CONFIDENTIAL TREATMENT REQUESTED BY NOVABAY PHARMACEUTICALS, INC.

This International Distribution Agreement (the “Agreement”) is effective as of the 9th day of January, 2012 (the “Effective Date”) by and between Pioneer Pharma Co. Ltd., with its principal place of business at Suite A-C 18F, HuDong Finance Building, No.1128, XiangYin Road, Shanghai, P.R.C. (“Pioneer”) and NovaBay Pharmaceuticals, Inc., a Delaware corporation with its principal place of business at 5980 Horton Street, Suite 550, Emeryville, CA 94608 (“NBY”), for the purpose of defining the rights and duties of the parties in connection with the distribution and potential development by Pioneer of NBY’s certain proprietary drug product.

 

WITNESSETH:

 

WHEREAS, NBY is engaged in the business of developing and commercializing certain therapeutic products, including the Product (as defined in the Agreement);

 

WHEREAS, Pioneer and its Holding Companies (as defined in the Agreement) have considerable experience in the marketing, sale and servicing of medical supplies, medical devices and pharmaceutical products;

 

WHEREAS, Pioneer wishes to obtain from NBY, and NBY wishes to grant to Pioneer, the right to distribute the Product in the Territory (as defined in the Agreement) subject to the terms and conditions set forth in this Agreement.

 

NOW, THEREFORE, for good and valuable consideration, the sufficiency and receipt of which are hereby acknowledged, the parties hereby agree as follows:

 

1.           Definitions.  As used in this Agreement, the terms defined below when capitalized shall have the following meanings:

 

(a)           “Applicable Laws” means all laws, ordinances, rules and regulations of any governmental entity or Regulatory Authority that apply to the Distribution, development and commercialization of Product in the Territory and the activities contemplated under this Agreement.

 

(b)           “Contract Year” means: (i) with respect to the first Contract Year, the 18-month period beginning on the date of receipt of the first MAA Approval, and (ii) with respect to each subsequent Contract Year, any 12-month period beginning on the end of the first Contract Year or an anniversary thereof.

 

 

(c)           “Customer” means any customer for the Product solicited by Pioneer, its Holding Companies and third party subdistributors within the Territory.

 

(d)           “Distribute” means to sell, distribute, market, promote, solicit orders for and provide services in connection with the Product.  “Distributed” and “Distribution” have correlative meanings.

 

(e)           “Holding Company” means any entity controlled by Pioneer.  For the purpose of this definition, control means: (i) direct or indirect ownership of fifty percent (50%) or more (or, if less than fifty percent (50%), the maximum ownership interest permitted by applicable law) of the stock or shares having the right to vote for the election of directors of such corporate entity or (ii) the possession, directly or indirectly, of the power to direct, or cause the direction of, the management or policies of such entity, whether through the ownership of voting securities, by contract or otherwise.

 

(f)           “MAA Approval” means approval of the MAA filed with SFDA.

 

(g)           “Marketing Approval Application” or “MAA” means an application filed with SFDA to obtain permission to commence marketing and sales in the Territory (excluding any pricing or reimbursement approval).

 

(h)           “Order” means a written description of the Product Pioneer desires to purchase that conforms to the requirements of this Agreement and is sent to NBY by mail, email, facsimile or similar means.

 

(i)           “Product” means NBY’s proprietary pharmaceutical product incorporating the compound internally referred to as NVC-101 as an active ingredient as currently developed for commercial sale under the name NeutroPhase® outside the Territory and as may be modified by mutual agreement of the Parties for approval by the SFDA, in the finished form (including the spray pump).  An initial draft of the specifications for the Product as currently developed for commercial sale outside the Territory is attached as Exhibit A and the Parties shall mutually agree from time to time to update such specifications as necessary for approval by the SFDA.

 

(j)           “Regulatory Authorities” means, with respect to a particular country or other regulatory jurisdiction, the regulatory agency, department, bureau or other governmental entity involved in regulating any aspect of the conduct, development, manufacture, market approval, sale, distribution, packaging or use of the Products, including without limitation the SFDA.

 

(k)           “SFDA” means the State Food and Drug Administration of China or any successor thereto.

 

 

 

(l)           “Territory” means People’s Republic of China, excluding Hong Kong, Macau and Taiwan.

 

2.           Appointment and Acceptance.

 

(a)           Grant of Distribution Rights.  Subject to the terms and conditions of this Agreement, NBY grants to Pioneer, and Pioneer accepts, an exclusive right to Distribute the Product directly to Customers in the Territory solely for indications approved by the SFDA for the Product.  Pioneer may appoint any of its Holding Companies in the Territory, solely for so long as such entity remains a Holding Company, to Distribute Product in the Territory in accordance with the terms and conditions hereunder.  In the event Pioneer wants to appoint any other third party (other than a Holding Company) to Distribute Product in the Territory, Pioneer shall enter into a written agreement (a “Subdistribution Agreement”) with such third party containing terms and conditions that are consistent with the terms and conditions of this Agreement and including provisions as materially protective of the Product and NBY as this Agreement. Pioneer shall, in addition to the quarterly report provided for under Section 6.7, provide NBY with a complete and updated list of third party subdistributors appointed by Pioneer for the Distribution of Product at the end of each quarter and otherwise upon NBY’s reasonable request.  Upon NBY’s request, Pioneer shall also provide NBY with a copy of the Subdistribution Agreement (with an English translation) with any such third party subdistributor (which copy may be redacted for information not relevant to the Distribution of Product). Pioneer shall take into reasonable consideration any concerns or issues raised by NBY with respect to any such third party subdistributors and the parties agree to discuss in good faith to resolve any such concerns or issues.  In any event, Pioneer shall remain responsible to NBY for all activities of its Holding Companies and/or third party appointees (including subdistributors and other subcontractors) to the same extent as if such activities had been undertaken by Pioneer itself.

 

(b)           No Distribution Outside Territory; Grey Market Activities.  Notwithstanding the rights granted to Pioneer to Distribute the Product in Section (a) above, to the extent permitted by Applicable Law, Pioneer shall not Distribute the Product outside the Territory and Pioneer shall not Distribute Product in the Territory for any indication unless and until the Product has received MAA Approval for such indications.  Pioneer shall use commercially reasonable efforts to prevent any Product that has been Distributed hereunder from being further sold, distributed or otherwise transported for use outside the Territory or for indications that the Product has not received MAA Approval, and Pioneer shall refer to NBY any inquiries and leads that Pioneer may receive for the purchase of Product for such purposes.

