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BISx INTERNATIONAL LICENSE AGREEMENT

Content License Agreement

BISx INTERNATIONAL LICENSE AGREEMENT | Document Parties: ASPECT MEDICAL SYSTEMS INC You are currently viewing:
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ASPECT MEDICAL SYSTEMS INC

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Title: BISx INTERNATIONAL LICENSE AGREEMENT
Governing Law: Massachusetts     Date: 8/13/2009
Industry: Medical Equipment and Supplies     Sector: Healthcare

BISx INTERNATIONAL LICENSE AGREEMENT, Parties: aspect medical systems inc
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Exhibit 10.3

Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.

BISx INTERNATIONAL LICENSE AGREEMENT

THIS Agreement is made and entered into as of April 14, 2009 (the “Effective Date”), by and between ASPECT MEDICAL SYSTEMS, INC. (“Aspect”), a Delaware, U.S.A. corporation having offices at One Upland Road, Norwood, Massachusetts 02062, U.S.A. and Philips Medizin Systeme Böblingen GmbH with offices at Hewlett-Packard-Strasse 2, 71034 Boeblingen, Germany (“Philips”).

     WHEREAS, Aspect possesses certain intellectual and industrial property rights;

     WHEREAS, Aspect is willing to grant, and Philips desires to acquire, non-exclusive worldwide rights to use such rights in accordance with the terms and conditions hereinafter set forth; and

     WHEREAS, Aspect and Philips wish to provide Philips customers with a more effective supply of BIS Sensors (as defined below) at competitive prices.

     NOW, THEREFORE, in consideration of the premises and mutual promises, terms and conditions hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Aspect and Philips (the “Parties”) do hereby agree as follows:

1.

 

DEFINITIONS

As used herein, the following terms shall have the following definitions.

 

1.1

 

Affiliates. “Affiliates” of a Party hereto shall mean companies which are controlled by, control or are under common control with such Party. A company shall be considered an “Affiliate” for only so long as such control exists. For the purposes of this definition, partnerships or similar entities where a majority-in-interest of its partners or owners are a Party hereto and/or Affiliates of such Party shall also be deemed to be Affiliates of such Party.

 

 

1.2

 

Agreement Term. “Agreement Term” shall mean the period beginning on the Effective Date and ending on the date of termination or expiration of this Agreement, as the case may be.

 

 

1.3

 

Aspect Products. “Aspect Products” shall mean those products available for purchase by Philips and its Affiliates as set forth in Exhibit A (Aspect Products and Purchase Prices).

 

 

1.4

 

BIS. “BIS” shall mean the Bispectral Index™ which is Aspect’s proprietary processed EEG parameter that directly measures the hypnotic effects of anesthetic and sedative agents on the brain.

 

 

1.5

 

BIS Engine. “BIS Engine” shall mean Aspect’s processing unit for deriving the BIS from the raw EEG signal.

 


 

 

1.6

 

BIS Product. “BIS Product” shall mean the BISx System and/or the BIS Engine, as the case may be.

 

 

1.7

 

BIS Ready. “BIS Ready” shall mean a Philips Patent Monitor with (a) a BIS port standard on the monitor ready to accept a BISx System, with BIS software installed on the host monitor, or (b) at least one available multi-connector port if such a dedicated BIS port is not utilized.

 

 

1.8

 

BIS Sensor. “BIS Sensor” shall mean a single use disposable or semi-reusable sensor manufactured by Aspect for use with the BISx System or the BIS Engine/DSC-XP in the OR, ICU and other sedation locations that is required to generate Aspect’s Bispectral Index. These sensors include the BIS Quatro Sensor, the BIS Extend Sensor and the BIS Pediatric Sensor.

 

 

1.9

 

BISx. “BISx” shall mean a device that acquires up to two channels of EEG and computes BIS and other EEG parameters, uniting the functionality of the existing Aspect’s BIS Engine and DSC-XP. BISx shall include enhancements and new features relating to consciousness monitoring that are made generally available by Aspect during the term of this Agreement.

 

 

1.10

 

BISx System. “BISx System” shall mean the system comprised of a BISx device with a Monitor Cable and a Patient Interface Cable (“PIC”) designed for use with the Philips Patient Monitor and is also known, including in Exhibit A, as a “BISx Kit”.

 

 

1.11

 

Business Day. “Business Day” shall mean a day on which Aspect’s offices are open for business in Norwood, Massachusetts, U.S.A., and on which Philips’ offices are open for business in Boeblingen, Germany.

