STRATEGIC ALLIANCE AGREEMENT

Strategic Alliance Agreement

You are currently viewing:

This Strategic Alliance Agreement involves

SIRNA THERAPEUTICS INC | ALLERGAN

. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here.

Title: STRATEGIC ALLIANCE AGREEMENT
Governing Law: California Date: 11/14/2005
Industry: BIOTRX

Search Strategic Alliance Agreement by:

EXHIBIT 10.4

FOIA CONFIDENTIAL TREATMENT REQUESTED

STRATEGIC ALLIANCE AGREEMENT

Between

S IRNA T HERAPEUTICS , I NC .

And

A LLERGAN

Effective

September 28, 2005

S TRATEGIC A LLIANCE A GREEMENT

T HIS A GREEMENT is entered into on September 28, 2005 (the “Effective Date”) between

A LLERGAN , I NC ., a Delaware Corporation having its principal place of business at 2525 Dupont Drive, Irvine, California 92612, A LLERGAN S ALES , LLC , a Delaware Limited Liability Company, having a place of business at 2525 Dupont Drive, Irvine, California 92612, United States , and A LLERGAN P HARMACEUTICALS H OLDINGS (I RELAND ) L TD . , an Irish company, having a registered address at Longphort House, Earlsfort Centre, Lower Leeson Street, Dublin 2, Ireland (collectively, “Allergan”) and

S IRNA T HERAPEUTICS , I NC ., a Delaware Corporation, having a place of business at 185 Berry Street, Suite 6504, San Francisco, CA 94107 (“Sirna”) (collectively, the “Parties”).

The Parties agree as follows.

1. D EFINITIONS

1.1 “Affiliate” means any entity that controls, is controlled by, or is under common control with a Party. An entity “controls” another if it owns more than fifty percent (50%) of the outstanding voting securities of a corporation or has a comparable equity interest in any other type of entity.

1.2 “Allergan Drug Delivery System ” or “ Allergan DDS ” means a Delivery System Controlled by Allergan.

1.3 “Allergan Named Target” means a Target designated by Allergan under this Agreement in accordance with Section 3.7 hereof.

1.4 “Alliance Manager” has the meaning set forth in Section 2.2(d).

1.5 “Backup Compound” means a Lead Compound that the JSC has selected pursuant to Section 3.10 as a backup candidate for clinical development.

1.6 “Compound” means a composition comprising [***]* as active ingredients, known as of the Effective Date or discovered pursuant to this Agreement subsequent to that date, against the Allergan Named Targets in the Field.

1.7 “Confidential Information” means all information disclosed by one Party to another and as further set forth in Section 10 hereof.

1.8 “Controlled” means, with respect to any material, data, information, or intellectual property right, that a Party owns, co-owns, or has a license to such material, data, information, or intellectual property right and has the ability to grant access, a license, or a sublicense to such

*	Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


		1

material, data, information, or intellectual property right to the other Party under this Agreement and its Affiliates and sublicensees for use or application in the Field without violating an agreement with, or infringing any rights of, a third party.

1.9 “Cost of Goods” or “COGS” means fully-burdened standard costs of supplying Compounds calculated in accordance with Sirna’s accounting methods consistently applied, which methodology will be calculated in compliance with U.S. generally accepted accounting principles (GAAP). Costs include raw materials, API, components, labor and overhead attributed to the production, processing, quality control, labeling and packaging of the product for the manufacture of bulk drug and Compounds. [***]*

1.10 A patent “Covers” a composition or method if the patent has not expired and if the composition or method would infringe, but for this Agreement, at least one claim of the patent and a court or other authority of competent jurisdiction has not held the claim to be invalid or unenforceable. An application “Covers” a composition or method if the composition or method would infringe a claim of the application were a patent to issue that recites the claim.

1.11 “Data” means any and all data and results generated by the Parties independently or jointly under this Agreement.

