Master Alliance Provisions Guide (MAPGuide)

MPP Amended and Restated Sublicense and Technology Transfer Agreement under BMS-MPP License Agreement

  • IP ownership & licensing | Use of background IP

§2 License Grant:

§2.1 Licensed Patent Rights and Licensed Manufacturing Know-How

(a) Upon the terms and subject to the conditions set out in this Sublicense Agreement, MPP hereby grants to the Sublicensee, and the Sublicensee hereby accepts, a non-exclusive, non-sublicenseable, royalty-bearing, non-transferable license under the Licensed Patent Rights and the Licensed Manufacturing Know-How to make, or have made, use, offer for sale, sell, have sold, export or import the Licensed Compound and Licensed Products anywhere in the world exclusively for ultimate use in the Field in the Territory.

(b) The Sublicensee will not have any right to practice the license granted under this clause 2.1 or otherwise exploit the Licensed Patent Rights and Licensed Manufacturing Know-How for any other purpose.

§2.2 Term of License Grant:

The license granted to the Sublicensee will expire upon the expiration of the last-to-expire of the Licensed Patent Rights that are granted and in force, unless where terminated earlier in accordance with this agreement. Following the expiration of such licenses in the Territory, the licenses granted in clause 2.1 with respect to Licensed Manufacturing Know-How will be fully paid-up and perpetual.

§2.3 Relation with the License Agreement:

(a) The Sublicensee acknowledges and agrees that this Sublicense Agreement is subject to and subordinate to the License Agreement.

(b) The Sublicensee hereby confirms that it has reviewed the terms and conditions of the License Agreement and agrees to not perform any acts or omissions that would place MPP in breach of the License Agreement.

(c) Under this Sublicense Agreement, the Sublicensee is entitled to make, have made, offer for sale, sell, have sold, export or import the Licensed Compound, whether inside or outside of the Territory, solely for the manufacture of Licensed Products exclusively for use in the Field in the Territory.

(d) Under this Sublicense Agreement, the Sublicensee is entitled to offer for sale, sell, have sold the Licensed Products to customers outside of the Territory solely to the extent that such Licensed Products will be exclusively used in the Field in the Territory.

(e) In the event that BMS or MPP becomes aware of any act or omission of a Sublicensee which constitutes a breach of this Sublicense Agreement, MPP will: (i) if the breach is capable of correction and does not give rise to an immediate right of termination under this Sublicense Agreement, direct the Sublicensee in writing to cure the breach within 90 days of MPP’s notice, with a copy of that writing to BMS; and (ii) if the breach remains uncured at the end of the specified period, or if there are otherwise grounds for termination under the Sublicense Agreement, and in each case if so requested by BMS, procure the termination of the relevant Sublicense Agreement in accordance with its terms.

(f) Nothing in this Sublicense Agreement will prohibit the Sublicensee from manufacturing and selling the Licensed Compound and Licensed Products in combination with other active pharmaceutical ingredients in the Territory, provided in each case that: (i) the Sublicensee has the legal right to manufacture and sell such other active pharmaceutical ingredients in the applicable country within the Territory; (ii) such manufacture and sale is in accordance with the licenses granted in this Sublicense Agreement; and (iii) BMS and MPP do not provide the Sublicensee with any representations, warranties or other assurances about Combination Products that include the Licensed Compound or the Licensed Products, including with respect to patents owned by third parties.

§7 Pharmacovigilance and Quality Matters:

§7.1 Pharmacovigilance

(a) If the Sublicensee becomes aware of any adverse reaction relating to the Licensed Compound or Licensed Products in connection with this Sublicense Agreement, the Sublicensee must inform BMS within 24 hours of its becoming aware and cooperate with BMS in fulfilling BMS’s reporting responsibilities under applicable laws and regulations.

(b) The Sublicensee will maintain effective and reliable systems for receiving and tabulating any reports of adverse reactions to the Licensed Products and to report such information on a timely basis to the relevant authorities and to BMS pursuant to the terms of this Sublicense Agreement.

§7.2 Quality

The Sublicensees will manufacture the Licensed Compound and Licensed Products in a manner consistent with:

(a) World Health Organization (WHO) pre-qualification standards; or

(b) the standards of any Stringent Regulatory Authority, defined as regulatory authorities which are members, observers or associates of the International Conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, as may be updated from time to time. Where such approvals are not yet available, the Sublicensee will obtain temporary approval through a WHO Expert Review Panel, as appropriate and if applicable.