 

 

1.12

 

Contract Year. “Contract Year” shall mean the 12-month period commencing on the Effective Date, and then each 12-month period thereafter.

 

 

1.13

 

Documentation. “Documentation” shall mean any and all user manuals, programmer’s guides, configuration guides, circuit diagrams, and help files related to the Software.

 

 

1.14

 

DSC-XP. “DSC-XP” shall mean Aspect’s digital signal converter using XP technology. The DSC-XP is a small box that is kept close to the patient that converts the analog EEG signals to digital signals for processing the BIS value.

 

 

1.15

 

Intellectual Property Rights. “Intellectual Property Rights” shall mean all forms of protection afforded by law to inventions, models, designs or technical information, and applications therefor or which otherwise arise or are enforceable under the laws of the United States, any other jurisdiction or any bi-lateral or multi-lateral treaty regime, including, but not limited to, any and all patents and patent applications (including additions, reissues, divisionals, continuations, continuations-in-part, substitutions, re-examinations, patent term extensions, registrations, supplemental protection term certificates, and renewals

 


 

 

 

of any of the foregoing), utility models, trademarks, trade secrets, registered and unregistered designs including mask works, copyrights, and moral rights.

 

 

1.16

 

IntelliVue Clinical Network. “IntelliVue Clinical Network” shall mean the software that enables wireless and wire line communications transmission of physiologic measurement data between Philips IntelliVue bedside monitors, central stations, applications servers, database servers and telemetry devices.

 

 

1.17

 

Licensed Technology. “Licensed Technology” shall mean the Aspect Products, the Software, Documentation and the Technical Information.

 

 

1.18

 

License Term. “License Term” shall mean the period beginning on the Effective Date and ending on the date of termination or expiration of this Agreement, as the case may be.

 

 

1.19

 

Material Product Change. “Material Product Change” shall mean any of the following changes to a BIS Product or any component thereof:

 

(a)

 

BIS Product or service design changes that affect regulatory compliance or safety or materially affect form, fit, function, reliability, serviceability, performance, functional interchangeability or interface capability of the BIS Product;

 

 

(b)

 

production process changes that materially affect design and/or production specifications;

 

 

(c)

 

change of manufacturing facility location or change of ownership of the manufacturing facility (to the extent such change in ownership is known to Aspect);

 

 

(d)

 

changes that modify Aspect’s quality system beyond editorial enhancements or continuous efficiency improvements in workflows; or

 

 

(e)

 

changes to regulatory status (including environmental compliance status) which affect any certification of Aspect or the manufacturing facility for the BIS Product.

 

 

1.20

 

Monitor Cable. “Monitor Cable” is a cable that connects the BISx to the Philips Patient Monitor and is also known, including in Exhibit A, as a “Host Cable”. The Monitor Cable connector will be supplied by Aspect or its manufacturer using designs supplied by Philips for final assembly with the BIS Products.

 

 

1.21

 

“Open Source Software” shall mean any software that is licensed under Open License Terms.

 

 

1.22

 

“Open License Terms” shall mean terms that require as a condition of use, modification and/or distribution of a work:

1. the making available of source code or other materials preferred for modification, or

2. the granting of permission for creating derivative works, or

 


 

3. the reproduction of certain notices or license terms in derivative works or accompanying documentation, or

4. the granting of a royalty-free license to any party under Intellectual Property Rights regarding the work and/or any work that contains, is combined with or otherwise is based on the work.

 

1.23

 

Philips Patient Monitor. “Philips Patient Monitor” shall mean all Philips multi-parameter patient monitors designed by Philips to accept a BIS Product.

 

 

1.24

 

Software. “Software” shall mean Aspect software programs that are integrated into the BIS Product.

 

 

1.25

 

Technical Information. “Technical Information” shall mean the trade secrets, know-how, computer programs (including copyrights in said software), knowledge, technology, means, methods, processes, practices, formulas, techniques, procedures, technical assistance, designs, drawings, apparatus, written and oral rectifications of data, specifications, assembly procedures, schematics and other valuable information of whatever nature, whether confidential or not, and whether proprietary or not, which is now (or hereafter, during the Agreement Term, becomes) licensable by Aspect and which is necessary for Philips’ integration, sale, distribution, use, installation, servicing or testing of an Aspect Product as permitted under this Agreement.

