EX-10.1 3 dex101.htm EXCLUSIVE CO-PROMOTION AGREEMENT CONFIDENTIAL EXCLUSIVE CO-PROMOTION AGREEMENT
Exhibit 10.1
CONFIDENTIAL
EXCLUSIVE CO-PROMOTION AGREEMENT
THIS AGREEMENT is entered into as of October 30, 2003 (the “Effective Date”) by and between CONCEPTUS, INC. a Delaware corporation, having an address of 0000 Xxxxxx Xxxxxx, Xxx Xxxxxx, Xxxxxxxxxx 00000 and its permitted assigns hereunder (hereinafter referred to as “CONCEPTUS”), and GYNECARE WORLDWIDE DIVISION OF ETHICON, INC., a New Jersey corporation, having an address of U.S. Xxxxx #00, Xxxxxxxxxx, Xxx Xxxxxx 00000 and its permitted assigns hereunder (hereinafter referred to as “GYNECARE”, together with CONCEPTUS, the “Parties” and each a “Party”).
An “Affiliate” of a person or entity means any individual, sole proprietorship, firm, partnership, corporation, trust, joint venture or other entity, whether de jure or de facto, which, directly or indirectly, controls, is controlled by or is under common control with such person or entity. As used in this definition, “control” means the possession, directly or indirectly, of the power to direct or cause the direction of the policies and management of a person or entity, whether by the ownership of stock, by contract or otherwise.
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
“Agreement” shall mean this Exclusive Co-Promotion Agreement.
“Calendar Quarter” shall mean each of the three (3) month periods commencing with January 1st, April 1st, July 1st and October 1st and ending, respectively, on the following March 31st, June 30th, September 30th and December 31st.
“Commercial Year” shall mean each twelve (12) month period starting on the Effective Date or an anniversary thereof, as applicable, during the Term of this Agreement.
“CONCEPTUS Patents” shall mean any patent or patent application in the Territory owned or controlled by CONCEPTUS during the Term of this Agreement relating to the Essure, method of manufacture or the use thereof.
“CONCEPTUS Trademarks” shall mean the trademarks set forth in Schedule A, such marks being owned and registered by CONCEPTUS or a CONCEPTUS Affiliate.
“Confidential Information” shall have the meaning provided in Section 12.1 hereof.
“Detail” (or “Details” and “Detailing”) means, with respect to either or both of the Product Lines, the activity undertaken by a sales representative during a face-to-face sales call on physicians or other health care professionals to provide information on the use, safety, effectiveness, warnings and other relevant characteristics of either or both of the Product Lines, in a fair and balanced manner consistent with the requirements of the FD&C Act, including, but not limited to, the regulations of 21 CFR Part 202, and using, as necessary or desirable, labeling or promotional materials, in an effort to increase use of the Product Lines.
“Effective Date” shall be the date shown at the top of page 1 of this Agreement.
“Essure Labeling” shall mean the labeling described in the FDA PMA submission for Essure, including but not limited to any required patient information, all labels and other written, printed or graphic matter upon any container, wrapper or any package insert or outsert utilized with or for the Essure created and developed by or for CONCEPTUS.
“FDA” shall mean the United States Department of Health and Human Services, Food and Drug Administration or any successor entity.
“FD&C Act” shall mean the United States Federal Food, Drug and Cosmetics Act, as amended from time to time.
“GYNECARE Patents” shall mean any patent or patent application in the Territory owned or controlled by GYNECARE during the Term of this Agreement relating to the Thermachoice device, method of manufacture or the use thereof.
“GYNECARE Trademarks” shall mean the trademarks set forth in Schedule B, such marks being owned and registered by GYNECARE or a GYNECARE Affiliate.
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
“GYNECARE Managed Strategic Customers” shall mean the list of customers attached hereto as Schedule C. Such list may be modified by the mutual written agreement of the Parties.
“Improvements” shall mean any adaptation, change, redesign, improvement, modification or development to a Product Line, the Raw Materials or the method or process of manufacture or process of manufacture or production of a Product Line.
“JMC” shall mean the Joint Management Committee formed by the parties to monitor all aspects of the Agreement, discuss issues and advise each Party prior to making certain decisions, including, developing marketing strategies, plans and budgets for co-marketing the Product Lines and coordinating marketing and sales activities and press releases relating to this Agreement, as further described in Section 2.2 hereof.
“Marketing Plan” shall have the meaning provided in Section 2.2 hereof.
“Net Sales” shall mean the revenue received by a Party, its Affiliates or sublicensees from the sale of its Product Line in the Territory to an independent third party less the following amounts: (i) discounts, including promotional, trade, volume or cash discounts, or rebates or coupon redemptions actually allowed or granted; (ii) credits or allowances actually granted upon claims or returns or pricing allowances, regardless of the party requesting the return; (iii) freight charges paid for customer delivery; (iv) sales, use, ad valorem or other taxes or other governmental charges levied on or measured by the invoiced amount whether absorbed by the billing or billed party and (v) allowances or credits to customers for damaged or defective goods.
