EX-10.1 2 dex101.htm AMENDED AND RESTATED SUPPLY AGREEMENT AMENDED AND RESTATED SUPPLY AGREEMENT
Exhibit 10.1
AMENDED AND RESTATED SUPPLY AGREEMENT
THIS AMENDED AND RESTATED SUPPLY AGREEMENT (the “Agreement”) is entered into this 25th day of May, 2007 (the “Effective Date”) by and between PLANTEX USA, Inc., a corporation organized under the laws of the State of New Jersey with offices at 0 Xxxxxxxxxx Xxxxx, Xxxxx 000, Xxxxxxxxxx, Xxx Xxxxxx 00000 (“PLANTEX”) and NOVACEA, Inc. (formerly known as D-Novo Therapeutics, Inc.) a corporation organized under the laws of the State of Delaware with offices at 000 Xxxxxxx Xxxx., Xxxxx 000, Xxxxx Xxx Xxxxxxxxx, Xx 00000 (“NOVACEA”) and hereby amends and restates that certain Supply Agreement as amended on or about January 24, 2006, March 21, 2006 and March 13, 2007 (the “Original Agreement”) entered into between the parties effective as of 27th day of December, 2001 (the “Original Effective Date”).
1. | DEFINITIONS |
The following words and phrases shall, for purposes of this Agreement, have the following meanings (with any term or phrase referred to below, or defined elsewhere in this Agreement, in the singular to include the plural and vice versa as the context requires):
“Action” shall mean any suit, action, investigation (governmental or otherwise), claim or proceeding initiated or filed against a party to this Agreement, which results in or could result in a Loss or Losses for which indemnification is required by the other party under Article 13 below.
“Active Pharmaceutical Ingredients” or “API” shall mean bulk, unformulated Calcitriol.
“Affiliate” of any party shall mean any Person that is controlled by, controls, or is under common control with such party. For this purpose, “control” of a corporation or other business entity shall mean the direct or indirect beneficial ownership of more than fifty percent (50%) in the equity of, or the right to appoint more than fifty (50) percent of the directors or management of such corporation or other business entity.
“Agreement” shall mean this Agreement as it is amended from time to time in the manner provided herein.
“ANDA” shall mean an Abbreviated New Drug Application filed with the FDA pursuant to its rules and regulations.
“Approval” shall mean any and all approvals, licenses, registrations or authorizations of the applicable Regulatory Authority necessary for the marketing of Finished Products in the relevant country in the Territory.
“cGMP” shall mean current good manufacturing practices as set forth in regulations issued by the FDA from time to time.
“Commercialization Partner” shall mean a commercial entity with global annual human pharmaceutical gross revenues of at least [*] dollars ($[*]).
“Contract Year” shall mean the twelve (12) month period measured from a specific date or event.
“DMFs” shall mean the drug master files covering the analysis and manufacture of the API, comprising any and all technical information in the possession of PLANTEX (or an Affiliate thereof), including, without limitation, analytical methods, stability and pharmaceutical data, impurities, and manufacturing processes with respect to the API.
“Effective Date” shall mean May 25, 2007.
“Finished Products” or “Finished Product” shall mean such pharmaceutical products developed and/or marketed by NOVACEA for the treatment and/or prevention of any cancer containing API as shall receive Approval for marketing by a Regulatory Authority.
“FDA” shall mean the United States Food and Drug Administration and all agencies under its direct control or any successor organization.
“FFDCA” shall mean the Federal Food, Drug and Cosmetic Act of 1934, as amended from time to time, and the regulations promulgated pursuant thereto, or any successor statute adopted to replace such act.
“Indemnified Party” shall mean the party to this Agreement entitled to be indemnified by the Indemnifying Party against a Loss or Losses pursuant to Article 13 below.
“Initial Launch” means the date on which NOVACEA (or any of its Affiliates or their respective licensees, if any) makes its first commercial sale in the Territory of any Finished Product to an unaffiliated third party.
[*] | Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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“Loss” or “Losses” shall mean any liability, loss, costs, damage or expense, including reasonable attorneys’ fees and expenses, incurred or suffered by a party to this Agreement, except for consequential damages, for which indemnification is required under Article 13 below.