(c)           No Conflicts.  Pioneer represents and warrants to NBY that except for the Product and the list of products set forth in Exhibit B attached hereto, it does not currently Distribute any products that directly compete with the Product (“Competing Products”).  Pioneer agrees that, during the Term (as defined in Section 15(a)) and to the extent permitted under Applicable Law, it will not Distribute any Competing Product in the Territory without NBY’s prior written approval.  If Pioneer Distributes products in the Territory that are deemed in NBY’s judgment to constitute Competing Products, such Distribution will be considered a breach of this Agreement and NBY shall have the right, at its sole discretion, to either (i) terminate this Agreement in accordance with Section 15 (b)(a), or (ii) convert the appointment in Section (a) above to a non-exclusive arrangement, in each case without prejudice to any rights or remedies available to NBY under Applicable Law.

 

 

 

3.           Annual Minimums, Ordering, Forecasts, Delivery, and Acceptance.

 

(a)           Annual Minimums.  During the Initial Term (as defined below in Section 15(a)), Pioneer shall purchase from NBY (as provided in this Article 3) for Distribution under this Agreement, not less than the minimum quantities set forth on Exhibit C (“Annual Minimums”).  Prior to the end of the third Contract Year and every other Contract Year thereafter, the parties will negotiate and establish the Annual Minimums for the two upcoming Contract Years, provided that such Annual Minimums will not be less than the Annual Minimum of the then-current Contract Year.  In the event that Pioneer fails to purchase sufficient quantities to meet the Annual Minimums, NBY shall have the right, at its sole discretion, to either (i) terminate this Agreement in accordance with Section 15 (b)(a), or (ii) convert the appointment in Section 2(a) above to a non-exclusive arrangement, in each case without prejudice to any rights or remedies available to NBY under Applicable Law.

 

(b)           Forecasts.  By the 15th day of each month, Pioneer shall provide NBY with its best, good-faith rolling forecast of the Product that Pioneer expects to order from NBY under this Agreement in the immediately succeeding three (3) month period (each, a “Forecast”).  Each Forecast shall be provided in writing, in such form as NBY reasonably requires.  Pioneer shall use commercially reasonable efforts to ensure that its Forecasts are as accurate as possible and its Orders do not significantly deviate from the Forecasts.

 

(c)           Orders.  Orders for Product by Pioneer shall be placed with NBY at least ninety (90) days prior to the requested date of receipt of such Product.  All Orders must, at a minimum, include the Product description, quantity of Product ordered, the applicable Price (as defined below in Section 4.2), requested delivery date(s), any export/import information as well as such other information NBY may reasonably request from time to time to enable NBY to fill the Order.  Pioneer shall order, at a minimum, [***] Units (as defined in Exhibit A) of the Product under each Order.

 

(i)           Acceptance, Suspension and Cancellation.  No Orders are binding upon NBY unless accepted by NBY in writing.  NBY may accept or reject any Order, in whole or in part, in its sole discretion.  Once accepted by NBY, Pioneer may cancel or reschedule Orders for Product only with NBY’s prior written approval.

 

 

(ii)           Order Terms.  Pioneer may use its standard purchase order form to order Product; however, the terms and conditions of this Agreement shall supersede any different, conflicting, or additional terms on Pioneer’s Orders, acknowledgment or other document related to the purchase and sale of Products and NBY hereby expressly rejects any terms in any order that are different from, in conflict with or in addition to the terms and conditions hereof.  It is the intention of both parties hereto that the acceptance, even in writing, of any such purchase or sales document does not constitute a modification or amendment of, or addition to, the terms of this Agreement unless accompanied by a written amendment in the form required by Section 20(a).

 

(d)           Delivery.  All Product delivered pursuant to this Agreement shall be suitably packed for shipment in NBY’s standard shipping cartons, marked for shipment, and delivered to a common carrier and shipped CIP (Incoterms 2010) point of entry (e.g. airport of dispatch) of the Territory as identified in the applicable purchase order, at which time title to the Product and risk of loss and damage shall pass to Pioneer.  Each Order may be delivered in installments. Unless otherwise instructed in writing by Pioneer, NBY shall select the carrier.  NBY shall, at its own cost and expenses, be responsible for the carriage and insurance of Products from the country of manufacture to the point of entry of the Territory. Pioneer shall bear all applicable taxes, duties and similar charges that may be assessed against the Product after delivery to the point of entry of the Territory.  Notwithstanding the passage of title under this Section (d), NBY retains and Pioneer grants a purchase-money security interest in the Product and in any proceeds from Pioneer’s resale of the Product, until the full invoice amount for such Product has been paid in full to NBY.

 

(e)           Return Authorizations.   All Products shall be deemed irrevocably accepted by Pioneer upon receipt.  Notwithstanding the foregoing, Pioneer may submit a warranty claim for any Product that do not conform to the limited warranty granted to Pioneer in accordance with Section 9(a) by requesting a return authorization for any Product from NBY by mail, e-mail or telefax with a proper explanation of the alleged defect.  Within ten (10) days of Pioneer’s receipt of such a return authorization, the Product should be returned to NBY with freight prepaid by Pioneer.  The party shipping Product pursuant to this Section (e) shall bear the entire risk of loss for Product during shipment.   NBY shall reimburse Pioneer for any costs of transportation incurred by Pioneer in connection with the proper return to NBY of non-conforming Product.  In the case of improperly returned Product, Pioneer shall pay transportation charges in both directions.  Except as provided in this Section (e), all Product delivered under this Agreement are non-returnable.

 

 

 

(f)           Inventory.  Pioneer shall stock and maintain an adequate inventory of all Product to satisfy commercially reasonable demand for such Product, as to avoid any backorder to the Customer.

 

 

 

 

4.          Prices and Payment Terms.

 

(a)           Technology Access Fees.  In consideration for the exclusive rights granted under the Agreement, Pioneer will pay NBY the following amounts as set forth below:

 

(i)           Within ten (10) days of the execution of this Agreement, Pioneer shall pay NBY a technology access fee in the amount of US$312,500;

 

(ii)           Within thirty (30) days of the submission of the first Marketing Approval Application for the Product to SFDA, Pioneer shall pay NBY a technology access fee in the amount of US$312,500; and

 

(iii)           Within thirty (30) days of the receipt of a MAA Approval of the Product from SFDA, Pioneer shall pay NBY a technology access fee in the amount of US$625,000.

