License and Development Agreement, dated as of August 27, 2017, by and between the Registrant and Pendopharm, a division of Pharmascience Inc

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Any refund or reimbursement of any of the foregoing amounts previously deducted from Net Sales shall be appropriately credited to Net Sales, or adjusted through allowances, upon receipt thereof.

 

For greater certainty "Net Sales" shall not include (i) sales or transfers between members of the group comprised of Pendopharm, Sublicensees, and their Affiliates; (ii) provision of Product for the purpose of conducting Clinical Trials in order to obtain Regulatory Approvals; (iii) disposal of reasonable quantities of Licensed Products for promotional or advertising purposes or regulatory or governmental purposes, but not to exceed 5% of Gross Sales ; and (iv) transfers or dispositions of reasonable quantities of Licensed Products to patients unable to purchase the Licensed Products, but not to exceed 5% of Gross Sales.

Such amounts shall be determined from the books and records of Pendopharm or its Affiliates or Sublicensees, as applicable, maintained in accordance with IFRS, consistently applied, except where IFRS is not the standard, in which case whatever the accounting standard is in effect will be applied.

 

Once the Licensed Products are approved for sale in the Territory by the applicable Regulatory Authority, if the Licensed Products are sold as part of a bundled transaction and there is no individual price for the Licensed Products in the transaction documentation (agreement, invoice etc.), the amount to be included in Net Sales shall be determined based on the pro rata allocation of the amount invoiced for all products included in such bundled transaction, based on the average per unit net sales price (calculated for the Calendar Quarter being reported) for such Licensed Products and the average per unit net sales price (calculated for the Calendar Quarter being reported) for every other product included in such bundled transaction and the number of units of Licensed Products and every other product included in such bundled transaction.

 

 

 

 

 

Edesa shall use reasonable commercial efforts to Develop the Licensed Products in the indications of hemorrhoids (with respect to EB02) and anal fissures (with respect to EB04) for the purposes of obtaining Regulatory Approval with the FDA.

 

On a Licensed Product by Licensed Product basis, Edesa agrees to provide Pendopharm with the US Data Package within sixty (60) Business Days of submission of the NDA to the FDA in the United States. Within the ninety (90) day period following the provision of the US Data Package to Pendopharm, Edesa will use reasonable efforts to answer potential questions Pendopharm may have and, upon Pendopharm' s request, provide any additional documents relating to the US Data Package that Edesa may have in its possession or Control.

Within ninety (90) days of its receipt of the US Data Package , Pendopharm will, on a Licensed Product by Licensed Product basis, inform Edesa in writing if Pendopharm would like to proceed with the preparation and submission of a Marketing Authorization application for the Licensed Products to the competent Canadian Regulatory Authority ("Acceptance to Proceed").

 

 

If Pendopharm does not provide Edesa with the Acceptance to Proceed within the period provided for in Section 2.3, Edesa will be entitled to, for the Licensed Product for which Pendopharm has not provided its Acceptance to Proceed, remove the Licensed Product from the scope of the license granted in this Agreement with immediate effect by giving written notice to Pendopharm, whereby all rights to that specific Licensed Product in the Territory granted to Pendopharm under this Agreement shall revert back to Edesa and Section 10.7(a) shall apply.

If Pendopharm declares Acceptance to Proceed, Pendopharm will be responsible for obtaining Marketing Authorization and any other Regulatory Approvals which may be required in the Territory for the sale and marketing of the Licensed Product in the Field and for generating any additional data which may be required for obtaining Marketing Authorization in the Territory at its own cost.

 

Pendopharm shall, at the earliest possible time after receipt of the US Data Package from Edesa, discuss with the competent Canadian Regulatory Authority whether Marketing Authorization in the Territory can be obtained on the basis of the US Data Package or whether additional clinical studies have to be performed in the Territory. If no further clinical studies should be required, Pendopharm will, subject to Section 2.3, use reasonable efforts to submit a Marketing Authorization application for the Licensed Products to the competent Regulatory Authority in the Territory.

 

 

 

 

 

If Pendopharm determines that clinical studies shall be performed in the Territory, Edesa will supply the required clinical supply of the Licensed Products to Pendopharm at actual cost. Detailed supply terms and responsibilities of the Parties regarding quality will be agreed in a separate supply agreement prior to the commencement of the supply of Licensed Products to Pendopharm, with the proviso that such additional terms must reasonably enable Edesa to meet the terms agreed with Edesa's contract manufacturer.