“Manufacture” and “manufacturing” and other forms of such word or phrase shall refer to the manufacturing, handling, packaging, storage and/or disposal of the API and the raw materials and components used in connection therewith.
“NDA” means a New Drug Application filed with the FDA pursuant to its rules and regulations.
“Original Agreement” means that certain Supply Agreement entered into between the parties effective as of 27th day of December, 2001 and as amended on or about January 24, 2006, March 21, 2006 and March 13, 2007.
“Original Effective Date” means 27th day of December, 2001.
“Party” or “Parties”, when referring to the parties to this Agreement shall mean and include PLANTEX and NOVACEA, or each of them individually.
“Person” shall mean any individual, partnership, association, corporation, trust or legal person or entity.
“Regulatory Authority” shall mean any and all governmental bodies, organizations and agencies whose approval is necessary to develop, manufacture, import, use, and or market Finished Products in the relevant country of the Territory
“Territory” shall mean worldwide.
2. | TERM |
The initial term of this Agreement shall begin on the Original Effective Date and unless terminated in the manner provided in Article 14 hereof, shall expire upon the expiration of the greater of (i) ten (10) Contract Years from the Original Effective Date or (ii) the tenth (10th) anniversary of the date occurring prior to the tenth anniversary of the Original Effective Date that NOVACEA receives marketing approval for Finished Product from the FDA (“Initial Term”). NOVACEA shall notify PLANTEX in writing within five (5) days following receipt of such marketing approval. This Agreement shall be automatically extended upon the same terms and conditions for successive two (2) year periods (“Renewal Term”) unless either Party shall have provided notice of its intent not to renew this Agreement not less than one (1) year prior to expiration of the Initial Term or any Renewal Term then in effect. For purposes of this Agreement “Term” shall refer collectively to the Initial Term and the Renewal Terms, unless the context otherwise requires.
3. | SCOPE OF THE AGREEMENT |
This Agreement shall apply to purchases during the Term by NOVACEA (and its
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Affiliates and their respective licensees and contract manufacturing vendors, if any) of API and their respective, direct or indirect, successors and permitted assigns, for the development, commercialization, distribution and sale of Finished Product in the Territory.
4. | DEVELOPMENT EFFORT |
NOVACEA agrees at its sole cost and expense to use its best efforts to obtain Approval to market Finished Product in such countries in the Territory as shall be reasonably determined by NOVACEA, except that NOVACEA shall use its best efforts to obtain FDA Approval to market Finished Product in the United States based upon a NDA or ANDA, as shall be determined by NOVACEA. Notwithstanding the foregoing, if NOVACEA enters into an agreement with an effective date of no later than [*] with a Commercialization Partner to commercialize the Finished Product, then the standard above shall not apply and instead the standard provided in NOVACEA’s agreement with such Commercialization Partner shall apply which will at least be a commercially reasonable efforts standard. Alternatively, if this Agreement is assigned to such Commercialization Partner, then the standard applicable to the Commercialization Partner shall be the commercially reasonable efforts standard. In connection with the FDA Approval described above, NOVACEA shall at its sole cost and expense conduct all tests and studies reasonably required to enable NOVACEA to apply for, obtain and maintain FDA Approval for Finished Product. In connection with the development of Finished Product and securing any Approvals, NOVACEA agrees, on behalf of itself, its Affiliates and their respective licensees or contract manufacturing vendors, if any, to use only API obtained from PLANTEX (or its Affiliates) and from the second source that NOVACEA proposes to utilize pursuant to Section 5.1 below, and purchase all their respective development requirements of API from PLANTEX (or its Affiliates) and such second source. Upon the execution and delivery of this Agreement, PLANTEX shall provide and deliver to NOVACEA without charge two (2) grams of API. Thereafter, NOVACEA shall be charged [*] dollars ($[*]) per gram for Developmental Orders (as herein defined) of API sold hereunder and such price shall not be subject to increase or decrease. Notwithstanding Section 6.2 below, such payment shall be due and payable upon delivery to NOVACEA of any Developmental Order or portion thereof. As used herein, “Developmental Orders” means orders placed prior to Approval by a Regulatory Authority and not in connection with commercial production in connection with commercial launch following any such Approval. After January 1, 2008, all Developmental Orders shall be minimum noncancellable orders for quantities of not less than [*] grams each, such quantities currently forecasted by NOVACEA at [*] grams for 2008, [*] grams for 2009 and [*] grams for 2010. For Developmental Orders on an annual basis after 2010, NOVACEA shall notify PLANTEX of its minimum noncancellable quantities for the applicable year (not to be less than [*] grams each year) no later than September 30 of the preceding calendar year. Each of the Developmental Orders shall be deliverable over periods not exceeding twelve (12) months, in partial shipments of not less than [*] grams each and not greater than [*] grams each; provided that PLANTEX shall use commercially reasonable efforts to deliver to NOVACEA or its designee quantities set forth in a Developmental Order quarterly shipments of no less than [*] percent ([*]%) of the applicable Developmental Order.