“Promotion Expenses” shall mean those costs, excluding corporate and administrative overhead, marketing personnel resources, sales representative costs and incentives but including costs incurred by a Party or for its account which are specifically identifiable to the advertising, promotion and marketing of the Product Lines by the Parties in the Territory and related professional promotion and education (to the extent not performed by sales representatives), including, without limitation, television and electronic advertisements, advertorials and infomercials, print advertisements, direct mail, exhibitions at seminars and conferences, promotional samples, sales and promotional literature or other materials and market research, in each case consistent with the Marketing Plan and otherwise with the terms of this Agreement.
“Promotional Materials” shall mean all sales representative training materials and all written, printed, graphic, electronic, audio or video matter, including but not limited to journal advertisements, sales visual aids, leave items, reprints, direct mail, direct-to-consumer advertising, internet postings, broadcast advertisements, and sales reminder aids (for example, scratch pads, pens and other such items), in each case created by the Party or the Parties or on its or their behalf and used or intended for use by either or both of the Parties in connection with any promotion of either or both of the Product Lines hereunder.
“Raw Materials” shall mean the materials, components, and packaging required to manufacture and package a Product Line in accordance with the Specifications.
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
“Recommend” or “Recommendation” shall mean in the case of CONCEPTUS, CONCEPTUS’s sales representatives providing marketing materials and recommending to potential customers the Thermachoice device exclusively over any other endometrial ablation products or procedures for use with the Essure Product Line and in the case of GYNECARE, GYNECARE’s sales representatives providing marketing materials and recommending to potential customers the Essure device exclusively over any other permanent birth control products or procedures for use with the Thermachoice.
“Regulatory Approvals” shall mean any approvals (including, but not limited to, FDA approval, labeling, pricing and reimbursement approvals), product, biologic and/or establishment licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the commercial manufacture, use, storage, importation, export, transport or sale of a Product Line in the Territory.
“Sales Force” of a Party shall mean such Party’s sales personnel calling on customers or potential customers of a Product Line or the Product Lines in the Territory.
“Specifications” shall mean the requirements with which a Product Line must conform as specified by 21 CFR §820.181 and device specifications, production process specifications, quality assurance procedures and specifications, packaging and labeling specifications, and installation, maintenance and servicing procedures and methods that are contained in the Device Master Record for the Product Line.
“Term of this Agreement” shall have the meaning provided in Section 8.1 hereof.
“Territory” shall mean the United States and its territories and possessions, including overseas United States military establishments.
“Thermachoice Labeling” shall mean the labeling described in the FDA PMA submission for Thermachoice, including but not limited to any required patient information, and all labels and other written, printed or graphic matter upon any container, wrapper or any package insert or outsert utilized with or for Thermachoice created and developed by GYNECARE.
“Third Party” shall mean any entity other than CONCEPTUS or GYNECARE.
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
must be a representative appointed by CONCEPTUS and one (1) of whom must be a representative appointed by GYNECARE. [*] The JMC shall coordinate any announcement, news release, public statement, publication or presentation relating to this Agreement subject to Section 14.15. Each Party shall bear its own costs of participating in the JMC. If the JMC is unable to reach agreement on an issue, the respective Chief Executive Officers or Presidents of the Parties shall use commercially reasonable efforts to jointly resolve the deadlock
(a) The JMC shall hold meetings at such times and places as shall be determined by the entire membership of the JMC (it being expected that meetings will alternate between the San Carlos, California offices of CONCEPTUS and the Somerville, New Jersey offices of GYNECARE), but in no event shall such meetings be held less frequently than twice a calendar year;
(b) The JMC may conduct meetings in person or by telephone or video conference or other means, provided that any decision made during a telephone conference meeting is evidenced in writing signed by one (1) of the members of the JMC from each Party;
(c) By mutual consent of the representatives of each Party, such consent not to be unreasonably withheld, either Party may invite other personnel of its organization to attend appropriate meetings of the JMC;
(d) The JMC shall keep minutes reflecting actions taken at meetings;
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
(e) The JMC may act without a meeting if prior to such action the JMC members agree regarding such action and a written consent thereto is signed by the Co-Chairs of the JMC; and
(f) The JMC may amend or expand upon the foregoing procedures for its internal operations by unanimous written consent.
