breach from Zentaris, AOI fails to cure such breach within ninety (90) days after receipt of Zentaris' notice thereof, Zentaris shall have the right to convert the exclusive license rights granted to AOI in the relevant country where such breach occurred into non-exclusive license rights, by furnishing written notice thereof to AOI, and shall be entitled to use all Development Data generated by AOI in the period from the Effective Date to the date of the relevant written notice for the development and commercialization of Perifosine and Contract Products in the relevant country.

3.3

After the First Commercial Sale in the Territory, AOI shall furnish Zentaris with quarterly reports of all of AOI's sales of Contract Products under this Agreement. Each such quarterly report shall (i) be furnished to Zentaris together with payment of royalties in accordance with Section 4.7 within forty-five (45) days after the close of the calendar quarter to which it corresponds; and (ii) state AOI's total sales of the Contract Products, broken down by country, during the calendar quarter, the Net Sales derived by AOI from such sales, and the royalties payable by AOI to Zentaris with respect to such Net Sales pursuant to Section 4.4 of this Agreement. In addition, commencing on April 1 in the calendar year following the date of the First Commercial Sale in the Territory, AOI shall provide Zentaris on or before April 1 in each calendar year with a brief summary of its marketing activities performed in the Territory in the previous calendar year and its marketing plans for that calendar year.

4.

Payments and Royalties

4.1

 In consideration for the rights and licenses granted by Zentaris to AOI under this Agreement, AOI shall pay to Zentaris the lump sum amount of [**** ******* ********] US Dollars (US$ [*******]), payable as follows:

(i)

On the Effective Date, [*** ******* ***** ********]US Dollars (US$ [*******]); and

(ii)

Twelve months following the Effective Date, [*** ******* ***** ********]  US Dollars (US$ [*******]).

4.2

In addition to the lump sum payment specified in Section 4.1 hereof and as further consideration for the rights and licenses granted by Zentaris to AOI under this Agreement, AOI shall make the following milestone payments to Zentaris, up to a maximum of [******** ******* *** ******* ***** ********] US Dollars (US$ [**********]):

(i)

Upon the earlier to occur: (i) completion of the first Phase II study for Perifosine conducted by AOI, its Affiliates or sublicensees, whatever occurs first, and (ii) upon completion of the first Phase II study for Perifosine conducted by the NCI, which demonstrates a [******] percent ([**] %) [******** **** **** * ********** ******** ***** ****]                                  

[*** ******* *** ******* ***** ********] US Dollars (US$ [*********])

(ii)

Upon completion of the first Phase III study for Perifosine conducted by AOI, its Affiliates, sublicensees or NCI, whatever occurs first

[*** *******] US Dollars (US$ [*********])

(iii)

Within ninety (90) days of the first grant of regulatory approval for a Contract Product in any country of the Territory to AOI, its Affiliates or sublicensees, whatever occurs first

[**** *******] US Dollars (US$ [*********])

(iv)

Within ninety (90) days of the first time the Net Sales in the Territory in any calendar year equal or exceed [*** ******* ***** *******] US Dollars (US$ [***********])

[*** *******] US Dollars (US$ [**********]).

Completion of a Phase II or Phase III study shall mean ninety (90) days following AOI’s receipt of the final statistics reports from such Phase II or Phase III study.

AOI shall inform Zentaris as soon as possible, however not later than within twenty-one (21) days following the occurrence of a milestone event.  Milestone payments are payable within fourteen (14) days after AOI' s receipt of an invoice issued by Zentaris for such milestone payment, but no earlier than the date set forth in such milestone.

4.3

All fees payable by AOI to Zentaris under Sections 4.1 and 4.2 hereof are non-refundable upon expiration or termination of this Agreement for any reason whatsoever.  None of the fees payable by AOI to Zentaris under Sections 4.1 and 4.2 may be credited against any of AOI's royalty obligations under Section 4.4 hereof.

4.4

As further consideration for the rights and licenses granted by Zentaris to AOI under this Agreement, AOI shall pay royalties to Zentaris equal to:

(i)

[*****]  percent ([*]%) on the first [*** ******* *******] US Dollars (US$ [***********]) of Net Sales in any calendar year; and

(ii)

[***] percent ([**]%) on Net Sales greater than [*** ******* *******] US Dollars (US$ [***********]) and up to and including [**** ******* *******]US Dollars (US$ [***********]) in any calendar year; and

(iii)

[******]percent ([**]%) on Net Sales above [**** ******* *******]US Dollars (US$ [***********]) in any calendar year.