 

 

The Parties will establish a shared website for the exchange of the information in relation to the Licensed Products to be exchanged between the Parties pursuant to the terms of this Agreement. Edesa will commence providing information pertaining to the US Data Package to Pendopharm after completion of the proof of concept clinical trials for each of the products and as such information becomes available. Each Party shall provide to the other Party copies of all clinical and non-clinical data and other results and analyses with respect to any Development activities with respect to the Licensed Products in the Field, for each of the Licensed Products and when and as such data, results and analyses become available and as soon as reasonably practicable. Subject to Applicable Law in the relevant territory, the aforesaid obligation shall also include data generated by Edesa's licensees and/or Pendopharm's Sublicensees, but shall, for purposes of clarity, exclude any commercial information. Such clinical and non-clinical data shall be prepared in the English language and in a format generally accepted by Regulatory Authorities, such as the FDA, Health Canada and/or the EMA. Further, any clinical studies undertaken by or on behalf of a Party shall include consents and authorizations which allow release of all protected health information of the study participants to the other Party and its licensees to the extent permitted by the Applicable Law and such releases and/or authorizations shall contain language which makes it clear to the study participant that any information related to the Licensed Products shall be kept confidential. Each Party shall furnish to the other Party regularly, at least every half a year, reports including the clinical and non-clinical data generated by it in the preceding half a year. For the avoidance of doubt, both Parties agree to only enter into any agreements with Sublicensees and/or Third Parties if the Sublicensee/Third Party undertakes the same obligations regarding disclosure and access to clinical and non-clinical data as Pendopharm undertakes pursuant to this Agreement, in particular pursuant to the foregoing sentences.

 

 

Pendopharm shall be responsible for all pricing and reimbursement approval proceedings relating to the Licensed Products in the Territory.

 

 

Pendopharm and Edesa each shall maintain, or cause to be maintained, records of their respective Development activities with respect to the Licensed Products in the Field in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the performance of their respective Development activities, and which shall be retained by such Party for at least three (3) years after the termination of this Agreement, or for such longer period as may be required by Applicable Law. Not more than once in a Calendar Year, each Party shall have the right, during normal business hours and upon reasonable notice, to inspect and copy any such records of the other Party. A Party shall provide the other Party with such additional information regarding the Development activities in relation to this Agreement as such Party may reasonably request from time to time.

 

After execution of this Agreement, Pendopharm and Edesa shall appoint one representative of each organization who will meet by teleconference at least two (2) times per year until the end of Phase III clinical trials in order to update each other on medical affairs and regulatory affairs and other relevant matters related to the Licensed Products in the Territory. Each party will use reasonable efforts to satisfy the requests of the other representative for access to specific information and documentation.

 

Subject to the terms of this Agreement, no later than three (3) months before market launch in the Territory, Edesa and Pendopharm shall discuss and develop mutually acceptable guidelines and procedures for (a) the investigation, exchange, receipt, recordation, communication (as between the Parties) and exchange of Adverse Event Experience information and all other information required by either Party in order to meet its pharmacovigilance responsibilities and (b) for the handling of any oral or written communication of dissatisfaction regarding the identity, quality, durability, reliability or performance of the Licensed Products, including appearance, low fills, foreign materials, foreign product, defective packaging or defective labeling. "Adverse Event Experience" shall mean (i) any finding from tests in laboratory animals or in vitro that suggests a significant risk for human subjects including reports of mutagenicity, teratogenicity or carcinogenicity and (ii) any undesirable, untoward or noxious event or experience associated with the clinical, commercial or other use or occurring following administration, of the Licensed Products in humans, occurring at any dose, whether expected or unexpected and whether or not considered related to or caused by the Licensed Products, including such an event or experience as occurs in the course of the use of the Licensed Products in professional practice, in a clinical trial, from overdose, whether accidental or intentional, from abuse, from withdrawal or from a failure of expected pharmacological or biological therapeutic action of the Licensed Products, and including those events or experiences that are required to be reported to any Regulatory Authority in the Territory.