3. SCOPE; FDA SUPPLEMENT APPROVAL AND CO-PROMOTION OF PRODUCT LINES
It is the objective of the Parties to (a) Recommend and/or Detail as provided below each other’s Product Line to potential customers in the Territory after FDA approval of Supplement 1 and prior to the expiration or termination of this Agreement, and (b) provide for the training of preceptors and physicians in the Essure and Thermachoice Product Lines. To achieve this and other objectives, the Parties agree as follows:
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
have the right to review and comment on the submission, but CONCEPTUS shall conduct all dialogue and contact with the FDA in connection with the supplemental PMA submissions. The JMC shall first attempt to resolve any disputes between the Parties resulting from any submissions or cost over-runs or delays
3.3 Preceptors and Physician Training.
(a) [*] CONCEPTUS shall be responsible for contracting with and training the CONCEPTUS Preceptors. CONCEPTUS, at its sole expense, shall be responsible for paying all the costs of the training of the Preceptors, including providing the personnel, equipment and samples to teach and certify the CONCEPTUS Preceptors to teach and certify other physicians in the proper use of the Essure device. CONCEPTUS, upon not less than thirty (30) days written notice, will notify GYNECARE of the times, dates and locations on the training sessions at which the CONCEPTUS Preceptors will be trained. CONCEPTUS will use all reasonable commercial efforts to contract for and appropriately train the CONCEPTUS Preceptors.
(b) [*] CONCEPTUS will contract for as independent contractors and be responsible for the payment of the costs of the CONCEPTUS Preceptors, which payment shall not exceed [*] per full day and [*] per half day of physician training and certification. [*] CONCEPTUS will provide Essure demo devices as needed for each physician to be trained by the CONCEPTUS Preceptors. [*]
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
CONCEPTUS shall have the right to review and monitor the physician training conducted by the CONCEPTUS Preceptors and to recommend any modifications to training to promote consistency and quality or lower cost.
(a) Each of the Parties shall supervise, train and maintain such competent and qualified sales representatives as may be required to perform the obligations as provided in this Agreement and in the Marketing Plan. GYNECARE shall make available for CONCEPTUS to train each of GYNECARE’s sales representatives who calls on potential customers in the Territory so that they are qualified to Detail Essure to physicians and CONCEPTUS shall have the right to administer a reasonable proficiency examination to each such GYNECARE sales representative. CONCEPTUS shall provide sufficient CONCEPTUS personnel, equipment, samples and training for the GYNECARE sales representatives calling on the potential customers in the Territory to be appropriately trained. This training is expected to be one (1) to two (2) days in total for all GYNECARE sales representatives. [*] GYNECARE will use its commercially reasonable efforts to arrange for its sales representatives to be trained by CONCEPTUS at mutually convenient times, locations and numbers (but not less than [*] sales representatives per session, unless approved by CONCEPTUS). Each Party shall be responsible for the costs and expenses of its respective employees, including travel and accommodations, in performing or attending such training. Each Party shall be responsible for the compliance of its Sales Force with all relevant terms of this Agreement and the Marketing Plan.
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
(b) Each of the Parties shall in all material respects conform its practices and procedures relating to its obligations under this Agreement for the Recommendation, and/or Detailing and promotion of the Product Lines in the Territory to all applicable laws, regulations and guidelines, including the FD&C Act, the Federal Health Care Programs Anti-Kickback Law, 42 U.S.C. 1320a-7b(b), the Health Industry Manufacturers Association (“HIMA”) and the American Medical Association (“AMA”) Guidelines on Gifts to Physicians from Industry (the “AMA Guidelines”), as the same may be amended from time to time, and shall promptly notify the other Party of and provide the other Party with a copy of any correspondence or other reports with respect to the Recommendation Detailing or promotion of the Product Lines submitted to or received from the U.S. Department of Health and Human Services or its components (including the FDA and the Office of the Inspector General), Health Canada, HIMA or the AMA relating to such laws, regulations and guidelines.
(c) At one Party’s reasonable request, the other Party shall provide copies of any written communications disseminated by it generally to its Sales Force promoting the Product Lines in the Territory relating to the Marketing Plan and the joint marketing strategy for the Product Lines other than compensation, salary or benefit plans or information.
(d) In connection with the Recommendation, Detailing or promotion of the Product Lines hereunder, no Party shall make any statement, representation or warranty, oral or written, concerning the Product Lines that is inconsistent with, or contrary to, the Thermachoice Labeling, the Essure Labeling, the Promotional Materials or the Marketing Plan.
(e) Each of the Parties shall give prompt written notice to the other Party of the date on which its Sales Force commences promoting the other Party’s Product Line in the Territory.
(f) Each of the Parties shall use commercially reasonable efforts to promptly refer but shall in no way be responsible for soliciting orders for the other Party’s Product Lines to the other Party.
(g) During the term hereof and for a period of six (6) months after the expiration or termination of this Agreement, neither Party shall solicit for employment or employ any officer or employee of the other Party of whom it first became aware as a direct result of this Agreement; provided that this provision shall not prevent either Party from employing any such persons who contact it on their own initiative (without any actions by such Party to encourage such contact) or respond to general solicitations of employment not specifically directed towards employees of the other Party.
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
contained herein shall be deemed to grant GYNECARE, either expressly or by implication, a license or other right or interest in any patent, trademark, copyright or other similar property of CONCEPTUS except as may be necessary for GYNECARE to Recommend and Detail Essure as expressly provided for in this Agreement and the Marketing Plan.
