DEVELOPMENT AND EXCLUSIVE LICENSE AGREEMENT
Exhibit 10.1
AGREEMENT, dated as of November 26, 2013, among Sgenia Solutiones, S.L. (“Sgenia”), XXXXX Biosystem, S.L. (“Subco”), a subsidiary wholly owned by Sgenia, both of which are formed under the laws of Spain, and Braeden Valley Mines Inc., a Nevada corporation (the “Company”).
1. Definitions.
a. “Affiliate” shall mean a corporation, association, foundation, institute, or other entity that directly or indirectly controls, is controlled by, or is under common control with another entity. Control means actual control, or ownership or other beneficial interest in, or control of, more than 50% of the voting stock or other voting interest of a corporation, association, foundation, institute, or other entity.
b. “Chip” shall mean any type of microcontroller chips, memory chip or similar microelectronic component programed with the Sgenia Software to detect MRSA/SA. The Chip will be protected against inverse engineering so as to protect the Sgenia Software.
c. “Designee” shall mean a corporation or other entity that is employed by, under contract to, or in partnership with Sgenia, Subco or Company, and a Sublicensee, or an Affiliate of the foregoing, to make, use, sell, promote, distribute, market, import, or export the Product.
d. “Effective Date” shall be the date on which this Agreement is executed by Sgenia, Subco and Company
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e. “Field” shall mean any and all uses.
f. “Health Registration” means any and all consents, licenses, registrations, authorizations, and approvals (including, where applicable, pricing and reimbursement approvals) required by a Regulatory Authority such as the United States Food and Drug Administration (“USFDA”), the European Agency for the Evaluation of Medical Products or any other Ministry of Health, for the distribution, sale, manufacture, or testing of the Product in the Field.
g. “Materials” shall mean the tangible physical material developed by Sgenia, Subco and Company and any Designees, Sublicensees, and Affiliates of the foregoing relating to the Products and substantially constructed from the components listed in Exhibit A hereto, and any progeny or derivatives thereof. “Sgenia-generated Materials” shall mean the tangible physical material developed by developed by Sgenia and/or Subco relating to the Sgenia Patents and substantially constructed from the components listed in Exhibit A hereto, and any progeny and derivatives thereof.
For the clarification of the calculation of Net Sales, if a Product is sold in combination with one or more other products or services, the services relating to installation and training at any time is included therein, but warranty and other revenue sources of any other products and services will not be included in the gross invoice or contract price of the Products for purposes of Net Sales, pursuant to the understanding that the Sgengia and Company have the right to generate other forms of income premised on the Product.
i. “Sgenia Patent” or “Sgenia Patents” shall mean the patents and patent applications listed in Exhibit B hereto; any application owned in whole or in part or filed by Sgenia; any continuation applications, divisional applications, or continuation in part applications that claim priority to the patents and/or applications listed in Exhibit B; any patents that issue from any of the foregoing; and any reissues, re-examinations, renewals, substitutions, and extensions of any of the foregoing.
j. “Patent Product” or “Patent Products” shall mean any product or service (or any component there) that is, incorporates, or relates to a Sgenia Patent for use in relation to devices to detect MRSA/SA and the discovery, development, manufacture, use, sale, distribution, rental, importation, exportation, or lease of which cannot be effected without infringing, in the relevant jurisdiction, a claim of a Sgenia Patent that has neither expired nor been declared invalid or that is described by a pending claim of a pending patent application within the Sgenia Patents covering the relevant jurisdiction.
k. “Product” or “Products” shall mean a Patent Product.
l. “Regulatory Authority” means any governmental authority in a country or region that regulates the manufacture or sale of medically related products, including the USFDA and the relevant European agency, and any successors thereto.
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m. “Sgenia Entity” means Sgenia, Subco and or any entity directly or indirectly controlling, controlled by or under common control with Sgenia from time to time.
n. “Sgenia Software” means software developed by or for any Sgenia Entity before or during the term of this Agreement, including (i) enhancements, additions and changes that (a) improves the function of, (b) adds a new function to or (c) substantially enhances the performance of Sgenia Software or any Product, including any improvements, new use or new functions, in any form, that have a value or utility separate from the Sgenia Software and any Product, (ii) error corrections and (iii) new releases.
o. “Sgenia Territory” means the Kingdom of Spain, as it exists or existed on September 1, 2013.
p. “Software Documentation” means any existing or hereinafter created installation guides, operating, training, and user manuals, functional and technical specifications, database schema and other documentation pertaining to the Sgenia Software to describe the manner of use of such software, or which includes standard operating instructions relating to such software, including but not limited to a copy of the standard associated control statements and other documentation used for operation and use of the software; manuals consisting of instructions and procedures for systems and operations personnel and end users, and any other related documentation.