[*] | Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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5. | COMMERCIAL SUPPLY. |
(ii) NOVACEA covenants that, to the extent that NOVACEA or its Affiliates or licensees or contract manufacturers elect to purchase from a source other than PLANTEX or its designated Affiliates any API for use in connection with its manufacture, sale and distribution of Finished Products within the Territory, NOVACEA shall treat as confidential and not disclose to such source any PLANTEX Confidential Information (as defined in Section 16.1, below) including, without limitation, PLANTEX’s product manufacturing procedures, levels of impurities, certified analytical standards and analytical methods, and shall cause its Affiliates, licensees and contract manufacturers to comply with this covenant.
(iii) Within sixty (60) days after the last day of each calendar year commencing the calendar year of first commercial sale of Finished Product in the United States, NOVACEA shall certify to PLANTEX in writing that: (i) neither NOVACEA nor any Affiliate or licensee or contract manufacturing vendor of NOVACEA or its Affiliates has in such calendar year purchased from any source other than PLANTEX or its designated Affiliates API for use in connection with the manufacture, sale or distribution of Finished Product in the Territory in excess of the amounts
[*] | Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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permitted in Section 5.1(i), above, and (ii) neither NOVACEA nor any of its Affiliates, licensees or contract manufacturing vendors has disclosed to any third party any PLANTEX Confidential Information in violation of the covenant set forth in Section 5.1(ii), above. PLANTEX shall have the right, not more than once each calendar year, during normal business hours and on at least ten (10) business days’ advance notice to NOVACEA, to inspect the books and records and facilities of NOVACEA and its Affiliates to confirm the accuracy of the certification made by NOVACEA pursuant to this Section 5.1(iii).
(iv) Subject to Section 13.2 below, in the event that NOVACEA is in breach of either of its covenants set forth in Sections 5.1(i) and 5.1(ii), above, then PLANTEX shall be entitled to seek all damages and other legal remedies resulting from such breach, including without limitation, the right to terminate this Agreement as provided in Section 14.1(ii), below.