 

For clarity, in the event (A) NBY fails to submit a Marketing Approval Application for the Product in the Territory to SFDA or (B) the SFDA determines that additional development of the Product is necessary for MAA Approval in the Territory and either (i) Pioneer does not elect to co-fund the Additional Development (as defined in Section 6.2) within sixty (60) days from receiving NBY’s notice thereof, or (ii) Pioneer elects to co-fund the Additional Development, but after the performance of such Additional Development and filing of the applicable Marketing Approval Application based thereon, NBY is still unable to obtain MAA Approval for the Product, then NBY will refund Pioneer US$312,500.

 

(b)           Product Payments.  Pioneer shall pay NBY the prices for the Product under this Agreement (the “Prices”) as set forth in Exhibit D, subject to a total cumulative deductions equal to U.S. $[***] plus any Additional Development Costs incurred by Pioneer, which deductions may be taken in accordance with the schedule set forth in Exhibit D.  Prior to each shipment of Products, NBY will submit an invoice to Pioneer and Pioneer shall pay by wire transfer [***]% of the invoiced amount upon shipment of the Products to China and pay the rest of the balance  by wire transfer ([***]% of the invoiced amount) within one hundred twenty (120) days from the Bill of Lading date.  The difference in the Price paid by Pioneer hereunder and the selling price charged by Pioneer to Customers shall be Pioneer’s sole remuneration hereunder.

 

(c)           Payment Terms.  All payments shall be made in U.S. Dollars in immediately available funds.  A monthly interest rate of [***] percent ([***]%), or the maximum rate permitted by Applicable Law, whichever is lower, shall be applied to all outstanding balances not paid.  All payments shall be net of bank charges and exchange commission, which shall be borne by Pioneer.

 

 

 

(d)           Taxes.  Prices are exclusive of all applicable taxes.  Pioneer agrees to pay all taxes or other charges associated with the Distribution and delivery of the Product ordered, including, but not limited to, sales, use, excise, value-added and similar taxes and all customs duties, tariffs or governmental impositions, provided these are incurred in the Territory, but excluding United States federal, state and local taxes on NBY’s net income.  In the event NBY is required to pay any taxes or charges incurred in the Territory in connection with the delivery or distribution of Products under this Agreement, Pioneer shall reimburse NBY for such taxes or charges paid by NBY.

 

 

5.           Marketing and Promotion.

 

(a)           Marketing and Sales Efforts.  Pioneer shall keep NBY reasonably informed of its marketing strategy and plans for the Product within the Territory (including meeting with NBY at least twice a year in person or by teleconference to discuss such matters) and shall incorporate NBY’s reasonable comments and suggestions with respect thereto.  Pioneer shall use its best efforts to promote and sell the Product in each province within the Territory as soon as possible after MAA Approval is obtained by or on behalf of NBY, including, without limitation, [***].  Any and all costs associated with advertising, sales, marketing, promotion, workshops, seminars, conventions, exhibits or other selling costs shall be the responsibility of Pioneer.

 

(b)           Materials.  Pioneer may use such advertising and promotional materials as NBY may provide from time to time.  In addition, Pioneer may create advertising and promotional materials for Product (including translations of such materials into the native languages of the Territory), provided that Pioneer shall submit all such materials to NBY (including the English translation thereof as applicable) for approval at least thirty (30) days prior to the use or distribution of such materials.  Pioneer agrees to amend any such materials if and as requested by NBY, prior to any use thereof.

 

6.           Regulatory and Quality Assurance.

 

(a)           MAA Approval.  NBY will have the right and responsibility to file and register all MAAs and seek all MAA Approvals in the Territory, and will own all right, title and interest in and to any and all MAAs and MAA Approvals in the Territory.  NBY will keep Pioneer reasonably informed with respect to such matters (including meeting with Pioneer at least twice a year in person or by teleconference to discuss such matters) and Pioneer agrees to execute such documents, render such assistance, and take such other action as NBY may reasonably request, at NBY’s expense, to apply for, register, perfect, confirm, and protect NBY’s rights in the MAA Approvals.  After NBY’s receipt of MAA Approvals in the Territory, if there is any material change(s) to NBY’s marketing approvals in U.S., NBY will promptly inform Pioneer of such change(s) and NBY, in its reasonable judgment, may file any additional Marketing Approval Applications with SFDA.

 

 

 

(b)           Further Development in the Territory.  If the SFDA determines that additional development of the Product (whether clinical studies or otherwise) is necessary for MAA Approval in the Territory (“Additional Development”), then NBY will provide written notice to Pioneer of such determination.  Within [***] days of its receipt of such notice, Pioneer may elect, at its sole discretion, by providing written notice to NBY, to participate in the Additional Development.  In the event Pioneer elects to co-fund the Additional Development, the parties will conduct any Additional Development in accordance with terms and conditions set forth in Exhibit E attached hereto.  In the event (i) Pioneer does not elect to co-fund the Additional Development within [***] days from receiving NBY’s notice thereof, or (ii) Pioneer elects to co-fund the Additional Development, but after the performance of such Additional Development and filing of the applicable Marketing Approval Application based thereon, NBY is still unable to obtain MAA Approval for the Product, then this Agreement will terminate automatically and NBY will refund Pioneer US$312,500.  Such refund under this Section 6.2 shall be Pioneer’s sole remedy and NBY’s sole liability with respect to the development and regulatory approval of the Product.

 

(c)           Permits.  To the extent permitted under Applicable Law, Pioneer, at its own cost, shall be responsible for obtaining all government and other approvals beyond MAA Approval, including permits, registrations, licenses, exemptions, exceptions and other permissions, etc., necessary and useful to the lawful Distribution and use of the Product in the Territory, including without limitation any pricing or reimbursement approvals, import and export licenses and permits (collectively, “Permits”), unless otherwise agreed in writing by the parties.  Pioneer shall confer with NBY as to the type of Permits which Pioneer may apply and keep NBY informed with respect to any Permit acquisitions.   In the event of termination or expiration of this Agreement, Pioneer agrees to execute such documents, render such assistance, and take such other action as NBY may reasonably request, at NBY’s expense, to apply for, register, perfect, confirm, and protect NBY’s rights in the Permits including (without limitation) an assignment of all such Permit applications or Permits to NBY or such other third party as NBY may designate in writing.

 

(d)           Regulatory.  Pioneer shall comply fully with any and all Applicable Laws of the Territory.  Pioneer acknowledges that its obligation to comply with all Applicable Laws of the Territory shall include, without limitation, the following requirements: (i) prior to placing the first Order under Section 3(c) for resale to a Customer, Pioneer shall hold valid Permits required for lawful Distribution of the Product; (ii) Pioneer shall maintain adequate written procedures for warehouse control and Distribution of Product in accordance with Applicable Laws and in such a form as to enable NBY and Regulatory Authorities to trace the location of the Product; (iii) Pioneer shall comply with Applicable Laws with regard to timely reporting of adverse events, and shall immediately (and in any event within 24 hours) notify NBY of any such adverse events.  Pioneer shall refer all written and oral complaints of any kind concerning the Product to NBY as promptly as possible (and in any event within 48 hours).  Pioneer shall keep a record of all Customer complaints.

