Master Alliance Provisions Guide (MAPGuide)

Ferring – MPP, Post-Partum Hemorrhage Prevention & Treatment (Heat Stable Carbetocin) MOU

  • Term & termination | Effects of termination
  • Term & termination | Term of agreement
  • Term & termination | Termination & withdrawal

MOU

1. Term and Termination. This MOU shall become effective on the date of last signature by either Party (“Effective Date”) and shall remain in effect until the later of the expiration, lapse or invalidation of the last remaining patent licensed by Ferring to MPP pursuant to this MOU (“Term”), unless terminated sooner by either Party as set forth below. It may be modified by mutual written consent of the Parties (provided always that the terms and conditions of the Existing Agreement and in particular any rights of, and commitments made by Ferring to, WHO and Merck shall not be prejudiced).

a) This MOU may be terminated by either Party with immediate effect by written notice to the other Party in the event of the other Party is in material breach of this MOU and/or the license and sublicense agreements executed pursuant to this MOU (as applicable to the Party), and where such breach is capable of remedy, such other Party fails to remedy such breach within thirty (30) days of written notice requiring such breach to be remedied.

b) This MOU shall automatically terminate in the event any of the following conditions occur: (i) the grant agreement between Unitaid and HRP is terminated prior to the completion of the Treatment Trial; or (ii) if a Party voluntarily commences any action or seeks any relief by liquidation, reorganization (other than for corporate reorganization), dissolution or similar act under any bankruptcy, insolvency or similar law or otherwise seeks any arrangement between or with its creditors or if a proceeding is commenced or an order, judgment or decree is entered seeking its liquidation, reorganization or dissolution or any other relief under any bankruptcy, insolvency or similar law or an arrangement is made with respect to its debts or business by its creditors with or without its consent.

c) All provisions of this MOU intended to survive expiration or prior termination of the MOU including, without limitation, Section 3 (Confidentiality), Section 4 (Press Releases and Other Communications), and Section 6 (Governing Law) shall so survive.

Annexure A: License Agreement

5. COMPLIANCE WITH APPLICABLE LAWS

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5.2 Ferring shall be entitled to terminate this Agreement immediately on written notice to MPP if MPP fails to perform its obligations in accordance with this Section 5. MPP shall have no claim against Ferring or any of Ferring’s Affiliates for compensation for any loss of whatever nature by virtue of the termination of this Agreement in accordance with this Section 5. To the extent (and only to the extent) that applicable law provides for any such compensation to be paid to MPP upon the termination of this Agreement, MPP hereby expressly agrees to waive (to the extent possible under applicable law) or repay to Ferring any such compensation or indemnity.

9. TERM AND TERMINATION

9.1 The term of this Agreement shall commence on the Effective Date and expire upon the later of the expiration, lapse or invalidation of the last remaining Licensed Patent (unless terminated earlier in accordance with its terms) (“Term”). Either Party may terminate this Agreement with immediate effect by written notice to the other Party if the other Party:

9.1.1. commits a material breach of this Agreement (including but not limited to MPP’s failure to terminate a Sublicense due to the Sublicensee’s material breach of the Sublicense), and where such breach is capable of remedy, such other Party fails to remedy such breach within thirty (30) days of written notice requiring such breach to be remedied; or

9.1.2. voluntarily commences any action or seeks any relief by liquidation, reorganization (other than for corporate reorganization), dissolution or similar act under any bankruptcy, insolvency or similar law or otherwise seeks any arrangement between or with its creditors or if a proceeding is commenced or an order, judgment or decree is entered seeking its liquidation, reorganization or dissolution or any other relief under any bankruptcy, insolvency or similar law or an arrangement is made with respect to its debts or business by its creditors with or without its consent.

9.2 Upon the expiry of this Agreement, or in the event that this Agreement is terminated earlier in accordance with its terms, MPP shall ensure that any Sublicenses already granted shall be immediately terminated in accordance with their terms (if that Sublicensee is in breach of the Sublicense) or converted (by way of MPP, Ferring and the relevant Sublicensee entering into a novation agreement transferring the rights and obligations of MPP under the Sublicense to Ferring) into a license between Ferring and the relevant Sublicensee(s) under the same terms and conditions of the Sublicense if that Sublicensee is not in breach of the Sublicense, and/or if the Sublicense has not otherwise been terminated earlier or expired. Notwithstanding anything in the foregoing, such conversion shall only occur if this Agreement is terminated earlier in accordance with its terms. Ferring shall not be required to convert a Sublicense into a license agreement between Ferring and the Sublicensee in the event this Agreement expires. This Section 9.2 shall survive any termination of this Agreement.

Annexure A, Schedule 3: Form of Sublicense

3. COMMERCIALISATION AND REGISTRATION

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3.6 If the Licensee sells, supplies or otherwise disposes of any Licensed Product in the Target Countries but has not obtained: (i) the necessary approvals from the Relevant Regulatory Authority and (ii) WHO pre-qualification or approval by a Stringent Regulatory Authority (or, as a provisional measure, a notification of no-objection has not been issued by a WHO Expert Review Panel for time-limited use of the Licensed Product), the Licensor shall be entitled to immediately terminate this Agreement by providing written notice to the Licensee.