q. “Sublicensee” shall mean any corporation or other business entity to whom Sgenia, Subco or Company has granted a sublicense to any of the rights transferred in this Agreement, including permitted sublicensees of such corporations or other business entities.
r. “Technical Information” shall mean any know-how, information (technical, process, clinical or other), knowledge, research, trade secrets, techniques, designs, data, Sgenia Software, Software Documentation, specifications, practices, procedures, assays, formulae, processes, systems, improvements, methods, skill, test and other data including chemical, pharmacological, toxicological and clinical test and other data, analytical and quality control data, and laboratory notes that:
(i) relate to Sgenia, Subco or Materials; and;
(ii) is owned by Sgenia or controlled by Sgenia with the right to grant an exclusive or nonexclusive sublicense to Subco and/or the Company; and
(iii) (1) was conceived, reduced to practice, or developed, in whole or in part, in the laboratories/offices of Sgenia and/or Subco before the Effective Date, and/or (2) is conceived, reduced to practice, or developed, in whole or in part, in the laboratories/offices of Sgenia and/or Subco after the Effective Date (“Future Technical Information”), but only to the extent before it is disclosed to an employee or consultant of Company or Sublicensee, Designee or Affiliates of the foregoing and relates to the Product.
s. “Territory” shall mean worldwide, unless Sgenia and Subco exercise their right to market and sell Product in the Sgenia Territory.
t. “Third Party” shall mean any entity other than Sgenia, Subco and Company, and the Sublicensees, Designees, or Affiliates of the foregoing.
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u. “Upfront, Milestone, and Lump Sum Payments” shall mean any funds, including but not limited to cash payments or cash equivalents, or securities, received by the Company from Sublicensees as full or partial consideration for the grant of any sublicense by the Company pursuant to Section 2(b); provided that funds derived from the following shall be excluded:
(i) Proceeds from the sale of equity or equity interests in Company, but only to the extent the price of the securities purchased are a good faith price resulting from an arms’ length transaction approved by the Company’s directors.
(ii) Loans and advances, but only to the extent they are repaid or reimbursed to the grantor.
(iii) Funds that are designated in writing to be used and actually used for research, development, manufacturing, commercialization, and marketing of Products, including operations support, testing, patent expenses, obtaining regulatory approval and upfront, milestone, lump sum and other payments to licensors of the Company.
(iv) Payments for Products that are calculated based on sales or a percentage of sales of a Product, but excluding a minimum payment or milestone payment which are not creditable against royalties. This subsection 1(q)(iv) shall not, in any way, affect the right of Sgenia or Subco to receive royalties under Section 7 of the Agreement.
v. “Valid Claim” shall mean a claim that has not expired and that has not been found invalid by a court of competent jurisdiction from which no appeal can be taken.
a. Sgenia and Subco jointly and severally grant to the Company, upon and subject to all the terms and conditions of this Agreement:
i. The sole and exclusive right and license under, and to use, practice, commercialize and exploit, the Sgenia Patents to develop, manufacture, have manufactured, make, have made, use, sell, have sold, import, export, distribute, rent or lease the Products (including without limitation any improvements and varisations thereto) in the Field throughout the Territory, together with the right to grant sublicenses as herein provided; and;
ii. To the extent Sgenia and Subco each has the power to so grant, the sole and exclusive right and license under, and to use, practice, commercialize and exploit, Technical Information and Material to develop, manufacture, have manufactured, make, have made, use, sell, have sold, export, import, distribute, rent or lease the Product (including without limitation any improvements and varisations thereto) in the Field throughout the Territory, together with the right to grant sublicenses as herein provided. Otherwise, the nonexclusive right and license under, and to use, practice, commercialize and exploit, Technical Information and Material to develop, manufacture, have manufactured, make, have made, use, sell, have sold, export, import, distribute, rent or lease the Product (including without limitation any improvements and varisations thereto) in the Field throughout the Territory, together with the right to grant sublicenses as herein provided.
b. Sgenia and Subco, each grants to the Company the right to grant sublicenses to other parties in the Field throughout the Territory other than the Sgenia Territory, either directly or through a Sublicensee, provided that: (i) the Company remains fully liable for the performance of its obligations in the Agreement; (ii) the Company remains fully liable for the performance of Sublicensees under the sublicense agreement; (iii) Sgenia shall have the right to review for seven (7) business days the final version of any proposed sublicense or material amendments thereto, and shall be permitted to disapprove of any proposed Sublicensee or material amendments thereto before execution solely if the proposed sublicense is otherwise in violation of the terms of this Agreement, which approval shall not be unreasonably withheld and the failure to respond by Sgenia within the seven (7) business day period shall constitute approval; and (iv) the sublicense shall not be inconsistent with any terms or conditions in this Agreement.