(b) GYNECARE retains and shall retain all proprietary rights and proprietary interests in Thermachoice until the point of sale and in all Promotional Materials relating thereto. CONCEPTUS will neither have nor represent that it has any control or proprietary or property interests in Thermachoice Promotional Materials solely developed or created by or on behalf of GYNECARE. Nothing contained herein shall be deemed to grant CONCEPTUS, either expressly or by implication, a license or other right or interest in any patent, trademark, copyright or other similar property of GYNECARE except as may be necessary for CONCEPTUS to Recommend Thermachoice as expressly provided for in this Agreement and the Marketing Plan.
(a) During the Term of this Agreement, CONCEPTUS shall create or co-create and develop with GYNECARE such Promotional Materials solely relating to Essure as are determined by the JMC to be necessary or appropriate under the Marketing Plan for distribution in the Territory, it being understood that the costs thereof shall be included in Promotion Expenses hereunder. CONCEPTUS shall provide GYNECARE with such Promotional Materials, in amounts which the Parties jointly determine are reasonable under the terms of the Marketing Plan. CONCEPTUS shall be responsible for complying with all regulatory requirements in the creation of such Promotional Materials and complying with any applicable government filing requirements.
(b) During the Term of this Agreement, GYNECARE shall create or co-create and develop with CONCEPTUS such Promotional Materials solely relating to Thermachoice as are determined by the JMC to be necessary or appropriate under the Marketing Plan for distribution of the Product Lines in the Territory, it being understood that the costs thereof shall be included in Promotion Expenses hereunder. GYNECARE shall provide CONCEPTUS with such Promotional Materials, in amounts which the Parties jointly determine are reasonable under the terms of the Marketing Plan. GYNECARE shall be responsible for complying with all regulatory requirements in the creation of such promotional materials and complying with any applicable government filing requirements.
(c) Other than with the advice and prior written consent of CONCEPTUS, GYNECARE shall not create or develop sales, promotional or other similar materials relating to the Essure for distribution to Third Parties.
(d) Other than with the advice and prior written consent of GYNECARE, CONCEPTUS shall not create or develop sales, promotional or other similar materials relating to Thermachoice for distribution to Third Parties.
(e) All co-promotional materials, sales materials or other similar materials and materials using a Party’s trademarks, trade names and/or trade dress shall be reviewed by such Party’s Copy Review/Sign-Off Committee prior to release for use by the other Party.
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
(f) Notwithstanding anything to the contrary herein, neither Party shall be required to distribute any Promotional Materials prepared after the Effective Date which it believes in good faith are inaccurate or misleading. The Parties shall distribute Promotional Materials of the type identified in this Section 3.7 in accordance with the terms of this Agreement and the Marketing Plan. Except as specifically permitted by this Section 3.7, neither Party shall distribute or have distributed any materials bearing the name of the other without the prior written approval of the other.
(g) CONCEPTUS shall own all right, title and interest in and to the Promotional Materials relating solely to Essure, including all copyrights appurtenant thereto but excluding any rights in or to the GYNECARE trademark. CONCEPTUS hereby grants to GYNECARE the limited, revocable right, during the Term of this Agreement, to use Promotional Materials generated pursuant to the Marketing Plan solely in connection with its promotion of Essure hereunder in accordance with the terms of this Agreement and the Marketing Plan.
(h) GYNECARE shall own all right, title and interest in and to the Promotional Materials relating solely to Thermachoice, including all copyrights appurtenant thereto but excluding any rights in or to the CONCEPTUS trademark. GYNECARE hereby grants to CONCEPTUS the limited, revocable right, during the Term of this Agreement, to use Promotional Materials generated pursuant to the Marketing Plan solely in connection with its promotion of Thermachoice hereunder in accordance with the terms of this Agreement and the Marketing Plan.
(i) The Parties shall jointly own all right, title and interest in and to the Promotional Materials relating to both Product Lines, including all copyrights appurtenant thereto but excluding any rights in or to the other Party’s trademarks, trade names and/or trade dress.
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
mutual written agreement of the Parties). Within sixty (60) days after the end of each full or partial Calendar Quarter during the Term of this Agreement, CONCEPTUS shall deliver to GYNECARE a true and accurate report of Net Sales sold by it, its Affiliates and distributors to the GYNECARE Managed Strategic Customers during such Calendar Quarter in the Territory, accompanied by all payments due under this Section 4.2 for the period covered by such report. Such report shall also include the information reasonably necessary for the GYNECARE to calculate Net Sales to the GYNECARE Managed Strategic Customers of the Essure product.
(a) CONCEPTUS or an Affiliate of CONCEPTUS shall retain the ownership of the entire right, title and interest in and to the CONCEPTUS Trademarks.
