Master Alliance Provisions Guide (MAPGuide)

Population Council – TherapeuticsMD, Nestorone Contraceptive Ring, License Agreement

  • Intellectual Property | Protection of IP

VI. OWNERSHIP AND INTELLECTUAL PROPERTY

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6.2 Patent Applications on Council Know-How

6.2.1 With respect to applications for patents that relate to Council Know-How, (a) Council will remain the owner of the application for patent, (b) Council will continue to bear the full costs of and responsibility for preparing, filing, and prosecuting, in its sole discretion, the application and (c) to the extent that any claims of such application for patent cover a Licensed Product, or the manufacture, use or sale thereof, such application for patent and any patents issuing thereon will constitute Council Patent Rights for purposes of this Agreement.

6.2.2 Where applications for patents covering any Council Know-How have not been filed:

(a) Council will, in its sole discretion subject only to the terms of Section 6.2.2(b), determine whether or not to file an application for patent in the Territory for such Council Know-How. If Council elects to file such an application, Council will bear the full costs of preparing, filing and prosecuting the application and maintaining any patents that issue thereon and Council will control the prosecution of such application using counsel reasonably acceptable to LICENSEE.

(b) If Council elects not to file an application for patent in the Territory covering any such Council Know-How that Council reasonably believes is likely to result in a material patent with respect to the License, then the following provisions will apply: (1) Council will notify the Joint Product Committee in writing of its decision not to file such an application for patent; (2) if LICENSEE disagrees with Council’s decision not to file such application, LICENSEE will have a reasonable opportunity to consult with Council though the Joint Product Committee in order to convince Council to file such an application; (3) if Council maintains its election not to file such application then (i) the information will remain Council Know-How; and (ii) LICENSEE will not have the right to file any applications for patent disclosing or claiming such Council Know-How anywhere in the world without the prior written consent of Council; and (4) if Council permits LICENSEE to file such application, then LICENSEE will have the right to file such applications for patent.

(c) Council will notify the Joint Product Committee regarding each application for patent filed by Council pursuant to this Section 6.2.2 and any patent issuing thereon that covers a Licensed Product, or the manufacture, use or sale thereof. Each such application and each such patent will constitute a Council Patent Right for purposes of this Agreement and (subject to any restrictions imposed by Third Party transferors or licensors of such Council Know-How) will be licensed to LICENSEE by Council as part of the License without any royalty or other payment other than the royalties and payments specified herein.

(d) In the event that Council decides to abandon an application or not to maintain a patent on an application that falls under Section 6.2.2(c), Council will give written notice to LICENSEE at least sixty (60) days prior to Council allowing such application to go abandoned or prior to Council not taking a necessary step to maintain such patent and LICENSEE will have the option of taking over the prosecution or maintenance of such application or patent at its sole expense. If LICENSEE elects to take over the prosecution or maintenance of such application pursuant to this Section 6.2.2(d), or if Council gives LICENSEE written permission to file any applications for patent pursuant to Section 6.2.2(b), Council will, to the extent permitted by applicable law, assign all its right, title and interest in such application or patent in the Territory to LICENSEE.

6.3 Patent Applications on Program Improvements. Council will be deemed the sole owner of all Program Improvements, provided that, to the extent any Program Improvement that is made solely by LICENSEE has utility outside the field of reproductive health and contraception in humans, then Council will be deemed hereby to have granted to LICENSEE a perpetual, irrevocable, fully-paid-up sublicensable exclusive license to such Program Improvement to research, develop, make, have made, sale, have sold, import and export products (for avoidance of doubt, other than Licensed Product) in fields outside of reproductive health and contraception in humans. To the extent that a Program Improvement is developed by or on behalf of one Party, that Party will promptly disclose such Program Improvement to the Joint Product Committee in writing with all relevant data supporting such Program Improvement. Council will determine whether or not to file an application for patent in the Territory for all Program Improvements. If Council elects to file such an application, Council will bear the full costs of preparing, filing, and prosecuting such application for patent and maintaining any patents that issue thereon and Council will control the prosecution of such application using counsel reasonably acceptable to LICENSEE.

6.4 Cooperation. Each Party will cooperate, and will cause its employees, consultants and subcontractors to cooperate with all reasonable requests of the other Party for assistance in preparation and prosecution and maintenance of any applications for patent and any patent issuing therefrom and any trademark and any registration issuing therefrom that is owned by the requesting Party hereunder. To the extent that any right, title, or interest in or to any intellectual property conceived, created, developed, or otherwise made by or on behalf of either Party or its Affiliates during the Term vests in a Party or its Affiliates, by operation of Law or otherwise, in a manner contrary to the ownership as set forth in this Article VI, such Party will, and hereby does, on behalf of itself and its Affiliates, irrevocably assign to the other Party any and all of such Party’s and its Affiliates right, title, and interest in and to such intellectual property without the need for any further action by any Party. Upon a Party’s reasonable request and at its expense, the other Party promptly will execute and deliver to the requesting Party any and all further documents and instruments or take other reasonable actions which may be necessary or appropriate to achieve and confirm the requesting Party’s ownership of the intellectual property that is the subject of this Article VI.