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c. All rights not specifically granted herein are reserved to Sgenia and Subco, respectively. Additionally, Sgenia has the right to limit the Territory to exclude the Sgenia Territory, solely for marketing and sale of the Product, upon 180 days advance notice to Company, which limitation will be for either a stated duration or for the balance of the Term of the licenses granted hereunder. In the event of such a limitation being effected by Sgenia, Company shall have the right to complete any pending orders for Product in the Sgenia Territory, and thereafter refer any new orders from within the Sgenia Territory, for delivery in the Sgenia Territory to Sgenia. It is understood, that the limitations on the Territory do not apply to Product that is delivered outside the Sgenia Territory or destined for ultimate original use outside the Sgenia Territory.
d. During the term of this Agreement, and subject to the terms hereof, Sgenia and Subco shall maintain the Technical Information and Sgenia-generated Materials that exist as of the Effective Date with the same care as is standard in their laboratories/offices, during which time the Company shall have the right to request transfer of Technical Information and Sgenia-generated Materials upon reasonable notice to the extent reasonably determined necessary to obtain the benefits of the licenses set forth here, provided that Company will not have the right to request transfer of the Sgenia Software.
e. As between Sgenia and Subco, on the one hand, and the Company, its Sublicensees and their Affiliates, on the other hand, the Company and its Sublicensees and their Affiliates shall own all inventions, discoveries, developments, improvements, new uses, enhancements and other technologies and intellectual property conceived, reduced to practice, developed, made or obtained by or on their behalf.
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d. Failure of a Stage; Accounting. (i) At the completion of Stages 1, 2 and 3 of the Budget and R&DP, Subco and Sgenia will jointly certify to Company that the stage has been completed and the objective of the stage has been fully achieved if not exceeded. Company, in its discretion may ask for any and all supporting documentation of the stage completion and goal achievement, including scientific data, test results, accounting documentation, and the like, the failure of which to be provided will be deemed to be a failure to achieve completion and goals of the stage. If a stage is not successfully completed and/or the objective of the stage is not met, then the Company will have the right to terminate the funding obligation of this Agreement. Stage success is defined as Stage 1: Prototype MRSA/SA sensor to be developed from Sgenia technology, having a capacity to detect MRSA and/or SA contamination; Stage 2: Produce & successfully laboratory test a minimum of 20 beta versions of the MRSA/SA sensor, delivering a pre serie (pre-production) design suitable for hospital use; and Stage 3: Obtain relevant health organisation approvals in the European Union and the U.S. to produce a final product ready for mass production and marketing.
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(ii) Subco shall provide reasonable verification from time to time as requested to Company that such amounts have been spent according to the Budget. In addition to the foregoing, at the end of each Stage, as defined herein, Subco will prepare a formal detailed accounting of the Budget, funding received and funding disbursed. Company may request the formal accounting to be audited by an independent Third Party auditory of its selection, and the costs of such audit will be borne by Company, provided that if the audit process reveals that the accounting is at an overall variance of 5%, then the cost of the audit will be split equally by the parties.
(iii) Any amounts not spent in Stages 1 and 2 of the Budget (as “Stages” are indicated in the Budget) will be carried forward to Stages 2 and 3, respectively, and any amounts not spent in Stage 3 will adjust funding required in the last month or months of Stage 3, it being understood that the funding is to cover actual expenses and not to provide a profit to Subco. Notwithstanding the foregoing, if the total funding of Subco for all three Stages is less than the total Budget as modified by the parties, then Sgenia will be paid 20% of the difference between the actual expenses of Subco pursuant to the Budget and the projected expenses in the Budget, and the balance of any saving will be returned to Company.
e. Subco Obligations under R&DP and Budget. Subco will use commercially reasonable efforts to commence the R&DP once the first funding of the Budget is received and to diligently perform its obligations set forth in the R&DP and to provide allocation of sufficient time and effort, using personnel with sufficient skills and experience, to execute and substantially perform its obligations under the R&DP and develop a commercially viable Product. Sgenia and Subco will use their commercial best efforts to communicate information within the scope of this Agreement to Company. Sgenia and Subco each will keep complete and accurate records pertaining to their activities hereunder consistent with the creation and maintenance of data, records and reports necessary or useful in the preparation, approval and maintenance of Health Registrations for the Product and sufficient to enable, for example, the efficient transfer of Product manufacturing know-how from Sgenia and Subco to Company.
5. Manufacture and Supply of Products
a. Designation of Manufacturing Parties. Company shall have the exclusive right and obligation to manufacture, formulate and package the Product for commercial and non-commercial purposes in the Field in and for the Territory, including the Sgenia Territory, and to supply Sgenia quantities of Product necessary to satisfy commercial demand in and for the Sgenia Territory to the extent required.
b. Marketing Committee. Sgenia and Subco, on the one hand, and Company, on the other hand, will establish and maintain a committee (“Marketing Committee”) with one representative from each and together those persons will appoint a third person to the committee that is independent of both Sgenia and Subco, on the one hand, and Company, on the other hand, to oversee the selection of markets to be addressed and the manufacture, formulation and packaging of the Product, the review by which will be reasonable and timely, however the final determinations of markets, manufacturing, formulation and packaging will be made by Company.