12. TERM AND TERMINATION

12.1 This Agreement shall be deemed to come into effect on the Effective Date and shall continue thereafter subject to the further provisions of this Section 12.

12.2 Unless otherwise terminated, this Agreement shall expire upon the expiration, lapse or invalidation of the last remaining Licensed Patents.

12.3 Save as otherwise provided in this Agreement, if the Licensee breaches any provision of this Agreement and if such breach (i) is material and incapable of correction; or (ii) is capable of correction but is not corrected within sixty (60) days after receiving written notice with respect to such default, the Licensor shall have the right to terminate this Agreement with immediate effect by giving written notice to the party in default.

12.4 If:

(a) Licensor becomes aware of an actual or threatened claim that Licensee’s use of the Licensed Patents in any Target Country infringes the intellectual property rights of a Third-Party; or

(b) Licensor receives notice from Ferring that Ferring’s right to grant licenses of the Licensed Patents is challenged,
Licensor shall (and Ferring shall be entitled to) notify the Licensee in writing, detailing the nature of such claim or challenge. Licensee shall, within ten (10) Business Days of receipt of such notice, and without prejudice to any of the Licensee’s other obligations or liabilities under this Agreement or the Licensor’s rights (including without limitation under Section 12.5), elect to:

(i) suspend the terms of this License in respect of the relevant Licensed Patent until such issue is resolved; or

(ii) confirm in writing that it will indemnify Licensor and Ferring against any Losses (as defined in Section 14.5) incurred by Licensor and/or Ferring in connection with Licensee’s continued use of such Licensed Patent pursuant to this License.

If Licensee does not so notify Licensor within ten (10) Business Days of Licensor’s initial notice, the license shall be deemed suspended pending resolution of the issue.

12.5 The Licensor may terminate this Agreement, either in whole or in relation to a particular Licensed Patent with immediate effect by notice in writing to the Licensee if:

(a) the Licensee breaches any of the provisions of Section 7;

(b) it is determined that the Licensee’s use of the Licensed Patents infringes the intellectual property rights of a Third-Party;

(c) Ferring’s right to grant licenses of the Licensed Patents expires or is terminated;

(d) Ferring or Licensor receives a Third-Party claim or demand for royalty payments relating to sales of the Licensed Product by the Licensee, unless the Licensee agrees to satisfy the claim should such a claim or demand become payable;

(e) the legal or beneficial ownership or control of the Licensee and/or any of its Affiliates changes in such a manner as Ferring shall in its sole discretion consider significant;

(f) Licensee repeatedly fails to comply with or to timely provide Licensor with any report or statement such as those contained in Section 10.2 of this Agreement;

12.7 Any Party may terminate this Agreement with immediate effect by providing a written termination notice to the other Party if, at any time, the other Party shall compound or make arrangements with its creditors or be adjudicated bankrupt or have a receiver appointed over all or any part of its assets or go into liquidation (whether voluntary or otherwise) otherwise than as part of a bona fide amalgamation or reconstruction without insolvency or suffer any insolvency event or analogous process under foreign laws.

12.8 Any change in the legal or beneficial ownership or control of the Licensee shall be immediately notified in writing to the Licensor and Ferring by the Licensee. For the purposes of this Section 12.8, “control” shall mean the ability of a person, entity or corporation to ensure, whether through ownership of shares or otherwise, that the affairs of a party are conducted in accordance with the wishes of such person, entity or corporation.

12.9 If Licensee fails to file for (i) regulatory approval of the Licensed Product before at least one Relevant Regulatory Authority or (ii) WHO pre-qualification of the Licensed Product or approval by Stringent Regulatory Authority within thirty-six (36) months from the Effective Date, Licensor shall have the right to terminate this Agreement with immediate effect by giving written notice to the Licensee.

12.10 If, in the reasonable opinion of the Licensor, the Licensee fails to promote access to the Licensed Product for use in the Field in the Territory in accordance with this Agreement, the Licensor shall give notice to the Licensee requiring it to cure such failure. If in the opinion of the Licensor, the Licensee fails to report reasonable progress within one hundred and eighty (180) days after receiving written notice with respect to the default, the Licensor shall have the right to terminate this Agreement with immediate effect by giving written notice to the Licensee. Without limitation to the generality of this Section 12.10 in exercising its reasonable opinion, the Licensor shall take into account the period within which the Relevant Regulatory Authorities provide the necessary approvals, normal development lead time for the Licensed Product, and progress reported by Licensee in its quarterly reports provided under Section 3.7.

12.11 Unless notice to the contrary is given by Ferring, this Agreement shall terminate immediately in the event that the Head License is terminated or expires. This Agreement shall be converted into a license between Ferring and the Licensee, provided that Licensee is not in breach of this Agreement, this Agreement has not expired or otherwise been earlier terminated; and that Ferring has notified both the Licensor and Licensee of such conversion.

12.12 Licensee may terminate this Agreement at any time by providing thirty (30) days written notice to Licensor.