 

 

1.26

 

U.S. Dollars. “U.S. Dollars” shall mean lawful money of the United States of America, in immediately available funds.

 

 

1.27

 

Philips BIS Products Solution. “Philips BIS Products Solution” shall mean the BIS Products in combination with Philips Patient Monitors.

2.

 

LICENSES TO INTELLECTUAL PROPERTY

 

 

2.1

 

Licenses .

 

(a)

 

For the term of this Agreement, subject to the terms and conditions of this Agreement, Aspect agrees to sell and Philips agrees, on behalf of itself and its Affiliates, to purchase the Aspect Products listed in Exhibit A (Aspect Products and Purchase Prices) and each Party agrees to negotiate an amendment to Exhibit A to include BIS-x4 when available (including the negotiation of the price thereof).

 

 

 

 

The Aspect Products purchased from Aspect under this Agreement shall only be used as part of, incorporated into, or integrated with, systems and products of Philips which Philips, its Affiliates, distributors or sub-distributors sell or lease to third-party users in the regular course of business. Philips, its Affiliates, distributors or sub-distributors shall only sell Aspect-approved accessories in connection with any BIS Product. Aspect agrees to provide Philips with all information in its possession that

 


 

 

 

 

is necessary for the interfacing and operation of the BIS Products with Philips Patient Monitors. Aspect agrees to provide Philips with information in its possession that will allow Philips to provide Aspect Products-specific service and support to the end-user.

 

 

(b)

 

Subject to the terms and conditions of this Agreement, during the term of this Agreement and, thereafter, solely as provided in Section 12.3(b)(i), Aspect hereby grants Philips a non-exclusive and non-transferable world-wide license (i) with the right to sublicense solely to Philips’ Affiliates, distributors and sub-distributors, to import, and (ii) with the right to sublicense solely to Philips’ Affiliates, distributors, sub-distributors and customers, to use, display and copy the Software provided by Aspect solely in connection with the sale and operation of the Aspect Products for use with a Philips Patient Monitor.

 

 

(c)

 

Subject to the terms and conditions of this Agreement, during the term of this Agreement and, thereafter, solely as provided in Section 12.3(b)(i), Aspect hereby grants Philips a non-exclusive and non-transferable world-wide license (i) with the right to sublicense solely to Philips’ Affiliates, distributors and sub-distributors, to copy, make alterations and derivative works, sell copies of, distribute, and import the Documentation provided by Aspect, and (ii) with the right to sublicense solely to Philips’ Affiliates, distributors, sub-distributors and customers, to use and display such Documentation and the derivative works thereof created in accordance with clause 2.1(c)(i), in each case solely in connection with the sale and operation of the Aspect Products for use with a Philips Patient Monitor.

 

 

(d)

 

All rights granted to customers to use the Software and Documentation with the Aspect Products shall survive any termination of the Agreement as long as the Software and Documentation is distributed to customers who are bound by terms at least as protective of the Software and Aspect’s Intellectual Property Rights therein as the terms set forth in Sections 2.1(e) and 2.1(f) of this Agreement; Philips shall be responsible for communicating these requirements to its customers and the customers of its Affiliates, distributors and sub-distributors. Any sublicense to a customer to use the Software and Documentation shall automatically terminate on the customer’s breach of any of the terms set forth in Section 2.1(e) or 2.1(f).

 

 

(e)

 

Philips shall not, without the express written consent of Aspect, disassemble, decompile or otherwise reverse engineer the Aspect Products or any part thereof (including the Software). Philips agrees to obligate its distributors, sub-distributors, its Affiliates and purchasers of Aspect Products not to disassemble, decompile or otherwise reverse engineer the Aspect Products or any part thereof without the express written consent of Aspect. If applicable law requires that Philips or any of its distributors, sub-distributors, Affiliates or customers have access to the source code of the Software, Philips shall notify Aspect if any such party desires such access and Aspect shall have the option to (i) perform the work to derive any required information at Aspect’s usual consulting rate, payable by

 


 

 

 

 

such party, or (ii) allow such party to access the source code solely for the legally required purpose.

 

 

(f)

 

Title to and ownership of any and all proprietary rights in or related to the Software and Documentation thereof shall at all times remain with Aspect or its licensor(s). Nothing in this Agreement shall be construed as a sale of any rights in the Software or Documentation. Any references in this Agreement to sale, resale or purchase of the Aspect Products, or similar references, shall, with respect to the Software and the Documentation, mean licenses of the Software and Documentation pursuant to Sections 2.1(b) and (c).