(b) CONCEPTUS shall, at its cost and expense, maintain the CONCEPTUS Trademarks in the Territory. GYNECARE agrees that in using CONCEPTUS Trademarks in its activities under this Agreement it will not represent in any way that it has any right or title to the ownership of the CONCEPTUS Trademarks or the registration thereof, and the registration will remain in the ownership of CONCEPTUS. Such CONCEPTUS Trademarks will be used by GYNECARE on behalf of, and in the interest of CONCEPTUS, and GYNECARE will first obtain the written approval of CONCEPTUS of the form and manner in which the CONCEPTUS Trademarks will be used upon, in connection with, or in relation to materials other than Promotion Materials as may be permitted by this Agreement.
(c) GYNECARE recognizes CONCEPTUS’s title in and to the CONCEPTUS Trademarks and to the registration thereof, and will not, at any time, do or authorize any act or thing that will in any way violate or impair the rights of CONCEPTUS in and to the CONCEPTUS Trademarks and the registration thereof. Wherever CONCEPTUS’s trademarks or tradenames are used, e.g., on any package, label or advertisement, the first or most prominent use shall always be accompanied by a legend acceptable to CONCEPTUS indicating that Essure™ is a trademark of CONCEPTUS and the CONCEPTUS trademarks and tradenames are licensed to GYNECARE by CONCEPTUS.
(d) GYNECARE shall, upon CONCEPTUS’s request, and at CONCEPTUS’s expense, reasonably assist CONCEPTUS in any action reasonably necessary or desirable to protect the CONCEPTUS Trademarks used or proposed to be used hereunder. GYNECARE shall as soon as practicable notify CONCEPTUS of any apparent infringement by a Third Party of any of the CONCEPTUS Trademarks.
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
(e) If CONCEPTUS reasonably determines it is necessary to discontinue the use of a CONCEPTUS Trademark, GYNECARE, after discussion and upon notice and demand from CONCEPTUS, shall immediately discontinue the use of any of the CONCEPTUS Trademarks. In the event of such discontinuance, CONCEPTUS shall select a new CONCEPTUS Trademark to be used with the Essure and shall promptly notify GYNECARE in writing of such selection.
(a) GYNECARE or an Affiliate of GYNECARE shall retain the ownership of the entire right, title and interest in and to the GYNECARE Trademarks.
(b) GYNECARE shall, at its cost and expense, maintain the GYNECARE Trademarks in the Territory. CONCEPTUS agrees that in using GYNECARE Trademarks in its activities under this Agreement it will not represent in any way that it has any right or title to the ownership of the GYNECARE Trademarks or the registration thereof, and the registration will remain in the ownership of GYNECARE. Such GYNECARE Trademarks will be used by CONCEPTUS on behalf of and in the interest of, GYNECARE, and CONCEPTUS will first obtain the written approval of GYNECARE of the form and manner in which the GYNECARE Trademarks will be used upon, in connection with, or in relation to materials other than Promotion Materials as may be permitted by this Agreement.
(c) CONCEPTUS recognizes GYNECARE’s title in and to the GYNECARE Trademarks and to the registration thereof, and will not, at any time, do or authorize any act or thing that will in any way violate or impair the rights of GYNECARE in and to the GYNECARE Trademarks and the registration thereof. Wherever GYNECARE’s trademarks or tradenames are used, e.g., on any package, label or advertisement, the first or most prominent use shall always be accompanied by a legend acceptable to GYNECARE indicating that GYNECARE Thermachoice® is a registered trademark of GYNECARE and the GYNECARE trademarks and tradenames are licensed to CONCEPTUS by GYNECARE.
(d) CONCEPTUS shall, upon GYNECARE’s request, and at GYNECARE’s expense, reasonably assist GYNECARE in any action reasonably necessary or desirable to protect the GYNECARE Trademarks used or proposed to be used hereunder. CONCEPTUS shall as soon as practicable notify GYNECARE of any apparent infringement by a Third Party of any of the GYNECARE Trademarks.
(e) If GYNECARE reasonably determines it is necessary to discontinue the use of a GYNECARE Trademark, CONCEPTUS, after discussion and upon notice and demand from GYNECARE, shall immediately discontinue the use of any of the GYNECARE Trademarks. In event of such discontinuance, GYNECARE shall select a new GYNECARE Trademark to be used with Thermachoice and shall promptly notify CONCEPTUS in writing of such selection.
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
(a) Each Party shall provide the other Party with such information relating to its own Product Line and training as the other Party may reasonably require and request during the Term of this Agreement in order to support the other Party’s effort for the Product Lines as provided in the Marketing Plan.
(b) During the Term of this Agreement and subject to any other provision of this Agreement, each Party will provide the other Party with all information relevant to the other Party’s performance obligation for their respective Product Lines under this Agreement and the Marketing Plan within the Territory within a reasonable time after such information becomes known to the Party, provided such information is not received from an independent Third Party under a secrecy obligation. Specifically, the Sales Force of each Party shall receive the such information at substantially the same time with respect to the Product Lines.