 

 

 

(e)           Quality Assurance.  Pioneer will maintain a characterized quality system in its organization and in particular will ensure that: (i) Pioneer will be able to proceed to recall specific Product if NBY so instructs; (ii) Pioneer keeps a file of the locations and conditions of all Product including any relevant batch and/or lot numbers in its Territory; and (iii) Pioneer personnel performing under this Agreement have appropriate technical skills, training, experience and expertise with respect to the Product to enable Pioneer to perform its responsibilities set forth herein.

 

(f)           Recalls.  Pioneer agrees that, if Pioneer discovers or becomes aware of any fact, condition, circumstance or event (whether actual or potential) concerning or related to any Product which may reasonably require a recall, market withdrawal, safety alert, and/or field correction under Applicable Law (each, a “Recall”) for such Product, Pioneer shall promptly communicate such fact, condition, circumstance or event to NBY within twenty-four (24) hours.  In the event (i) any Regulatory Authority requests a Recall for any Product, (ii) a court or other government agency of competent jurisdiction orders a Recall, or (iii) NBY determines, in its sole discretion, that a Recall of any Product should be conducted, Pioneer shall promptly implement any such Recall, but in any event not later than forty-eight (48) hours following receipt of notice from NBY.  NBY shall be solely responsible for all Recall determinations and shall control all aspects of the Recall process, including communicating with the applicable Regulatory Authorities or other third parties concerning the Recall.  Pioneer may not initiate or conduct a Recall of any Product without prior written approval by NBY.  NBY, at its own expense, shall replace any Product under Recall ordered by Pioneer (whether sold to a Customer or in inventory) or provide a full refund to Pioneer for any such Product.

 

(g)           Records and Reports.  Pioneer shall provide NBY with quarterly sales tracing reports that include Customer address, Product and any relevant serial, batch or lot numbers in such form and by such means as NBY reasonably requires.

 

(h)           Packaging.  Unless otherwise approved by NBY in writing, Pioneer shall not repackage or otherwise alter or modify the Product, and shall only resell the Product in the same packaging as originally received from NBY.  In addition, except for the addition of information required by Applicable Law, Pioneer shall not re-label Product supplied to Pioneer by NBY hereunder without the prior written consent of NBY.

 

7.           Audit, Books and Records.  NBY reserves the right for it or its representatives to audit Pioneer and to inspect Pioneer’s facilities to confirm compliance with the obligations of this Agreement once a year, or at a frequency which is reasonably needed by NBY to comply with Applicable Laws.

 

 

 

 

8.           Intellectual Property.

 

(a)           Product.  Pioneer acknowledges that the Product and any accompanying documentation and/or promotional or training materials are covered by intellectual property rights owned or licensed by NBY; and other than as expressly set forth in this Agreement, no license or other rights in such intellectual property are granted to the Pioneer, and all such rights are hereby expressly reserved by NBY.  Accordingly, Pioneer shall not (i) modify any Product or documentation NBY provides to Pioneer without the prior written approval of NBY or (ii) reverse engineer any Product, or otherwise attempt to discern the trade secret information of the Products, nor encourage or assist any third party in doing so.

 

(b)           Trademarks.  During the Term, Pioneer shall have the right to indicate to the public that it is an authorized distributor of the Product and to advertise within the Territory the Product under the trademarks, marks, and trade names that NBY may adopt from time to time, including “NeutroPhase” and the Chinese character trademark for “NeutroPhase”  (collectively, “NBY’s Trademarks”).  NBY’s Trademarks shall at all times remain the exclusive property of NBY and all use of NBY’s Trademarks shall inure to the exclusive benefit of NBY.

 

(c)           Trademark Restrictions.  All representations of NBY’s Trademarks that Pioneer intends to use shall be exact copies of those used by NBY or shall first be submitted to NBY for approval (which shall not be unreasonably withheld) of design, color and other details.  Pioneer shall not engage in any activity, which would adversely affect the name, reputation or goodwill of NBY or the Product.  In addition, Pioneer shall fully comply with all reasonable guidelines, if any, communicated by NBY concerning the use of NBY’s Trademarks.  In no event may Pioneer use or authorize any use of any of NBY’s Trademarks in any domain name whether registered, owned, or operated by or on behalf of Pioneer.  Pioneer shall not challenge or assist others to challenge NBY’s Trademarks (except to the extent such restriction is expressly prohibited by Applicable Law) or the registration thereof or attempt to register any trademarks, marks or trade names confusingly similar to those of NBY.  Any violation of the foregoing shall be deemed a material breach of this Agreement that is incapable of cure, entitling NBY to terminate this Agreement immediately upon notice to Pioneer.  Except as set forth in this Article 8, nothing contained in this Agreement shall grant or shall be deemed to grant to Pioneer any right, title or interest in or to NBY’s Trademarks.  Upon termination of this Agreement, except as provided in Section 15(c)(i), Pioneer shall immediately cease to use any and all of NBY’s Trademarks.

 

9.           Warranty and Disclaimers.

 

(a)           Limited Product Warranty.  To the extent permitted under Applicable Law, NBY warrants to Pioneer (and not to Customers) that NBY will manufacture the Product in accordance with then-current good manufacturing practices (GMP) promulgated by the applicable Regulatory Authority and other applicable laws, rules and regulations and all Products supplied to Pioneer hereunder conform to the specifications therefor for the period of the shelf life as set forth in the packaging thereof.  To the extent permitted under Applicable Law, NBY provides no warranties of any kind, whether express or implied, to Customer and Pioneer shall be responsible for providing a warranty to Customers and handling Customer warranty claims and returns for allegedly non-conforming Product.  Any warranty made by Pioneer to its Customers with respect to the Product shall not obligate NBY in any way and Pioneer shall retain full responsibility for the performance of any warranties extended to the Customer.  All Pioneer warranty claims shall be made in accordance with Section 3(e) above.  Subject to the foregoing and to Section 9(b) below, upon NBY’s confirmation of a failure of any Product to conform to the limited warranty provided hereunder, NBY will, in its sole discretion, either replace the non-conforming Product or credit Pioneer’s account for the non-conforming Product purchase price paid therefor.