 

 

(g)

 

Philips and its customers shall have the right to create a reasonable number of backup copies of the Software, Documentation and any Technical Information solely for disaster recovery and/or contingency purposes.

 

 

2.2

 

Use of Technical Information.

 

 

 

 

Subject to the terms and conditions of this Agreement, Aspect grants to Philips a paid-up, non-exclusive worldwide right and license, with the right to sublicense solely to Philips’ Affiliates, during the Agreement Term to use, display, copy and import the Technical Information in connection with the exercise by Philips and its Affiliates of its rights and licenses granted in Section 2.1, and for no other purpose and Philips may distribute such Technical Information to its Affiliates solely for such purpose. All Technical Information shall be considered to be the Proprietary Information of Aspect for the purposes of Section 8.

 

 

2.3

 

Philips Trademarks, Service Marks, and Trade Names .

 

 

 

 

Philips on behalf of its ultimate parent Koninklijke Philips Electronics NV (“KPENV”) hereby grants Aspect a non-exclusive license under those certain trademarks as listed on Exhibit F (the “Philips Trademarks”) for the sole purpose of promoting the Aspect Products in promotional material, advertisement and/or in written technical literature [**] (“Purpose”). Such license is granted provided Aspect fully satisfies all of the provisions relating to/imposed on Aspect as set forth below:

 

(a)

 

Aspect in its use of the Philips Trademarks shall adhere to the trademark guidelines of Philips and KPENV;

 

 

(b)

 

Aspect shall use the Philips Trademarks consistent and solely in accordance with the Purpose;

 

 

(c)

 

Aspect shall use the Philips Trademarks only at trade shows and for advertising within brochures and marketing materials (“Licensed Use”);

 

 

(d)

 

Aspect shall not use the Philips Trademarks without Philips’ prior written permission wherein permission must be agreed to by Philips for each type of Licensed Use;

 


 

 

(e)

 

Aspect agrees to use the Philips Trademarks only in the form and manner provided and approved by Philips;

 

 

(f)

 

Aspect shall make available to Philips a sample of each type of Licensed Use (final version) for purposes of verification of usage being in accordance with the terms and conditions of this Section 2.3.

 

 

(g)

 

Notwithstanding anything to the contrary in this Section 2.3, (i) Aspect may identify Philips as a customer of Aspect, including without limitation on Aspect’s web site during the Agreement Term, the form and content of which is subject to Philips’ review and approval as set forth in this Section 2.3, such approval not to be unreasonably withheld or delayed; and (ii) all promotional material, advertisements and/or written technical literature using Philips Trademarks that were previously developed and approved by Philips under the agreement dated the 6th day of August, 1999, by and between Aspect and Philips (formerly Hewlett-Packard GmbH), as amended through the Effective Date (“1999 Agreement”) during the period from January 1, 2007 until the Effective Date of this Agreement shall remain approved under this Agreement;

 

 

(h)

 

Philips hereby reserves all rights, title and interest in and to the Philips Trademarks not specifically granted herein;

 

 

(i)

 

Philips shall at all times, anywhere in the world, and whether or not in competition with Aspect, have the right to use and/or authorize the use of the Philips Trademarks, or any portion thereof, in any way Philips may desire;

 

 

(j)

 

Aspect shall indemnify, defend and hold Philips, and all other legal entities which are, directly or indirectly, owned or controlled by KPENV and all of each of their respective officers, directors and employees harmless from and against any and all losses, costs, claims, damages (including court costs and attorney’s fees), liability, demands or expenses, which may arise out of or derive in any way from Aspect’s use of the Philips Trademarks except in the event of a breach of the representations or warranties by Philips as set forth in this Section 2.3. Philips hereby agrees to defend, indemnify and hold Aspect harmless from any claims arising out of Philips breach of any representations, warranties or agreements as set forth in this Section 2.3;

 

 

(k)

 

Philips represents and warrants that the use of the licensing rights under the Philips Trademarks granted to Aspect under this Section 2.3 shall not infringe upon the common law or statutory trademark rights of any third parties;

 


 

 

(l)

 

Aspect agrees that it will do nothing inconsistent with the ownership of the Philips Trademarks by KPENV and that all uses of same shall inure to the benefit of and be on behalf of KPENV;

 

 

(m)

 

Aspect agrees that nothing in this Agreement shall give Aspect any right, title or interest in the Philips Trademarks other than the right to use the Philips Trademarks in accordance with this Section 2.3;