 

 

 

 

 

Edesa will supply the Licensed Products to Pendopharm subject to the terms of a separate supply agreement, the terms of which shall be agreed by the parties in good faith, with the proviso that such additional terms must reasonably enable Edesa to meet the terms agreed with Edesa's contract manufacturer. On a product by product basis, the parties will enter into good faith negotiations within thirty (30) days of Edesa's receipt of Pendopharm's Acceptance to Proceed.

 

 

 

 

 

 

 

 

 

 

 

 

 

Except as expressly provided herein, the parties grant no other right or license to the other party, including any rights or licenses to the Licensed Patents, the Licensed Know-How, any other Patents or other Intellectual Property Rights, or any improvements to any of the foregoing.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Edesa or its licensees, through patent attorneys or agents of its or their choice and at its or their sole cost and expense, shall have the right, but not the obligation, to file, obtain, prosecute and maintain the Licensed Patents and all foreign counterparts thereof owned or Controlled by Edesa on the Effective Date and at all times during the Term. With respect to the Territory, Edesa shall not, and shall perform reasonable endeavours to procure that its licensees other than Pendopharm, do not, abandon or cease the prosecution of any such application for a Licensed Patents or permit any registration of a Licensed Patents issuing therefrom to lapse without first notifying Pendopharm and permitting Pendopharm to continue the preparation, filing, prosecution and maintenance of such applications or registrations or pay any required fees in the name of Edesa, at Pendopharm's expense and through patent attorneys of its choice. Pendopharm shall not become an assignee of any Licensed Patent as a result of its continuing the prosecution or registration of a Patent or paying any fees according to this Section 0. If Pendopharm makes such expenses, Pendopharm shall have the right to deduct such expenses from any royalty payment to be made to Edesa pursuant to Section 6.1.

 

 

 

Subject to Sections 10.4 and 10.5, Pendopharm shall be authorized to select the trademark(s) for the Licensed Products(s) in the Territory in accordance with Applicable Law and the requirements of the Regulatory Authority (the "Trademarks"). Pendopharm shall own the Trademarks and shall be solely responsible for the prosecution, registration and maintenance of the Trademarks.

 

Pendopharm shall have the first right to commence and control any application under the Patented Medicines (Notice of Compliance) Regulations ("PM(NOC)") in connection with the Licensed Products in the Territory. Accordingly, Edesa shall advise Pendopharm within thirty (30) days of any grant of any of its patents and/or patent applications with respect to the Licensed Products, subject to Edesa having learnt of said grant. In such case, Pendopharm shall be responsible for all legal costs it incurs in pursuing any such application, and Pendopharm shall be entitled to retain any award of costs granted in its favor. The Party who commenced and controlled such an application shall also have the sole obligation to defend any proceeding under Article 8 of the PM(NOC) in respect of a withdrawn, dismissed or discontinued application commenced by that Party under the PMNOC, including the obligations to pay all legal costs incurred in defending such proceeding and all awards of damages and costs made by the court. Edesa, at the request of Pendopharm, shall cooperate in all reasonable respects with Pendopharm in the pursuit or defense of such claims including, but not limited to, Edesa accepting to be added as a party to said application or claim where necessary.

 

 

Edesa shall consult and cooperate with Pendopharm with a view to obtaining issued Licensed Patents that meet the criteria for listing on the Patent Register of Health Canada pursuant to the Patented Medicines (Notice of Compliance) Regulations ("Patent List"). Edesa consents to Pendopharm including any such issued Licensed Patents on the Patent List for the Licensed Products and will provide any necessary assistance to Pendopharm in order to list the issued Licensed Patents in a timely manner.

 