[*] | Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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5.5 Forecasts and Purchase Orders. [*] months prior to the date on which NOVACEA, in good faith, anticipates Approval, NOVACEA will provide PLANTEX with [*] month rolling forecasts of its requirements by calendar quarter for API. Thereafter, such rolling forecasts shall be delivered to PLANTEX on or before the fifteenth (15th) day of each calendar quarter during the Term. The first calendar quarter of each [*] month rolling forecast shall be binding on PLANTEX and NOVACEA and shall constitute a firm purchase order (“Firm Purchase Order”) for the API indicated for such calendar quarter. PLANTEX shall supply NOVACEA with (i) the quantities set forth on each such Firm Purchase Order and (ii) such additional amounts as NOVACEA may order in excess of its forecasted amounts for such calendar quarter, provided that PLANTEX shall have confirmed and accepted such additional orders within thirty (30) days of PLANTEX’s receipt of NOVACEA’s written request for such additional amounts. PLANTEX agrees to use commercially reasonable efforts to meet any such additional orders. In the event that PLANTEX determines, based in part on NOVACEA’s good faith [*] month rolling forecast, on a consistent basis and in accordance with PLANTEX’s standard accounting practices, in good faith (other than for reasons of force majeure as provided for in Section 15, below), that its revenues derived from manufacturing API are not equal to or exceed the costs for manufacture of API, and that it will therefore discontinue the manufacture of API worldwide and terminate its delivery obligations to NOVACEA, and any other third party, by giving to NOVACEA not less than [*] months prior written notice, NOVACEA and/or its licensees shall have the right, within the first [*] months of such [*] month period, to make a minimum [*] month purchase commitment in an amount sufficient to bring such revenues to a level equal to manufacturing costs plus [*] percent, in which case PLANTEX shall not be entitled to discontinue the manufacture of API and terminate its delivery obligation hereunder, but will instead be obligated to continue the manufacture and delivery of API, as required by NOVACEA or its licensee. The terms and conditions of this Agreement shall apply to all purchase orders hereunder and if any terms and conditions contained in such purchase orders shall conflict with any terms and conditions contained herein, the terms of this Agreement shall control. No additional terms or conditions set forth in any such purchase order (other than the quantities and delivery dates set forth therein and conforming to the provisions of this Agreement) shall be binding upon PLANTEX, unless agreed to in writing by PLANTEX. Any additional terms therein contained shall be deemed to be a proposed offer of amended terms that shall be deemed rejected by PLANTEX and of no force or effect, notwithstanding any action or inaction by PLANTEX other than its express written approval of such additional terms.
[*] | Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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DMF for API or utilize an additional site in the event that PLANTEX makes a good faith determination that it is necessary to relocate such site or to utilize an additional site in order to meet NOVACEA’s requirements of API. Such plan shall contemplate completion of relocation and securing necessary regulatory approvals within [*] of the determination by PLANTEX that such relocation was required. In the event that relocation has not been completed within such [*] period, NOVACEA’s sole remedy shall be to terminate this Agreement.
[*] | Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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6. | PRICE; PAYMENTS; DELIVERY |
6.1.1 The price payable to PLANTEX hereunder for API shall be [*] dollars ($[*]) per gram. During development of the Finished Product, PLANTEX agrees not to increase the price of API with respect to developmental quantities. At such time as NOVACEA receives FDA approval to market Finished Product, , provided that NOVACEA purchases not less than [*] grams of API in the first Contract Year following Approval by a Regulatory Authority and in each Contract Year after the second anniversary of such Approval, the maximum price payable for API hereunder shall be [*] dollars ($[*]) per gram, except that such pricing may be adjusted upwards for changes in the Consumer Price Index as follows: after the first anniversary of the Effective Date, prices charged following Approval by a Regulatory Authority in any Contract Year following the date hereof shall be determined by multiplying the price of [*] dollars ($[*]) per gram by a fraction x/y, when (x) shall equal the Current Index (as herein defined) and (y) equals the Base Index (as herein defined). As used herein the Current Index shall be the Consumer Price Index – All Urban Consumers (CPI-U), as published by the United States Department of Labor over the twelve (12) month period reported in such index immediately preceding the first day of each such Contract Year herein. The Base Index shall be the Consumer Price Index – All Urban Consumers (CPI-U), as published by the United States Department of Labor for November 2001 (Base Index of 100). Commencing with the third anniversary of the Effective Date, once, during each Contract Year thereafter, PLANTEX agrees to negotiate in good faith a price adjustment provided that NOVACEA can demonstrate that API is otherwise available, upon comparable