 

 

(n)

 

Philips shall have the sole right and discretion to bring infringement or unfair competition proceedings involving the Philips Trademarks. Under no circumstances shall Aspect take any action or has any right to enforce Philips’s rights in the Philips Trademarks;

 

 

(o)

 

Aspect’s license of the Philips Trademarks in accordance with this Section 2.3 is expressly conditioned on Aspect’s execution and delivery of this Agreement and continued compliance with the terms of this Section 2.3. Philips may terminate this Agreement immediately if Aspect breaches any term or condition contained in this Section 2.3 which has not been cured within thirty (30) days after written notice of breach is delivered to Aspect. Aspect agrees to immediately discontinue the use of the Philips Trademarks if such cure is not complete within this thirty (30) day time period. Aspect further agrees that upon termination of this Agreement, all rights in the Philips Trademarks and the goodwill connected therewith shall remain the property of KPENV;

 

 

(p)

 

In the event that Philips decides, at its sole discretion, as a result of a cease and desist demand from a third party (or an agreement resulting therefrom) or a judicial order to cease and desist from using any one or more of the Philips Trademarks, Aspect shall immediately cease using said any one or more of the Philips Trademarks;

 

 

(q)

 

Aspect shall not use any other trademark in combination with any of the Philips Trademarks without prior written approval of Philips which shall be in Philips’ sole discretion; and

 

 

(r)

 

In the event of expiration or termination of this Agreement, the licensing rights under the Philips Trademarks of this Section 2.3 immediately terminates. Upon termination of this Agreement any reference to Philips and its trademarks must be promptly removed from any literature or other display and any existing literature containing any reference to Philips and its trademarks must no longer be distributed. Aspect may not use the Philips Trademarks in connection with the delivery by Aspect of any services.

 

 

2.4

 

Aspect Trademarks, Service Marks and Trade Names .

 

(a)

 

Aspect hereby grants Philips the right to use the trademarks, service marks and trade names claimed by Aspect listed in Exhibit E hereto, as may be

 


 

 

 

 

amended from time to time by mutual agreement of the Parties’ respective relationship managers (the “Aspect Trademarks”) on a non-exclusive basis only for the License Term and solely for display or advertising purposes in connection with the Aspect Products manufactured and sold in accordance with this Agreement, the form and content of which is subject to Aspect’s review and approval, such approval not to be unreasonably withheld or delayed. All display and advertising material using the Aspect Trademarks that were developed and approved under the 1999 Agreement shall remain approved under this Agreement. During the License Term, Philips and its Affiliates may also use, without Aspect’s prior written consent, Philips or third-party trademarks, service marks and trade names other than the Aspect Trademarks in connection with the BIS Products; provided, however Philips shall, and shall ensure that its Affiliates, will make reasonable efforts to use the Aspect Trademarks in a manner which makes them at least as large and prominent as any other similar third party trademarks, service marks, or trade names appearing on any such label, display or advertisement. Philips may not use the Aspect Trademarks in connection with the delivery by Philips of any services.

 

(b)

 

Philips and its Affiliates shall be required to mark those Philips Patient Monitors that are BIS Ready with Aspect’s “BIS Ready” logo in form of a laser printed, printed, or sticky label. The marking will be of a mutually agreeable size and will be placed at a mutually agreeable location on such Philips Patient Monitor. Notwithstanding the foregoing, if no mutually agreeable place or size can be determined then Philips’ labeling obligations shall be considered fulfilled with providing one loose sticky label “BIS Ready” with each such monitor shipped. Aspect shall provide the required number of “BIS Ready” sticky labels to Philips free of charge.

 

 

(c)

 

Each of Philips and its Affiliates shall

 

 

(i)

 

whenever it uses the Aspect Trademarks in any technical literature, product literature or advertisement, include a statement at least once in each piece of literature that the Aspect Trademarks are trademarks claimed by Aspect;

 

 

(ii)

 

use the Aspect Trademarks in compliance with Aspect’s guidelines for using the Aspect Trademarks;

 

 

(iii)

 

not modify any of the Aspect Trademarks in any way and not use any of the Aspect Trademarks on or in connection with any goods or services other than the Aspect Products.

 

2.5

 

Right to Sublicense .