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c. Technology Transfers. All intellectual property developed by Sgenia and/or Subco at any time during the collaboration and term hereof related to the manufacturing, formulation and/or packaging process shall be shared and licensed to Company on a royalty-free basis. Sgenia and Subco each agrees to engage in ongoing manufacturing, formulation and/or packaging related technology transfer to Company and its designees, and to the extent such activities are after the funding period set forth in the Budget, the Company shall reimburse the Sgenia and/or Subco for actual costs associated with such transfer.
d. Supply of Chips. Sgenia or Subco will supply the Chips to Company for use in the Product.
(i) Supply. Sgenia or Subco will supply to Company all of its requirements for Chips that hold the Sgenia Software necessary for the operation of the Product and its manufacture. Time shall be of the essence in the providing the quantity of Chips that have been requested by the Company. The Chips to be provided shall be of a quality standard that equals or exceeds that required for the Products as designed by Sgenia or Subco.
(ii) Price Of Chips. The pricing of the Chips supplied will be at a price as set forth in Exhibit F hereto. Payment terms shall be net 60 days. All purchases shall be invoiced by Sgenia and/or Subco. All invoices shall be itemized, and all applicable discounts and returns shall be clearly identified. Sgenia and Subco shall promptly provide and/or make available to Company any information reasonably requested in connection with the reasonable review of the data used to arrive at the cost of goods sold. Sgenia and Subco, on the one hand and Company on the other hand shall give due regard during negotiations regarding the cost of goods sold if a dispute arises to actual and forecasted changes in volume and the affect thereof on the cost of goods sold.
(iii) Cost of Delivery. The Chips supplied by Sgenia and Subco will be packed in standard shipping packages, sent via Federal Express Priority Overnight shipping, and delivered to the address specified by Company. Freight charges shall be F.O.B. destination, prepaid and allowed (Company is not responsible for paying freight charges). Title, risk and/or loss from damage of goods in transit shall be the responsibility of Sgenia and/or Subco.
(iv) Returns. If any Chips are found to be defective by manufacturing standards or otherwise, and/or unsuitable for their intended and developed use, Company shall immediately notify Sgenia or Subco for assistance. Sgenia and Subco, jointly and severally will assist Company or their agents (including manufacturers) in assessing the situation, determine the need for Chip replacement and make a recommendation for further action to the mutual satisfaction of both parties. For items ordered in error by the Company, then the Company shall pay return freight charges. For items shipped in error by Sgenia or Subco to Company, Sgenia and Subco shall incur return freight charges.
(v) Inspection. The Chips furnished shall be exactly as specified in each order and as required for the manufacture of the Product and shall be subject to inspection by Company or its agents (including its manufacturers) at all times and places. If, prior to final acceptance or use of any goods, which shall be deemed completed the later of twenty (20) calendar days after receipt of such goods or incorporation of such goods in a manufactured Product, they are found not as specified in an order or are otherwise damaged or not meeting the quality standards of the Chip, Company or its agents (including its manufacturers) may reject them by immediate shipment to Sgenia or Subco or as otherwise instructed by Sgenia or Subco, and Company may require Sgenia and Subco to correct or replace them without charge. If Sgenia or Subco is unable or refuses to correct such items within a time deemed reasonable by Company, then Company may terminate such order in whole or in part. Sgenia and Subco shall bear all risks as to rejected goods and, in addition to any costs for which Sgenia and Subco may become liable to Company, shall reimburse Company for all transportation costs, other related costs incurred, or payments to Sgenia and/or Subco in accordance with the terms of each order for unaccepted goods incidental thereto. Notwithstanding final acceptance and payment, Sgenia and Subco shall be liable for fraud or such gross mistakes as amount to fraud.
