Families of Spinal Muscular Atrophy Licenses Potential Treatment for SMA to Repligen Corporation.

Biotech Week November 4, 2009 Families of Spinal Muscular Atrophy (FSMA) announced that it has entered into a groundbreaking exclusive license agreement with Repligen Corporation for the development of a potential treatment of Spinal Muscular Atrophy (SMA) (see also Spinal Muscular Atrophy).

SMA, the leading genetic killer of children under the age of two, is typically marked by the degeneration of muscle movement including the muscles that control crawling, walking, swallowing or breathing. There are no approved therapies for the treatment of SMA, which affects one in every 6,000 babies. One in every 40 people carries the gene that causes SMA, indicating approximately 7.5 million carriers in the United States.

Families of SMA was started by a small group of parents in 1984 who wanted to raise funds for SMA research and support all affected families. FSMA has funded $50 million for SMA research, raised from individual donations and through fundraising events held by volunteer families and Chapters.

FSMA made investments of $13 million during the last decade to bring this specific program to the cusp of clinical development. Through FSMA’s leadership, the research has resulted in a drug candidate that treats the underlying cause of SMA. In preclinical studies, the drug has been shown to efficiently cross the blood brain barrier – a critical feature for a neurological drug – and prolong survival significantly in two different mouse models of SMA. go to web site spinal muscular atrophy

Often an “Orphan Disease,” such as SMA, will not be “adopted” by the pharmaceutical industry because there is limited financial incentive to make new medications to treat smaller patient populations. This license agreement marks a significant milestone for the SMA community by securing the commitment of an industrial partner to develop potential treatments through the highly expensive human clinical trial phases. here spinal muscular atrophy

“At this point in the program, joining forces with a corporate partner to advance into clinical studies is the best way to meet our objective of accelerating drug development for SMA,” said Kenneth Hobby, President of Families of SMA. “Repligen is an ideal partner for this program with the necessary resources and expertise to invest in and focus on successfully developing this new treatment for SMA. We are very excited to partner with Repligen and look forward to making our combined efforts successful in delivering an effective treatment to our patients.” “Families of SMA has made remarkable progress in defining a series of highly potent compounds which may be clinical candidates for SMA,” stated Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation. “We look forward to working with FSMA and their collaborators in the development of what we hope will be an important new treatment for SMA.” Through the agreement with Repligen, Families of SMA has the potential to recover its investments through a series of milestone payments if the program successfully progresses through clinical stages and eventually reaches market approval.

GREAT LAKES WEEK EVENTS SCHEDULED FOR DETROIT, OCT. 11-14.

States News Service October 3, 2011 Chicago — The following information was released by the U.S. Environmental Protection Agency:

The U.S. Environmental Protection Agency and Great Lakes Week sponsors have organized a week of activities focused on highlighting Great Lakes protection and restoration, identifying emerging issues, and charting a path forward for further progress. Gathering the annual meetings and conferences of various organizations in one place, makes this one of the most wide-ranging Great Lakes summits in history.

The following meetings and events are scheduled, locations are provided:

October 11 Great Lakes Commission Press Conference (Book Cadillac).

Great Lakes Commission Annual Meeting (Book Cadillac).

International Joint Commission – Science Advisory Board Lake Erie Public Meeting (Wayne State University).

October 12 Great Lakes Commission Annual Meeting (Book Cadillac).

International Joint Commission – Special Workshop: “Progress Since 1987″ (Wayne State University).

GLRI Task Force Meeting (Closed Press – Wayne State University).

Announcements will follow during the Joint Session.

Great Lakes Week Joint Press Conference (Wayne State University).

12:15 p.m., Conference Room E, McGregor Conference Center.

Great Lakes Week Joint Session (Wayne State University) – Open to Public.

Media check in at 12:50 p.m.

Keynote presentations and video:

Cameron Davis, Senior Advisor to the EPA Administrator for the Great Lakes. go to site detroit institute of art

Lisa P. Jackson, EPA Administrator and Great Lakes Interagency Task Force Chair.

FrankyEttawageshik, Executive Director, United Tribes of Michigan.

Matthew Cullen, COO of Rock Enterprises.

Binational Report and Public Forum with senior officials from EPA and Environment Canada Susan Hedman, EPA Regional Administrator and Great Lakes National Program Manager Michael Goffin, Great Lakes Regional Director, Environment Canada.

IJC Special Presentation to the Joint Session.

Great Lakes Week Panel and Town Hall.

Cameron Davis, Senior Advisor to the EPA Administrator for the Great Lakes.

Michael Goffin, Great Lakes Regional Director, Environment Canada.

Lana Pollack, U.S. Section Chair, International Joint Commission.

Pierre Trepanier, Commissioner, Canadian Section, International Joint Commission.

Dr. Carol Miller, Wayne State University (Moderator).

Prof. Marcia Valiente, University of Windsor (Moderator).

Great Lakes Week Welcome Reception hosted by the Healing Our Waters – Great Lakes Coalition (Detroit Institute of Art) – Separate registration for reception required. go to web site detroit institute of art

October 13 International Joint Commission Biennial Meeting (Wayne State University).

7th Annual Healing Our Waters – Great Lakes Coalition Conference (Book Cadillac).

U.S. Areas of Concern Program Annual Meeting (Book Cadillac).

Keynote: Rachel Jacobson, Acting Assistant Secretary for Fish and Wildlife and Parks, Department of the Interior.

Former Vice President Al Gore’s Special Presentation to the International Joint Commission Biennial Meeting (Wayne State University).

Outside recording not allowed, live feed will be available online.

Healing Our Waters Poster Happy Hour and Great Laker Awards (Book Cadillac).