(c) Each Party shall promptly report to the other Party all information necessary to permit such other Party to make timely reports as required by any governmental regulatory agency in the Territory regarding the Product Lines and shall promptly report within twenty-four (24) hours any customer complaints or findings associated (i) with the joint use of the Product Lines or (ii) with the use of the Product Lines that may suggest hazards, contraindications, side effects or precautions pertinent to the safety and/or performance of either of the Product Lines or require the alteration of Recommendation or Detailing activities by a Party’s Sales Force. Each Party agrees to promptly notify the other Party of any FDA audit, or any audit by any other regulatory body, of its facilities used for the manufacture of its Product Line, or any request for information from the FDA, or other regulatory body, related to the manufacture of its Product Lines, as soon as practicable after the Party receives notice of such audit or request. All such communications shall be held in confidence by the Parties pursuant and subject to the terms of Article 12. Should either Party learn of any hazard that is severe, serious or unexpected, concerning the Product Lines, such hazard data shall be communicated to the other Party immediately in writing or confirmed in writing if such immediate communication is non-written. Notwithstanding anything in this Agreement to the contrary, each Party shall be responsible for complying with all applicable laws regarding the reporting of such hazards to governmental authorities with respect to its own Product Line. The aforementioned information shall be addressed as follows:
in the case of
GYNECARE to: [*]
in the case of
CONCEPTUS to: [*]
or to such other address as may thereafter be provided by either Party.
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
(d) Each Party shall respond to medical questions or inquiries relating to their respective Product Line received by the other Party or at its sole discretion, provide to the other Party, if requested, information to enable the other Party to respond to medical questions or inquiries relating to its Product Line. All such information shall be held in confidence by the receiving Party pursuant and subject to the terms of Article 12 hereof. Each Party shall use commercially reasonable efforts to keep such information current. The Parties shall coordinate responses to anticipated inquiries and questions.
(e) CONCEPTUS shall set up appropriate sales tracking systems to separately track sales at each GYNECARE Managed Strategic Customer account in the Territory where Essure is purchased and maintain appropriate records thereof.
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CONCEPTUS shall keep complete and accurate records in connection with the payments provided for under this Agreement and the information described in Article 4 hereof. CONCEPTUS shall submit to GYNECARE unaudited quarterly sales records and reports relating to Essure sales during the Term to the GYNECARE Managed Strategic Accounts (broken down by account) promptly, but in no case, more than sixty (60) days after such Calendar Quarter. GYNECARE shall have the right to nominate an independent firm of certified public or chartered accountants who shall have access no more than once each year during the Term and once after Termination of this Agreement to the books and records of CONCEPTUS relating to the Essure sales during the Term to the GYNECARE Managed Strategic Accounts during reasonable business hours for the purpose of verifying any amounts payable, or information provided relating to amounts payable, under this Agreement. The fees and expenses of the accountants performing such verification shall be borne by GYNECARE, unless, in the case of payments, CONCEPTUS’s records are inadequate to perform such verification or any amount actually due exceeds five percent (5%) or more of amounts reported in which case CONCEPTUS shall bear the costs and expenses of such verification.
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
Essure then in the possession of GYNECARE, its Affiliates and any of their respective Sales Forces and CONCEPTUS shall promptly return to GYNECARE all Promotional Materials and samples of Thermachoice then in the possession of CONCEPTUS, its Affiliates and any of their respective Sales Forces.
(b) GYNECARE shall have the right to terminate the Agreement immediately upon notice to CONCEPTUS if a court rejects the [*] and CONCEPTUS or if the settlement agreement between [*]. and CONCEPTUS expires or is terminated for any reason. In the event of a termination by GYNECARE under this Section 8.4(b), CONCEPTUS shall reimburse GYNECARE for any and all of the expenses it has undertaken pursuant to this Agreement, including but not limited to, the payments made by GYNECARE under Section 4.1 hereof, the training of physicians, preceptors and sales representatives in Essure and its efforts and expenses associated with seeking and obtaining Supplement 1 and Supplement 2.
(c) GYNECARE shall have the right to terminate the Agreement upon written notice if CONCEPTUS fails to obtain FDA approval for Supplement 1 on or prior to [*].
(d) GYNECARE shall have the right to terminate the Agreement upon written notice if GYNECARE or CONCEPTUS is unsuccessful in gaining procedure adoption from the trained and certified physicians due to negative clinical experience or if the concomitant procedure is unfavorably reimbursed. Unsuccessful procedure adoption shall be defined as an average of one (1) or fewer procedures involving the concomitant use of Thermachoice and Essure performed per month per physicians trained and certified in Essure under this Agreement for any four (4) month period during the term of this Agreement. Unfavorable reimbursement shall be defined as device reimbursement for the concomitant use which is less that the average selling price of each of the two (2) Product Lines when used separately.