 

 

 

(b)           Warranty Limitations.  NBY shall not be liable for misbranding with respect to any Product labeling or package insert text provided or used by Pioneer, or any translation thereof and NBY shall not be liable for any Product adulteration or failure to meet the Product specifications due to shipping, handling, storage, use or packaging of the Product by Pioneer, its Holding Companies, its third party contractors or their respective personnel.

 

(c)           Pioneer Warranties.  Pioneer warrants that its entry into this Agreement is rightful and does not violate any other Agreement to which it is a party, and its conduct in performing its obligations under this Agreement shall conform to all Applicable Laws, general and local industry and medical standards and good commercial practices.

 

(d)           Disclaimer.  SUBJECT TO NBY’S WARRANTIES TO PIONEER AS DESCRIBED IN SECTION (a), AND TO THE EXTENT PERMITTED UNDER APPLICABLE LAW, THE PRODUCT ARE PROVIDED TO PIONEER ON AN “AS IS” BASIS AND WITHOUT WARRANTY OF ANY KIND.  EXCEPT AS EXPRESSLY SET FORTH IN SECTION 9.1, NBY DOES NOT MAKE ANY OTHER WARRANTY TO PIONEER, WHETHER EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, WITH RESPECT TO PRODUCT, SPECIFICATIONS, SUPPORT, SERVICE OR ANY OTHER MATERIALS AND NBY SPECIFICALLY DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT, AND FITNESS FOR A PARTICULAR PURPOSE.

 

(e)           Limitation of Liability.  TO THE EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT SHALL NBY BE LIABLE TO PIONEER FOR ANY INCIDENTAL, SPECIAL, PUNITIVE OR CONSEQUENTIAL DAMAGES, INCLUDING LOST PROFITS, COST OF PROCUREMENT OF SUBSTITUTE GOODS, OR ANY INDIRECT DAMAGES EVEN IF NBY HAS BEEN INFORMED OF THE POSSIBILITY THEREOF AND NOTWITHSTANDING THE FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY STATED HEREIN.  WITHOUT LIMITING THE FOREGOING, EXCEPT AS OTHERWISE PROVIDED UNDER SECTION 6.2, NBY’S AGGREGATE LIABILITY ARISING OUT OF THIS AGREEMENT SHALL BE LIMITED TO THE TOTAL AMOUNT PAID BY PIONEER TO NBY FOR THE PRODUCT IN THE [***] MONTH PERIOD IMMEDIATELY PRECEDING THE EVENT GIVING RISE TO SUCH LIABILITY.

 

 

 

 

10.           Training and Support.  Upon Pioneer’s reasonable request, NBY will use reasonable efforts to provide training to Pioneer personnel, at Pioneer’s expenses and at times and location mutually acceptable to both parties.  Pioneer shall provide all support on the Product to Customers.  NBY shall use reasonable efforts to provide technical support to Pioneer if Pioneer is unable to resolve a technical issue with respect to the Product.  Nothing under this Section 10 shall obligate NBY to furnish any assistance, information or documentation directly to any Customer.

 

11.           Insurance.  Each party shall maintain insurance with a reputable insurance company in an amount reasonably sufficient to cover all of its obligations under this Agreement.  Upon each party’s request, the other party shall furnish to the first party a certificate of insurance evidencing that such insurance is in effect.  Each party shall notify the other party within thirty (30) days of any cancellation or material change in its insurance policy.  If either party’s insurance policy required hereunder is cancelled or expires, such party shall furnish the other party a new certificate evidencing that replacement coverage is in effect.

 

12.           Confidential Information.

 

(a)           Obligation.  Except for the purposes of performing its obligations and exercising its rights under this Agreement, during the Term (as defined in Section 15(a)) hereof and for five (5) years thereafter, each party shall hold in confidence and not use or disclose to any third party any product, technical, marketing, financial, business or other proprietary information (“Proprietary Information”) disclosed to such party by the other.  Without limiting the foregoing, the terms of this Agreement shall be considered Proprietary Information of both parties; provided that each party may disclose the term of this Agreement in communication with existing and potential investors, partners, acquirers, licensees, consultants, advisors (including financial advisors, lawyers and accountants) on a need to know basis, in each case under appropriate confidentiality provisions substantially equivalent to those of this Agreement.

 

(b)           Limitation.  Notwithstanding the foregoing, Proprietary Information shall not include information that: (i) was publicly known or made generally available without a duty of confidentiality prior to the time of disclosure by the disclosing party to the receiving party; (ii) becomes publicly known or made generally available without a duty of confidentiality after disclosure by the disclosing party to the receiving party; (iii) is in the rightful possession of the receiving party without confidentiality obligations at the time of disclosure by the disclosing party to the receiving party as shown by the receiving party’s then-contemporaneous written files and records kept in the ordinary course of business; or (iv) is obtained by the receiving party from a third party without an accompanying duty of confidentiality without a breach of such third party’s obligations of confidentiality.  In the event the receiving party is legally compelled to disclose Proprietary Information of the disclosing party, the receiving party shall provide notice as soon as is reasonably practicable to the disclosing party, if legally permissible, and shall provide reasonable assistance to the disclosing party to obtain a protective order or otherwise prevent public disclosure of such Proprietary Information.  If the disclosing party fails to obtain a protective order or other appropriate remedy, the receiving party will furnish only that portion of the Proprietary Information that is legally required to be disclosed.  Nothing in this Section shall impair either Party’s compliance with any requirements of the Securities and Exchange Commission or the stock market on which such Party’s securities are traded.

 

 

 

 

(c)           Prior Agreement.  This Agreement supersedes the Confidentiality Agreement between the Parties dated April 4, 2011 (the “Prior Agreement”) with respect to information disclosed thereunder.  All information exchanged between the Parties under the Prior Agreement shall be deemed Confidential Information of the disclosing Party and shall be subject to the terms of this Article 12.

 

 

 

 

13.          Indemnity.

 

(a)           By NBY.  Subject to Section (c), NBY shall indemnify, defend or settle and hold Pioneer and its affiliates harmless from and against any and all liabilities, damages or expenses (including reasonable legal expenses and attorneys’ fees) (collectively, “Losses”) resulting from any suit, claim, action or demand brought by a third party (each, a “Third Party Claim”) arising out of: (a) any breach of any of NBY’s representations and warranties under Article 9, or (b) the gross negligence or intentional misconduct of NBY or any of its agents, directors, officers and employees; in each case except to the extent such Third Party Claim is covered by Pioneer’s indemnification obligations below.

 

(b)           By Pioneer.  Subject to Section (c), Pioneer shall indemnify, defend or settle and hold NBY and its affiliates harmless from and against any and all Losses resulting from any Third Party Claim arising out of: (a) any breach by Pioneer of its obligations, duties or responsibilities under this Agreement; (b) the gross negligence or intentional misconduct of Pioneer or any of its agents, directors, officers and employees, (c) any acts or omissions of Pioneer or its personnel in Distributing or developing the Product; in each case except to the extent such Third Party Claim is covered by NBY’s indemnification obligations above.

 

(c)           Indemnification Procedure.  To be eligible to be indemnified hereunder, the indemnified party shall provide the indemnifying party with prompt notice of the Third-Party Claim giving rise to the indemnification obligation pursuant to this Article 13 and the right to control the defense (with the reasonable cooperation of the indemnified party) and settlement of any such claim; provided, however, that the indemnifying party shall not enter into any settlement that admits fault, wrongdoing or damages without the indemnified party’s written consent, such consent not to be unreasonably withheld or delayed. The indemnified party shall have the right to participate, at its own expense and with counsel of its choice, in the defense of any claim or suit that has been assumed by the indemnifying party; provided that the indemnifying party shall have no obligations with respect to any Losses resulting from the indemnified party’s admission, settlement or other communication without the prior written consent of the indemnifying party.

 

14.           Non-Assignment.  Pioneer shall not have the right to assign, delegate, subdivide or otherwise transfer any obligations or rights under this Agreement without the prior written consent of NBY, which consent shall not be unreasonably withheld.  NBY may freely assign this Agreement.  Any attempted assignment in violation of this Article 14 shall be null and void.

 

***Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commission.

 

 

 

15.           Term and Termination.

 

(a)           Term.  The term of this Agreement shall commence on the Effective Date and shall continue in full force and effect until the end of the fifth Contract Year (the “Initial Term”), unless earlier terminated in accordance with the terms and conditions of this Agreement.  Thereafter, the parties may mutually agree in writing to renew this Agreement for additional five (5) year terms (each a “Renewal Term,” and collectively with the Initial Term, the “Term”); subject to the parties’ agreement to review and establish, prior to the initiation of the Renewal Term and every second Contract Year thereafter during the Renewal Term, the transfer price and Annual Minimums in good faith based on material changes in the costs of manufacture and market demand.

 

(b)           Termination.  Either party may terminate this Agreement prior to its expiration and upon thirty (30) days prior written notice if: (a) a party breaches any material term (including any payment terms) of this Agreement and the breaching party has not cured the breach within such thirty (30) day period; (b) a party is the subject of a liquidation or insolvency, or the filing of bankruptcy, or similar proceeding(s) (provided that in the case of involuntary proceedings, such proceedings are not dismissed within sixty (60) days of filing); or (c) the other party ceases to actively engage in the business to which this Agreement relates.  Without limiting the foregoing, in the event (i) Pioneer does not elect to co-fund the Additional Development or (ii) the parties fail to obtain MAA Approval from SFDA for the Product, this Agreement shall automatically terminate as set forth in Section 6(b).

 

(c)           Effect of Termination.

 

(i)           Upon expiration or notification of termination of this Agreement, Pioneer shall submit to NBY within thirty (30) days a list of all Products in Pioneer’s inventory as of the effective date of expiration or termination.  Unless otherwise mutually agreed by the parties, Pioneer shall have sixty (60) days following the expiration or termination of this Agreement to continue to Distribute any Product in Pioneer’s inventory as of the effective date of expiration or termination.  NBY may also elect to repurchase unused (brand new) Product in Pioneer’s inventory as of termination or of expiration of this Agreement at the Price paid by Pioneer less a [***]% restocking fee.  Pioneer shall also provide a list of the names, addresses, telephone numbers and purchase history of Customers upon termination or expiration of this Agreement. Except as otherwise permitted in this Section (i), all rights and licenses of Pioneer hereunder with respect to NVC-101 and the Product shall automatically terminate and all Permits held by Pioneer shall revert to NBY.

 

(ii)           Each party shall, within thirty (30) days of the effective date of termination or expiration, either (a) return to the other party all of the other party’s Proprietary Information then in a party’s possession, custody or control or (b) certify to the other party in writing that all copies of such Proprietary Information have been destroyed.

 

 

 

 

(iii)           To the extent permitted under Applicable Law, upon the termination of this Agreement in accordance with its terms, except for obligations incurred prior to the effective date of termination, neither party shall have any obligation to the other party, or to any employee, agent or representative of a party, for compensation or for damages of any kind, whether on account of loss by a party, or by such employee, agent or representative of present or prospective sales, investments, compensation or goodwill; provided, however, that nothing in this Section 15(c)(iii) shall relieve either Party of any liability for willful misconduct, gross negligence, or breach of contract.

 

(iv)           If proper notice of termination is given for any reason, notwithstanding any credit terms made available to Pioneer prior to that time, any shipments during the period prior to termination shall be paid for by bank transfer or by certified or cashier’s check prior to such shipment.

 

(v)           To the extent permitted under Applicable Law, Pioneer’s ability to pursue selling its remaining inventory of Product during the sixty (60) days after expiration or termination of this Agreement pursuant to Section (i), or, to extent otherwise expressly permitted in this Agreement, Pioneer’s right to sell such inventory if not so repurchased by NBY, shall constitute Pioneer’s sole remedy for the expiration or termination of this Agreement.

 

(d)           Survival.  The provisions of Sections 6(d), d(e), 6(f), 9(a) (with respect to Product under warranty), 9(b) (with respect to Product under warranty), 9(d), 9(e), (c), (d) and (e), and Articles 1, 2 (with respect to Product which were in Pioneer’s inventory at the time of termination of the Agreement), 7, 8, 11, 12, 13, 14, 19 and 20 shall survive termination or expiration of this Agreement.  All other provisions of this Agreement shall terminate upon any termination or expiration of this Agreement.

 

(e)           Accrued Obligations.  Expiration or termination of this Agreement for any reason shall not release either party hereto from any obligation (including payment obligations) or liability which, at the time of such expiration or termination, has already accrued to the other party or which is attributable to a period prior to such expiration or termination, nor preclude either party from pursuing all rights or remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement.

 

16.           Events Beyond Control.  Neither party shall be liable for any failure to fulfill any term or condition of this Agreement (other than the obligation to pay) if fulfillment has been delayed, hindered or prevented by an event of force majeure including, but not limited to, any strike, lockout or other industrial dispute, acts of the elements, compliance with requirements of any governmental port or international authority, plant breakdown or failure of equipment, inability to obtain equipment, fuel, power, materials or transportation, or by any circumstances whatsoever beyond its reasonable control, including, but not limited to, demand for Product in excess of NBY’s ability to produce Product and alleged or demonstrated infringement by the Product or their use of any proprietary right of a third party.  In the event of excess demand for Product, NBY may allocate the supply of Product among its customers in the manner it deems most appropriate. In any case, NBY will use commercially reasonable efforts to supply confirmed Orders to Pioneer.

