Master Alliance Provisions Guide (MAPGuide)

Population Council – TherapeuticsMD, Nestorone Contraceptive Ring, License Agreement

  • Liability | Representations & Warranties

IX. REPRESENTATIONS AND WARRANTIES

9.1 Representations and Warranties of Both Parties. Council and LICENSEE each hereby represents and warrants to the other, as of the Effective Date, as follows:

9.1.1 It is an entity duly organized, validly existing and in good standing under the laws of the jurisdiction of its formation and has all requisite power and authority, corporate or otherwise, to conduct its business as now being conducted, to own, lease and operate its properties and to execute, deliver and perform this Agreement.

9.1.2 Neither it, nor any of its employees or consultants who will be undertaking any activities related to this Agreement or the subject matter thereof, has been debarred or is the subject of debarment or other disciplinary proceedings by the FDA or any Regulatory Authority in the Territory.

9.1.3 No consent, approval, order or authorization of, or registration, declaration or filing with, any governmental agency is required to be obtained or made by or with respect to such Party in connection with its execution, delivery and performance of this Agreement.

9.1.4 The execution, delivery and performance by it of this Agreement and the transactions contemplated thereby have been duly authorized by all necessary corporate action and stockholder action and will not (i) violate any applicable laws or regulations or (ii) result in a breach of or constitute a default under any material agreement, mortgage, lease, license, permit or other instrument or obligation to which it is a party or by which it or its properties may be bound or affected.

9.1.5 It is not under any contractual obligation to any Third Party that conflicts with the terms of this Agreement or that limits the rights of such Party to fulfill its obligations hereunder.

9.2 Representations and Warranties of Council. Council hereby represents and warrants to LICENSEE, as of the Effective Date, as follows:

9.2.1 Except as set forth on Exhibit A, it owns each of the Council Patent Rights set forth on Exhibit A.

9.2.2 it has sufficient rights and power to grant the exclusive license to LICENSEE which it purports to grant herein.

9.2.3 all inventors of any Council Patents have assigned their entire right, title and interest in, to and under such Council Patents to Council.

9.2.4 the patents and patent applications listed on Exhibit A hereto constitute all the Council Patent Rights in existence as of the Effective Date.

9.2.5 all payments, fees or other obligations to be made or satisfied by Council to any regulatory authority, patent office or Third Party in any jurisdiction have been, and are as of the Effective Date, fully satisfied with respect to each item within the Council Technology and no action with any regulatory authority, patent office or Third Party with respect to the Council Technology is required to be taken within sixty (60) days after the Effective Date.

9.2.6 as of the Effective Date, no patent application or patent within the Council Patent Rights is the subject of any inter partes review, interference, derivation proceeding or other protest proceeding in any patent office in the Territory.

9.2.7 to its knowledge, as of the Effective Date, there is no information, material, fact or circumstance that would constitute inequitable conduct, fraud or misrepresentation with respect to any Licensed Patents.

9.2.8 Council has received no notice and has no reason to expect such notice of any Claim by any Third Party or any Council employee that (a) such Third Party or employee has any rights to Council Technology or the Licensed Product that prevent Council from granting to LICENSEE the License; (b) manufacture, sale, importation or use of the Licensed Product currently in clinical development within the Field as contemplated hereby infringes any Third Party rights; or (c) Council Patent Rights (to the extent representing issued patents) are invalid or unenforceable.

9.2.9 To Council’s knowledge as of the Effective Date, there are no errors in the inventorship set forth in any of the patent applications comprising Council Patent Rights.

9.2.10 the API Supply Agreement attached as Schedule 2.3.1(a) and the Letter Agreement attached as Schedule 2.3.1(b) are true and accurate copies of such agreements other than with respect to redacted terms.

9.2.11 Council is not in breach of (a) the API Supply Agreement or (b) the Letter Agreement.

9.2.12 Council has not received any written notice that the API Supply Agreement or the Letter Agreement has been terminated or breached.

9.3 Representations and Warranties of LICENSEE. LICENSEE hereby represents and warrants to Council, as of the Effective Date, as follows:

9.3.1 LICENSEE has sufficient resources, experience and expertise available to it to enable it to perform its obligations under this Agreement reasonably in accordance with pharmaceutical industry standards and strictly in accordance with all applicable Laws.

9.4 Mutual Limitations on Warranties. OTHER THAN THE REPRESENTATIONS AND WARRANTIES MADE BY THE PARTIES PURSUANT TO SECTIONS 9.1, 9.2 AND 9.3, THE PARTIES DISCLAIM ANY AND ALL OTHER REPRESENTATIONS AND WARRANTIES WHETHER EXPRESS OR IMPLIED, INCLUDING ANY REPRESENTATIONS OR WARRANTIES OF NON-INFRINGEMENT, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE OR ANY REPRESENTATIONS OR WARRANTY ARISING FROM COURSE OF DEALING OR USAGE OF TRADE.