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
violation of any applicable law, rule or regulation and such violation cannot be remedied by reasonable modifications of this Agreement or (iii) the other Party is in material breach of Section 13, or (iv) the other Party is in material breach of any other representation, warranty, covenant, agreement or obligation under this Agreement and fails to cure such breach within twenty (20) days of a written notice from the non-breaching Party, or if a cure cannot reasonably be effective in such time, fails to commence in such time or fails to diligently pursue a cure to completion or (v) the other Party’s Product Line has been subject to a recall or market withdrawal.
(a) such Party (i) is a corporation duly organized, validly existing and in good standing under the laws of the state in which it is incorporated, (ii) has the corporate power and authority and the legal right to own and operate its property and assets, to lease the property and assets it operates under lease, and to carry on its business as it is now being conducted, and (iii) is in compliance with all requirements of applicable law, except to the extent that any noncompliance would not have a material adverse effect on the properties, business, financial or other condition of such Party and would not materially adversely affect such Party’s ability to perform its obligations under this Agreement;
(b) this Agreement is a legal and valid obligation binding upon such Party and enforceable in accordance with its terms, and the execution, delivery and performance of the Agreement by such Party does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over it. Each Party expressly represents and warrants that it has the full power and authority to enter into this Agreement and to carry out the obligations contemplated hereby;
(c) it has taken all necessary corporate action on its part to authorize the execution and delivery of this Agreement;
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
(d) the manufacture, use, importation, offer for sale or sale of its Product Line as contemplated hereunder does not infringe any Third Party’s intellectual property right;
(e) the use of its trademarks, trade names or trade dress pursuant to the terms of this Agreement and the Marketing Plan does not and will not infringe the rights of any third party;
(f) that with respect to all regulatory filings to obtain Regulatory Approvals, the data and information in such Party’s submissions are and shall be free from fraud and/or material falsity, that the Regulatory Approvals have not been and will not be obtained either through bribery or the payment of illegal gratuities, that the data and information in such Party’s submissions are and shall be accurate and reliable for purposes of supporting approval of the submissions, and that the Regulatory Approvals shall be obtained without illegal or unethical behavior of any kind;
(g) it has obtained, to the extent it is required to do so, all necessary governmental approvals required in connection with the manufacture, sale and marketing of its Product Line in the Territory, including but not limited to PMA approval from the FDA; no governmental authority has threatened any action to revoke any governmental approval for its Product Line, and that the submissions which it made to the FDA were made in good faith and contained accurate and complete data and information regarding its Product Line as required by applicable laws, rules and regulations; it shall maintain for the term of this Agreement or any extension thereof all PMA approval for its Product Line; furthermore, it shall file, and maintain at its own cost for its Product Line, all appropriate registrations with the FDA and similar regulatory authorities in the Territory countries which have the authority to approve the sale of its Product Line for use in humans; and
(h) during the term of this Agreement or any extension thereof, its Product Line shall be of merchantable quality, fit for the purpose intended by this Agreement and free from defects in design, material and workmanship and manufactured and delivered in accordance with the terms of this Agreement, all applicable present and future statutes, laws, and regulations, including without limitation, good manufacturing practices (“GMP”), QSRs and ISO 9000 requirements and that during the term of this Agreement or any extension thereof its Product Line will not be adulterated or misbranded at the time of delivery to Third Parties within the meaning of the FD&C Act.
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
10. OWNERSHIP OF INTELLECTUAL PROPERTY AND PATENT RIGHTS.
(ii) If CONCEPTUS learns of any misappropriation of any GYNECARE Patents, GYNECARE Trademarks or Information (the “GYNECARE Product Rights”), or any infringement or threatened infringement by a Third Party of the GYNECARE Patents in the Territory, CONCEPTUS shall promptly notify GYNECARE and shall provide GYNECARE with all available evidence of such misappropriation or infringement.
(ii) GYNECARE shall have the sole right, but not the obligation, to institute, prosecute and control at its own expense any action or proceeding with respect to infringement of any GYNECARE Patents or any misappropriation of the GYNECARE Product Rights in the Territory, by counsel of its own choice. CONCEPTUS shall cooperate with GYNECARE, at GYNECARE’s expense, in any such action or proceeding brought by GYNECARE against a Third Party. Any amounts recovered by GYNECARE pursuant to this subsection (b) shall belong exclusively to GYNECARE.
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
(c) Settlement with a Third Party. CONCEPTUS shall have the sole right to control settlement of actions relating to the CONCEPTUS Product Rights and GYNECARE shall have the sole right to control settlement of actions relating to the GYNECARE Product Rights.
11. INDEMNIFICATION; INSURANCE
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
The Parties will, through the JMC, mutually agree on the Information which is to presented to the doctors relating to the Detailing of the Product Lines. This Information is not considered to be Confidential Information. Each of the Parties will limit the dissemination of Confidential Information of the other Party throughout its organization to those with a need to know.