1.12 “Delivery Systems” or “DDSs” means a substrate, encapsulant, mechanical device, ocular implant or other means for delivering Licensed Product to a patient in need of treatment, which Delivery System, in the absence of a Drug would have no therapeutic utility.

1.13 “Development Compound” means a Pre-Development Compound that the JSC has designated pursuant to Section 3.12 for clinical development.

1.14 “Development Plan” means a plan prepared by Allergan in collaboration with Sirna for the development of Development Compounds, [***]*, as amended or modified from time to time by the JSC.

1.15 “Development Team” has the meaning set forth in Section 2.2(c).

1.16 “Development Team Leader” has the meaning set forth in Section 2.2(c).

1.17 “Drug” means a composition intended for use in the cure, mitigation, treatment, or prevention of disease.

1.18 “FDA” means the U.S. Food and Drug Administration, or any Regulatory Authority that is the successor thereto.

1.19 “Field” means conditions and diseases affecting the [***]* and treatments for such conditions and diseases. Such conditions and diseases include, for example, [***]*.

*	Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


		2		CONFIDENTIAL

1.20 “First Commercial Sale” means in any country, the first sale for use by the general public of a Licensed Product after required marketing and pricing approvals have been granted by the Regulatory Authority of that country.

1.21 “FTE” means one full time-equivalent research and/or development employee, with qualifications in the relevant field, defined as [***]* scientific hours of effort per year. The FTE rate will be [***]* to be adjusted upward at a rate of [***]* per year every year on the anniversary of the Effective Date.

1.22 “Lead” is a Compound identified against each Allergan Named Target by Sirna pursuant to Section 3.9.

1.23 “Lead Compound” is a Lead selected by JSC pursuant to Section 3.10 for evaluation in the Field.

1.24 “Licensed Product” means a Development Compound for which the Parties obtain the approval from any Regulatory Authority to sell for use by the general public in the Field.

1.25 “JSC” means the “Joint Steering Committee” described in Section 2

1.26 [***]*

1.27 “Net Sales” means, with respect to a given period of time, gross sales in such period, less the following deductions from such gross amounts which are actually incurred, allowed or paid, and specifically relate to Licensed Products:

credits or allowances actually granted for damaged products, returns or rejections of product, price adjustments and billing errors;

governmental and other rebates (or equivalents thereof) granted to managed health care organizations, pharmacy benefit managers (or equivalents thereof), federal, state/provincial, local and other governments, their agencies and purchasers and reimbursers or to trade customers, to the extent allowed and taken;

normal and customary trade, cash and quantity discounts, allowances and credits to the extent allowed or taken;

[***]*;

transportation costs, including insurance, for outbound freight related to delivery of the product to the extent included in the gross amount invoiced and not subject to reimbursement;

*	Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


		3		CONFIDENTIAL

sales taxes, VAT taxes and other taxes directly linked to sales of Licensed Products to the extent included in the gross amount invoiced, to the extent payable by Allergan and not subject to reimbursement; and

[***]*

Sales between Allergan and its Affiliates will be excluded from the computation of Net Sales, but the subsequent final sales to third parties by such Affiliates will be included in the computation of Net Sales. No other costs, including without limitation the costs incurred in the manufacturing, selling, advertising and/or distribution of Licensed Products will be deducted in the computation of Net Sales.

If a Licensed Product is sold in the form of a combination containing i) a Licensed Product and ii) a Drug, Net Sales for such a combination product will be calculated by multiplying actual Net Sales of the combination product by the fraction A/(A+B), where “A” is the is the sales price of such Licensed Product in the combination when sold separately and “B” is the total sales price of such other biologically active component in the combination when sold separately. If the Licensed Product and the other biologically active component are not sold separately, the percentage of the total cost of the combination product attributed to cost of the Licensed Product will be multiplied times the sales price of the combination product to arrive at Net Sales.