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e. Commercial Supply to Sgenia or Subco.
i. Supply. If requested by Sgenia or Subco, Company shall supply all of their requirements for Product necessary to satisfy commercial demand in and for the Sgenia Territory, which product is for original use in the Sgenia Territory. During any period when the total quantities of Product that can be manufactured by Company shall be less than the volume of Product required or ordered by Company, on the one hand, and Sgenia and Subco on the other hand, and Company will be unable to supply the full amount of Product ordered by Sgenia and Subco due to a manufacturing shortage, Company will allocate any available Products among all buyers, itself and its Affiliates, and shall deliver to Sgenia and/or Subco such portion of the available Product as their purchases during the previous six (6) months bears to their total purchase of such Product during such period.
ii. Price to Sgenia Parties. All Product manufactured by Company and sold to Sgenia and Subco for commercial purposes shall be supplied to them at a price equal to the Company’s cost of goods sold, as determined in accordance with USGAAP, plus zero percent (0%). Company shall promptly provide and/or make available to Sgenia and Subco any information reasonably requested in connection with the reasonable review of the data used to arrive at the Company’s cost of goods sold. Sgenia and Subco, on the one hand and Company on the other hand shall give due regard during negotiations regarding the cost of goods sold if a dispute arises to actual and forecasted changes in volume and the affect thereof on the cost of goods sold.
f. Warranty. All Product supplied by Company to Third Parties and to Sgenia and Subco hereunder will, at the time of delivery, (i) be manufactured in accordance with the manufacturing specifications, practices and procedures established from time to time by Company in agreement with Sgenia and Subco, (ii) be free from material defects and from contamination resulting from faulty manufacture, and conform to the specifications of the Product and quality control standards agreed upon by the parties hereto, and (iii) be labeled and packaged in accordance with the specifications from time to time agreed upon by the parties hereto. Company warrants that all manufacturing and packaging operations conducted by it in connection with the Products shall be conducted in conformity with this Agreement and the Health Registrations and all other applicable laws and regulations and that it shall maintain all records required by law to be maintained in connection with such operations.
COMPANY MAKES NO REPRESENTATION OR WARRANTY EXCEPT AS MAY BE EXPRESSLY SET FORTH IN THIS AGREEMENT, AND COMPANY EXPRESSLY DISCLAIMS ANY AND ALL IMPLIED WARRANTIES, INCLUDING ALL IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
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g. Quality Assurance and Control.
i. Quality Certifications. Company will be responsible for manufacturing the Product and maintaining the quality requirements to preserve the permits, licenses and approvals necessary for the proper manufacture of the Product. Company will maintain all documentation relating to the manufacture and or quality control of the Product for the required periods by statute or regulation. Sgenia and Subco will have the right, during normal business hours to review such documentation at its expense, and Company will cooperate to make the documentation available. Additionally, Sgenia and Subco will have the right, during normal business hours, to have access to Company’s manufacturing facilities upon reasonable notice at any time during the manufacture of the Product and all related material and for quality audits, to observe the manufacture, packaging, labeling and storage of the Product.
ii Samples. Sgenia and Subco may obtain samples of each batch of products, at their expense, equivalent to the cost to Company.
h. Regulatory Matters.
i. Regulatory Responsibility. Sgenia and Subco, jointly and severally, are solely responsible for preparation, filing, prosecution and maintenance of all Health Registrations required to be filed with any Regulatory Authority with regard to the Product (herein, together the “Responsible Party”) worldwide, as required by Company to be able to license, manufacture, market, sell and deliver the Product, including but not limited to the Sgenia Territory. All Health Registrations and other Regulatory Authority approvals, including within the Sgenia Territory, will be jointly owned by Sgenia, Subco and Company. The costs incurred by the Responsible Party in the preparation, filing and submission of such Health Registration and Regulatory Authority approvals in all jurisdictions will be borne by Company, pursuant to a budget developed jointly by Sgenia and Subco on the one hand and Company on the other hand. Company will have the right to require pre-approval of payments to be made under the budget and has sole right to authorize payments under the budget, including the right to discontinue the Health Registration and/or Regulatory Authority approvals in any particular jurisdiction or region or in relation to any Product. Except as otherwise provided in an applicable R&DP, the Responsible Party shall oversee, monitor and coordinate all regulatory actions, communications and filings with and submissions, including filings and submissions of supplements and amendments thereto, to Regulatory Authorities with respect to the Product and shall give Company a reasonable opportunity for prior review of all such material communications, filings and submissions. Health Registrations and other approval by Regulatory Authorities are to be commenced in Stage 3 of the R&DP. In its sole discretion, Company has the right to assume the obligations hereunder of the Responsible Party at any time.
ii. Regulatory Meetings and Correspondence. Except as otherwise provided in the R&DP, the Responsible Party shall be responsible for interfacing, corresponding and meeting with Regulatory Authorities with respect to the Product, and Company will promptly refer any contacts or questions from Regulatory Authorities to the Responsible Party. Both the Responsible Party and Company will be entitled to attend all meetings and, if reasonably practicable, telephone conferences with Regulatory Authorities. The Responsible Party and Company shall agree on the types of telephone and other forms of consultation with Regulatory Authorities that the parties will be required to notify the other party of and permit the other party to participate in.
iii. Reporting Adverse Elements. Each of Sgenia, Subco and Company agree to timely share information freely with respect to, and will develop and agree upon safety data exchange procedures governing the collection, investigation, reporting, and exchange of, information concerning any malfunction of the Product, product quality, manufacturing process, product complaints involving malfunction of the Product and other regulatory issues, sufficient to permit each party to comply with its legal obligations. The safety data exchange procedures will be promptly updated if required by changes in legal requirements or by agreement between the parties. The Responsible Party will be responsible for reporting all required safety and malfunction data to the appropriate Regulatory Authorities in accordance with applicable laws and regulations.
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a. Marketing and Sales Strategy. Company will be responsible for all decisions regarding the marketing and sales of the Product, subject to the review and coordination thereof through the Marketing Committee (referenced in Section 5.a.). Notwithstanding the foregoing, Sgenia and Subco, together, will have the right to obtain from Company marketing and sales plans and data for the purpose of commenting on and suggesting market and sales strategy. Marketing coordination shall be implemented through the Marketing Committee, and strategies and tactics for marketing, selling and otherwise commercializing the Products, including without limitation prices of marketed Products, method of sales and distribution, organization and management of sales and marketing, packaging and labeling, appointment of distributors and other terms and conditions for such sales and marketing shall be reviewed by the Marketing Committee. The Marketing Committee shall also coordinate the exchange of sales and marketing plans and promotional literature, and coordinate and implement marketing and marketing strategies and tactics, joint sales force training program, sales forecasts and post Health Registration studies for the Product. Notwithstanding the foregoing, Company will use commercially reasonable efforts to commercialize the Product that receives Health Registration and other Regulatory Approval, in a particular country jurisdiction or defined region, taking into account the scientific and commercial potential for the Product as determined by the Marketing Committee and agreed by the Company. To this end the Marketing Committee will establish periodic marketing and sales effort targets on a country-by-country or defined regional basis for the Product, which if not altered from time to time will continue for future periods, and the failure of Company to meet such schedule or 90% of any marketing or sales targets shall be deemed to be the failure of Company to use commercially reasonable efforts. Sgenia will provide sixty (60) days' notice to Company, if, in Sgenia’s opinion, Company is not using its commercially reasonable efforts to market and sell the Product in a particular country or defined region in order for the parties to discuss the situation and for Company to make diligent and continuing efforts to rectify the situation. If the parties finally agree that Company is not using such commercially reasonable efforts or it is shown by clear documentary evidence that the Company has failed to meet such schedule or marketing or sales effort targets as may be revised, Company shall have an additional 150 days to cure the situation. If Company shall fail to cure such situation within such 150 day period, then Company’s rights with respect to such country or defined region shall automatically become non-exclusive. In such event, Sgenia or Subco or a designee shall be entitled to exercise all rights of Company with respect to such jurisdiction. For clarification, the failure of the Product to meet the Health Registration requirements or other necessary approval of a Regulatory Authority for a particular country or defined region will not be basis to assert that the Company failed to satisfy its obligation to use commercially reasonable efforts to market and sell the Product.
e. Marketing Support by Sgenia and Subco. To the extent reasonably required or requested by Company, both Sgenia and Subco will make available on a regular basis, and from time to time, personnel, non-Confidential Information (as defined herein), and other marketing materials to aid and facilitate the manufacture, commercialization, marketing and sales of Company and any Designees, Sublicensees and Affiliates of the foregoing, at the expense of Sgenia and Subco, jointly and severally, provided that reasonable, actual out of pocket expenses of Sgenia and Subco, as the case may be, will be reimbursed by Company in accordance with its regular reimbursement policy for its employees. In addition, in order to facilitate and further the marketing of the Product and all aspects of the branding, establishment of good will and financing of Company, the Company is entitled to make reference to Sgenia’s and Subco’s input into the Product and the development procees and Sgenia’s and Subco’s business, assets, history, personnel and involvement in other projects, technologies and products directly and indirectly related to the Sgenia Patents, the Sensory Technology and the Products.
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i. Net Sales during such quarter for the Product, in local currency and United States dollars, with notation of the applicable exchange rate then used;
ii. The names of the royalty-bearing Products, gross sales, Net Sales, and any taxes withheld.
iii. A description of any other payments accruing to one or the other parties under Section 7;
iv. A calculation under Section 7 of the amounts due to Subco and to be deducted from such amount or to be due to Company, making reference to the applicable subsection thereof.
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i. was known to the party prior to receipt thereof from the other party;
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ii. was or becomes a matter of public information or publicly available through no act or failure to act on the part of party charged with maintaining confidential the Confidential Information;
iii. was acquired from a Third Party entitled to disclose it;
iv. was discovered or developed independently without reference to or use of such Confidential Information.
a. Each party disclaims any obligation or liability arising under the license provisions of this Agreement and any other provision of this Agreement, if any other party is, by a final determination in a governmental action, found to have materially violated material governmental regulations in the course of taking steps to bring any Product to a point of practical application.
b. Each party shall comply upon notice from any other party with all governmental requests directed to a party (and timely relayed by it in writing) and provide all information and assistance necessary to comply with the governmental requests.
c. Each party shall comply with all applicable government regulations in force and effect, including, but not limited to, federal, state, provincial and municipal legislation.