 

 

 

 

Except as agreed to subject to the terms of this Agreement, Philips shall not have the right to sublicense any of the rights or licenses granted hereunder without Aspect’s prior written consent in Aspect’s sole discretion; provided, however it is understood that Philips shall have the right to grant sublicenses consistent with the terms and conditions of this Agreement to Philips’ Affiliates, distributors, sub-distributors, and customers without Aspect’s prior written consent,

 


 

 

 

 

provided, however, that Philips shall not have the right to grant any sublicense to customers under the Aspect Trademarks.

 

2.6

 

No Rights by Implication .

 

 

 

 

No rights or licenses with respect to Licensed Technology are granted or deemed granted hereunder or in connection herewith, other than those rights or licenses expressly granted in this Agreement.

 

 

2.7

 

Software and Computer Programs .

 

 

 

 

Philips shall retain and shall not, without the express written consent of Aspect, alter or obscure any notices, markings or other insignia which are affixed to the Software, the Documentation or any part thereof at the time of delivery of such Software or such Documentation. The Software shall be considered to be the Proprietary Information of Aspect for the purposes of Section 8.

 

 

2.8

 

Limited Warranty .

 

 

 

 

Aspect represents and warrants to Philips that, as of the Effective Date, Aspect knows of no claim by any third-party of infringement by Aspect on such party’s patent, trademark, copyright, trade secret or other Intellectual Property Rights covering the Aspect Products, Software, Documentation, or Technical Information. Aspect further represents and warrants that it owns all right, title, and interest in and to the Aspect Products, Software, Documentation, and Technical Information, including all Intellectual Property Rights thereto, or has the full lawful right to grant the licenses to the Licensed Technology as set forth herein.

 

 

2.9

 

DISCLAIMER OF WARRANTY .

 

 

 

 

EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH HEREIN, INCLUDING BUT NOT LIMITED TO EXHIBIT D, ASPECT MAKES NO OTHER EXPRESS OR IMPLIED WARRANTY, STATUTORY OR OTHERWISE, CONCERNING THE LICENSED TECHNOLOGY OR ANY OTHER INFORMATION COMMUNICATED TO PHILIPS, INCLUDING WITHOUT LIMITATION NO WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE, AND NO WARRANTIES AS TO QUALITY OR THE USEFULNESS OF THE LICENSED TECHNOLOGY FOR ITS INTENDED PURPOSE.

 

3.

 

CHANGES TO BIS PRODUCTS AND PATIENT MONITORS

 

3.1

 

Notifications of Changes to BIS Products .

 

 

 

 

Aspect shall have the right, at any time and from time to time, to make substitutions and modifications to BIS Products that, in Aspect’s reasonable judgment, do not constitute Material Product Changes, and Aspect shall not be required to provide Philips with notification of any such substitutions or modifications.

 

 

3.2

 

Material Product Changes .

 

 

 

 

In the event that any proposed substitution or modification is expected by Aspect to be a Material Product Change, Aspect shall give Philips written notice of such

 


 

 

 

 

proposed substitution or modification as early as possible in the development process, but in any case no later than the earlier of (i) at least [**] days prior to the planned release of such change if no significant changes are likely to be required to be implemented by Philips in Philips Patient Monitors, or (iii) at least [**] prior to the planned release of such modifications if significant changes are also likely to be required to be implemented by Philips in Philips Patient Monitors. If Philips does not provide written approval of any such proposed changes (which approval shall not be unreasonably withheld) Aspect shall continue to deliver the unchanged version of the BIS Product for at least [**] according to the regular forecast mechanism and, [**] prior to the termination of supply, offer Philips a final opportunity to purchase up to [**]% of the volume ordered in the previous [**]. Aspect shall provide the appropriate verification and validation information for evaluating the effect of the change on the BIS Products.

 

3.3

 

Required Changes .

 

 

 

 

Notwithstanding anything contained in this Agreement to the contrary, Aspect reserves the right from time to time during the License Term to require Philips, after consulting with Philips, to modify or improve any Aspect Product (including without limitation the software programs used in connection with the BIS Product) if the modification or improvement reasonably relates to efficacy or patient safety. Provided that such modifications are feasible and commercially reasonable, Philips shall implement those modifications to the BIS Products and associated Philips Patient Monitors being manufactured or to be manufactured and to modify and improve BIS Products previously manufactured and shipped to customers in order to incorporate such changes on a schedule at Philips’ reasonable discretion. If such modifications, improvements, or changes are implemented by Philips, it will be with Aspect’s reasonable assistance and, to the extent that the required change is caused by the BIS Product (other than the Monitor Cable), at Aspect’s expense.