If a Licensed Product is sold in the form of a combination containing i) a Licensed Product and ii) a Delivery System, Net Sales of the Licensed Product with respect to such a combination product will be equal to Net Sales of the combination.

1.28 “Patent Cost Reimbursement” means Patent Costs relating to the Sirna Patents licensed to Allergan hereunder, with respect to which Allergan will be obligated to reimburse Sirna as provided in Article 9.

1.29 “Patent Costs” means the fees and expenses paid to outside legal counsel and other third parties, and investigation, filing, prosecution and maintenance expenses incurred by and on behalf of a Party in connection with the filing, prosecuting, and maintaining of a patent or application.

1.30 “Pre-Development Compound” means a Lead Compound that has been selected by the JSC to advance into IND-enabling studies.

1.31 “Regulatory Authority” means an agency of any government having the authority to regulate the sale, manufacture, marketing, testing and/or pricing of drugs.

*	Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


		4		CONFIDENTIAL

1.32 “Research Plan” is that document attached hereto as Exhibit A and as amended from time to time by the JSC, as provided for in this Agreement.

1.33 “Research Team” has the meaning set forth in Section 2.2(b).

1.34 “Research Team Leader” has the meaning set forth in Section 2.2(b).

1.35 “Research Term” means [***]* from the Effective Date of this Agreement and as further set forth in Section 3.7 hereof, unless terminated sooner as set forth in the Agreement.

1.36 “RNAi” or “RNA interference” means, for the purposes of this Agreement, [***]*.

1.37 “RNAi Data” has the meaning set forth in Section 7.6.

1.38 “Scientifically and Commercially Reasonable and Diligent Efforts” means those efforts consistent with the exercise of prudent scientific and business judgment, as applied to other research, development and commercialization programs or products of similar scientific and commercial potential within the relevant product lines of Allergan and its Affiliates, or Sirna and its Affiliates, as the case may be.

1.39 “siNA” means a synthetic [***]*.

1.40 “Sirna 027” has the meaning set forth in Exhibit E.

1.41 The “Sirna 027 Clinical Development Plan” comprises the documents attached hereto as Exhibits B, C, and D .

1.42 “Sirna Know-How” means all scientific information relating to the use of the Compounds in research and development in accordance with the Research Plan or the Development Plan, including the assays used to carry out research relating to the Compounds, so far as such information is Controlled by Sirna and Sirna is not prevented by contractual obligation from licensing or disclosing such information to Allergan.

1.43 “Sirna Patents” means a) the patents and applications listed in Exhibit F; b) any application that claims priority to the foregoing patents and applications; and c) any patent that issues from any of the applications described in clauses a) and b) above.

1.44 “Target” means [***]*.

1.45 “Third Party Licensee” means a third party, not an Affiliate, to which a Party licenses its rights to sell Licensed Products.

1.46 “Tuschl License” means a certain worldwide license agreement dated September 8, 2003, entered into by and between Sirna and the University of Massachusetts Medical School for the intellectual property (patent application filed by Tuschl et al., International PCT Publication No. WO 01/75164) covering short interfering RNA (siRNA).

*	Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


		5		CONFIDENTIAL

2. S COPE AND M ANAGEMENT OF C OLLABORATION

2.1 Scope of the Collaboration .

Scope . Each Party will use Scientifically and Commercially Reasonable and Diligent Efforts to carry out its obligations as specified under Section 3.1 of this Agreement and will keep the JSC informed on the progress of the collaboration.

Sirna Obligations .

(i)

Personnel . Sirna will commit such employees and resources to the collaboration as necessary to fulfill its obligations under this Agreement.

(ii)

Sirna will take the lead in development of Leads and chemical synthesis of all Compounds (including Leads, Pre-Development Compounds, Development Compounds, Back-up Compounds, and Licensed Products). This will include preparing specific plans, performing the majority of work, acting as project leader and requesting Allergan support when needed.