6.5 Patent Filing Procedures

6.5.1 Once a determination has been made by Council to file a patent application for Council Know-How or Program Improvements, each Party will, for patents prosecuted by it pursuant to this Agreement, make Commercially Reasonable Efforts to:

(a) file applications for letters patent;

(b) prosecute all pending and new patent applications and defend against oppositions filed against the grant of letters patent for such applications, including by avoiding where reasonably practicable, the use of extensions of deadlines that could reasonably impact the term and potential adjustment to the term of any patent that might issue thereon;
(c) upon and after the grant of any letters patent, maintain such letters patent in force by duly filing all necessary papers and paying any fees required for such purpose;

(d) keep the other Party reasonably informed of the status of all such applications for patent in the Territory, including by providing copies of material correspondence with the United States Patent and Trademark Office (“USPTO”) regarding such applications far enough in advance to permit such other Party a reasonable opportunity (if available) to comment on any proposed response to any such material correspondence received from the USPTO, which comments, if any and if received by a prosecuting Party in a timely manner, shall be reasonably considered by Council in formulating its response, and if rejected, the Parties shall discuss the Council’s reasons for rejecting such comments; to that end, each Party agrees to instruct applicable prosecution counsel to send copies of any material correspondence with the USPTO not later than seven (7) days following receipt by such prosecution counsel thereof; and

(e) obtain such patent extensions, adjustments or restorations of patent terms as may become available from time to time.

6.6 Council Patent Rights

6.6.1 Council will use Commercially Reasonable Efforts to (a) prosecute and maintain Council Patent Rights by duly filing all necessary papers and paying any fees required for such purpose by the patent laws of the particular country in which such Council Patent Right was granted, and (b) obtain such patent extensions or restorations of patent terms as may become available from time to time in any country regarding Council Patent Rights.

6.6.2 In the event Council decides not to prosecute or maintain a Council Patent Right or seek a patent extension or restoration, Council will give LICENSEE written notice at least 60 days prior to Council allowing such application to go abandoned or prior to Council not taking a necessary step to maintain such patent or seek such a patent extension or restoration, and LICENSEE will have the option of taking over the prosecution or maintenance of such application or patent or seeking such patent extension or restoration, in each case at its sole expense. If LICENSEE elects to take over the prosecution or maintenance of any application or patent or to seek such a patent extension or restoration, in each case pursuant to this Section 6.2.2, Council will, to the extent permitted by applicable law, assign all its right, title and interest in such application or patent in the Territory to LICENSEE.

6.7 No Challenge. LICENSEE will not and will ensure that its sublicensees and their respective Affiliates and do not challenge the validity or enforceability of any of the patents that are licensed to Licensee hereunder or assist any Third Parties to do the same. If LICENSEE or any of its distributors, or sublicensees or their respective Affiliates challenges or supports a Third Party challenge to the validity or enforceability of any such patent or assists any Third Party to do the same, LICENSEE will pay Council’s reasonable costs and expenses (including attorneys’ fees) for defending against such challenge, which payments will be made on a monthly basis in arrears.

VII. INFRINGEMENT BY OR CLAIMS AGAINST THIRD PARTIES

7.1 Notices. Each Party will advise the Joint Product Committee promptly upon its becoming aware of: (a) any unlicensed activities which such Party believes may be an actual or impending infringement in the Territory of any patent or other proprietary right owned or applied for by it or the other Party and related to the Licensed Product or the development, manufacture, use, importation, or sale thereof; (b) any attack on or appeal of the grant of any patent owned or applied for by it or the other Party and related to the Licensed Product or the development, manufacture, use, or sale thereof; (c) any application for patent by, or the grant of a patent to, a Third Party in respect of rights which may be related to the Licensed Product so as to potentially affect the development, manufacture, use, importation, or sale thereof or which may claim the same subject matter as or conflict with any patent owned or applied for by it or the other Party and related to the Licensed Product, or the development, manufacture, use, importation, or sale thereof; or (d) any application made for a compulsory license under any patent owned or applied for by it or the other Party and related to the Licensed Product or the development, manufacture, use, importation, or sale thereof.

7.2 Control of Enforcement

7.2.1 The Parties will determine through discussions at the Joint Product Committee whether or not to take whatever legal or other action is required in response to activities requiring notice under Section 7.1 (“Protective Action”). If the Joint Product Committee determines that such Protective Action is warranted, then, unless the Joint Product Committee determines otherwise, LICENSEE will, at LICENSEE’s expense, commence and prosecute such Protective Action at the direction of the Joint Product Committee or its designee. Council will, at LICENSEE’s expense, cooperate with LICENSEE in such action, including, without limitation, being joined as a Party to such action if such joinder is necessary for standing. Notwithstanding, Council will be responsible for its own internal costs associated with such action. Each Party may be represented by counsel of its own selection at its own expense in such Protective Action. Any recovery obtained as a result of such Protective Action, whether by judgment, award, decree, or settlement, will, after reimbursement of the Parties for their reasonable costs and expenses associated with such Protective Action, be retained by LICENSEE and included in and added to the total gross amounts invoiced for sales of Licensed Product for purposes of calculating royalties under the terms of Section 3.3. To the extent such recovery is insufficient to reimburse the Parties’ associated reasonable costs and expenses fully, then a Party’s share of the recovery will be the product of the total amount recovered with that Party’s reasonable costs and expenses divided by the sum of both Parties’ reasonable costs and expenses.

VIII. INFRINGEMENT OF THIRD PARTY RIGHTS

8.1 Third Party Claims. LICENSEE and Council will each promptly notify the Joint Product Committee of any Claim by a Third Party against LICENSEE or Council, or any Affiliate or sublicensee of Council or LICENSEE, alleging infringement of such Third Party’s intellectual property rights as a result of the development, manufacture, marketing, sale, importation, or use of the Licensed Product anywhere in the Territory. As directed by the Joint Product Committee, the Parties will cooperate and use Commercially Reasonable Efforts to resolve such claimed infringement, with each Party entitled to participate in the defense and to be represented by counsel of its choice, with each Party being responsible for the fees of its counsel; provided, however, that if it appears reasonably likely that the claimed infringement will give rise to a Claim for indemnification hereunder, then the Party against whom such Claim for indemnification would be made will have the first right to defend against such Claim in accordance with Article XIII below.