terms and conditions as provided for herein, from an alternative supplier (other than NOVACEA or any Affiliate thereof) holding an approved FDA DMF and offering such API at a price that is more than [*] percent below the price offered by PLANTEX herein. NOVACEA shall be relieved of the requirements purchase obligations set forth in Section 5.1 of this Agreement and PLANTEX shall not be subject to the sole supply provisions set forth in Section 5.3 of this Agreement for such Contract Year or any subsequent Contract Year if, despite such good faith negotiations, NOVACEA and PLANTEX are unable to reach a mutually satisfactory price within forty-five (45) days of the date on which NOVACEA notifies PLANTEX of such pricing availability. Nothing contained herein to the contrary shall require PLANTEX to supply API at the pricing offered by any third party supplier. Additionally, PLANTEX and NOVACEA agree that they shall from time to time during the Term of this Agreement negotiate in good faith reductions in the price payable per gram based on (i) NOVACEA purchases of quantities of API in excess of [*] grams in a Contract Year or (ii) a significant reduction in PLANTEX’s costs to manufacture API. Following the date of Initial Launch, PLANTEX shall give NOVACEA prompt notice of any significant reduction in PLANTEX’s costs to manufacture API. Such reduction shall initially be determined based on PLANTEX’s costs to manufacture API as of the date of Initial Launch. PLANTEX’s costs to manufacture API shall be determined from year to year on a consistent basis and in accordance with PLANTEX’s standard accounting practices. For purposes hereof, a “significant reduction” shall mean a reduction of [*] percent or more, calculated on a cumulative basis (i.e., the reduction may occur over a period of greater than one (1) year). On each anniversary of the Effective Date, PLANTEX shall give NOVACEA notice of PLANTEX’s costs to manufacture API as of such date.
[*] | Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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6.1.2 The prices hereunder are F.O.B. PLANTEX’s facilities in New Jersey.
NOVACEA shall pay all invoices net within thirty days (30) days of invoice date by bank wire transfer, by automated clearinghouse (electronic funds transfer) or by such other means as the parties may otherwise agree to in United States Dollars in the requisite amount to such bank account as PLANTEX may from time to time designate. In the event that NOVACEA is delinquent in payment of invoices hereunder beyond the terms granted, PLANTEX, in its discretion, may suspend further shipments of API. Amounts not paid when due shall accrue interest payable at the rate of twelve (12) percent per annum, not to exceed the maximum rate of interest permitted by law. Any such interest charges shall be due and payable on demand.
Delivery of all API sold by PLANTEX to NOVACEA hereunder shall be made, and title thereto and risk of loss thereof shall pass, to NOVACEA upon receipt of the API by NOVACEA at NOVACEA’s facility.
7. | INTENTIONALLY LEFT BLANK |
8. | WARRANTIES; ACCEPTANCE AND CLAIMS |
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supply either samples of the API that are allegedly defective or some other evidence of deficiency that PLANTEX shall specify. If there is a disagreement between the Parties as to whether any API conforms to specifications, or meets the warranties set forth in Section 8.1 above, then samples and/or batch records, as appropriate, from the batch that is in dispute promptly will be submitted for testing and evaluation to an independent testing laboratory as shall be agreed to in writing by both Parties. The determination of such independent testing laboratory shall be binding upon the parties. If it is determined that the nonconformity is due to damage to API (a) caused by NOVACEA or its agents or (b) which occurs subsequent to delivery of such API to NOVACEA, PLANTEX shall have no liability to NOVACEA with respect to such nonconformity and the cost of any testing and evaluation by such testing laboratory shall be borne by NOVACEA. If it is determined that the nonconformity was not the result of either (a) or (b) above, then PLANTEX shall credit NOVACEA’s account for the price invoiced for such nonconforming API (or if payment therefor has previously been made by NOVACEA, pay NOVACEA the amount of such credit or offset the amount thereof against other amounts then due to PLANTEX.
9. | DEBARMENT |
Each party represents and warrants to the other that neither it nor any of its officers, directors, or employees performing services under this Agreement has been debarred, or convicted of a crime which could lead to debarment, under the Generic Drug Enforcement Act of 1992, 21 United States Code Sec. 306 (a) and (b). In the event that either party, or any of its officers, directors, or employees performing services under this Agreement, (a) becomes debarred or receives notice of action or threat of action with respect to its debarment or (b) becomes the object of any investigation or subject of any report regarding such party, or any of its officers, directors, or employees performing services under this Agreement, in connection with any activity that could result in debarment or suspension or refusal of approval, including without limitation any inspection report, warning letter, notice of opportunity for hearing in a case of debarment, or any other Justice Department, FDA or other federal or state government inquiry or action bearing on potentially illegal activities, such party shall notify the other party immediately.