 

 

3.4

 

Notification of Discontinuance .

 

 

 

 

Aspect agrees to notify Philips in writing not less than [**] in advance of the discontinuance of any BIS Product. Philips shall be able to place orders for [**] after receipt of the written notice in any case. In addition, Philips shall be entitled to determine its lifetime-buy quantities and place a corresponding last purchase order no later than [**] prior to the planned obsolescence date.

 

4.

 

INCIDENT REPORTING AND CORRECTIVE ACTIONS

 

4.1

 

Aspect shall immediately, but no later than within 48 hours, provide Philips with a written notice upon Aspect becoming aware of the occurrence of any of the following events: (i) Aspect recalls any BIS Product, or ceases or suspends the sale of any BIS Product due to any problem which relates to such BIS Product’s efficacy or patient safety in any country; (ii) any defect of any Licensed Technology, which relates to such BIS Product’s efficacy or patient safety, is published, publicly reported or made known to the public by any third party, or found by or reported to Aspect; or (iii) any Licensed Technology is determined to have contributed to or caused a death or serious injury.

 


 

 

4.2

 

Philips shall immediately, but no later than within 48 hours, provide Aspect with a written notice upon Philips becoming aware of the occurrence of any of the following events: (i) Philips identifies the need to recall its BIS Products, or ceases or suspends the sale of its BIS Products due to any problem which Philips believes relates to such BIS Product’s efficacy or patient safety in any country, it being understood that any decision to proceed with a recall of BIS Products sold hereunder shall not be made by Philips before consulting with Aspect; (ii) any defect of any BIS Product or the Licensed Technology, which relates to such BIS Product’s efficacy or patient safety, is published, publicly reported or made known to the public by any third party, or found by or reported to Philips; or (iii) any BIS Product or the Licensed Technology is determined to have contributed to or caused a death or serious injury, or any BIS Product or the Licensed Technology malfunctioned and if that malfunction occurred again, it would be likely to contribute to or cause a death or serious injury.

 

 

4.3

 

Aspect, itself or through its Affiliates, is responsible for determining complaints and Medical Device Reporting (“MDRs”) and related submissions to the FDA and other regulatory authorities for the BIS Products. Philips, itself or through its Affiliates, is responsible for determining complaints and MDRs and related submissions to the FDA and other regulatory authorities for the Philips BIS Products Solution (other than the BIS Products).

 

 

4.4

 

Subject to the provisions of Sections 4.1, 4.2 and 4.3 above, Philips is responsible for the overall Philips BIS Products Solution and is therefore responsible to perform recalls and corrective actions with respect thereto.

 

 

4.5

 

Any corrective action will be at Philips’ expense if clearly caused by the Philips Patient Monitor. Philips will reimburse Aspect for Aspect’s documented cost directly resulting from such corrective actions within 60 days of completion of the corrective action.

 

 

4.6

 

Aspect will reimburse Philips for Philips’ documented cost directly resulting from such corrective actions within 60 days of completion of the corrective action if clearly caused by any BIS Product, as described in Exhibit B.

 

 

4.7

 

Philips and Aspect will share the cost if both Parties’ products contribute to the cause, proportionate to the extent of each Party’s respective degree of cause as mutually agreed. Aspect’s Vice President of Regulatory and Quality Affairs and a senior business director, together with the most senior executive with regulatory responsibility and a senior business director from Philips Healthcare Informatics/Patient Monitoring business unit, will negotiate in good faith a reasonable settlement of the issue. If after twenty (20) Business Days, the Parties in good faith fail to agree the issue will be escalated for resolution in accordance with Section 13.4(b).

 


 

5.

 

PRODUCT DEVELOPMENT (BIS PRODUCTS AND MONITOR CABLE)

 

 

 

The existing implementation of BIS in Philips Patient Monitors utilizing the BIS Products has been developed under a previous development contract. Both Parties anticipate that there will be advances in the BIS technology over time and agree that reasonable efforts should be made, if mutually agreed, to keep the Philips BIS implementation up-to-date according to the latest Aspect technology and performance. Therefore, an ongoing project is established between the companies to cover these ongoing improvement efforts.

 

 

5.1

 

Project Management .

 

5.1.1

 

Each Party shall appoint a “Project Manager” who shall oversee and manage the joint R&D project on a day-to-day basis.