(iii)

Sirna will provide Allergan with the Data and other relevant information necessary for Allergan to conduct its activities under the Agreement, subject to any limitations or reservations in other agreements.

(iv)

Sirna will provide an updated draft Research Plan as necessary (at a minimum once per year) to the JSC for approval.

Allergan Obligations .

(i)

Personnel . Allergan will commit such employees and resources as necessary to fulfill its obligations under this Agreement.

(ii)

Allergan will provide Sirna with the Data and other relevant information necessary for Sirna to conduct its activities under the Agreement, subject to any limitations or reservations in other agreements.

(iii)

Other than as set forth herein, Allergan will take the lead in all activities under this Agreement, e.g., in using a Backup Compound, Lead Compound, Pre-Development Compound, or Development Compound to bring a Licensed Product from discovery through development and into the commercial market, including regulatory submissions and commercialization strategies. This will also include preparing plans and budgets, funding all the activities, performing the majority of work, acting as project leader, and requesting Sirna’s assistance when needed.

(iv)

Allergan will provide an updated draft Research Plan and Development Plans as necessary (at a minimum once per year) to the JSC for approval.


		6		CONFIDENTIAL

2.2 Management of the Collaboration .

Joint Steering Committee .

(i)

Formation and Membership . The Parties will establish a joint steering committee (the “JSC”) no later than thirty (30) days after the Effective Date. Each Party will have at least one JSC representative with senior level decision-making authority within that Party. Each Party will be free to change its representative members at any time upon written notice to the other Party. The collaborative effort contemplated hereunder will be conducted under the overall direction of a Joint Steering Committee or JSC comprised of six (6) members. Three (3) members will be appointed by each of Allergan and Sirna.

(ii)

Chairperson . The JSC will be chaired by an Allergan representative during the first year. Sirna may name the chair during the subsequent year, and the Parties will alternate thereafter in appointing chairs to a one-year term. The chair will be responsible for overseeing meetings of the JSC and may have such other responsibilities as the JSC determines.

(iii)

Responsibilities . The JSC will be responsible for directing the collaboration, including approving, reviewing, monitoring, providing input and suggesting changes to the Research Plan and Development Plans. The responsibilities of the JSC include, as appropriate:

(1)

Monitoring all of the research and development under this Agreement. Any such research and development must be described in a plan submitted to the JSC for its consent. The JSC will monitor the progress of such research and may at any time request reports describing it with as much specificity as the JSC may determine;

(2)

Selection of Lead Compound(s) from a series of Leads;

(3)

Selection of a Pre-Development Compound(s) for IND-enabling clinical studies from one or more Lead Compounds;

(4)

Selection of a Development Compound(s) for human clinical development from one or more Pre-Development Compounds;

(5)

Determination that an Allergan Named Target is no longer suitable for further research and development under the collaboration;

(6)

Review and approval of achievement of clinical milestones; and

(7)

Alerting management of both Parties when there are significant changes in the timeframe and/or costs contained in the budget, and when target dates will not be met, what remedial actions are to be taken.


		7		CONFIDENTIAL

(iv)

Meetings . The JSC will meet in person a minimum of four (4) times a year on an approximately quarterly basis at times mutually convenient to both Parties or as otherwise required for the purposes of the collaboration. Meetings will alternate between Sirna’ and Allergan’s facilities, unless otherwise agreed by the Parties. The JSC may meet more often at such other times as agreed by the JSC, and such interim discussions may occur in person or by means of telephone or video conferences. Each Party will bear the travel, lodging and board expenses associated with attendance at JSC meetings by its JSC members, Research Team Leaders, Development Team Leaders, research team members, and development team members, as appropriate. A reasonable number of non-voting representatives of either Party with relevant experience or expertise may also attend JSC meetings as approved by the JSC chairperson.