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10. | FDA INSPECTIONS AND COMMUNICATIONS |
PLANTEX shall promptly notify NOVACEA of any FDA notices of violation or deficiency letters relating to the API. Each party shall promptly deliver to the other party all reports, data information and correspondence received by it from the FDA or any state or local authority with respect to the API (or Finished Product) and any cGMP issues relating thereto and any written response information, data or correspondence delivered by such party to the FDA at any state or local authority with respect to the API and shall cooperate to the extent reasonably requested by such other party in its response to the FDA or such other state or local authority.
11. | COMPLAINT HANDLING ADVERSE DRUG REACTION REPORTS |
12. | ACCESS TO FACILITIES AND AUDIT RIGHTS |
12.1 Upon reasonable notice, NOVACEA shall have the right, exercisable upon prior written notice no more frequently than on an annual basis, during normal business hours, with a maximum of two (2) persons, to inspect those areas of the facilities where API is manufactured for NOVACEA (or its Affiliates) and to review the pertinent records relating to the manufacturing, packaging and quality control of the API.
12.2 PLANTEX agrees to keep full, clear and accurate books and records with respect
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to costs of commercial manufacture of API for a minimum period of three (3) years after the relevant cost determination is made pursuant to Section 5.5. PLANTEX further agrees, upon reasonable prior notice, to permit such books and records to be examined during normal business hours by an independent nationally recognized accounting firm selected by NOVACEA and reasonably acceptable to the PLANTEX for the purpose of verifying the cost plus [*] percent price under Section 5.5. Such audit shall not be performed more frequently than once per calendar year nor more frequently than once with respect to records covering any specific period of time and shall be conducted under appropriate confidentiality provisions, for the sole purpose of verifying the accuracy and completeness of the financial, accounting and numerical information and calculations provided in Section 5.5. Such examination is to be made at the expense of NOVACEA, except in the event that the results of the audit reveal an overpayment of for API of [*] percent ([*]%) or more over the period being audited, in which case reasonable audit fees for such examination shall be paid by PLANTEX.
13. | INDEMNIFICATION |
NOVACEA shall indemnify, defend, save and hold PLANTEX and each of its Affiliate, officers directors, employees and agents harmless from and against Loss or Losses resulting from, or arising out of (a) any material breach of any warranty or material non-fulfillment or non-performance by NOVACEA of any agreement, covenant or obligation of NOVACEA contained in this Agreement; (b) any actual or alleged defect in any Finished Product sold by NOVACEA or any of its Affiliates or their respective licensees, if any, not resulting from a material breach of this Agreement by PLANTEX; (c) any alleged infringement or violation of any patent, trade secret or proprietary rights used by NOVACEA or any of its Affiliates or their respective licensees or contract manufacturing vendors, if any, in manufacturing, importing or selling of Finished Product, or (d) FDA enforcement action, inspection or Finished Product recalls or market withdrawals resulting from NOVACEA’s or any of its Affiliates or their respective licenses or contract manufacturing vendors, if any, failure to manufacture Finished Product in accordance with all applicable laws, rules, orders or regulations.
13.2 Limitation of Liability. IN NO EVENT SHALL ANY PARTY BE LIABLE TO THE OTHER UNDER ANY PROVISION OF THIS AGREEMENT OR UNDER ANY CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY FOR ANY RESULTANT, INDIRECT, SPECIAL OR EXEMPLARY DAMAGES OR, SPECIFICALLY, CONSEQUENTIAL DAMAGES OR DAMAGE TO GOODWILL AND REPUTATION.