International Joint Commission walking tour of the Detroit River (Leaves from Wayne State University).

Boat tour aboard the Detroit Princess (Leaves from the Detroit Riverfront at 7 p.m. sharp) – Separate registration required.

October 14 International Joint Commission Biennial Meeting (Wayne State University).

7th Annual Healing Our Waters – Great Lakes Coalition Conference (Book Cadillac).

Messages from Members of Congress and the U.S. Senate.

U.S. Areas of Concern Program Annual Meeting (Book Cadillac).

The addresses of the locations for the events and meetings are:

Wayne State University Community Arts Auditorium/McGregor Memorial Conference, 495 W. Ferry.

Westin Book Cadillac Hotel, 1114 Washington Blvd.

Detroit Institute of Art, 5200 Woodward Ave.

Detroit Princess, 201 Civic Center Drive.

Clean Bills of Lading for Damaged Cargo: Is it Legal?(Legislation)

Mondaq Business Briefing December 14, 2010 | Walker, Graham Edited by Graham Walker A clean bill of lading is one that does not contain any annotations (i.e. no “clausing” or remarks) regarding the condition of the cargo to which it relates.

If it is apparent to a master that cargo is damaged or in a condition that does not truly reflect its description on the bill of lading, the master may insert qualifying words noting that the cargo is in some way damaged or defective or deficient. In these circumstances, the bill of lading is described as a “claused”, “foul” or “dirty” bill of lading. billofladingnow.net bill of lading

Legally, a master is justified in refusing to sign the bill of lading in circumstances where the shipper/charterer has presented the master with a bill of lading that does not accurately describe the cargo, even where the charter party requires the master to sign bills of lading “as presented”.

Sometimes, however, charterers or shippers attempt to negotiate the wording that the master wishes to insert on the bill of lading, so as to cast less doubt on the integrity of the cargo, or even to remove the qualifying words altogether. As long as the final wording accurately describes the cargo, this is an acceptable practice.

Professor Tetley describes a letter of indemnity as a written undertaking by a shipper to indemnify a carrier for any responsibility that the carrier may incur for having issued a clean bill of lading when, in actual fact, there is a dispute as to the condition of the cargo received on board the carrying vessel.

This practice is designed to set up an “indemnity regime” in favour of the carrier should an innocent third party holder of the bill of lading (e.g. a consignee, endorsee or a financial institution) institute a claim against the carrier as a result of the cargo being received in a damaged condition, despite a clean bill of lading.

The injured third party, having relied upon the alleged good order and condition of the cargo at the time of loading, as evidenced by the clean bill of lading, has often already paid for the cargo only to receive damaged goods.

As explained below, the practice of issuing letters of indemnity in these circumstances can be fraught with risk. In many cases, Canadian courts will refuse to enforce such letters of indemnity, leaving the master and ship-owners with little to secure their claim against such shippers.

Courts have often held that such letters of indemnity are tantamount to an agreement to defraud a third party. For example, as early as 1928 in United Baltic Corporation Ltd v. Dundee, Perth & London Shipping Company Ltd, Mr. Justice Wright stated that: in our site bill of lading

“The practice of issuing clean bills of lading when goods are damaged is very reprehensible. It leads to trouble, and the people who do it ought to suffer trouble”.

Over time, however, the practice of carriers accepting letters of indemnity from shippers has developed as a commercial way of resolving a dispute at the port of loading as to whether the cargo received for shipment is in fact damaged. This, of course, is often a subjective opinion that necessitates an understanding of the nature of the cargo and its intended use by the receiver.

According to Professor Tetley, the letter of indemnity given by the shipper to the carrier in exchange for the clean bill of lading has been held to be unlawful, and therefore been treated as unenforceable by some courts.

As Morris L.J. stated in in Brown Jenkinson & Co. Ltd v. Percy Dalton (London) Ltd.:

“On the facts as found, and, indeed, on the facts which are not in dispute, the position was, therefore, that at the request of the defendants the plaintiffs made a representation which they knew to be false and which they intended should be relied on by persons who received the bill of lading, including any banker who might be concerned. In these circumstances, all the elements of the tort of deceit were present. Someone who could prove that he suffered damage by relying on the representation could sue for damages. I feel impelled to the conclusion that a promise to indemnify the plaintiffs against any loss resulting to them from making the representation is unenforceable. The claim cannot be put forward without basing it on an unlawful transaction. The promise on which the plaintiffs rely is, in effect, this: “if you will make a false representation which you will deceive endorsees or bankers, we will indemnify you against any loss that may result to you”. I cannot think that a court should lend its aid to enforce such a bargain”.

As the practice of the issuance of letters of indemnity develops, Canadian courts will have to decide whether, as a matter of public policy, they must refuse to enforce letters of indemnity given in exchange for the issuance of clean bills of lading.

Policy considerations abound. On one hand, it is a well-established rule that the condition of the goods must correspond to the description contained in the bill of lading when issued. The opposite may subject vulnerable and innocent third parties to what some call the illegal and deceitful agreement entered into between the shipper and the carrier. Moreover, the practice of signing clean bills of lading for defective cargo may also void insurance coverage provided by Protection and Indemnity clubs “P & I clubs”.

On the other hand, given the often subjective nature of the debate that sometimes arises over whether particular cargo is damaged, it is arguable that letters of indemnity are the most efficient way to deal with such disagreements, rather than clausing of bills of lading and denying the shipper the opportunity, in most cases, to draw down payment from letters of credit. Given these considerations it remains to be seen whether and to what extent Canadian courts will enforce letters of indemnity provided in exchange for clean bills of lading in cases involving allegedly damaged cargo, in the future.

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