Edesa hereby represents and warrants to Pendopharm that, as of the Effective Date and unless otherwise set forth below, at all times during the Term:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PendopharmPendopharm agrees to defend, indemnify and hold Edesa, its Affiliates, its sub-contractors and its licensees and their respective directors, officers, employees and agents (each a "Edesa Indemnity Party") harmless against any and all claims, suits, judgments, losses, liabilities, damages, costs, fees and expenses (including reasonable attorneys' fees) (collectively, "Losses") resulting from or arising out of (i) the negligence or willful misconduct on the part of PendopharmPendopharm, its Affiliates, sub-contractors and Sublicensees and their respective directors, officers, employees and agents (each a "PendopharmPendopharm Indemnity Party") in relation to the carrying out of this Agreement, (ii) the negligent or willful breach by a Pendopharm Indemnity Party of any terms of this Agreement, or (iii) the breach, whether negligent or not, of any of Pendopharm's representations and warranties in Article 8 of this Agreement by a PendopharmPendopharm Indemnity Party, except for those Losses which Edesa has an obligation to indemnify a PendopharmPendopharm Indemnity Party pursuant to Section 9.2 hereof, as to which Losses each Party shall indemnify the other to the extent of their respective liability, and provided further that Pendopharm shall not be obligated to indemnify any Edesa Indemnity Party for any Losses to the extent such Losses arise as a result of negligence or willful misconduct on the part of such Edesa Indemnity Party.

Edesa agrees to defend, indemnify and hold Pendopharm, its Affiliates, its sub-contractors and its Sublicensees and their respective directors, officers, employees and agents harmless against any and all Losses resulting from or arising out of (i) the negligence or willful misconduct on the part of any Edesa indemnity Party in relation to the carrying out of this Agreement, (ii) the negligent or willful breach by a Edesa Indemnity Party of any terms of this Agreement, or (iii) the breach, whether negligent or not, of any of Edesa's representations and warranties in Article 8 of this Agreement by an Edesa Indemnity Party, except for those Losses which Pendopharm has an obligation to indemnify a Edesa Indemnity Party pursuant to Section 9.1 hereof, as to which Losses each Party shall indemnify the other to the extent of their respective liability, and provided further that Edesa shall not be obligated to indemnify any Pendopharm Indemnity Party for any Losses to the extent such Losses arise as a result of negligence or willful misconduct on the part of such Pendopharm Indemnity Party.

 

The indemnification obligations set forth in this Article 9 shall survive the termination or expiration of this Agreement and remain in full force and effect for a term ending three (3) years after the end of the shelf life of the last Licensed Products sold by Pendopharm, its Affiliates or a Sublicensee in relation to any claim based on events which occur during the Term hereof.

 

TO THE FULL EXTENT ALLOWED BY LAW THE PARTIES EXCLUDE ANY LIABILITY, WHETHER BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE), OR ANY OTHER LEGAL THEORY, FOR CONSEQUENTIAL, SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE OR EXEMPLARY DAMAGES OR OTHER SIMILAR OR LIKE DAMAGES OR DAMAGES FOR LOSS OF PROFITS, REVENUES OR DATA, ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT OR THE PERFORMANCE OR BREACH HEREOF, EVEN IF THE PARTY HAS BEEN ADVISED OF THE POSSIBILITY THEREOF.

 

 

 

 

 

 

 

 

 

Pendopharm shall have the right to terminate this Agreement upon one-hundred and twenty (120) days prior written notice to Edesa.

 

Edesa shall have the right to terminate this Agreement upon thirty (30) days written notice to Pendopharm, in the event Edesa (i) is unable to recruit the requisite number of participants in the proof of concept clinical study or (ii) the proof of concept clinical study is unable to be completed due to a failure of obtaining the required approval (e.g. ethics board approval) or has been terminated due to concerns regarding the safety of participants following the use of the Licensed Products.

If either Party commits a material breach of this Agreement, the other Party shall have the right to terminate this Agreement by giving written notice to the breaching Party in sufficient detail to ascertain and respond to the alleged breach. Termination shall take effect sixty (60) days after receipt of such notice by the breaching Party unless within the same time period the breach has been cured.

 

 

To the extent permitted under Applicable Law, if one of the Parties shall go into liquidation, other than for the purpose of a bona fide reorganization, or a receiver or trustee be appointed for its property or estate, or if such Party files for a voluntary petition in bankruptcy or application for insolvency or is adjudged bankrupt or insolvent, and whether or not any of the aforesaid acts be the outcome of a voluntary act of that Party, the other Party shall be entitled to terminate this Agreement forthwith by written notice to the first Party.