 

 

 

 

17.           U.S. Foreign Corrupt Practices Act.  Pioneer warrants that in the performance of its obligations under this Agreement, Pioneer will not act in any fashion or take any action which will render NBY liable for a violation of the U.S. Foreign Corrupt Practices Act (“FCPA”), which prohibits the offering, giving or promising to offer or give, directly or indirectly, money or anything of value to any official of a government, political party or instrumentality thereof in order to assist Pioneer or NBY in obtaining or retaining business.  NBY shall have the right to immediately terminate this Agreement should Pioneer make any payment which would violate the U.S. FCPA.  Pioneer shall indemnify and hold NBY harmless, and hereby forever releases and discharges NBY, from and against all losses, liabilities, damages and expenses (including reasonable attorneys’ fees and costs) resulting from Pioneer’s breach of this Article 17.

 

18.           Independent Contractors.  The relationship of the parties established by this Agreement is that of independent contractors, and nothing contained in this Agreement shall be construed to create any other relationship between the parties.  Neither party shall have any right, power, or authority to assume, create or incur any expense, liability, or obligation, express or implied, on behalf of the other.

 

19.           Notice.  All notices issued or served under this Agreement shall be in writing and shall be deemed to have been sufficiently given if transmitted by facsimile (receipt verified), email (receipt verified) or by express courier service (signature required) or seven (7) days after it was sent by registered letter.   All notices shall be sent to the following, except as otherwise specified by either party in writing:

 

NBY:	Pioneer:
NovaBay Pharmaceuticals, Inc.	Pioneer Pharma Co. Ltd.
5980 Horton Street, Suite 550, Emeryville, CA 94608 United States	Suite A-C 18F, HuDong Finance Building, No.1128, XiangYin Road, Shanghai, P.R.C 200433

Attention:  Roy Wu Phone:    ###-###-####	Attention: Hanson Han Phone: 86-21-55971095
Fax:    ###-###-#### Email: ***@***	Fax:   86-21-55971121 Email: ***@***
With a copy to:   Wilson Sonsini Goodrich & Rosati PC	With a copy to:   Leo Liu
650 Page Mill Road	Pioneer Pharma Co. Ltd.
Palo Alto, CA 94304 Attention:  Ian B. Edvalson, Esq. Phone: 650 ###-###-####	Suite A-C 18F, Hudong Finance Building No.1128, XiangYin Road
Fax: 650 ###-###-####	Shanghai, PRC 200433
Email: ***@***	Phone:86-21-55971120; Mp ###-###-####
	Fax: : 86-21-55971121 Email ***@***

 

20.           Miscellaneous.

 

(a)           Waiver; Amendment.  The failure of either party to enforce its rights under this Agreement at any time for any period shall not be construed as a waiver of such rights unless evidenced in writing and signed for on behalf of both parties.  Any modification or amendment of, or addition to, the terms of this Agreement shall not be effective unless in a writing conspicuously entitled “Amendment of Agreement” which begins with a proposal to amend this Agreement and specifies exactly each change to be made and which is signed by an authorized officer of both parties.

 

 

 

 

(b)           Governing Law.  This Agreement shall be governed by and construed in accordance with the laws of Hong Kong without regard to the conflicts of laws provisions and excluding the 1980 U.N. Convention on Contracts for the International Sale of Goods.

 

(c)           Severability.  The provisions of this Agreement under which the liability of NBY is excluded or limited shall not apply to the extent that such exclusions or limitations are declared illegal or void under Applicable Laws in the Territory, unless the illegality or invalidity is cured under the Applicable Laws of the Territory by the fact that the law of Hong Kong governs this Agreement.  Subject to the foregoing, if any provision of this Agreement is held to be void, invalid or unenforceable, the same shall be reformed to give the fullest effect to the intention of the parties when executing this Agreement while complying with Applicable Law or stricken if not so conformable, so as not to affect the validity or enforceability of the remainder of this Agreement.

 

(d)           Dispute Resolution.  In the event of any dispute, controversy or claim between the parties hereto arising out of this Agreement, the parties agree to attempt to resolve such dispute in good faith through direct negotiations for a period of thirty (30) days.  Any dispute, controversy or claim between the parties hereto arising out of or relating to this Agreement which cannot be resolved through direct negotiations shall be settled by binding arbitration in accordance with and subject to the then applicable rules (“Rules”) of the International Chamber of Commerce (“ICC”) and such arbitration shall be administered by ICC with a single arbitrator selected from a list of arbitrators proposed by ICC in accordance with the Rules.  The arbitrator shall allow such discovery as is appropriate and consistent with the purposes of arbitration in accomplishing fair, speedy and cost-effective resolution of disputes.  The costs of the arbitration including the arbitrators’ fees shall be shared equally by the parties. Each party shall bear its own costs, including attorney’s and witness’ fees, incurred in connection with the arbitration. Judgment upon the award rendered in any such arbitration may be entered in any court of competent jurisdiction, or application may be made to such court for a judicial acceptance of the award and an enforcement, as the law of such jurisdiction may require or allow.  Unless otherwise mutually agreed to by the parties, in the event NBY initiates such arbitration, such arbitration shall take place in Hong Kong, China, and in the event Pioneer initiates such arbitration, such arbitration shall take place in San Francisco, California.  Any arbitration under this Agreement shall be conducted in English, regardless of the location for such arbitration.

 

(e)           Language.  This Agreement is in the English language only, which language shall be controlling in all respects, and all versions hereof in any other language shall not be binding on the parties hereto.  All communications and notices to be made or given pursuant to this Agreement shall be in the English language.

 

 

 

 

(f)           Currency.  All amounts specified in this Agreement are in United States Dollars, and all payments by one party to the other party under this Agreement shall be paid in United States Dollars.

 

(g)           Headings.  Headings herein are for convenience of reference only and shall in no way affect interpretation of this Agreement.

 

(h)           Registrations.  If this Agreement is required to be registered with any governmental authority in the Territory, Pioneer shall cause such registration to be made and shall bear any expense or tax payable in respect thereof.

 

(i)           Compliance With Applicable Law.  The parties shall each comply with all Applicable Laws in performing its duties hereunder.