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a. Sgenia, by counsel it selects to whom Company has no reasonable objection, in cooperation and consultation with counsel appointed by Company, will prepare, file, prosecute and maintain all Sgenia Patents in Sgenia’s name and in countries designated by the Company determined in collaboration with Sgenia in such a process so as to permit Company to fulfill its obligations hereunder to manufacture, commercialize, market and sell the Product. Company shall have the right to meaningfully participate in the patent strategy and patent drafting and filing activities relating to the Product. Notwithstanding the foregoing, in the event of any disagreement with respect to the preparation, filing, prosecution, or maintenance of Sgenia Patents, final decisions shall be made by Sgenia in its sole discretion acting reasonably and in good faith and subject to the objectives of this Agreement.
b. Sgenia shall provide Company with a draft of any materials that it plans to submit to any domestic or foreign patent office ("Patent Office") in connection with the filing or prosecution of Sgenia Patents with sufficient advance notice to allow Company a reasonable period of time to review and comment upon such materials. Sgenia shall provide Company with any materials received from any Patent Office in connection with the filing or prosecution of Sgenia Patents.
c. Sgenia will be responsible for all expenses in filing, prosecuting and maintaining the Sgenia Patents (“Patent Expenses”), including without limitation, attorneys’ fees, the costs of any interference proceedings, oppositions, reexaminations, or any other ex parte or inter partes administrative proceeding before patent offices, taxes, annuities, issue fees, working fees, maintenance fees and renewal charges.
d. Sgenia shall have the right and obligation to initiate and/or control a legal proceeding involving the validity, enforceability, or infringement of the Sgenia Patents. Sgenia shall have the right to settle the claims asserted in such proceeding on any terms and conditions that it deems desirable in its sole discretion, which terms and conditions may include the granting by the Company to the opposing party of a sublicense to the Sgenia Patents, Technical Information, or Materials and Sgenia-generated Materials; provided, however, that the granting of any such sublicense shall be subject to Company's prior written approval, which shall not materially impair the licenses granted hereunder, which approval shall not be unreasonably withheld or delayed. Company’s failure to approve a settlement because of an objection of a Sublicense shall not constitute a reasonable basis for refusing to approve a settlement.
e. Company may request that Sgenia take steps, at Sgenia’s expense, to stop a Third Party selling products or services in competition with the Product and/or from infringing an issued patent falling within the definition of Sgenia Patents by providing Sgenia with written notice of such request accompanied by written evidence demonstrating prima facie competition and/or infringement of such patent. Company shall have the right to initiate and control legal proceedings against any such third-party infringer in its own name and at Company's own expense unless Sgenia, not later than ninety (90) days after receipt of such notice, either (i) causes such infringement to cease, or (ii) initiates legal proceedings against the third-party infringer. If Company controls the legal proceeding, Company shall not settle the proceeding without Sgenia’s prior written approval, which shall not be unreasonably withheld or delayed.
f. Any recovery, whether by way of settlement or judgment, pursuant to an actual or threatened legal proceeding shall first be used to reimburse the party in control of the proceeding for its costs and legal fees incurred to conduct such proceedings. The balance of such recovery shall be divided seventy-five percent (75%) to the party that initiated the legal proceeding and twenty-five percent (25%) to the other party.
g. In the event that a party to the Agreement initiates and/or controls a proceeding involving Sgenia Patents pursuant to this section, the other party shall cooperate fully with and supply all assistance reasonably requested by the party initiating such proceeding, including, without limitation, joining the proceeding as a party if requested. The party that initiates a legal proceeding involving the Sgenia Patents shall have sole control of that proceeding and shall reimburse the other party for any reasonable expenses incurred in providing assistance and cooperation in accordance with this Section. The party in control of a proceeding shall keep the other party reasonably apprised of the status of the proceeding.
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13. Marking.
a. Prior to the issuance of a Sgenia Patent, the Company will xxxx the Product made, used, sold, offered for sale, imported, or otherwise disposed of by the Company under the license granted in this Agreement with the words “Patent Pending,” and following the issuance of one or more patents, with the numbers of such patents. The Company shall cause Sublicensees, Designees, and Affiliates of the foregoing to comply with the marking requirements of this section.
a. This Agreement is made subject to any restrictions concerning the export of products or technical information from the United States of America which may be imposed from time to time by the government of the United States of America. The parties shall cooperate with one another as reasonably necessary to permit compliance with the laws and administrative regulations of the United States relating to the control of exports of commodities and technical data (“Export Laws”). Each party hereby assures the other they and their Affiliates, Designees and Sublicensees will not export or re-export, directly or indirectly, any technical information acquired from any other party under this Agreement or any products using such technical information or any part thereof to any country for which a validated license is required for such export or re-export under the Export Laws in effect at the time without first obtaining such a validated license.
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a. This Agreement shall be effective as of the Effective Date and shall continue in full force and effect until its termination in accordance with this Section 16.
b. Unless terminated earlier under any provision of this Agreement, the term of the licenses granted under this Agreement in a country or countries shall extend for forth (40) years.
c. The licenses granted under this Agreement may be terminated by either party upon a party’s failure to cure a material breach. The licenses granted under this Agreement may also be terminated by Sgenia and Subco on the one hand in the event Company commits any act of bankruptcy, becomes insolvent, or files a petition under any bankruptcy or insolvency act.
d. Upon any termination of this Agreement, all permitted sublicenses granted by the Company under it shall be assigned to Sgenia or Subco, as determined by Sgenia. In the event of termination of this Agreement, each Sublicensee may continue its license directly from Sgenia or Subco, as assigned, if Sublicensee is not in breach of its sublicense and thereafter all payments due under the Sublicense shall be paid directly to the licensor, which shall have no obligation to the Company with respect thereto. Notwithstanding the foregoing, Sgenia and/or Subco shall have the right to terminate any sublicense that places upon it obligations different from or in excess of the obligations Sgenia owes to Company under this Agreement.
e. Sections 5.f.iii (but only for the longer of any statutory period or one (1) year), 7, 8, 9, 11, 12, 15.c, 16.f and g., 17 - 27 will survive any termination or expiration of this Agreement.
f. Any termination of this Agreement shall not adversely affect any rights or obligations that may have accrued to either party prior to the date of termination, including without limitation, the payment obligations of this Agreement.
g. Upon any termination of this Agreement for any reason other than Company's failure to cure a material breach of this Agreement, the Company, Designees, Sublicensees, and Affiliates of the foregoing shall have the right to dispose of Product or substantially completed Product then on hand, and to complete orders for Product then on hand, and royalties shall be paid to Sgenia and/or Subco with respect to such Product pursuant to this Agreement.
h. Notwithstanding anything to the contrary in the Agreement, to the extent the manufacture of a Product infringes an issued patent within the definition of Sgenia Patents, the sale of that Product after the expiration date of the issued patent shall still constitute a royalty-bearing sale.
i. The rights provided in this Section 16 shall be in addition and without prejudice to any other rights which the parties may have with respect to any breach or violations of the provisions of this Agreement.
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if to Sgenia, to: C/Chile, 4 Xxxxxxxx XX
00000 Xxx Xxxxx xx Xxxxxx
Xxxxxx, Xxxxx
if to Subco, to: C/Chile, 4 Xxxxxxxx XX
00000 Xxx Xxxxx xx Xxxxxx
Xxxxxx, Xxxxx
In each case with a copy to: Xxxxx Bermuy y Asociados, S.L.
X/ Xxxxxxxx, 0 – 0x
00000 Xxxxxx, Xxxxx
if to the Company, to: Braeden Valley Mines, Inc.
Xxxx Xxxxxx Xxxxxxxxxxx 00, Xxxxxx 0
|
00000 Xxxxxxxx, Xxxxx
with a copy to (which will not
represent notice): Golenbock, Eiseman, Assor, Xxxx & Xxxxxx LLP
000 Xxxxxxx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Attention: Xxxxxx X. Xxxxxxx, Esq.
or to such other address as a party may specify by notice hereunder.
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23. Governing Law. This Agreement shall be governed by substantive laws of the State of New York applicable to agreements made and to be fully performed in New York, and without reference to the conflict of laws principles of any jurisdiction. Each party agrees that it shall not argue to any court or other tribunal that the substantive laws of the State of New York do not govern the construction and enforcement of this Agreement. The parties agree that any and all claims arising under or related to this Agreement shall be heard and determined only in either the United States District Court for the Southern District of New York or in the courts of the State of New York located in the City and County of New York, and the parties irrevocably agree to submit themselves to the exclusive and personal jurisdiction of those courts and irrevocably waive any and all rights any such party may now or hereafter have to object to such jurisdiction.
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Sgenia Soluciones, S.L.
By: /S/ Xxxxx Xxxx
Name: Xxxxx Xxxx
Title: Administrador Unico – Chief Executive Officer
XXXXX Biosystem, S.L.
By: /S/ Xxxxx Xxxx
Name: Xxxxx Xxxx
Title: Administrador Unico – Chief Executive Officer
Braeden Valley Mines Inc.
By: /S/ B. Xxxxxxxxx Xxxxxxx
Name: B. Xxxxxxxxx Xxxxxxx
Title: President
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