 

 

 

 

 

 

 

 

 

 

Neither Party shall be held liable or responsible to the other Party or be deemed to have defaulted under or be in breach of this Agreement for failure or delay in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party, including fire, floods, earthquakes, embargoes, epidemics, war, acts of war, terrorist acts, insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, act of God or acts, omissions or delays in acting by any Regulatory Authority or the other Party; provided, however, that the Party so affected shall use reasonable commercial efforts to avoid or remove such causes of non-performance, and shall continue performance hereunder with reasonable dispatch whenever such causes are removed. The affected Party shall provide the other Party with prompt written notice of any delay or failure to perform that occurs by reason of force majeure, stating the nature of the event, its anticipated duration, and any action being taken to avoid or minimize its effects. In the event that such force majeure event (i) lasts for more than one hundred eighty (180) days and (ii) has a material adverse effect on the performance of the obligations of the affected Party, the non-affected Party shall have the right to terminate this Agreement upon written notice to the affected Party.

 

 

 

 

 

 

 

 

 

Upon the effective date of expiration or termination of this Agreement for any reason, either Party may request in writing, and the other Party shall either, with respect to Confidential Information to which such other Party does not retain rights hereunder: (i) promptly destroy all copies of such Confidential Information in the possession of the other Party and confirm such destruction in writing to the requesting Party; or (ii) promptly deliver to the requesting Party, at the other Party's expense, all copies of such Confidential Information in the possession of the other Party; provided, however, the other Party shall be permitted to retain one (1) copy of such Confidential Information for the sole purpose of performing any continuing obligations hereunder or for archival purposes as well as electronic copies which are automatically generated by computer systems during back up procedures. All retained Confidential Information shall continue to be subject to the terms of this Agreement for the period set forth in Section 12.1.

 

 

This Agreement together with the Exhibits hereto contains the entire understanding of the Parties with respect to the subject matter hereof. All prior express or implied agreements and understandings, either oral or written, are superseded by this Agreement. This Agreement may be amended and the written form requirement set forth herein may be waived only by a written instrument duly executed by all Parties hereto.

 

 

 

 

Any notice required or permitted hereunder shall be in writing, shall refer specifically to this Agreement, and shall be delivered personally by hand, by an overnight courier service or by facsimile transmission, and shall be addressed to the Party to whom it is to be given at the address or facsimile number shown below:

Each Party may, at any time, substitute for its previous record address any other address by giving prior written notice of the substitution in accordance with this Section 13.3. Any such notice shall be deemed to have been given and received on the date of delivery, if received prior to 5:00 p.m. local time, on a Business Day. If the notice is received after 5:00 p.m., local time on a Business Day, or is received on a day which is not a Business Day, then such notice shall be deemed to have been given and received on the first Business Day thereafter.

The failure of either Party to insist upon the strict performance of any provisions hereof or to exercise any right or remedy shall not be deemed a waiver of any right or remedy with respect to any existing or subsequent breach or default; the election by either Party of any particular right or remedy shall not be deemed to exclude any other; and all rights and remedies shall be cumulative.

 

In the event any provisions of this Agreement are or become invalid or unenforceable the remaining provisions of this Agreement shall remain in effect. The invalid or unenforceable provisions shall be replaced by a valid or enforceable one which most closely reflects the original commercial intent of the Parties.

 

 

 

 

During the Term and for a period of two (2) years thereafter, neither Party shall actively recruit or solicit any employee of the other Party or its Affiliates. For the avoidance of doubt, nothing shall limit a Party from engaging in general recruitment efforts through advertisements so long as the employees of the other Party and its Affiliates are not specifically targeted in such recruitment effort.

 

 

It is expressly agreed that Edesa and Pendopharm shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture or agency. Neither Edesa nor Pendopharm shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other, without the prior consent of the other Party to do so.

 

 

Each of the Parties shall use all reasonable efforts to take, or cause to be taken, all action or do or cause to be done, and to assist and cooperate with each other Party in doing, all things necessary, proper or advisable to consummate and make effective, in the most expeditious manner practicable, the transactions contemplated by this Agreement (in each case, to the extent that the same is within the control of such Party).

 

 

Each Party shall promptly do, execute, deliver or cause to be done, executed and delivered all further acts, documents and things in connection with this Agreement that the other Party may reasonably require for the purposes of giving effect to this Agreement.

 

The parties have expressly required that this Agreement and all documents and notices relating hereto be drafted in English. Les parties aux presentes ont expressement exige que la presente convention et tous les documents et avis qui y sont afferents soient rediges en anglais.