 

(j)           Entire Agreement.  This Agreement, and all exhibits attached hereto, constitute the entire understanding and contract between the parties and supersedes any and all prior and contemporaneous, oral or written representations, communications, understandings, and agreements between the parties with respect to the subject matter hereof.  Notwithstanding the foregoing, to the extent the terms and conditions of this Agreement conflict with the terms and conditions of any exhibit, the terms and conditions of this Agreement shall govern.  The parties acknowledge and agree that neither of the parties is entering into this Agreement on the basis of any representations or promises not expressly contained herein.

 

[The remainder of this page intentionally left blank; the signature page follows.]

 

 

 

 

 

 

Pioneer Pharma Co. Ltd.			NovaBay Pharmaceuticals, Inc.
Name:	XinZhou Li		Name:	Ramin (Ron) Najafi, Ph.D.
Title:	President and CEO		Title:	Chairman & CEO
Signature:	/s/ XinZhou Li		Signature:	/s/ Ron Najafi
Date:	January 9, 2012		Date:	January 9, 2012

 

 

 

 

 

 

 

Each unit of the Product consists of one 40 mL vial of formulated NVC-101 and one spray pump packed in a cardboard box with label (each, a “Unit”).

 

 

Composition:                                    [***]

 

Fill Weight:                                       40 g

 

Container:                                         Type I borosilicate amber glass bottle (40 mL)

 

Closure:                                             White polypropylene cap with PTFE liner

 

Storage Condition:                          Room Temperature, 15 -25°C

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

·

First Contract Year:  [***] Units

·

Second Contract Year:  [***] Units

·

Third Contract Year:  [***] Units

 

Prior to the end of the Third Contract Year and every other Contract Year thereafter, the parties will negotiate and establish the Annual Minimums for the upcoming two Contract Years, provided that such Annual Minimums will not be less than the Annual Minimum of the then-current Contract Year.

 

 

 

 

 

 

 

 

Prices:

 

·

Each 40ml vial of formulated NVC-101:  US$[***] -- US$[***]

·

Each spray pump:  US$[***]

Deduction Schedule:

 

Pioneer will have the right to take deductions from the transfer price of the Product in accordance with the schedule below until the total cumulative deductions equal US$[***] plus any Additional Development Costs incurred by Pioneer:

 

·

For the first [***] units of Product ordered in a Contract Year:  US$[***] price deduction per Unit

·

For all units of Product ordered after the first [***] units in a Contract Year:  US$[***] price deduction per Unit

 

 

Any remaining deduction credit will be applied in the following Contract Year(s) in accordance with the deduction schedule above.

 

 

·

If Pioneer purchases [***] Units of Product in the first Contract Year, then it will have a right to deduct US$[***] from the first [***] Units of Product and US$[***] from the next [***] Units of Product in the first Contract Year;

·

If Pioneer purchases [***] Units of Product in the second Contract Year, then it will have a right to deduct US$[***] from the first [***] Units of Product and $[***] from the next [***] Units of Product in the second Contract Year;

·

If Pioneer purchases [***] Units of Product in the third Contract Year, then it will have a right to deduct its remaining credit of US$[***] from the first [***] Units of Product in the third Contract Year.

 

 

 

 

In the event Pioneer elects to co-fund the Additional Development, the parties will conduct any Additional Development in accordance with the terms and conditions set forth in this Exhibit E.

 

 

The parties shall promptly establish a joint development committee (“JDC”) comprised of an equal number of representatives of each of the parties to govern the Additional Development.  The JDC shall hold meetings (either in person or by teleconference) at such times and places as the parties may mutually agree.  The responsibilities of the JDC are: (i) reviewing and approving the Development Plan (as defined below) and any amendments thereof, (ii) overseeing, reviewing and coordinating the parties’ implementation of the Development Plan, (ii) reviewing and approving any contract research organization for the management or performance of any clinical study set forth in the Development Plan,  (iii) reviewing and approving the protocol of each clinical study set forth in the Development Plan, and (iv) undertaking and/or approving such other matters as set forth in the Development Plan or otherwise as the parties mutually agree.  Decisions of the JDC shall be made by consensus of all JDC members; provided that in the event the JDC is unable to reach consensus with respect to a particular matter within thirty (30) days from the date such matter was initially referred to the JDC, then NBY shall have the final decision making authority with respect to such matter.

 

21.           The parties shall jointly develop a development plan describing each party’s responsibilities in such Additional Development and the estimated timeline, budget and other resource requirements therefor (the “Development Plan”), subject to the JDC’s review and approval.  Once approved by the JDC, the Development Plan shall be attached to this Exhibit E.  Each Party shall use commercially reasonable efforts to perform and complete the responsibilities assigned to it in accordance with the Development Plan and all Applicable Laws. Each Party shall: (i) be responsible for day-to-day implementation and operations of the activities assigned to it under the  Development Plan; and (ii) to keep the other party reasonably informed as to the progress of such activities as reasonably requested by the other party and as otherwise determined by the JDC.  Each party shall maintain complete and accurate records that sufficiently and properly reflect all work done and results achieved during the performance of Additional Development in accordance with Applicable Laws and in good scientific manner consistent with the applicable industry standards.

 

22.           Each party will bear 50% of Additional Development Costs up to a total amount of US$[***], and Pioneer will bear 100% of all Additional Development Costs in excess of US$[***]; provided that Pioneer will have the right to deduct the Additional Development Costs it bears pursuant to this Section 3 from the Price of the Product as described in the price deduction schedule under Exhibit D.  Each party shall keep full and accurate books and records related to its performance of the Additional Development in accordance with applicable accounting principles and good business practices.  As used herein, “Additional Development Costs” means all reasonable third party direct costs incurred to conduct the Additional Development in accordance with the Development Plan.

 

For example, if the parties incurred Additional Development Costs in the amount of US$[***], then each party would bear US$[***] and Pioneer would bear an additional US$[***]; and Pioneer will have the right to deduct the Additional Development Costs it bears in the amount of US$[***] (US$[***] + US$[***]) from the Price of the Product as described under Exhibit D.

 

23.           As between the parties, NBY will own all data, results and technologies developed in connection with the conduct of Additional Development, and all intellectual property rights therein (collectively, “Development IP”), in each case whether developed solely by (or on behalf of) Pioneer or NBY, or jointly by (or on behalf of) both parties.  Each party shall promptly disclose to the other party any Development IP generated in the course of performing the Additional Development.  Pioneer shall assign and hereby assigns to NBY or its designee, all right, title and interest Pioneer may have in or to the Development IP.  Pioneer agrees to execute (or cause to be executed) any and all documents and to perform such other acts for the purpose of perfecting the foregoing assignment, each at NBY’s request and expense.