(v)

Minutes . On an alternating basis between the Parties (beginning with Allergan), a Party’s Alliance Manager will be responsible for keeping accurate minutes of the applicable JSC meeting, including all decisions made and actions taken. Drafts of the minutes will be delivered to the other Party’s Alliance Manager within ten (10) business days after the meeting for distribution to that Party’s other JSC members. Each Party has the right to request amendments to the minutes within five (5) business days after receiving them. The Party responsible for the minutes will revise the minutes in accordance with all requested amendments and will provide revised minutes to the other Party within five (5) business days after receipt of any requested amendments. Minutes are effective when approved by both Parties.

(vi)

Decision Making. All decisions of the JSC must be unanimous. If the JSC is unable to reach unanimous consent on an issue, it will submit the issue to the Executive Vice President, Research and Development of Allergan, and the Chief Executive Officer of Sirna, who will confer in good faith to resolve the dispute; should these executives fail to agree, the decision of the Allergan executive will become the binding decision of the JSC, provided, that no such decision may impose on Sirna any obligation or liability inconsistent with this Agreement, Research Plan, and/or Development Plan, in effect as of the Effective Date, without Sirna’s consent.

(vii)

Limitation of Powers . The JSC has only those powers that are specifically delegated to it herein, including the powers to amend the plans attached to this Agreement as Exhibits A-D, but does not have the power to amend this Agreement.

Research Team .

(i)

Research Team . The Parties will assign appropriate personnel to carry out their scientific obligations under this Agreement (collectively known as the


		8		CONFIDENTIAL

“Research Team”) in accordance with the Research Plan. Each Party will assign one individual to be the Research Team Leader for that Party.

(ii)

Responsibilities . The Research Team shall be responsible, with oversight and approval by the JSC, for formulating and executing the specific details of the research in accordance with the deadlines and deliverables in the Research Plan. The Research Team will also be responsible for drafting any updates or modifications to the Research Plan as appropriate and submit it to the JSC for approval.

(iii)

The representatives of each of the Research Teams may meet as deemed appropriate and necessary by the respective Research Team Leader to discuss the activities, under the Research Plan.

Development Team .

(i)

Development Team . The Parties will assign appropriate personnel to carry out their scientific obligations under this Agreement (collectively known as the “Development Team”) in accordance with the Development Plan. Each Party will assign one individual to be the Development Team Leader for that Party.

(ii)

Responsibilities . The Development Team will be responsible, with oversight and approval by the JSC, for formulating and executing the specific details of development in accordance with the deadlines and deliverables in the Development Plan. The Development Team will also be responsible for drafting any updates or modifications to the Development Plan as appropriate and submit it to the JSC for approval.

(iii)

The representatives of each of the Development Teams may meet as deemed appropriate and necessary by the respective Development Team Leader to discuss the activities, under the Development Plan.

Alliance Management .

(i)

Alliance Management . Each Party will assign an Alliance Manager who will manage the relationship between the Parties to achieve the overall goals of the collaboration. The Alliance Managers, who may be a member of the JSC, will be invited to attend all the JSC, Research Team and Development Team meetings.

(ii)

Responsibilities . The Alliance Managers will be responsible for senior level program and project management oversight and leadership as well as relationship management of the collaboration including, but not limited to: developing a set of operating guidelines for alliance management of the collaboration; coordinating the development and communication of the Research Plan and Development Plan; identifying and managing any changes to the Research Plan and Development Plan; managing the


		9		CONFIDENTIAL

collaboration across all projects; determining roles and responsibilities for team members on specific projects within the collaboration; overseeing project timelines and deliverables; tracking and reporting program status, progress, changes and issues to the JSC; coordinating Research Team and Development Team meetings, milestone meetings and JSC meetings; and tracking, analyzing and reporting project results to demonstrate value and impact on the collaboration.

