Back to top

COLLABORATION AND STRATEGIC ALLIANCE AGREEMENT

Strategic Alliance Agreement

COLLABORATION AND STRATEGIC ALLIANCE AGREEMENT You are currently viewing:
This Strategic Alliance Agreement involves

Collaboration and Strategic Alliance | Confirma Inc | Guardian Technologies International, Inc

. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here.
Title: COLLABORATION AND STRATEGIC ALLIANCE AGREEMENT
Governing Law: Virginia     Date: 5/18/2007
Industry: TEXTLE     Sector: CYCLIC

Search Strategic Alliance Agreement by:

Document Title:

Entire Document: (optional)

50 of the Top 250 law firms use our Products every day

COLLABORATION AND STRATEGIC

ALLIANCE AGREEMENT


This Collaboration and Strategic Alliance Agreement (this “Agreement”) is entered into as of March 23, 2007, by and between Guardian Technologies International, Inc., a Delaware corporation (“Guardian”), and Confirma Inc., a Washington state corporation (“Confirma”).


RECITALS


WHEREAS, Guardian owns rights to certain know-how, trade secrets, proprietary intellectual property, and patent applications relating to image clarification, visualization, and computer-aided-detection (“CAD”) in image processing, based on its 3i Signature Mapping TM algorithmic technology for clarification, visualization and detection of a variety of uses including, but not limited to, medical imaging modalities.


WHEREAS, Confirma owns rights to certain know-how, trade secrets, proprietary intellectual property, patents and patent applications relating to medical image processing, visualization, and CAD. Confirma is also a leader in the development, and marketing of CAD systems and accessories for magnetic resonance imaging (“MRI”) in medical imagery and wishes to expand its markets and products clinical applications.


WHEREAS, Confirma and Guardian wish to enter into this Agreement in order to conduct collaborative research towards development of advanced, industry leading product/products for the analysis and detection of medical conditions across a variety of clinical applications by taking advantage of the respective technologies and other resources and assets of Confirma and Guardian, on the terms and subject to the conditions of this Agreement.


NOW, THEREFORE, in consideration of the terms and conditions contained herein, and for other valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows.



AGREEMENT


I .

Definitions


A.

“Affiliate” means any person, directly or indirectly, controlling, controlled by or under common control with any other person. “Control” shall mean the direct or indirect ownership of 50% or more of the voting interest in, or 50% or more of the interest in the income of, such other person, or the ability to appoint, elect or direct at least 50% of the governing body of any such person.


B.

“Alliance Coordinator” means the person designated by a Party pursuant to Section III( e) of this Agreement, to be the primary contact person for such Party for purposes of this Agreement.


C.

“FDA” means the United States Food and Drug Administration, and any successor entity that may be established hereafter which has substantially the same authority or



responsibility currently vested in the United States Food and Drug Administration.


D. “Governing Rules” means the general guidelines established by the Managing Committee pursuant to Section III (d) of this Agreement, which will be used to guide generally the activities of the Managing Committee and the Parties which are undertaken pursuant to this Agreement.


E. “Implementation Strategy” means the comprehensive approach and strategy, which is developed by the Managing Committee with respect to the development and implementation of business activities under this Agreement. The Implementation Strategy shall generally relate to the delivery of medical imaging products and technologies by Confirma and Guardian, which imaging products and technologies incorporate into Confirma Products and Guardian 3i image processing technologies,


F.

3i technology” means an interconnected set of digital image and data processing methodologies, including but not limited to methodologies that encompass three domains common to imaging informatics: image processing, data mining, and rules generation through machine learning that enables automatic detection and decision-making. In the image processing domain, a component called Signature Mapping is used, which is a dynamic and iterative process, in which specifically designed algorithms impact image pixels that represent the target material in a way that causes these groups of related pixels to react in a unique collective way. This response-based reaction generates new groups of self classifying pixel features that result in a unique set of signatures for each material. The resulting “signature mapped” data, enables the implementation of a rich set of imaging tools that provide new clinical approaches to imaging (that can be used in medicine). These include image clarification and visualization, feature extraction, tissue characterization and quantification, disease detection, monitoring and staging.


G.

“Project Intellectual Property” means any intellectual property rights which arise from the joint activities conducted pursuant to this Agreement, and which shall be jointly owned as set forth in Section VI of this Agreement.