[*] | Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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14. | TERMINATION |
(i) The expiration of the Initial Term or any Renewal Term;
(ii) The breach by either party of any provision of this Agreement which is not cured within thirty (30) days from the date of written notice delivered to the defaulting party in the case of a payment default, and within ninety (90) days from the date of such notice in all other cases, unless such breach, not involving the payment of money, is of a nature that cannot be cured within such ninety (90) day period and the breaching Party initiates the cure of such breach and proceeds diligently to remedy same provided, however, that only the aggrieved party can terminate this Agreement pursuant to this subsection (ii);
(iii) The mutual written agreement of the parties to this Agreement;
(iv) The filing of a bankruptcy petition by or against a party or the appointment of a receiver for the assets or business of a party that is not dismissed within sixty (60) days from the date of such filing or appointment;
(v) The continuation of any act of force majeure for a period of six (6) months or longer; or
(vi) Election of either party upon two (2) years prior written notice to the other party, given not earlier than the third anniversary of the FDA Approval of Finished Products.
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15. | FORCE MAJEURE |
Except for the obligation of any party to make payments to the other party pursuant to this Agreement (which shall not be deferred or extended for any reason), neither party to this Agreement shall be responsible to the other party for any failure to perform or delay in performing if such failure or delay is due to any strike, riot, civil commotion, sabotage, embargo, war or act of God or other cause beyond its reasonable control. Neither party shall be responsible for any failure to perform or delay in performing due to inability to obtain deliveries where such inability is caused by the supplier of such party; however, it shall not be an act of force majeure where PLANTEX, at the time it received the forecasts and purchase orders from NOVACEA, failed to make its best efforts to ascertain the ability of its suppliers to make timely shipments to it, and to inform NOVACEA thereof, as required in this Agreement.
16. | CONFIDENTIALITY |
[*] | Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. |
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16.5 Survival. The terms of this Section 16 shall survive termination of this Agreement.
17. | GENERAL PROVISIONS |
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(b) Either Party may assign this Agreement to an Affiliate of such Party upon prior written notice thereof to the non-assigning Party. Such notice shall be accompanied by an undertaking, in form reasonably satisfactory to the non-assigning Party, assuring that the assigning Party shall not be released of any obligations and remain primarily liable for the obligations of the assigning Party hereunder. Either Party may also assign this Agreement to a non-Affiliate upon prior written notice to the non-assigning Party in the event of a merger or acquisition of the assigning Party or the sale by the assigning Party to such non-Affiliate of all or substantially all of the assets (including, without limitation, the NDA or ANDA for the Finished Products) to which this Agreement relates provided that such successor has assumed all liabilities of the assigning Party hereunder.
If to PLANTEX: | PLANTEX USA Inc. | |
0 Xxxxxxxxxx Xxxxx | ||
Xxxxx 000 | ||
Xxxxxxxxxx, Xxx Xxxxxx 00000 | ||
Attention: President | ||
Fax Number: 0-000-000-0000 | ||
If to NOVACEA: | NOVACEA, Inc. | |
000 Xxxxxxx Xxxx. | ||
Xxxxx 000 | ||
Xxxxx Xxx Xxxxxxxxx, XX 00000 | ||
Attention: President | ||
Fax Number: 0-000-000-0000 |
17.3 Publicity. Except to the extent required by law or deemed appropriate by legal counsel to comply with securities laws, including the furnishing of a press release and the filing of such documents and information with the Securities and Exchange Commission as may be required by federal securities laws and the filing of any report, statement or document required by any other federal or state regulatory body, neither party to this Agreement shall publish, disclose or otherwise announce the existence of this Agreement or the terms hereof with out the consent of the other party, which consent shall not be unreasonably withheld.
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17.5 Governing Law. This Agreement shall be governed and construed in accordance with the laws of the State of New Jersey, without regard to principles of conflicts of law.
PLANTEX USA, INC. | NOVACEA, INC. | |||||||
By: | /s/ Xxxxxx Xxxxxx | By: | /s/ Xxxx Xxxxxx | |||||
Name: | Xxxxxx Xxxxxx | Name: | Xxxx Xxxxxx | |||||
Title: | President | Title: | Chief Executive Officer | |||||
By: | /s/ Xxxxx Xxxxxxxxx | |||||||
Name: | Xxxxx Xxxxxxxxx | |||||||
Title: | CFO |
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