4.5

In the event that Contract Product is sold in the form of a combination product containing one or more products or technologies which are themselves not Perifosine, the Net Sales for such combination product shall be calculated by multiplying the sales price of such combination product by the fraction A/(A+B) where A is the invoice price of Perifosine or the fair market price of Perifosine if sold to an Affiliate and B is the total invoice price of the other products or technologies or the fair market price of the other products or technologies if purchased from an Affiliate. If A and B cannot be reasonably calculated (e.g., if there is not a market for either or both of the components of the combination product), then the Co-ordination Committee will meet to agree on the relative portion of the value of the combination product that is represented by each component. If the Co-ordination Committee cannot agree within ninety (90) days of the First Commercial Sale on the relative proportion attributable to each, then the matter will be referred to a face-to-face meeting of the CEO's of each of the Parties. If the CEO's are unable to reach an agreement within ninety (90) days, the matter will be subject to arbitration pursuant to Section 16.5.

4.6

Royalty payments shall be made on a country by country and a Contract Product by Contract Product basis for the lifetime a Valid Claim of any of the Zentaris' Patent Rights falling under Section 1.24 (a) above or for a period of ten (10) years from the date of First Commercial Sale in the respective country, whichever term is longer. In countries in which the Contract Product is not covered by a Valid Claim of Zentaris' Patent Rights, AOI shall only pay [*****] percent ([**]%) of the applicable royalty set forth above for any Net Sales of such Contract Product, provided, however, if such Contract Product is sold in a generic form in such country by a party other than AOI, its Affiliates or sublicensees, and such generic form has a market share of more than [***********]  percent ([**]%), then AOI shall not pay any royalties on Net Sales for such Contract Product.

4.7

All payments by AOI to Zentaris under this Agreement shall be paid in US Dollars. In the event that any Net Sales received by AOI are received in any currency other than US Dollars, for purposes of calculating the royalties payable by AOI under Section 4.4 hereof, such Net Sales shall be converted into US Dollars at the prevailing open market currency conversion rate (commercial selling rate) as quoted by the Wall Street Journal fixing rate, issued by Reuters at 3 pm on the last day of the calendar quarter in which such Net Sales were received by AOI.

4.8

Royalties under Section 4.4 shall be paid on a calendar quarterly basis. Each quarterly royalty payment by AOI under Section 4.4 shall be paid within forty-five (45) days after the close of the calendar quarter to which it corresponds.

4.9

In the event that any fee payable by AOI under Section 4.1 or 4.2 is not paid to Zentaris on or before the due date therefore, as specified herein, or any quarterly royalty payment under Section 4.6 is overdue, the unpaid overdue amount shall bear interest, at a rate equal to five (5) percentage points over the prime rate as quoted by Citibank NA.

4.10

All payments by AOI to Zentaris under this Section 4 shall be paid in full, without deduction for any sales, use, excise, withholding or other similar taxes. All payments are exclusive of value added tax, which shall if applicable, be invoiced separately. Notwithstanding the foregoing, in the event that AOI is required to withhold any taxes on any amount payable to Zentaris hereunder, under the applicable laws of any country within the Territory, AOI shall at Zentaris' request and cost use its best efforts to obtain and furnish Zentaris with official tax receipts, or other evidence of payment of such withholding taxes, sufficient to permit Zentaris to demonstrate the payment of such withholding taxes, in order to establish Zentaris' right to a credit for such withholding taxes against Zentaris' German income tax liability. AOI shall provide Zentaris with all assistance reasonably requested by Zentaris in connection with any application to any competent tax authorities in any country within the Territory to qualify for the benefit of a reduced rate of withholding taxation under any applicable Double Tax Treaty.

4.11

AOI shall maintain for a period of five (5) years complete and accurate books and records of account, in accordance with generally accepted accounting principles, of all transactions and other business activities under this Agreement, sufficient to confirm the accuracy of all reports furnished by AOI to Zentaris under Section 3.3 hereof, and all payments by AOI to Zentaris under this Section 4. Upon reasonable written notice of no less than 30 days to AOI but in no event more than once per year, Zentaris or a certified public accountant designated by Zentaris and reasonably acceptable to AOI shall have the right to audit such books and records of account of AOI and to review the terms of any sublicenses granted by AOI (provided always that in the case of review by a certified public accountant, the relevant public accountant enters into an appropriate confidentiality agreement with AOI), in order to confirm the accuracy and completeness of all such reports and all such payments. Zentaris shall bear all costs and expenses incurred in connection with any such audit; provided, however, that if any such audit reveals a variance of the greater of [***]  percent ([*]%) or [*********** *********]US Dollars (US$ [******]) between the amount of payments actually due and the amount of payments made to Zentaris in any calendar quarter, then, in addition to paying the full amount of such underpayment, plus accrued interest in accordance with Section 4.9 hereof, AOI shall reimburse Zentaris for all such external costs and expenses reasonably incurred.

5.

Development Work, Co-Ordination Committee

5.1

A draft development plan is attached hereto as Exhibit 5.1 . AOI shall be responsible for conducting all necessary research and development activities in order to obtain the necessary Regulatory Approvals for the Contract Products in the Territory and to maximize the commercial potential of the Contract Products. AOI shall be solely responsible for all costs and expenses incurred by AOI in conducting, or otherwise in connection with, such research and development, including but not limited to the costs of clinical supply for the NCI Phase II studies. As soon as possible, following the Effective Date, Zentaris shall use its best efforts to obtain from the NCI a written letter granting AOI permission to cross-reference the IND owned by the NCI.  Additionally, Zentaris shall permit AOI to access the documentation of the manufacturing process (equivalent to a Drug Master File) for Perifosine for AOI’s IND filing and for the filing of the NDA if Zentaris is AOI’s primary manufacturer.

5.2

The Parties shall form a Co-ordination Committee, which shall be comprised of up to four (4) professionally and technically qualified representatives, two (2) from each Party. Each Party shall provide the other Party with written notice of its representatives for the Co-ordination Committee within ten (10) days after the Effective Date of this Agreement and, thereafter, immediately upon replacement. The Co-ordination Committee shall meet twice a year and more often upon request of either Party. The meeting places shall alternate between the offices of the Parties in Frankfurt and New York, provided, that any meeting requested by a Party in addition to the biannual meetings shall be held at the place of the other Party.

5.3

The Parties shall form a Co-ordination Committee, which shall be comprised of up to four (4) professionally and technically qualified representatives, two (2) from each Party. Each Party shall provide the other Party with written notice of its representatives for the Co-ordination Committee within ten (10) days after the Effective Date of this Agreement and, thereafter, immediately upon replacement. The Co-ordination Committee shall meet twice a year and more often upon request of either Party. The meeting places shall alternate between the offices of the Parties in Frankfurt and New York, provided, that any meeting requested by a Party in addition to the biannual meetings shall be held at the place of the other Party.

5.4

All decisions of the Co-ordination Committee regarding the development plan shall be made in good faith in the best interest of this Agreement and shall be unanimous. In the event that the Co-ordination Committee is unable to agree upon an amendment of the development plan requested by AOI after good faith attempts to resolve such disagreement in a commercially reasonable fashion, then either Party may refer the disagreement to a personal face-to-face meeting between the Chief Executive Officer of Zentaris and the Chief Executive Officer of AOI which meeting shall take place within fourteen (14) days of the date of the relevant referral. If the Chief Executive Officer of Zentaris and the Chief Executive Officer of AOI cannot resolve such disagreement in a mutually acceptable manner within a further fourteen (14) days after such personal face-to-face meeting, then AOI shall have the casting vote. 

5.5

An additional goal of the Co-ordination Committee shall be to coordinate clinical and pre-clinical studies that are being conducted by each of the Parties in the Territory, with respect to AOI, and outside of the Territory, with respect to Zentaris, to minimize duplication of efforts and studies and to maximize combined resources to obtain Development Data that is useful for each of the Parties.  Accordingly, each Party shall provide the Co-ordination Committee with written notice of all pre-clinical and clinical studies, including any known investigator initiated trials, together with the results thereof, of the use of the Contract Products and/or Perifosine in the Field, conducted by that Party during the continuance of this Agreement. Each Party shall make available to the other Party, and to the members of the Co-ordination Committee, copies of all Development Data prepared by or for that Party during the continuance of this Agreement. All Development Data furnished by one Party to the other Party under this Agreement shall be deemed Confidential Information of the Party furnishing such results, studies, scientific information, know-how or other data.

6.

Use of Development Data

6.1

Subject only to Section 6.2 below, each Party will disclose to the other Party all Development Data, which it generates or which is generated by its licensees during the period of this Agreement, and each Party shall be entitled to disclose such Development Data to its licensees. The Parties shall ensure that its licensees agree to the disclosure of their Development Data to the other Party and its licensees and keep confidential all Development Data disclosed to them pursuant to this Section 6.1 except for the use of Development Data for Regulatory Filings. Each Party and their licensees shall be entitled to use the Development Data disclosed pursuant to this Section 6.1 for the development and commercialization of Perifosine and/or Contract Product in accordance with