H.

“Law” means any local, state or federal rule, regulation, statute or law relevant to the activities undertaken pursuant to this Agreement or applicable to either of the Parties with respect to any matters set forth herein.


I.

“Losses” means any liabilities, damages, costs or expenses, including without limitation, reasonable attorneys’ fees (including the allocable cost of in-house counsel), which arise from any claim, lawsuit, demand or other action by any third party other than one of the Parties or an Affiliate of one of the Parties.


J. “Managing Committee” means the committee established pursuant to Section III which is responsible for the development and oversight of all activities pursuant to this Agreement, in accordance with the terms of this Agreement.


K.

“Confirma Products” means any products, supplies or other goods which are designed, developed, manufactured or marketed by Confirma independent of Guardian and this Collaboration Agreement, whether existing on the date of this Agreement or subsequently developed, acquired or otherwise obtained by Confirma, including all Confirma Background IP.




L.

“Party” or “Parties” means Confirma or Guardian, or Confirma and Guardian, collectively, as appropriate.


M.

“Senior Management Representative” means an executive officer of each Party designated to facilitate the resolution of disputes hereunder, as described in Section III of this Agreement.


N.

“Target Product(s)” means a product(s) developed for an application that utilize Guardian’s technologies including, but not limited to, Guardian’s 3i imaging technologies and Confirma Products which are to be delivered through the cooperative efforts of the Parties as contemplated by this Agreement.


II .

General Agreement


Confirma and Guardian shall collaborate to design, develop and clinically evaluate imaging technologies for commercialization for the detection and characterization of specifically targeted medical conditions, utilizing Confirma Products and Guardian’s 3i technology, as set forth herein. The identification of product and or clinical applications technical candidates, and the specific terms regarding the scope and type of the collaborative efforts (including, without limitation, the economic terms with respect to the parties), shall be determined from time-to-time in accordance with Sections III and IV of this Agreement.


III.

Managing Committee


A.

Confirma and Guardian shall establish a Managing Committee hereunder, which shall consist of two (2) representatives from each of Confirma and Guardian. The initial designees are set forth in Schedule A hereto. Confirma and Guardian may each from time-to-time replace its respective representatives on the Managing Committee, in its sole and absolute discretion, by notice to the other Party the goal of the group is to provide focus and direction order to leverage both companies capabilities and technologies.


B.

It is among the objectives of the Parties to work together to conduct collaborative research towards development of an advanced, industry leading product/products for the analysis and detection of medical conditions across a variety of clinical applications by taking advantage of the respective technologies and other resources and assets of Confirma and Guardian, on the terms and subject to the conditions of this Agreement, and to design, develop and implement the Target Products in a reasonably practicable fashion, subject however, to the respective corporate regulatory, financial and other obligations and considerations of each of the Parties from time-to-time determined. To achieve this objective, the Managing Committee shall be responsible for identifying Guardian’s imaging technologies which are appropriate candidates for consideration under this Agreement, and establishing an Implementation Strategy for those Guardian imaging technologies from time-to-time designated and determined by the Managing Committee.


C.

The Managing Committee shall meet at such times and places as it shall determine appropriate to carry out its responsibilities hereunder. Such meetings may be in person or by means of telephonic communication. Either Party may designate an alternate member of the Managing Committee to act on behalf of a member on a



temporary or interim basis, in the reasonable discretion of such Party. Either Party through its Managing Committee members, may call a meeting of the Managing Committee by giving written notice thereof to the members of the other Party.


D.

The Managing Committee shall establish guidelines to govern the strategic activities, co-development and related activities of the Parties; the Managing Committee shall also establish such guidelines with respect to operational matters at such time as a Target Product is commercialized or in a pre-commercialized phase, as contemplated by this Agreement. All such guidelines shall be subject to the qualification of Section III (G) hereof. The Managing Committee shall be responsible for taking such other actions as may be provided for or contemplated by this Agreement, subject at all times to the requirements of Section III (G), including the establishment and implementation of the “Governing Rules.”


F.

The Parties shall each name one (1) of its Managing Committee members as its Alliance Coordinator, who shall be the primary contact for purposes of this Agreement, except to the extent the Parties may otherwise agree. Either Party may change its designation of Alliance Coordinator, in its sole and absolute discretion, upon written notice to the other Party.


F.

If a disagreement arises between the Parties as to any matters within the scope of this Agreement, either Party may give written notice to the other. If the Alliance Coordinators are unable to resolve the dispute satisfactorily, despite their good faith efforts, within thirty (30) days of receipt of such notice, either Alliance Coordinator may request a meeting of the Managing Committee, which will, in good faith, diligently seek to resolve the dispute. If the Managing Committee is unable to resolve the dispute, notwithstanding the exercise of good faith efforts, within thirty (30) days after such meeting, then, unless otherwise agreed by the Alliance Coordinators, the matter shall thereafter formally be referred to a Senior Management Representative of each of the Parties, the initial designations of which are set forth in Schedule A. Either Party may, in its sole discretion, change its designee of the Senior Management Representative by written notice to the other. Except as expressly provided in the immediately following sentence, neither Party shall initiate any formal action against the other, including, without limitation, the formal commencement of arbitration proceedings or the formal filing of legal action, until at least thirty (30) days have elapsed since the first communication between the Senior Management Representatives hereunder. Notwithstanding the foregoing, either Party may initiate proceedings to seek injunctive relief before the time period otherwise required hereunder shall elapse, if such Party in good faith believes that it will suffer irreparable harm without the initiation of such proceedings.


G.

Notwithstanding anything to the contrary contained in this Agreement, the authority of the Managing Committee shall at all time be subject to the respective requirements and obligations of the quality systems and regulatory policies and procedures, and internal corporate governance requirements, of each of Guardian and Confirma. The Managing Committee shall establish Governing Rules, which shall serve as guidelines for the general activities under this Agreement, and Implementation Strategies relative to the activities for each Target Product, all of which shall supplement the terms hereof, but which procedures and systems shall satisfy and be consistent with the respective policies, procedures, and systems of Confirma and Guardian. In that regard, the Parties shall reasonably cooperate in an attempt to assure their respective



systems do not unduly impede the execution of the intent of this Agreement. Without limiting the generality of the foregoing, the operations and authority of the Managing Committee shall be consistent with the underlying corporate policies of each party with respect to the operation of clinical trials and studies, regulatory affairs relating to development, promotion, worldwide distribution and servicing of the delivery of Target Products, quality assurance activities, medical device and adverse event reporting requirements, patent strategies, and the like. The Managing Committee shall establish a proposed approach for the Governing Rules within ninety (90) days of the execution of this Agreement that shall consider the relevant respective obligations of the parties.


IV.

Target Products


The Parties shall diligently pursue the design, development and ultimate commercialization of Target Products designated by the Managing Committee. For each Target Product designated as such by the Parties, the Managing Committee shall develop an Implementation Strategy, which shall consist of a comprehensive plan with respect to such activities. It is the intention of the Parties that they will cooperate jointly in such activities, as from time-to-time mutually determined by the Managing Committee and agreed to by the Parties. The Parties currently contemplate that the Implementation Strategies with respect to each Target Product may be developed in one or more phases, and may include or address, without limitation, the following:


A.

Formulation of Guardian 3i imaging technologies for delivery via Confirma, including, without limitation, enhancement, clarification, detection, and characterization technologies. Confirma shall be responsible generally for developing appropriate MRI product/technology alternatives.


B.

Clinical research, including the design, development, implementation and analysis of joint clinical trials and protocols, feasibility studies and similar activities from time-to-time agreed to by the Parties.


C.

Strategies and physical requirements for the integration of the Guardian 3i technologies relative to the Target Products.


D.

Market research activities.


E.

Patent strategies with respect to Project Intellectual Property.


F.

Strategies and activities relative to the requisite regulatory approvals of and post-market regulatory compliance for the components of the Target Products.


G.

Market development activities, which may include, without limitation, educational and other programs for healthcare professionals and third-party payors.


H.

Marketing activities, which may include, without limitation, activities directed to patients, healthcare professionals and third party payors.


I.

Clinical and technical services to provide support relative to the delivery systems for the Target Products, which may be based upon the current Confirma model of providing technical services for Confirma Products and 24-hour clinical services.


J.

Sales and related worldwide distribution activities relating to the Target Products,



including the composition and structure of the sales force or distribution network, or ot


This is only a partial view of this document. We have millions of legal documents and clauses drafted by top law firms. learn more search for free browse for free learn more