 

 

5.1.2

 

The Project Managers shall meet regularly based on the project needs to assess the project status and discuss and resolve any issues or problems. These meetings may be held face-to-face or as telephone or videoconferences.

 

 

5.1.3

 

Each Party shall bear its own development, communication and travel costs.

 

 

5.2

 

Philips Development Responsibilities .

 

 

 

 

Philips will be responsible for any changes (design or material) to the Philips Patient Monitor to integrate the BIS Products with the Philips Patient Monitor and the visualization of BIS data. This includes the Philips Patient Monitor connector and the appropriate communication software to interface the BIS Products with Philips Patient Monitors.

 

5.2.1

 

Philips will be responsible for the necessary Philips Patient Monitors hardware and software (changes, upgrades, maintenance) to allow the user to configure BIS parameters, to display the BIS-related information on the Philips Patient Monitor display, and to pass on BIS-related data through the IntelliVue Clinical Network and other Philips Patient Monitor outputs.

 

 

5.2.2

 

Philips shall make reasonable commercial efforts to follow Aspect’s guidelines and recommendations concerning processing and visualization of BIS data with respect to the operation and visualization logic, philosophy and visual, audible and haptic experience (“look-and-feel”) of Philips Patient Monitors and other Philips products that store, process, display or provide patient data.

 

 

5.2.3

 

Philips shall be responsible for testing and validation of the BIS Products integration with the Philips Patient Monitors.

 

 

5.2.4

 

Depending on the complexity of the connector assembly, Philips acknowledges, subject to good faith negotiation and mutual agreement of the Parties, that it may be involved in the manufacturing and assembly process of any new Monitor Cable required to interface Philips Patient Monitors with the BISx System.

 

 

5.2.5

 

Philips shall assume regulatory responsibility for the combination of the BIS Products with Philips Patient Monitors as provided in Section 9 of this Agreement.

 


 

 

5.3

 

Aspect Development Responsibilities .

 

 

 

 

For changes to the current BIS Products, Aspect shall provide Philips with the necessary Technical Information to support the integration of the new or modified BIS Products with Philips Patient Monitors. This includes information to facilitate the development and/or refinement of a Philips Patient Monitor connector, of an appropriate communications software to interface the BIS Products to the Philips Patient Monitors, and of an appropriate user interface for BIS in the Philips Patient Monitor. Aspect shall inform Philips and provide said Technical Information as early in the development process as possible, in any case no later than (i) any other Aspect partner (who has an agreement with similar terms and conditions as this Agreement) gets informed about the plans and specifications, (ii) six (6) months prior to commercial availability for any change that may affect the specifications and documentation of the Philips BIS Products Solution, or (iii) twelve (12) months prior to commercial availability for any change that requires changes in the Philips Patient Monitors as well.

 

 

5.3.1

 

Aspect shall design, develop and test the BIS Products according to the mutually agreed upon specifications.

 

 

5.3.2

 

Aspect shall make commercially reasonable efforts to maintain backward compatibility with installed base Philips Patient Monitors for any new or changed BIS Products and/or 2-channel BIS sensors.

 

 

5.3.3

 

Upon Philips completing the integration of the BIS Products into a Philips Patient Monitor (including when any new model of a BIS Ready Philips Patient Monitor is developed/introduced), Aspect will “certify” this integration. This entails Aspect verifying the accurate display on the Philips Patient Monitor. Once successfully verified, Aspect will provide Philips with a letter so certifying. To facilitate the certification process, Philips will lend to Aspect a Philips Patient Monitor for testing purposes. Said Philips Patient Monitor will be provided to Aspect, at Philips’ cost and expense, within thirty (30) days after execution of this Agreement, and will be kept updated by Philips to the latest available state as far as the BIS functionality is concerned. Aspect will return such equipment to Philips, at Aspect’s cost and expense, within thirty (30) days after termination of this Agreement.

6.

 

SALES BY ASPECT TO PHILIPS

 

 

6.1

 

Offer and Acceptance; Pricing . Philips’ and its Affiliates’ purchases of Aspect Products during the first calendar year shall be at the prices set forth in Exhibit A (Aspect Products and Purchase Prices), except as noted in Sections 6.2 and 6.4. The Parties have agreed, subject to applicable law, to initiate at least once a year discussions on market conditions and trends as well as transfer pricing of Aspect Products.

 

 

6.2

 

Additional costs which have been agreed upon in writing (both NRE and incremental unit cost) for customi


 
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