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
The amount of Confidential Information to be disclosed shall be completely within the discretion of the disclosing Party. To the extent practical, Confidential Information shall be disclosed in tangible form and marked as “Confidential.” Information disclosed in an intangible form, such as orally or by visual inspection, shall not be considered Confidential Information unless the disclosing Party confirms in writing the fact and general nature of the disclosure within one (1) month after it is made.
Notwithstanding anything in this Agreement to the contrary, neither Party shall at any time provide the other Party with any technical information or data, including but not limited to, technical information relating to their respective Product Lines, including but not limited to, information and data relating to formulation, analytical methods, unless such technical information is already in the public domain.
(a) For the purpose of obtaining and maintaining any necessary Regulatory Approvals for the sale of Product Lines under this Agreement in the Territory;
(b) To the extent that the disclosing Party may agree in writing, such agreement shall be obtained prior to such disclosure by receiving Party;
(c) To the extent that such Confidential Information can be demonstrated by written records or other credible evidence to be known to the receiving Party or its Affiliates at the time of receipt thereof from the disclosing Party or becomes known to the receiving party other than from the disclosing Party or their authorized employees or agents (provided that such source is not prohibited from disclosing such portions to the Recipient by any contractual, fiduciary or other legal obligation); and
(d) To the extent that such Confidential Information is or may become a matter of public knowledge by virtue of the action of a party other than the receiving Party or its Affiliates.
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
foregoing, neither Party shall be prohibited or restricted in any marketing or selling of its Product Lines to any party, including any party that is one of the GYNECARE Strategic Managed Customers, after the termination of this Agreement, if such marketing and selling is part of an effort targeted at a general market of which some or all of the GYNECARE Managed Strategic Customers are a part, provided however, if GYNECARE terminates this Agreement pursuant to Section 8.5, 8.6(iii) or 8.6(iv) the provisions of Section 4.2 shall survive for two (2) years after the termination of this Agreement.
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
matters related to a Party’s activities under this Agreement, each Party shall (a) comply with all applicable laws and regulations issued by national, state and local authorities, (b) inform the other Party promptly of any significant adverse event (e.g., fires, explosions, accidental discharges) and (c) inform the other promptly of any allegations or findings of violations of applicable laws or regulations. If a Party fails to meet any of these conditions, the other Party may terminate this Agreement upon ten (10) days prior written notice to the other Party if the other Party has not cured such breach within such time.
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
Agreement shall be deemed to prevent or preclude a Party from entering into and consummating such a sale or merger or from acquiring any other entity; provided, however, that in such event either Party shall have the right, at its sole discretion, to terminate this Agreement thirty (30) days after providing written notice of termination or upon the closing of the transaction, whichever date is later. Any assignment or delegation, or any other transfer or change of control by sale, acquisition, merger, or otherwise, or attempt at the same, other than as permitted hereunder, made in the absence of such prior written consent shall be void and without effect. If a Party assigns this Agreement to an Affiliate, such Party will also promptly inform the other Party and guarantee the performance by its Affiliate of all of such Party’s obligations under the Agreement.
If to GYNECARE, notices must be addressed to:
[*]
With a copy to [*]
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
In the case of notices given pursuant to Section 11.4:
[*]
With a copy to:
[*]
If to CONCEPTUS, notices must be addressed to:
[*]
With a copy to:
[*]
In the case of notices given pursuant to Section 11.4:
[*]
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
THE ARBITRATOR SHALL NOT AWARD ANY PARTY PUNITIVE, EXEMPLARY, MULTIPLIED OR CONSEQUENTIAL DAMAGES INCLUDING LOSS OF PROFITS, AND EACH PARTY HEREBY IRREVOCABLY WAIVES ANY RIGHT TO SEEK SUCH DAMAGES.
EACH PARTY HERETO WAIVES ITS RIGHT TO TRIAL OF ANY DISPUTE BY JURY.
EACH PARTY HERETO WAIVES ANY CLAIM TO PUNITIVE, EXEMPLARY, MULTIPLIED OR CONSEQUENTIAL DAMAGES INCLUDING LOSS OF PROFITS FROM THE OTHER.
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
CONCEPTUS, INC. | ETHICON, INC. BY ITS WORLDWIDE DIVISION GYNECARE | |||||||
By: |
| By: |
| |||||
Name: | Xxxx Xxxxxxxxxx | Name: |
| |||||
Title: | President & CEO | Title: |
|
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
SCHEDULE A
CONCEPTUS TRADEMARKS
Essure
Conceptus
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SCHEDULE B
GYNECARE TRADEMARKS
GYNECARE
Thermachoice®
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
SCHEDULE 3.2
PRE-MARKETING APPROVAL AND EXPENSE
[*]
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
SCHEDULE C
GYNECARE MANAGED STRATEGIC CUSTOMERS
[*]
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
SCHEDULE 11.4
Insurance Coverages
[*]
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.
SHEDULE 13.2
XXXXXXX & XXXXXXX POLICY
ON THE EMPLOYMENT OF YOUNG PERSONS
[*]
[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately.