Contract
Exhibit 10.39 FORM OF DISTRIBUTION AND MARKETING AGREEMENT by and between ALFACELL CORPORATION and USP PHARMA SPOLKA Z.O.O.
Effective as of July 25, 2007 |
DISTRIBUTION AND MARKETING AGREEMENT This Distribution and Marketing Agreement (the “Agreement”) is effective as of July 25, 2007 (“Effective Date”) and is by and between Alfacell Corporation, a Delaware corporation with principal offices at 000 Xxxxxx Xxxxx, Xxxxxxxx, Xxx Xxxxxx 00000 (“Alfacell”) and USP Pharma Spolka Z.O.O., a corporation formed under the laws of Poland with principal offices at c/o US Pharmacia International, Inc., 000 Xxxxxxxxxx Xxxxx, Xxxxx 0X, Xxxxxxxxx, Xxxxxxxx 00000 (“Distributor”). Alfacell and Distributor are referred to herein each as a “Party” and collectively as the “Parties”). WHEREAS, Alfacell is developing ONCONASE® for oncological uses and WHEREAS, Alfacell desires to appoint Distributor as the exclusive distributor in the Territory of Product for use in the Field and Distributor desires to accept such appointment, all on and subject to the terms and conditions hereinafter set forth. NOW, THEREFORE, subject to the terms and conditions of this Agreement, and in consideration of the covenants and agreements hereinafter set forth, as well as other good an valuable consideration, the receipt and sufficiency of which is acknowledged by the Parties, the Parties agree as follows. “AAA” shall have the meaning set forth in Section 18(c). “Additional Purchase Order” shall have the meaning set forth in Section 3(g). “Affiliate” of an entity means, for so long as one of the following relationships is maintained, any corporation or other business entity controlled by, controlling, or under common control with another entity, with “control” meaning direct or indirect beneficial ownership of more than fifty percent (50%) of the voting stock of such corporation, or more than fifty percent (50%) interest in the decision-making authority of such other business entity, or a corporation in which the maximum amount of stock permitted by law to be held by another entity is beneficially owned by such other entity. “Alfacell Indemnitees” shall have the meaning set forth in Section 9(b). “Annual Forecast” shall have the meaning set forth in Section 3(f). “Annual Minimum” shall have the meaning set forth in Section 3(c). “Applicable Law” shall mean all applicable laws, rules, regulations, guidelines and standards. “CPR” shall have the meaning set forth in Section 18(b). “Disclosing Party” shall have the meaning set forth in Section 16. “Dispute” shall mean dispute, controversy or claim between the Parties based on or arising out of this Agreement, any obligation or warranty hereunder or the breach or alleged breach thereof. “Distribute” shall mean to promote, market, distribute and sell. |
“Distribution Commitment” shall have the meaning set forth in Section 2(b). “Distributor Indemnitees” shall have the meaning set forth in Section 9(a). “EMEA” shall mean the European Agency for the Evaluation of Medicinal Products. “Extended Term” shall have the meaning set forth in Section 13(a). “Field” shall mean human therapeutic uses in the field of oncology. “Fiscal Quarter” shall mean the three (3) month period ending on January 31, April 30, July 31, or October 31 of each calendar year, as the context requires. “First Commercial Sale” shall mean the date of the first arm’s length transaction, transfer or disposition for value to a Third Party of a Product by or on behalf of Distributor or any Affiliate or permitted Sub-distributor in such country. “Indemnitee” shall mean a Distributor Indemnitee or an Alfacell Indemnitee. “Indemnitor” shall have the meaning set forth in Section 9(c). “Initial Indication” shall mean the treatment of Mesothelioma with Product. “Initial Term” shall have the meaning set forth in Section 13(a). “JCC” shall have the meaning set forth in Section 8(b). “Liaison” shall have the meaning set forth in Section 8(a). “Marketing Materials” shall mean, to the extent permitted by Applicable Law, all sales, education and marketing materials including all patient and physician communications and materials, websites, educational materials and presentations, and detailing products and premiums. “Net Sales” shall mean, on a country-by-country basis, the gross invoiced sales price for all Product sold by Distributor, its Affiliates or permitted Sub-distributors to Third Parties throughout the Territory during each Fiscal Quarter, less the following amounts incurred or paid during such Fiscal Quarter with respect to sales of Product regardless of the Fiscal Quarter in which such sales were made: |
* * * * * * * * * * |
“Net Sales” shall not include sales or transfers between Distributor and its Affiliates or Sublicensees, unless Product is consumed by the Affiliate or Sublicensee. “Notice of Breach” shall have the meaning set forth in Section 13(b)(i). “Notice of Termination” shall have the meaning set forth in Section 13(b)(i). “Patent Rights” shall mean the rights and interests in and to issued patents and pending patent applications (including inventor’s certificates and utility models) in any country or jurisdiction within the Territory, including all provisionals, substitutions, continuations, continuations-in-part, divisionals, supplementary protection certificates, renewals, all letters patent granted thereon, and all reissues, |
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reexaminations, extensions, confirmations, revalidations, registrations, patents of addition thereof, PCTs and foreign counterparts, owned, controlled, partnered, or licensed by a Party. “Product” shall mean ONCONASE® (ranpirnase) for injection. “Product Cost” shall mean * * * * * * * * * *. “Purchase Order” shall have the meaning set forth in Section 3(f). “Receiving Party” shall have the meaning set forth in Section 16. “Regulatory Approval” shall mean any and all approvals (including pricing and reimbursement approvals), product and establishment licenses, registrations or authorizations of any kind necessary for the development, pre-clinical and/or human clinical testing, manufacture, quality testing, supply, use, storage, importation, export, transport, marketing and sale of a Product (or any component thereof) for use in the Field in any country or other jurisdiction in the Territory. “Remedial Action” shall have the meaning set forth in Section 7(b). “Specifications” shall mean the final commercial specifications for Product established by Alfacell. “Sub-distributors” shall have the meaning set forth in Section 2(a). “Taxes” shall mean sales, use, import, export, excise, value added and similar taxes, and customs duties and assessments, however designated, that are incurred or assessed in connection with the purchase of Product under this Agreement, the sale or use of Product or transactions contemplated under this Agreement, excluding (for the avoidance of doubt) income tax imposed on Alfacell. “Territory” shall mean the countries of Poland, Lithuania, Estonia, Latvia, Belarus and the Ukraine. “Third-Party Claims and Expenses” shall mean claims, actions, causes of action, liabilities, losses, costs and expenses (including reasonable attorneys’ fees) incurred thereby or caused thereto arising out of third-party claims. “Transfer Price” shall have the meaning set forth in Section 3(b). “Up-front Fee” shall have the meaning set forth in Section 5(a). “Valid Claim” shall mean a claim in an issued, unexpired patent or in a pending patent application among the Patent Rights covering Product that (a) has not been finally cancelled, withdrawn, abandoned or rejected by any administrative agency or other body of competent jurisdiction, (b) has not been revoked, held invalid, or declared unpatentable or unenforceable in a decision of a court or other body of competent jurisdiction that is unappealable or unappealed within the time allowed for appeal, (c) has not been rendered unenforceable through disclaimer or otherwise, and (d) is not lost through an interference proceeding. |
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approval of Alfacell, which shall not be unreasonably withheld, delayed, or conditioned. The Parties shall discuss such plan, and Distributor’s performance against it, at meetings of the JCC. |
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(a) Development and Approval. Alfacell shall use its commercially reasonable efforts to obtain and maintain (and shall have the
sole right and responsibility for obtaining and maintaining) all necessary Regulatory Approvals in
the Territory for Product. All Regulatory Approvals shall be obtained and maintained in the name
of Alfacell. Distributor shall, at its sole cost and expense, provide all cooperation reasonably
requested by Alfacell in connection with its Product development and obtaining and maintaining of
Product Regulatory Approval. Distributor shall not perform any Product development, including the
conduct of preclinical, clinical, marketing, or post-marketing studies on Product absent the express
prior written consent of Alfacell. Any permitted studies shall be conducted with the participation
of and at the direction of Alfacell. |
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(b) Supply. Distributor shall obtain Product only from Alfacell or its designated manufacturer. Alfacell shall
supply to Distributor all of its Product requirements. As partial payment for Product, upon delivery
of Product by Alfacell in accordance with Section 3(g) below, Distributor shall pay to Alfacell *
* * * * * (the “Transfer Price”). The foregoing payment shall be in addition to any other payments hereunder, including those set forth in Section 5. * * * * * * * * *. |
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(c) Annual Minimum. Not less than * * * * * after First Commercial Sale, the Parties shall agree on annual minimum Product
sales for * * * * * * (the “Annual Minimum”). Each Party’s Liaison shall * * * * * * to the end of each calendar year, agree on any adjustments to the Annual Minimum for the following calendar year. |
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(d) Commercial Pricing. Distributor shall have the right to set Product pricing for customers in its sole discretion. |
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(e) Initial Product Delivery. Not less than * * * * * * prior to the anticipated date of First Commercial Sale * * * * * * *, the
Parties agree to meet and determine the approximate date on which Product will be first be shipped
to Distributor. In addition, the Parties shall agree upon an initial one (1)-year forecast of Distributor’s Product requirements. |
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(f) Product Forecasts and Purchase
Orders. Not less than * * * * * prior to initial Product delivery and, thereafter, * * * * * * * prior to
the first business day of every Fiscal Quarter, Distributor shall submit to Alfacell a rolling quarterly
forecast * * * * * (“Annual Forecast”) detailing its Product requirements by Product accompanied by purchase orders for * * * * * * (each, a “Purchase Order”). * * * * * * * Distributor, and the Purchase Orders for the second Fiscal Quarter shall be firm, non-cancelable and binding on Distributor unless modified in writing by Distributor by written notice to Alfacell received by Alfacell at least * * * * * prior to the scheduled delivery date in such month, provided that the difference between the forecast Purchase Order and the modified Purchase Order for a given Fiscal Quarter shall * * * * * * of the forecast Purchase Order. From time-to-time, Distributor may place additional Purchase Orders for Product with Alfacell either by written purchase order or by electronic or other ordering processes established and mutually approved by Distributor and Alfacell (“Additional Purchase Orders”), and Alfacell will attempt to
fill Additional Purchase Orders, but shall not be in breach of this Agreement should it fail to do so. |
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(g) Delivery. Subject to the foregoing, Alfacell shall use commercially reasonable efforts to deliver Product in
order to meet the quantity ordered and delivery dates specified in Distributor’s Purchase Orders. In Distributor’s name and at Distributor’s risk and expense, Alfacell will deliver Product in accordance with standard operating procedures established by Alfacell and approved by Distributor, such approval not to be unreasonably withheld, delayed or conditioned. Alfacell’s Transfer |
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(b) Equity Investment. In partial consideration of the appointment of Distributor as exclusive distributor of Product as
set forth herein, the Parties have entered into that certain Stock Purchase Agreement dated as of
the date hereof. |
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(c) Milestones. In partial consideration of the appointment of Distributor as exclusive distributor of Product as
set forth herein, Distributor will pay to Alfacell the following milestone payments within ten (10)
days after such milestone is met: |
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MILESTONE | PAYMENT | |
* * * * * * * * | * * * * * * | |
* * * * * * * * | * * * * * * | |
* * * * * * * * | * * * * * * | |
* * * * * * * * | * * * * * * | |
* * * * * * * * | * * * * * * |
(d) Royalties. In partial consideration of the appointment of Distributor as exclusive distributor of Product as
set forth herein, and subject to the other terms of this Agreement (including the remainder of this
Section 5), commencing on the date of the First Commercial Sale of each Product in each country in the Territory and continuing for the Term, Distributor shall pay to Alfacell a royalty equal to * * * * * * of Net Sales of any Product sold by Distributor and/or its Affiliates and/or permitted Sub-distributors, provided that royalty payments for any given Fiscal Year plus the Transfer Price for Product sold to produce the underlying Net Sales shall not exceed a total of * * * * * * of the relevant Net Sales (the “Royalty Cap”). Reconciliation of the Royalty Cap shall be made on a fiscal year-basis as part of the calculation of royalties due for each fiscal year’s final Fiscal Quarter. |
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(e) Sales Reports. Within thirty (30) days after the end of each Fiscal Quarter, Distributor shall deliver a report to
Alfacell that sets forth, on a country-by-country basis, the number of Products sold; sales price;
the applicable royalty rate under this Agreement; the royalties payable in each country’s currency, including an accounting of deductions taken in the calculation of Net Sales; the applicable exchange rate to convert from each country’s currency to United States Dollars under this Section; the royalties payable in United States Dollars; and other significant sales metrics as reasonably requested by Alfacell. For purposes of determining when a sale of any Product occurs under this Agreement, the sale shall be deemed to occur on the earlier of (a) the date the Product is shipped or (b) on the date of the invoice to the purchaser of the Product. |
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(f) Timing of Payments. Distributor shall pay (i) the Up-front Fee on the Effective Date, (ii) the Transfer Price upon Product
delivery, (iii) all royalty payments owed to Alfacell hereunder in arrears, within forty (40) days
from the end of each Fiscal Quarter in which such payment accrues, and (iv) all milestone payments
within ten (10) days of the achievement of such milestone. All payments to Alfacell are exclusive
of Taxes. Distributor shall pay all Taxes. |
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(g) Overdue Royalties. Subject to the other terms of this Agreement, any payments not paid within the time period set forth
in this Section 5 shall bear interest at a rate of * * * * * * per month from the due date until
paid in full, provided that in no event shall said annual rate exceed the maximum interest rate permitted
by Applicable Law in regard to such payments. Such royalty payment when made shall be accompanied
by all interest so accrued. Said interest and the payment and acceptance thereof shall not negate
or waive the right of Alfacell to any other remedy, legal or equitable, to which it may be entitled
because of the delinquency of the payment. |
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(h) Accounting. All payments hereunder shall be made in the United States in United States dollars. Conversion of
foreign currency to United States dollars shall be made at the conversion rate existing in the United
States (as reported in The Wall Street Journal) on the last business day of the quarter immediately preceding the applicable Fiscal Quarter. If The Wall Street Journal ceases to be published, then the rate of exchange to be used shall be that reported in such other business publication of national circulation in the United States as the Parties reasonably agree. |
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(i) Distributor’s Books
and Records. Distributor shall maintain accurate and complete books and records for a period of at least six (6)
years (or such longer period as may correspond to Distributor’s internal records retention policy) for each reporting period in which sales occur showing the sales, use and other disposition of Product by Distributor, its Affiliates and Sub-distributors in sufficient detail to enable the amounts payable to Alfacell hereunder to be accurately determined and otherwise to verify compliance by Distributor (and its Affiliates and Sub-distributors) with all obligations under this Agreement. Distributor shall permit its books and records to be audited, reviewed and copied (“examined” or “examination”) from time-to-time by authorized employees of, or attorneys and/or accountants selected by, Alfacell with at least ten (10) days advance written notice to Distributor, but not more frequently than once a year without cause. Such examination shall be during normal business hours and shall be made at the expense of the entity conducting
it, except that if the results of the examination for any year reveal that Distributor has underpaid Alfacell by an amount exceeding five (5) percent, then Distributor shall pay the reasonable costs and expenses incurred by the examining entity and its representatives in conducting such examination. Distributor shall immediately pay to Alfacell any underpayment revealed by such examination and accrued interest thereon. |
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6. INSPECTION OF DISTRIBUTOR FACILITIES AND RECORDS Distributor agrees to permit representatives of any relevant regulatory or governmental authority to access at any reasonable time during normal business hours relevant records, information (and where applicable make copies of the same), personnel and facilities. Distributor shall immediately notify Alfacell if any governmental or regulatory authority schedules, or without scheduling begins, an inspection or audit. Distributor shall make every reasonable effort to permit Alfacell to be present at or participate in such inspection or audit if the same relates directly or indirectly to this Agreement. In addition, Distributor will immediately provide Alfacell copies of any correspondence from or draft communications with (including any notes) government or regulatory authorities relating directly or indirectly to this Agreement. 7. COMPLAINTS, ADVERSE EVENT REPORTING AND RECALLS (i) Alfacell shall be responsible for the prompt review, evaluation and documentation of all complaints relating to Product, with Distributor’s reasonable cooperation. Distributor shall forward to Alfacell, within five (5) days—and within 24 hours with respect to reports of serious injury or serious adverse events—of initial receipt, all complaints received concerning Product, including, without limitation, all reports of serious injury, other adverse events, misuse, improper promotion or other problems. Distributor shall cooperate with Alfacell’s investigation of complaints, including (as reasonably necessary) by providing detailed distribution records to Alfacell and cooperating to notify affected customers. The Party whose conduct or omission caused the complaint shall be responsible for resolving it, at its expense, with the reasonable cooperation of the other Party. (ii) Alfacell and Distributor agree that if either Party discovers or becomes aware of any fact, condition, circumstance or event (whether actual or potential) concerning or related to Product that may reasonably require a report, a recall or market withdrawal of Product in the Territory, such Party shall promptly communicate such fact, condition, circumstance or event to the other Party within twenty-four (24) hours. In the event (i) any governmental entity or regulatory body requests that Product be recalled or withdrawn, (ii) a court of competent jurisdiction orders such a recall or withdrawal, or (iii) Alfacell determines that the Product should be recalled or withdrawn from the market, the Parties shall take all appropriate remedial actions with respect to such recall or withdrawal of Product (“Remedial Action”). Alfacell shall be responsible for all reporting, vigilance reporting and recalls associated with |
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Product, and Alfacell shall be the primary contact person for any communications to any governmental entity, regulatory body, the media and customers concerning the Remedial Action, with Distributor’s reasonable cooperation (including providing detailed distribution records and information helpful in the notification of customers). The Party whose breach of any of its representations, warranties or covenants contained herein is primarily attributable as the cause or basis for such Remedial Action shall be liable for, and shall reimburse the other Party for, all costs reasonably incurred as a result of such action, including replacement cost of any Product affected thereby. Alfacell shall notify Distributor within forty-eight (48) hours of undertaking a Remedial Action, and the reasons therefor. The Parties shall cooperate fully with one another to obtain all information reasonably required by regulatory or governmental authorities related to Product. |
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shall create or imply liability for Alfacell where such liability is expressly disclaimed or limited under this Agreement. |
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hereunder shall name the other Party as an additional insured with respect to this Agreement. Each Party shall deliver to the other a certificate from the insurance carrier or broker evidencing such coverage and the fact that the other Party is named as an additional insured and noting any exclusions and agreeing to provide no less than five (5) days’ prior written notice to the other Party in the event of a material change in coverage or policy cancellation. Alfacell hereby warrants as follows: |
(i) If Product is not returned within thirty (30) days of delivery, Distributor may not return a Product to Alfacell for any reason without Alfacell’s prior written consent; provided that (for the avoidance of doubt) this shall not limit Alfacell’s indemnification obligations for Third-Party Claims and Expenses based on a breach of the Product warranty as provided in Section 10(d). (ii) EXCEPT FOR, AND WITHOUT LIMITING, ALFACELL’S INDEMNIFICATION OBLIGATIONS UNDER SECTION 9(a) WITH RESPECT TO THIRD-PARTY CLAIMS AND EXPENSES ARISING OUT OF OR RESULTING FROM SUPPLIER’S BREACH OF THE PRODUCT WARRANTY IN SECTION 10(d), SUPPLIER’S EXCLUSIVE LIABILITY, AND THE EXCLUSIVE REMEDY OF DISTRIBUTOR, FOR SUPPLIER’S SUPPLY OF DEFECTIVE PRODUCT SHALL BE REPLACEMENT OF SUCH PRODUCT OR CREDIT THEREFOR. The warranty set forth in Section 10(d) is void if Product failure or deficiencies are (1) the result of occurrences, mishandling or modification during or after shipment to Distributor or (2) caused by an act or omission of Distributor, Affiliates, employees, agents or permitted Sub-distributors or any of their respective employees or agents. |
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Distributor hereby warrants as follows: |
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(i) This Agreement may be terminated by a Party for material breach of this Agreement by the other Party, unless the breaching Party shall have remedied such breach within ninety (90) days (thirty (30) days if the breach is a failure to pay money) following its receipt of written notice from the other Party describing such breach in detail, which notice shall include a statement of the intent to terminate this Agreement unless such breach is remedied (“Notice of Breach”). In the event such breach is not remedied within ninety (90) days (thirty (30) days if the breach is a failure to pay) from the breaching Party’s receipt of the Notice of Breach, the non-breaching Party may terminate this Agreement within ninety (90) days after the end of the initial cure period (or such longer time as the Parties may agree in writing) by sending a notice of termination to the breaching Party (“Notice of Termination”). This Agreement shall terminate thirty (30) days following the breaching Party’s receipt of such Notice of Termination. For the sake of clarity, any breach of Section 2(e), 2(f) 3(a) or 7 shall be deemed a material breach of this Agreement. (ii) This Agreement may be terminated by either Party by written notice to the other in the event that the other Party shall go into liquidation, or seek the benefit of any bankruptcy or insolvency act, or a receiver or trustee is appointed for its property or estate, or it makes an assignment for the benefit of creditors, whether any of the aforesaid events be the outcome of the voluntary act of such Party or otherwise, and such procedures are not terminated within ninety (90) days. (iii) Alfacell may terminate this Agreement as provided in Section 2(b). (iv) Alfacell may immediately terminate this Agreement in the event that Distributor challenges in any forum the validity, enforceability, scope or any other elements of Patent Rights covering a Product. (v) A Party may terminate this Agreement as provided in Section 15. |
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(c) Termination Rights; Survival of
Obligations. The termination of this Agreement for any reason shall be without prejudice to Alfacell’s right to receive all payments accrued and unpaid for Product delivered at or prior to the effective date of such termination and to the remedy of either Party hereto in respect of any previous breach of any of the covenants herein contained. The termination of this Agreement shall not release Alfacell from its obligation to deliver all Product ordered by Distributor prior to the notice of termination, unless the termination is based on Distributor’s breach of this Agreement or failure to meet the requirements of Section 2. Following termination or expiration of this Agreement, Distributor shall have the right to sell any Product remaining in its inventory, or which has been ordered prior to the notice of termination but not delivered, for a period of not more than six (6) months from the date of termination or expiration.
Distributor’s payment obligations hereunder and the provisions of Sections 2(e), 4, 5(e), 5(g), 5(h), 5(i), 6, 7, 9, 10(d)(ii), 12, 13(c), 14, and 16 - 26, shall survive termination or expiration of this Agreement, as shall such other provisions that, by their context, are logically intended to survive. |
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14. IP – OWNERSHIP; DEFENSE; INFRINGEMENT BY THIRD PARTIES All intellectual property (including inventions, whether patentable or not, and know how) conceived or developed by Distributor that relates to Product shall be the sole and exclusive property of Alfacell. Distributor shall disclose to Alfacell all such intellectual property and, upon the request of Alfacell, assign, and cause its employees and agents to assign, to Alfacell all rights in such intellectual property. Distributor shall not file for any Patent Rights that might cover Product. Alfacell shall have sole responsibility for the writing, filing, prosecution, maintenance and defense of all Patent Rights covering Product. Distributor shall notify Alfacell in writing in the event it becomes aware of any third-party infringement or threatened infringement of any patent or other intellectual property right in or to the Product. Alfacell shall have the exclusive right, in its discretion, to control any enforcement against such infringement or threatened infringement. Distributor shall fully cooperate with and provide all assistance to Alfacell in connection with Alfacell’s fulfillment of its obligations under this Section. If either Party shall be delayed or hindered in or prevented from the performance of any act required hereunder by reason of strike, lockouts, labor troubles, restrictive governmental or judicial orders or decrees, riots, insurrection, war, acts of God, inclement weather or other reason or cause reasonably beyond such Party’s control (each a “Disability”), then performance of such act shall be excused for the period of such Disability. The Party incurring the Disability shall provide notice to the other of the commencement and termination of the Disability. Should a Disability continue for more than three (3) months, the Party unaffected by the Disability may terminate this Agreement upon prior written notice to the affected Party. Should the Disability equally affect the performance of both Parties, then such termination shall only be by mutual written agreement. Each Party (the “Receiving Party”) acknowledges that all scientific, technical, financial and commercial information (written, oral, tangible or observed) previously disclosed by or obtained (prior to the Effective Date) from the other Party (the “Disclosing Party”) or hereafter possessed or obtained by the Receiving Party concerning the business, manufacturing, products or plans of the Disclosing Party, including, but not limited to, information relating to the Disclosing Party’s research, development, manufacturing or marketing methods, plans, issues and difficulties, financial plans and records, |
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intellectual property protection, and arrangements or negotiations with suppliers to or customers of, or others having significant dealings with, the Disclosing Party, shall be deemed to be the Disclosing Party’s confidential information (“Confidential Information”) and shall be maintained by the Receiving Party, its Affiliates and Sub-distributors, and their respective employees, agents and directors, in confidence at all times during the term of this Agreement, and for a period of five (5) years after this Agreement has expired or been terminated for any reason, except as otherwise permitted in writing by the Disclosing Party. Without limiting the foregoing, each of the Parties further agrees to use the same degree of care concerning the other Party’s Confidential Information as it uses to protect its own confidential and proprietary technical information to prevent the unauthorized disclosure to any third party of such Confidential Information and to not use the other Party’s Confidential Information for any purpose except for those purposes contemplated by this Agreement.. Any information owned by Alfacell pursuant to Section 14 shall be the Confidential Information of Alfacell. The obligations hereunder shall not apply to Confidential Information: (A) which the Receiving Party can demonstrate by written records was known to it prior to the date of disclosure by the Disclosing Party; provided that such information was not obtained by the Receiving Party through wrongful disclosure by a third party receiving such information in confidence from the Disclosing Party; (B) which is now in the public knowledge, or becomes public knowledge in the future other than by breach of this Agreement by the Receiving Party; (C) which, as can be established by written records, is independently developed by the receiving Party without benefit of Confidential Information received from the Disclosing Party; (D) which is disclosed to the Receiving Party, after the date of disclosure by the Disclosing Party, by a third party having a right to make such disclosure; or (E) which is required to be disclosed by Applicable Law or proper legal, governmental or other competent authority, or the rules of any securities exchange on which any security issued by either Party is traded, or included in any filing or action taken by the receiving party to obtain or maintain government clearance or approval to market Product; provided, however, that when permitted by the provisions of Applicable Law, the Receiving Party shall use its reasonable best efforts to protect the confidentiality of such Confidential Information submitted to governmental agencies or authorities pursuant to this Agreement, and; provided, however, further, that, with regard to a court order or similar process, the Party whose information is to be disclosed shall be notified sufficiently in advance of such requirement so that it may seek a protective order (or equivalent) with respect to such disclosure, which the other Party shall fully comply with; and, provided, however, further, that in the case of a disclosure required to comply with the rules of any securities exchange, the Party required or intending to disclose the other Party’s Confidential Information will provide the other Party with a reasonable opportunity to review such disclosure prior to its public release or filing with a regulatory authority and will consider in good faith reasonable changes to such disclosure requested by the other party. All notices, consents and approvals hereunder shall be in writing and shall be deemed to have been properly given and to be effective on the date of delivery if delivered in person, by international courier service or by facsimile transmission (provided a faxed copy is also sent by international courier service, provided that notices of breach or notices of termination of this Agreement shall not be sent by |
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facsimile transmission) to the respective address or facsimile number provided below or to such other address or facsimile number as a Party shall designate by written notice to the other in such manner: |
If to Distributor: | USP Pharma Spolka Z.O.O. c/o US Pharmacia International, Inc. 000 Xxxxxxxxxx Xxxxx, Xxxxx 0X Xxxxxxxxx, Xxxxxxxx 00000 Attention: Xxxxxxx Xxxxxxxx Facsimile: (000)000-0000 |
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with a copy to: | Xxxxxx & Xxxxxx LLP 000 Xxxxxxx Xxxxxx, XX Xxxxxxxxxx, X.X. 00000-0000 Attention Xxxxxx Xxxx Facsimile: (000) 000-0000 |
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If to Alfacell: | Alfacell Corporation 000 Xxxxxx Xxxxx Xxxxxxxx, Xxx Xxxxxx 00000 Attention: Xxxxxx Xxxxxxxx Facsimile: (000) 000-0000 |
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With a copy to: | Xxxxxx Xxxxxx LLP Times Square Tower 0 Xxxxx Xxxxxx Xxx Xxxx, Xxx Xxxx 00000 Attention: Xxxxx X. Xxxxxxx Facsimile: (000) 000-0000 |
(i) In the event of any Dispute, a Party shall give detailed written notice of such Dispute to the other Party. The Parties shall attempt in good faith to resolve such Dispute in a voluntary, amicable and expeditious manner through mediation pursuant to Section 18(b). (ii) The Parties shall endeavor to resolve any dispute arising out of or relating to this Agreement by mediation in New York, New York under the International Institute for Conflict Prevention and Resolution (“CPR”) Mediation Procedure then currently in effect. Unless the Parties agree otherwise, the mediator will be selected from the JAMS panel of neutrals. If the dispute is not resolved within thirty (30) days of a Party’s written request for mediation, there is no further obligation to mediate. (iii) If the Parties are unable to resolve any Dispute through mediation as required by Section 18(ii), the Dispute shall be resolved by binding arbitration in accordance with the rules of the American Arbitration Association (“AAA”). The arbitration proceeding shall be commenced and conducted and completed in New York, New York. The Dispute shall be resolved by one (1) neutral arbitrator, to be mutually agreed upon by the Parties within forty-five (45) days following the receiving Party’s receipt of the written notice from the other Party requesting arbitration. In the event the Parties do not reach agreement on a single arbitrator within such 45-day period (such period being subject to extension by the Parties’ mutual agreement), then the arbitration shall be conducted by three (3) neutral |
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This Agreement may be executed in counterparts with the same effect as if both Parties had signed the same document. All such counterparts shall be deemed an original, shall be construed together, and shall constitute one and the same instrument. [Remainder of page is intentionally left blank] |
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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the day and year first above written. |
ALFACELL CORPORATION | ||
By: | ___________________________________ | |
Name: ____________________________________ | ||
Title: _____________________________________ | ||
Date: _____________________________________ | ||
USP PHARMA SPOLKA Z.O.O. | ||
By: | ___________________________________ | |
Name: ____________________________________ | ||
Title: _____________________________________ | ||
Date: _____________________________________ | ||
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TABLE OF CONTENTS |
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1. | DEFINITIONS | 1 | |
2. | APPOINTMENT; EXCLUSIVITY | 4 | |
(a) | Appointment of Distributor | 4 | |
(b) | Marketing and Distribution Commitment | 4 | |
(c) | Marketing and Distribution Plan | 4 | |
(d) | Manner of Marketing and Distribution | 5 | |
(e) | Distributor’s Exclusivity Obligations | 5 | |
(f) | Sales Outside the Field or Territory | 5 | |
(g) | Appointment of Sub-distributors | 5 | |
3. | PRODUCT | 6 | |
(a) | Development and Approval | 6 | |
(b) | Supply | 6 | |
(c) | Annual Minimum | 6 | |
(d) | Commercial Pricing | 6 | |
(e) | Initial Product Delivery | 6 | |
(f) | Product Forecasts and Purchase Orders | 6 | |
(g) | Delivery | 6 | |
4. | PRODUCT LABELING, PRODUCT LITERATURE | 7 | |
5. | PAYMENT FROM DISTRIBUTOR | 7 | |
(a) | Up-front Fee | 7 | |
(b) | Equity Investment | 7 | |
(c) | Milestones | 7 | |
(d) | Royalties | 8 | |
(e) | Sales Reports | 8 | |
(f) | Timing of Payments | 8 | |
(g) | Overdue Royalties | 8 | |
(h) | Accounting | 8 | |
(i) | Distributor’s Books and Records | 9 | |
6. | INSPECTION OF DISTRIBUTOR FACILITIES AND RECORDS | 9 | |
7. | COMPLAINTS, ADVERSE EVENT REPORTING AND RECALLS | 9 |
22 |
23 |
23. | ASSIGNMENT | 19 |
24. | INDEPENDENT CONTRACTOR | 19 |
25. | PRESS RELEASES | 19 |
26. | COUNTERPARTS | 20 |
24 |