3. C ONDUCT OF R ESEARCH AND D EVELOPMENT

3.1 The Parties will conduct the research and development described in the Research Plan and Development Plan, including the Sirna-027 Clinical Development Plan, and as set forth in this Section 3 below. The JSC may at any time amend in writing a plan, provided, that no such amendment may impose on Sirna any obligation or liability except as specifically set forth in this Agreement, Research Plan, and/or Development Plan, in effect as of the Effective Date, without Sirna’s consent. Allergan and Sirna will each use Scientifically Reasonable and Diligent Efforts to research, develop and commercialize Licensed Products in the Field, in the manner set forth (or to be set forth) in the Research Plan and/or Development Plan, subject to the provisions of Sections 3.6 and 3.13.

As to Sirna 027

3.2 Sirna will complete [***]* all phase I clinical trials of Sirna 027, as described in the Sirna-027 Clinical Development Plan.

3.3 Sirna will manufacture and supply Sirna 027 to Allergan in the quantities and having the characteristics specified by the Sirna-027 Clinical Development Plan, for which Allergan will pay to Sirna [***]*.

3.4 As of the Effective Date, Sirna 027 will be a Development Compound.

3.5 Allergan agrees to advance Sirna 027 into Phase II clinical trials for age-related macular degeneration (“AMD”) as set forth under the Sirna 027 Clinical Development Plan within [***]* of the Effective Date, [***]*. Allergan will be responsible for all costs associated with such clinical trials, and any additional clinical trials and commercialization efforts that the JSC decides to undertake. In support of such trials, Sirna will complete a pre-clinical toxicology program, [***]*.

3.6 In the event that [***]*

the Parties will negotiate in good faith regarding the possibility of [***]* on terms to be mutually agreed upon; and

if after [***]* months the Parties are unable to agree upon the terms of [***]*, then all rights to Sirna 027 and the associated data and results will automatically

*	Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


		10		CONFIDENTIAL

revert to Sirna without any further obligation to Allergan, and Allergan will cease to have any rights to Sirna 027.

[***] *.

As to Other Compounds

3.7 For a period of [***]* after the Effective Date, Allergan will have the right to designate up to a total of [***]* Targets [***]* in Year 1 and [***]* over [***]*, with no more than [***]* in any one of those years), solely for use in the Field, by giving notice to the JSC of its selection. The JSC will then notify Sirna of the identity of the Targets designated by Allergan. Allergan will be required to name the first [***]* within [***]* of the Effective Date of this Agreement. Allergan will be required to name the next [***]* within [***]* from the Effective Date of this Agreement. For the purposes of this Agreement a [***]* targeting [***]* will constitute one Target. As to other [***]*, Allergan has the option of i) counting it as [***]*; or ii) counting it as [***]* on the condition that the provisions of Section 3.9(f) will apply.

3.8 Allergan will not have the right to designate any Targets beyond the [***]* from the Effective Date. For a period of [***]* after the Effective Date, Allergan may at any time [***]* Target [***]*, provided that Sirna [***]* against the Allergan Named Target [***]*.

3.9 For a period of [***]* after the Effective Date:

Sirna will develop, according to the Research Plan, Leads directed against each of the Allergan Named Targets designated pursuant to Section 3.7. Sirna will promptly notify the JSC upon the identification of Leads against an Allergan Named Target. Sirna will perform [***]* all in vitro research described in the Research Plan relating to the identification and evaluation of Leads, and will provide to Allergan Data and methodologies sufficient to reproduce such research internally.

On the approval of the JSC [***]*, Sirna will design, manufacture, and supply to Allergan Lead Compounds, in the quantities and having the characteristics specified by the Research Plan, for which Allergan will pay to Sirna [***]*.

On the approval of the JSC [***]*, Sirna will develop analytical methods for Lead Compounds to support the evaluation of Lead Compounds in the in vivo test systems, for which Allergan will pay to Sirna [***]* to compensate Sirna for such work.

On the approval of the JSC [***]*, Sirna will develop process and analytical development methods to support IND filing and GMP synthesis, stability studies, and API, for which Allergan will pay to Sirna [***]* to compensate Sirna for such work.